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This review compares contemporary with traditional medicine and indigenous pharmacopoeias. A new approach for an indigenous pharmacopoeia is explored. Kaitiakitanga and conservation of medicinal plants, as well as sustaining and strengthening rongoā Māori and improving health outcomes through developing Te Tauihu Pharmacopoeia is an aspiration. Valuing medicinal plants as taonga and acknowledging traditional understanding along with guiding tikanga, including respect, humility, honesty, transparency and permission from knowledge holders, are prerequisites for such an initiative. Pharmacopoeias have traditionally described the making of healing medicines. Hundreds of these have been compiled, some dating back prior to 1,000 AD, notably the Chinese Pharmacopoeia in 250 AD. Despite a drive for standardisation, there are different styles including regional and indigenous pharmacopoeias, arising from different rationales for their development. In Aotearoa-New Zealand there are no current pharmacopoeias; historical and recent laws and policies have either impeded or fallen short of the commitment made by other countries to traditional medicines. Reversing the erosion of traditional knowledge resulting from colonisation is an important driver for written versions of indigenous verbal pharmacopoeias, but a new pharmacopoeia based on verbal traditions, historical information, and mātauranga Māori cannot be pursued lightly, and should be led by indigenous knowledge holders. [ABSTRACT FROM AUTHOR]

INTRODUCTION. Antibiotic active substances have a distinct class of organic impurities other than related substances or organic solvents, namely, process-related impurities, such as N,N-dimethylaniline and 2-ethylhexanoic acid and its derivatives. These compounds are used as reagents in the production process, and national and international pharmacopoeias require that their residual levels should be controlled.AIM. This study aimed to justify the requirements for the control of process-related impurities in antibiotic active substances.MATERIALS AND METHODS. The study analysed general chapters and individual monographs on antibiotic active substances of the State Pharmacopoeia of the Russian Federation and international pharmacopoeias, including the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopeia (USP), and The International Pharmacopoeia (Ph. Int.). The study also analysed registration dossiers for local and imported antibiotic active substances listed in the Russian State Register of Medicines. The study used comparative and content analysis methods.RESULTS. The Ph. Eur. requires that 2-ethylhexanoic acid should be controlled in antibiotic active substances, such as semisynthetic and fermentation-derived antibiotics. In contrast, the USP does not include this quality attribute in individual monographs. The Ph. Eur. and USP individual monographs on semisynthetic antibiotics require manufacturers to control residual levels of N,N-dimethylaniline. This is probably due to the high toxicity of N,N-dimethylaniline. The relevant requirements of the State Pharmacopoeia of the Russian Federation are harmonised with those of the Ph. Eur. According to the analysis of registration dossiers, manufacturers replace 2-ethylhexanoic acid and N,N-dimethylaniline with less toxic reagents and, if necessary, control the residual levels of these alternative reagents in accordance with the general requirements for residual organic solvents.CONCLUSIONS. Current technological processes can produce antibiotic active substances without the use of 2-ethylhexanoic acid and N,N-dimethylaniline. Therefore, the concept of process-related impurity control in active substances should be based on risk assessment. Furthermore, the relevant general chapters should require testing for 2-ethylhexanoic acid and N,N-dimethylaniline only if these compounds are used in the production process.

INTRODUCTION. Raw materials of biological origin can contaminate medicines with depressor substances, such as histamine, acetylcholine, bradykinin, serotonin, and prostaglandins. In the Russian Federation, tests for the content of these impurities are conducted in anaesthetised healthy cats in accordance with the General Chapter Test for depressor substances of the State Pharmacopoeia of the Russian Federation. The global trend towards ending animal testing and the search for ways to eliminate animal tests for depressor substances motivate researchers to study international approaches to the determination of histamine-like substances.AIM. This study aimed to analyse Russian and international approaches to the control of biologicals for depressor substances and to consider the applicability of alternative instrument-based physicochemical methods for the determination of histamine-like impurities, with a view to reducing animal testing.DISCUSSION. The rationale for reducing the use of animals as test systems is set forth in Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. In 2023, the European Pharmacopoeia Commission initiated the removal of in vivo tests for histamine-like substances from the European Pharmacopoeia. However, China and India use animal testing as the basic method for assessing the safety of medicines. In the Russian Federation, the control of depressor substances is regulated under General Chapter 1.2.4.0008.18 of the State Pharmacopoeia of the Russian Federation. Since the publication of General Chapter 42-0063-07 Test for histamine in edition XII in 2007, the State Pharmacopoeia of the Russian Federation has included a compendial text providing for a reduction in the number of cats used for testing. At present, Russian scientists are searching for targeted physicochemical and immunochemical methods for the determination of depressor substances. It has been demonstrated that a reasonable approach is to assess the need for testing a particular medicinal product in animals on a case-by-case basis. This approach will help minimise the number of in vivo tests and maintain an adequate quality of medicines at the same time.CONCLUSIONS. Despite the global trend towards ending animal testing, it is still necessary and required to control medicines for the content of depressor substances. Nevertheless, there is no global consensus on the need to use animals for this purpose. The absence of a separate general chapter/monograph, or references to it, will not change the fact that histamine-like substances are controlled worldwide. The decision to exclude in vivo methods from the European Pharmacopoeia necessitates the search for alternative test methods and the implementation of additional manufacturing controls to minimise the contamination risk for finished medicinal products. Studies have shown that high-performance liquid chromatography can determine the content of histamine in a limited amount of a medicinal product.

INTRODUCTION. Regular reviews of the current portfolio of general chapters and monographs are essential to ensure the well-balanced development of the State Pharmacopoeia of the Russian Federation (Ph. Rus.) in line with the priorities of the national healthcare system.AIM. This study aimed to identify the most promising areas for further Ph. Rus. development through an analysis of recent legislative changes in Russia and the current compendial portfolio.DISCUSSION. This article compares Ph. Rus. editions XIV and XV, analyses the key features and structure of edition XV, and reviews amendments to the regulations governing the Ph. Rus. publication. The current compendial portfolio is dominated by monographs on chemical active substances; it also includes a substantial number of monographs on herbal drugs and herbal drug preparations. Noteworthy, edition XV is the first Ph. Rus. edition to include a separate section dedicated to monographs on excipients necessary for the development of pharmacy compounding. Moreover, this article analyses the coverage of active substances that are used for the production of listed vital and essential medicines.CONCLUSIONS. The authors outlined the priority areas for the development of quality standardisation. The Ph. Rus. should continue developing monographs on active substances that are used for the manufacturing and compounding of listed vital and essential medicines. In addition, the coverage of herbal drugs should be expanded. The Ph. Rus. should develop monographs on excipients that are used for the manufacturing and compounding of medicinal products. Finally, the Ph. Rus. should complete the development of requirements for biological medicinal products and relevant test methods.

Glycopyrrolate is a competitive muscarinic receptor antagonist used in the treatment of sialorrhea, especially in pediatrics. Degradation research was conducted to better understand the stability of the active pharmaceutical ingredient (API). Using an HPLC-UV method, we evaluated the chemical stability of the oral solution of the galenic compound glycopyrrolate 0.5 mg/mL under different storage conditions. Method validation was performed according to the International Council for Harmonization (ICH) Q2(R2) guidelines. The results of the stability study of the galenic compound in different storage conditions, with the exception of those stored in glass containers at 45 °C for more than 3 months, were stable (100 ± 10% of the nominal concentration). The aim of this work was to study the stability of the galenic compound glycopyrrolate in two different types of containers and at three different storage temperatures. Glycopyrrolate showed degradation beyond the limits only in glass at 45 °C and after 2 months of storage. The results indicate that oral liquid dosage forms of glycopyrrolate are stable for at least 210 days when stored at room temperature or at 4 °C, in glass or PET, for at least 7 months, maintaining product quality according to the standards established by the European Pharmacopoeia, ensuring long-term coverage for pediatric patient therapies. [ABSTRACT FROM AUTHOR]

Medicinal plants, due to their potential therapeutic properties, have been employed in the national healthcare systems of various countries, including Vietnam. In Vietnam, at least 1,863 plant species have been officially used. However, limited information is reported on the standardizations of these plant extracts in the most up-to-date Vietnamese Pharmacopoeia 5.0, which only covers 19 monographs of plant extracts. Thus, this work presents the standardization of the ethanolic extract of the crab claw ["Càng cua" in Vietnamese] Peperomia pellucida (L.) Kunth, Piperaceae family, a wild-growing short-day vegetable plant commonly found in the South of Vietnam. The research described all the required characteristics of the Peperomia pellucida extract, their experimental processes, and the proposed acceptable criteria. These parameters included appearances, identification (apiol, thin layer chromatography, Rf = 0.214), loss on drying (6.38 ± 0.04%), total ash (23.9 ± 0.5%), heavy metals (≤ 20 ppm), microbial limits, and assay (total phenolic content of 677.97 ± 0.17 µg gallic acid equivalent/g powder). The complete standard data could be considered to be incorporated into the Vietnamese Pharmacopoeia in the future. [ABSTRACT FROM AUTHOR]

INTRODUCTION. The lack of a unified approach to establishing generic (grouping) names, which must be specified for herbal medicinal products, presents a challenge to developers and manufacturers preparing registration dossiers, as well as to regulators reviewing their submissions.AIM. This study aimed to set forth common approaches to establishing generic names for herbal medicinal products based on studying the terminology used in different legal systems.DISCUSSION. The authors analysed the pharmaceutical terminology used for herbal medicinal products at national and supranational levels in the Russian Federation, the Eurasian Economic Union (EAEU), the Republic of Belarus, the European Union (EU), the United Kingdom, and the United States. This analysis revealed differences in the terminology used in the Russian Federation and the EAEU. For example, the definition of “herbal drugs” is more detailed in the EAEU documents than in the Russian documents, and the definitions of “herbal drug preparation” and “herbal medicinal product” are not the same as well. The authors analysed the approaches to generic naming of herbal medicinal products and detected some improperly formed generic names in the regulatory documentation and Russian State Register of Medicinal Products. In addition, the study revealed variability in generic names proposed by different manufacturers for medicinal products having the same trade name. The authors described the selection of generic names for herbal medicinal products, including fatty or essential oils and liquid or dry extracts. The authors touched upon generic naming of some types of source plants when the morphological group of the herbal drug or the name of the source plant is ambiguous, the Latin name and the Russian name of the herbal drug are inconsistent, or the Latin name of the resulting product or the morphological group of the herbal drug is erroneous. The authors systematised and unified approaches to generic naming of herbal medicinal products with due regard to the species of source plants, the morphological groups of herbal drugs, and the production technology and composition of herbal medicinal products. The authors analysed typical errors in establishing conventional and generic names for herbal drugs and herbal medicinal products associated with incorrectly identified morphological groups of herbal drugs, incorrect source plant names, mismatching structures of Latin and Russian names of herbal drugs, erroneous Latin names of the resulting products, or wrongly assigned morphological groups of herbal drugs.CONCLUSIONS. According to the analysis of the names of herbal drugs, herbal drug preparations, and herbal medicinal products used in the State Pharmacopoeia of the Russian Federation (editions XI–XV), the Pharmacopoeia of the EAEU, and the European Pharmacopoeia, the terminology of these legal systems is harmonised to a high degree. The alignment of terminology is the closest between the regulatory documents of the EAEU and the EU. The terms and names used in Russia need further unification. The results of this study can be used in Russian pharmacopoeial practice to develop regulatory documents, prepare registration dossiers, and conduct expert reviews of submissions for herbal medicinal products.

Medicinal plants have active elements that can be used for cures or making drug precursors. According to the World Health Organization, 80% of the world's population depends on these plants as traditional treatments to meet their health care needs. Illicium verum Hook. F. (star anise) is an extensively used spice in traditional Chinese cuisine as a flavoring agent or a historical medicine for vomiting, stomachache, flatulence, and rheumatism and is included in the Chinese Pharmacopoeia. Some active components of star anise are essential oil, anethole, trans-anethole, sesquiterpenoids, shikimic acid, lignans, etc., which possess anxiolytic, neuro-protective, antibacterial, antifungal, anti-inflammatory, antiemetic, anti-flu, antidiarrheal, antispasmodic, anti-diabetic, antioxidant, anti-thrombotic, and anti-tumour effects that are discussed in this review article.

Foot fungus (Candida, molds, dermatophytes) is a fairly common problem. According to the WHO, one-fifth of the world’s population is affected by fungal skin diseases. The prevalence of mycosis of the feet, which affects every second person, is especially increasing. Such a pathology can appear quite unexpectedly and at an inappropriate time. Today, Ukraine is under aggressive pressure from its northern neighbor, and military personnel are not only constantly at risk of receiving combat injuries and wounds, but also due to active hostilities, they may not have access to the necessary hygiene products, get cold, overheat in the sun, or not have time to change their clothes in time. and shoes. The reality is the absence or delay of treatment; the disease progresses and can spread quickly. If mycosis has appeared in one soldier, it can quickly affect others. Therefore, the problem of providing medical and pharmaceutical care is an urgent issue today. Expanding the assortment of drugs with the above action will ensure the needs of the Armed Forces and civilian patients with this dermatological pathology. It will be able to optimize antifungal therapy regimens. For quite a long time, 1,2,4-triazole derivatives have been a promising class of organic compounds that attract the attention of scientists from various fields. It has been proven that 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol has high antifungal activity. A potential medicinal product based on this medicinal substance can be used for the treatment of various dermatological diseases. To continue the creation of new effective dosage forms for the effective therapy of mycosis of the feet, the urgent task of today is the development of an express, accurate, reliable, and affordable method of quantitative determination of the substance under study. The aim of the work is to develop an express, sensitive and easy-to-implement UV-method for the quantitative determination of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol. Materials and methods. The research object is a working standard sample of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol provided by NUNVF, LLC “Brovapharma” according to the “Research and production technological regulations for the production of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazol-4-yl)imino)methyl)phenol” developed based on scientific developed by the Ukrainian Military Medical Academy in conjunction with the National Military Medical Clinical Center “Main Military Clinical Hospital” (term of validity of the regulations until 12/31/2034). Isopropanol of grade “chemically pure” was used as a solvent. Analytical equipment: spectrophotometer Specord 200, electronic scales Radwag XA 210.4Y, class A measuring vessels. Results. An express, eco-friendly spectrophotometric method was developed for the quantification of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol in isopropanol area, having analytically maximum at 310 nm. The studied solutions are stable for 30 minutes. The analytical technique is linear in the range of concentrations 0.440–0.754 mg/100 ml (70–130 %). The detection and quantification limits were 5.80 % and 15.70 % respectively. The score was 0.76, according to the “greenness” icon of the analytical technique, using the tools AGREE. The prediction of the total uncertainty of the results of the developed method is 1.70 % (max∆As 2.00 %). The proposed method is relevant according to the requirements of the State Pharmacopoeia of Ukraine. Conclusions. Pharmaceutical development, introduction into industrial production and further prescribing by dermatovenerologists of an effective, safe, and harmless medicinal product will help to expand the range and reduce the level of high import dependence of the domestic market of medicinal products, which will create a more complete and balanced system of medicinal supply in Ukraine and optimize antifungal therapy schemes.

Pharmacopoeias are important resources for the quality control of medicinal plants and their products. Considering that approximately 80% of the world population to different extents relies on medicinal plants for the prevention and treatment of medical ailments the safety and suitability of medicinal plants is extremely important. Unfortunately, for many medicinal plants the active component or group of components responsible for their pharmacological activity are unknown. In such cases, the standardization of the medicinal plant material is performed using reference compounds that are either contained in the plant, but are known to not mediate the plants biological activity or are not contained in the plant at all, but find use as auxiliary reagents, for example, to help identify the necessary chromatographic zones/peaks. Additionally, many medicinal plants do not have qualitative or quantitative analysis procedures in place or use methods with low selectivity (spectrophotometry, colour reactions). In these cases, it is impossible to confidently and adequately standardize the medicinal plant material. Two other issues that complicate medicinal plant standardization include the variability of its chemical composition depending on multiple biotic and abiotic factors and the lack of sufficient data on the chemical composition of some plants. In this review, we analyzed medicinal plants common to the Eurasian Economic Union (EAEU), European, United State and Japanese Pharmacopoeias. We have analysed and systematized literature data devoted to the relation between the chemical composition and pharmacological activity of the plants presented in this review. Based on the analysed data, we have suggested more rational and adequate methods for the quality assessment and quantitative standardization of medicinal plants. [ABSTRACT FROM AUTHOR]

Scientific relevance. The gradual transition to the common pharmaceutical market within the Eurasian Economic Union (EAEU) is expected to be completed by the end of 2025, and a new regulatory framework is currently being developed at both the national and supranational levels. The main changes in Russian national legislation are aimed to harmonise it with EAEU legislation. However, Russian national legislation will continue regulating a range of issues related to the life cycle of medicines.Aim. This study aimed to compare the Russian and EAEU legal frameworks regulating medicines before and after January 2026, as well as to analyse the risks of conflicts of laws between these legal systems.Discussion. Analysing the causes of potential conflicts of laws between Russian and EAEU legislation, the authors consider solutions for such conflicts outlined in the legal system of the Russian Federation, as well as the applicability of these solutions to specific situations in the national and supranational regulation of medicines. This study analyses the stages in the life cycle of medicines associated with the highest risk of conflicts of laws, including clinical trials, the development of pharmacopoeial requirements, and the designation of orphan medicines. The authors examine the relationships between authorisation procedures during the transition period with both legal systems in effect. The analysis highlights the issues that will continue to be regulated under Russian national legislation after the completion of the transition period, such as the inclusion of active substances in the Russian State Register of Medicines, the authorisation of medicines during armed conflicts or other emergencies, and the interchangeability of medicines. Given the evolving requirements of the regulatory environment, this study provides suggestions for enhancing the regulatory framework and recommendations for applicants.Conclusions. After the complete transition to the common market in the EAEU, certain requirements of Russian Federal Law No. 61-FZ “On Circulation of Medicines” of 12 April 2010 will remain effective in the Russian Federation. Therefore, during the transition period, applicants for authorisation should consider the partial continuation of national regulation after 2026 when developing their regulatory affairs strategies.

Scientific relevance. Cardiac glycosides have been used in medicine for over two centuries. Current studies suggest that biologically active substances from this group can be used to treat not only heart conditions but also viral infections, cancers, and other diseases. Therefore, quality control methods for cardiac glycosides are becoming increasingly relevant.Aim. Based on a review of Russian and international quality standards, as well as up-to-date scientific data, this study aimed to identify promising methods for the identification and quantification of cardiac glycosides in herbal drugs and herbal medicinal products, as well as to evaluate the possibility of substituting physicochemical methods for biological methods.Discussion. The methods that are currently used to standardise cardiac glycosides are either not selective or require laboratory animals (biological test systems). According to a study of pharmacopoeial methods for the identification of cardiac glycosides in herbal drugs and herbal medicinal products, chemical identification tests and thin-layer chromatography continue to be relevant. Quantitative testing of herbal drugs and extracts uses biological and non-selective (spectrophotometry) methods, whereas chromatography is described only in general and individual monographs for herbal drug preparations containing individual cardiac glycosides and medicinal products containing these preparations. Upon analysing quality standards and scientific publications, the authors identified potentially promising methods for the quantification of cardiac glycosides in herbal drugs, herbal drug preparations, and herbal medicinal products, namely chromatographic methods.Conclusions. Reverse-phase high-performance liquid cjromatography (HPLC) with spectrophotometric detection is the most suitable method for pharmacopoeial analysis. The development of an HPLC-based analytical procedure to determine the cardiac glycoside content will provide an opportunity to advance from biological or non-selective methods to more ethical and selective up-to-date techniques.

Paracetamol is a widely used over-the-counter drug for managing fever and pain, but its quality may vary among different brands, especially in low- and middle-income countries, where counterfeit and substandard medicines are prevalent. This study evaluated the physicochemical properties of fifteen brands of 500 mg paracetamol tablets sold in various pharmacies in Freetown, Sierra Leone using identification tests, friability tests, assay, dissolution tests, and mass variation.The results showed that three brands were not registered with the Pharmacy Board of Sierra Leone, and two brands did not meet the requirement for labelling (no manufacturing date). All the brands met the requirement for mass variation, friability tests and assays. The percentage assay of the different brands ranged from 96.17 %w/w to 101.97 %w/w. However, two brands did not meet the specification for dissolution, with P012 releasing about 21.23 % ± 5.76 of the drug within 45min.Most of the paracetamol brands evaluated met the physicochemical test specification. However, two brands failed the dissolution test, two brands did not meet the labelling requirement and three brands were identified as unregistered products with the National Medicines Regulatory Authority in Sierra Leone. This study underscores the necessity of enhancing monitoring and post-market surveillance of pharmaceuticals in Sierra Leone to ensure they comply with regulatory requirements.

Foot fungus (Candida, molds, dermatophytes) is a fairly common problem. According to the WHO, one-fifth of the world's population is affected by fungal skin diseases. The prevalence of mycosis of the feet, which affects every second person, is especially increasing. Such a pathology can appear quite unexpectedly and at an inappropriate time. Today, Ukraine is under aggressive pressure from its northern neighbor, and military personnel are not only constantly at risk of receiving combat injuries and wounds, but also due to active hostilities, they may not have access to the necessary hygiene products, get cold, overheat in the sun, or not have time to change their clothes in time. and shoes. The reality is the absence or delay of treatment; the disease progresses and can spread quickly. If mycosis has appeared in one soldier, it can quickly affect others. Therefore, the problem of providing medical and pharmaceutical care is an urgent issue today. Expanding the assortment of drugs with the above action will ensure the needs of the Armed Forces and civilian patients with this dermatological pathology. It will be able to optimize antifungal therapy regimens. For quite a long time, 1,2,4-triazole derivatives have been a promising class of organic compounds that attract the attention of scientists from various fields. It has been proven that 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl) phenol has high antifungal activity. A potential medicinal product based on this medicinal substance can be used for the treatment of various dermatological diseases. To continue the creation of new effective dosage forms for the effective therapy of mycosis of the feet, the urgent task of today is the development of an express, accurate, reliable, and affordable method of quantitative determination of the substance under study. The aim of the work is to develop an express, sensitive and easy-to-implement UV-method for the quantitative determination of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol. Materials and methods. The research object is a working standard sample of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl) imino)methyl)phenol provided by NUNVF, LLC "Brovapharma" according to the "Research and production technological regulations for the production of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazol-4-yl)imino)methyl)phenol" developed based on scientific developed by the Ukrainian Military Medical Academy in conjunction with the National Military Medical Clinical Center "Main Military Clinical Hospital" (term of validity of the regulations until 12/31/2034). Isopropanol of grade "chemically pure" was used as a solvent. Analytical equipment: spectrophotometer Specord 200, electronic scales Radwag XA 210.4Y, class A measuring vessels. Results. An express, eco-friendly spectrophotometric method was developed for the quantification of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol in isopropanol area, having analytically maximum at 310 nm. The studied solutions are stable for 30 minutes. The analytical technique is linear in the range of concentrations 0.440-0.754 mg/100 ml (70-130 %). The detection and quantification limits were 5.80 % and 15.70 % respectively. The score was 0.76, according to the "greenness" icon of the analytical technique, using the tools AGREE. The prediction of the total uncertainty of the results of the developed method is 1.70 % (maxΔAs 2.00 %). The proposed method is relevant according to the requirements of the State Pharmacopoeia of Ukraine. Conclusions. Pharmaceutical development, introduction into industrial production and further prescribing by dermatovenerologists of an effective, safe, and harmless medicinal product will help to expand the range and reduce the level of high import dependence of the domestic market of medicinal products, which will create a more complete and balanced system of medicinal supply in Ukraine and optimize antifungal therapy schemes. [ABSTRACT FROM AUTHOR]

Ancient people sought out drugs in nature to prevent, cure, and treat their diseases, including mental illnesses. Plants were their primary source for meeting their healthcare needs. In Algeria, folk medicine remains a fundamental part of the local intangible knowledge. This study aims to conduct a comprehensive ethnomedicinal investigation and documentation of medicinal plants and the different plant formulations traditionally used in Algeria for the treatment of pain, psychiatric, and neurological disorders. It also intends to improve the current knowledge of Algerian folk medicine. Several scientific databases were used to accomplish this work. Based on this investigation, we identified 82 plant species belonging to 69 genera and spanning 38 distinct botanical families used as remedies to treat various psychological and neurological conditions. Their traditional uses and methods of preparation, along with their phytochemical composition, main bioactive constituents, and toxicity were noted. Therefore, this review provides a new resource of information on Algerian medicinal plants used in the treatment and management of neurological and psychological diseases, which can be useful not only for the documentation and conservation of traditional knowledge, but also for conducting future phytochemical and pharmacological studies. [ABSTRACT FROM AUTHOR]

Gentamicin sulfate is a broad-spectrum bactericidal aminoglycoside antibiotic produced by Micromonospora purpurea and used in clinical practice as an active substance containing a mixture of gentamicins C1 and C2. Gentamicin content is a standardised parameter controlled as part of a pharmaceutical product review. Currently, the quality control of the active substance gentamicin sulfate involves the use of high-performance liquid chromatography (HPLC) for the indirect identification of the component composition by comparison with a reference standard and for its quantification by calibration against the reference standard.The aim of the study was to develop a procedure for identifying and quantifying the components of the active substance gentamicin sulfate using nuclear magnetic resonance (NMR) spectroscopy that would not require reference standards.Materials and methods. The authors studied a sample of the active substance gentamicin sulfate using an Agilent DD2 NMR spectrometer operating at 600 MHz to record NMR spectra and an Agilent 1200 HPLC system equipped with a multiple wavelength detector (MWD) to obtain chromatograms.Results. Having determined the spectral properties of the C1, C1A, C2, C2A and C2B gentamicins comprising the active substance, the authors observed characteristic signals of the same type that corresponded to each of the gentamicins and did not overlap with other signals in the 1H and 13C spectra. These characteristic signals provided spectral markers indicative of the gentamicins of interest in the sample, with normalised integrated intensities equal to the mole fractions of the analytes. The authors compared NMR and HPLC measurements of the active substance composition.Conclusions. The authors developed a procedure for identifying and quantifying the constituents of the active substance gentamicin sulfate by 1H and 13C NMR spectroscopy, which requires less effort than HPLC procedures and no reference standards for the intended applications.

Abstract Background Substandard anti-malarial agents pose a significant challenge to effective malaria control and elimination efforts especially in sub-Saharan Africa. The quality of anti-malarials in most low-and-middle income countries (LMICs) is affected by several factors including inadequate regulation and limited resources. In this study, the pharmacopeial quality of artemether–lumefantrine (AL) in low and high malaria transmission settings in Uganda was assessed. Methods This was a cross-sectional study conducted among randomly selected private drug outlets. The AL anti-malarials available in drug outlets were purchased using overt method. The samples were screened for quality using visual inspection, weight uniformity, content assay and dissolution tests. The assay test was done using liquid chromatography–mass spectrometry (LC–MS). The samples were considered substandard if the active pharmaceutical ingredient (API) content was outside 90–110% range of the label claim. Dissolution test was conducted following United States Pharmacopoeia (USP) method. Data was analysed using descriptive statistics and presented as means with standard deviations, frequencies, and proportions. Correlation between medicine quality and independent variables was determined using Fisher’s exact test of independence at 95% level of significance. Results A total of 74 AL anti-malarial samples were purchased from high (49/74; 66.2%) and low (25/74; 33.8%) malaria transmission settings. The most common batch of AL was LONART, 32.4% (24/74), with 33.8% (25/74) being ‘Green leaf’. Overall prevalence of substandard quality artemether–lumefantrine was 18.9% (14/74; 95% CI: 11.4–29.7). Substandard quality AL was significantly associated with setting (p = 0.002). A total of 10 samples (13.5%) failed artemether content assay test while, 4 samples (5.4%, 4/74) failed the lumefantrine assay test. One sample from a high malaria transmission setting failed both artemether and lumefantrine assay content test. Of the samples that failed artemether assay test, 90% had low (

Introduction: Standardization is an import factor in ensuring the safety, efficacy, and quality of herbal medicines, and facilitates their international commerce. Heavy metal poisoning due to herbal medicines has been reported in many countries. Here, to better understand the current state of harmonization, we compared regulations for arsenic and heavy metals in herbal medicines across seven countries and two regions with two international standards. Methods: We studied the monographs of herbal medicines of seven countries and two regions, as well as the WHO guidelines and ISO standards. We then compared the limits and test methods adopted for elemental impurities in herbal medicines listed in the monographs and standards among countries. Results: The number of herbal medicines assessed amounted to over 2000. Limits and test methods adopted for elemental impurities in herbal medicines varied by country/region and organization. Although WHO recommends a uniform upper limit for lead and cadmium for all herbal medicines, some countries set unique upper limits for individual herbal medicines. ISO 18664:2015 lists only instrumental analysis methods, whereas Japan and India list only chemical methods. Conclusions: Many countries do not adhere to the WHO or ISO recommendations on elemental impurities in herbal medicines. These findings suggest the presence of differences in regulations for herbal medicines among countries/regions, likely rooted in cultural differences and policies aimed at maintaining the diversity of herbal medicines. Regulatory convergence by "loose harmonization" to internationally agreed standards appears a feasible option to maintain diversity and safety, and promote international trade in herbal medicines. [ABSTRACT FROM AUTHOR]

On the occasion of the centenary of the discovery of polarography, this article studies the mutual interactions between polarography and pharmacy. It highlights the relationship of the discoverer of polarography, Jaroslav Heyrovský (1890–1967), to pharmacy. The article shows how quickly and widely polarography has been applied to pharmacy. The contribution of polarography to the quality control of pharmaceutical substances and dosage forms is discussed, including some interesting solutions to problems with the measurement of substances that are difficult to determine electrochemically. The integration of polarography into pharmacopoeias is also followed. Next, the use of polarography in the determination of drugs and their metabolites in biological samples for pharmacological purposes is discussed. Finally, the application of polarography in the development of new drugs is reviewed. Although classical polarography on a dropping mercury electrode is nowadays seldom used, its contribution to pharmacy is considerable, and, moreover, new voltammetric methods derived from polarography still have a useful and irreplaceable position in pharmacy. [ABSTRACT FROM AUTHOR]

The fast development of diagnostic and therapeutic radionuclide technologies requires enhanced legislative regulation of radiopharmaceuticals. The article addresses the challenge of classifying radiopharmaceuticals depending on the manufacturing technology, radionuclide properties, and clinical use. The review covers the current legislative and regulatory requirements for radiopharmaceutical medicinal products. It also describes the trends in radiopharmaceutical regulation development in Russia and the Eurasian Economic Union, taking into account the corresponding legislative frameworks.

Objective. To assess antibiotic use in three hospitals in three Caribbean countries based on data from 2013 and 2018 using the World Health Organization Essential Medicines List “Access, Watch, Reserve” (AWaRe) classification. Methods. A retrospective observational study, which analyzed the World Health Organization Point Prevalence Survey data from three hospitals in three Caribbean countries, to examine proportional AWaRe group antibiotic use for the top ten inpatient indications. The Access-to-Watch ratio was calculated, and the top three antibiotics prescribed in each hospital were determined. Results. The final data set included 376 prescriptions for the top ten indications in 766 inpatients. The hospital antibiotic use point prevalence for Hospital 1 was 35.6%, Hospital 2 was 48.6%, and Hospital 3 was 47.1%. The Access-to-Watch ratio for the top ten indications was 2.45, 1.36, and 1.72 in the three hospitals. Access group prevalence was 71.0% in Hospital 1, 57.6% in Hospital 2, and 63.2% in Hospital 3. There were no Reserve antibiotics prescribed in any of the institutions. The most common indication for Watch prescription was skin and soft tissue infections in Hospital 1 and pneumonia in Hospital 2 and 3. Conclusions. This study draws urgent attention to evidence of a high proportion of Watch antibiotic prescribing and lack of Reserve group antibiotics in three Caribbean countries. This research provides data that may inform national formulary and antimicrobial stewardship policy-making across the settings analyzed and the wider region.

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Synsepalum dulcificum, a potent natural sweetener, is notably used in the traditional treatment of Diabetes mellitus in Nigeria though scientific explanation for its use is not well known. In this study, the phytochemical, proximate and hypoglycemic potential of the leaf and stem extracts (ethanol and aqueous) of S. dulcificum were investigated. The phytochemical and proximate analysis were carried out using a standard protocol. In-vivo assay protocols on alloxan-induced diabetic albino rats was followed in determining the hypoglycemic potentials of the extracts (concentrations: 100 mg/Kg, 200 mg/Kg, 400 mg/Kg), using glibenclamide as a standard drug. The aqueous leaf extract gave a higher yield (19.67%) compared to ethanolic extract (17.15%). Phytochemical analysis revealed the presence of flavonoids, saponins, terpenoids, tannins, phenols, steroids, cardiac glycosides and alkaloids in varying degrees in the plant's parts. Proximate analysis showed higher lipid (23.30%) and protein (12.94%) in leaves and higher fibre content in stems (30.00%). The aqueous leaf extract at a high dose (400 mg/kg) gave the best glucose lowering effect (66.67 mg/dL) compared to the medium dose (78.33 mg/dL) and the standard drug (70.00 mg/dL). The albino rats were unable to survive at the lower dose (100 mg/kg) of all the extracts. The observed hypoglycemic effect of the aqueous leaf extract may be linked to significant tannins, flavonoids and saponins in the extract, as these phytochemicals have been reported to exhibit blood sugar lowering potentials. The results from this study confirmed that the leaf aqueous extract as a potential anti-diabetic agent and justified the folkloric use of Synsepalum dulcificum in the management of diabetes mellitus in Nigeria. [ABSTRACT FROM AUTHOR]

Developing evidence-based uses of herbal medicines and natural product-based drug discovery are two core aims of ethnopharmacology. This requires an understanding of the medicinal plants and the traditional medical knowledge associated with them which is a basis for cross-cultural comparison. The botanical drugs of traditional medical systems are still not understood well, even for wellknown and widely respected traditions like Ayurveda. In this study, a quantitative ethnobotanical analysis was performed on the single botanical drugs included in the Ayurvedic Pharmacopoeia of India (API), presenting an overview on the medicinal plants of Ayurveda from perspectives of plant systematics and medical ethnobotany. Part-I of API includes 621 single botanical drugs, which are sourced from 393 species (323 genera in 115 families). Of these, 96 species yield two or more drugs, together accounting for 238 drugs. Taking the traditional concepts, biomedical uses and the pragmatic disease classification into account, therapeutic uses of these botanical drugs are sorted into 20 categories, which meet primary health demands. The therapeutic uses of the drugs sourced from the same species may differ considerably, but 30 of the 238 drugs are used in highly similar way. The comparative phylogenetic analysis identifies 172 species with high potential for specific therapeutic uses. This medical ethnobotanical assessment for the first time provides a comprehensive understanding on the single botanical drugs in API from the perspective of medical botany using an "etic" (scientistoriented) approach. This study also highlights the importance of quantitative ethnobotanic methods in understanding traditional medical knowledge. [ABSTRACT FROM AUTHOR]

Background: Substandard anti-malarial agents pose a significant challenge to effective malaria control and elimination efforts especially in sub-Saharan Africa. The quality of anti-malarials in most low-and-middle income countries (LMICs) is affected by several factors including inadequate regulation and limited resources. In this study, the pharmacopeial quality of artemether–lumefantrine (AL) in low and high malaria transmission settings in Uganda was assessed. Methods: This was a cross-sectional study conducted among randomly selected private drug outlets. The AL anti-malarials available in drug outlets were purchased using overt method. The samples were screened for quality using visual inspection, weight uniformity, content assay and dissolution tests. The assay test was done using liquid chromatography–mass spectrometry (LC–MS). The samples were considered substandard if the active pharmaceutical ingredient (API) content was outside 90–110% range of the label claim. Dissolution test was conducted following United States Pharmacopoeia (USP) method. Data was analysed using descriptive statistics and presented as means with standard deviations, frequencies, and proportions. Correlation between medicine quality and independent variables was determined using Fisher's exact test of independence at 95% level of significance. Results: A total of 74 AL anti-malarial samples were purchased from high (49/74; 66.2%) and low (25/74; 33.8%) malaria transmission settings. The most common batch of AL was LONART, 32.4% (24/74), with 33.8% (25/74) being 'Green leaf'. Overall prevalence of substandard quality artemether–lumefantrine was 18.9% (14/74; 95% CI: 11.4–29.7). Substandard quality AL was significantly associated with setting (p = 0.002). A total of 10 samples (13.5%) failed artemether content assay test while, 4 samples (5.4%, 4/74) failed the lumefantrine assay test. One sample from a high malaria transmission setting failed both artemether and lumefantrine assay content test. Of the samples that failed artemether assay test, 90% had low (< 90%) artemether content. All the samples passed visual inspection and dissolution tests. Conclusion: Artemether–lumefantrine agents, the recommended first-line treatment for uncomplicated malaria with APIs outside the recommended pharmacopeial content assay limit is common especially in high malaria transmission settings. There is need for continuous surveillance and monitoring of the quality of artemisinin-based anti-malarials across the country by the drug regulatory agency. [ABSTRACT FROM AUTHOR]

Background: Quality and quantity assurance of herbs are global concerns. This study aimed to classify and compare the monographs and test procedures of Senna parts and preparations according to two editions of BP and USP-NF. The monographs and specifications were compared to suggest a practical approach to extract relevant data. Methods: BP 2015 and 2020, USP-NF 39-34 and 43-38, and scientific databases were used for literature review. Results: In both editions of USP-NF, determination of heavy metals was solely included for the powder and tablet of sennosides. In both editions of BP, assessment of microbial contamination was merely included in the monograph of dry extract of Senna, not for the rest of the monographs. Comparing two editions of BP indicated that in BP 2020, LC and HPTLC methods were added to assure the quality of pods and leaflets of Senna species. Conclusion: Preparation of tabular data will assist analysts in extracting desired information and guidelines to prepare licensed herbal products. This approach could be applicable to select relevant tests according to the facilities and equipment of laboratories.

Herbal medicines, made up of different plants materials are used worldwide to treat various disorders and are widely accepted by large number of population. But due to climatic changes and lack of knowledge w.r.t. identification and preparation of the drugs, it is essential that quality evaluation of herbal medicines must be carried out to manifest the drug as potent and safe. Karkati beej churna is an ayurvedic herbal formulation which is used in the treatment of urinary disorders. The present study focusses on the quality evaluation of Karkati beej churna w.r.t. parameters like organoleptic chracteristics, physicochemical parameters, microscopic evaluation, phytochemical screening and chromatographic profiling. A Thin layer chromatographic profile was obtained for saponins as saponins are considered as one of the plant diuretics. The results thus obtained for all the above mentioned parameters can be used for future references. [ABSTRACT FROM AUTHOR]

Herpes Simplex Viruses (HSV) viruses are highly contagious that commonly cause dermatitis, encephalitis, meningitis and genitourinary infections and also can lead to cervical cancer. For treatment of HSV infections, several physical methods and antiviral drugs are introduced, antiviral medications can also prevent or reduce outbreaks. The use of herbal medicine with antiviral effects attracted worldwide attentions. The aim of this review article is to introduce the Iranian Herbal Pharmacopoeia (IHP) with antiviral potential against two HSV serotypes and help to evaluate and develop the new drugs from natural sources. To provide this review, relevant articles in some authentic databases including PubMed, Web of Science, Science Direct, Scopus, Google Scholar and SID (scientific information database), from 1967 to April 2022 were collected, and selected botanicals from (IHP) with their scientific names and classifications and their outcome (CC50 and IC50) were introduced. In this review, scientific data regarding anti-herpetic activities of Iranian Herbal Pharmacopoeia (IHP) showed that 34 herbs from 17 families have antiviral potential to inhibit two HSV serotypes. According to families, Lamiaceae family has the highest percentage (29.41 %) of plants with antiviral activity against two HSV serotypes, also review of recent data showed that Salvia officinalis, Melissa officinalis, Securigera Securidaca, Hyssopus officinalis, Quercus brantii, Artemisia aucheri and Curcuma longa have remarkable antiviral activity against two HSV serotypes. Results of this review suggest that further research to identify and purify the bioactive compounds to determine the molecular mechanisms of action is needed.

The Coronavirus Disease (COVID-19) is sweeping around the world at a rapid pace resulting in severe health crises across the globe. The pandemic condition has forced the government, regulatory authorities, bio/pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The race for development of medicines and vaccines for treatment of COVID-19 is well under way and regulatory authorities are making efforts to safely deliver it into hands of public. As ever, pharmacopoeias played an active role in providing a framework of standards for the development, manufacturing, and quality of life-saving COVID-19 related medicines. The COVID-19 crisis has compelled the pharmacopoeias to redefine their role and show unprecedented levels of flexibility in extending their services to the stakeholders, developing new drug standards, and simultaneously ensuring the safety of their staff. During this pandemic, pharmacopoeias operated in a triangular chain system with regulators and pharmaceutical manufacturers to evaluate potential products for treatment of COVID-19. The present article provides an insight on the roles, challenges, and responses of the pharmacopoeias to deal with the current situation due to COVID-19 and emphasizes on new opportunities for collaborations to set standards for COVID-19 related drugs.

The ongoing development of the Pharmacopoeia of the Eurasian Economic Union and the current trend for harmonisation of the Russian Pharmacopoeia with the world leading pharmacopoeias suggest the necessity of studying how different pharmacopoeias use nuclear magnetic resonance (NMR) for quality control of medicinal products. The aim of the study was to compare the extent of medicine quality characteristics assessed by NMR in the Russian and foreign pharmacopoeias. The review summarises the experience of various national and world pharmacopoeias in using the NMR method for quality control of medicines and certification of pharmacopoeial reference materials. The comparative analysis covered the following quality parameters: active ingredient identification, determination of the composition of non-stoichiometric compounds, determination of the average polymer chain length in polymers and block copolymers, determination of the absolute content of the active ingredient, identification and quantification of impurities, polymorphism, and crystallinity. It was shown that the United States and Japanese Pharmacopoeias are leading the way in introducing the NMR method into pharmacopoeial analysis. There have been some positive trends in the introduction of the NMR method in the State Pharmacopoeia of the Russian Federation as well. It was concluded that changes are needed in the general chapters “Nuclear Magnetic Resonance Spectroscopy” and “Reference Standards” of the State Pharmacopoeia of the Russian Federation, 14th ed. in order to harmonise the texts with those of the Eurasian Pharmacopoeia and the European Pharmacopoeia and to allow for the possibility of direct identification of a substance by complex analysis of NMR spectral data, without comparing the test sample and the reference standard spectra. The NMR method should be included in the list of absolute methods used for determination of purity of primary chemical reference substances during certification.

Man has always used plants to cure himself. He attributed to the Providence, then to Nature the fact that beside a disease, there is always its remedy. The Fulani of Diamaré have a great knowledge of plants and have adopted against fevers remedies available in all seasons. Can we say that all these remedies are effective in themselves? It is up to phytobiochemistry to answer the question. [ABSTRACT FROM AUTHOR]

Background: The use of dose administration aids in automated ward dispensing devices requires the repackaging of medications, which may impact their stability compared with the original manufacturer's packaging., Objectives: This study aimed to assess the physical and chemical stability of clozapine tablets for up to 84 days after repackaging., Methods: A total of 900 tablets of clozapine 100 mg (Viatris) were repackaged and stored under five different conditions to conduct physical and chemical stability tests on days 0, 28, 56 and 84. The results were compared with control tablets in their original packaging. Visual inspections of tablet appearance were performed. Physical tests included assessments of mass uniformity, friability and resistance to crushing, following the standards of the European Pharmacopoeia 11th edition. The chemical stability was determined using ultra-high performance liquid chromatography with tandem-mass spectrometry detection (UHPLC-MS/MS) to measure clozapine concentration, N-desmethyl-clozapine, and monitor clozapine degradation to detect formation of any degradation products other than N-desmethyl-clozapine., Results: Visual examination showed changes in the appearance of tablets only in those stored under UV light. Mass uniformity met standards for all tablets over 84 days. None passed the friability test due to tablet cracking after tumbling. A gradual deterioration in tablet hardness was observed with the resistance to crushing test. In terms of chemical stability, N-desmethyl-clozapine was undetected in any of the tablets stored under all conditions, and the mean concentration of clozapine remained within the target range over 84 days., Conclusion: N-desmethyl-clozapine was not detected and clozapine concentrations remained stable under all storage conditions. The tablets were compliant with the mass uniformity test in each condition. However, the tablets were cracked in the friability test and gradual deterioration in tablet hardness was observed. In the light of these results, the Vinatier Hospital pharmacy has chosen to establish a shelf life for clozapine tablets of 84 days., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual inspection of P2S is a release control whose methods are described in monographs of the European Pharmacopoeia (2.9.20) and the United States Pharmacopeia (1790). However, these non-automated visual methods require training and proficiency testing of personnel. The main objective of this work was to compare the reliability and speed of analysis of two visual methods and an automated method for detecting visible particles by image analysis in P2S. Furthermore, these methods were used to evaluate sources of particulate contamination during pre-production processes (washing, disinfection, depyrogenation) and production (filling, capping)., Materials and Methods: Three pharmacy technicians examined 41 clear glass vials of type I, 10 and/or 50 mL through manual visual inspection (MVI), semi-automated (SAVI), and automated (AVI) inspection. The vials were distributed as follows: (i) 16 vials of water for injection containing either glass particles (224 µm or 600 µm), stopper fragments, or textile fibres; (ii) five sterile injectable specialties; (iii) 20 vials of water for injection prepared under different pre-production conditions., Results and Discussion: MVI and SAVI detected 100% of visible particles compared with 28% for AVI, which showed a deficiency in detecting textile fibres. All three methods correctly analysed P2S that did not contain visible particles. The three methods detected particles in vials maintained under International Organization for Standardization (ISO) 9 pre-production conditions. However, detections by (i) MVI and SAVI, and by (ii) AVI of particles contained in vials maintained under ISO 8 pre-production conditions were deemed satisfactory and unsatisfactory, respectively., Conclusion: The importance of visual inspection of P2S requires rapid, sensitive, and reliable detection methods. In this context, MVI and SAVI have proven to be more effective than AVI for a more competitive financial, training, and implementation investment., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY. Published by BMJ.)

Proper assessment of the quality of the obtained phytosubstances from the raw materials under study involves establishing the level of requirements for its quality. In this regard, the aim of the work is to establish the pharmacopoeial level of requirements for the quality of medicinal plant raw materials containing cardiac glycosides, based on the results of a comparative evaluation of pharmacopoeial monographs. 16 pharmacopoeias were used to collect data, of which 4 were homeopathic. The search was performed according to the keywords denoting the names of cardiac glycosides and pharmacopoeia types of medicinal plant raw materials in Latin and the language of pharmacopoeia. Based on the comparative analysis, the main list of quality indicators has been established, taking into account the requirements of national standards, which include: definition; identification, including macro- and microscopy, physico-chemical methods for determining biologically active substances; tests that include the determination of foreign impurities, weight loss during drying, the content of total ash, ash insoluble in hydrochloric acid; quantitative determination; microbiological purity; radionuclides, heavy metals, storage conditions and shelf life. Thus, unified requirements for the quality of medicinal plant raw materials containing cardiac glycosides have been developed, and optimal regulated norms for the main quality indicators have been determined, and their relationship with the quantitative content of cardiac glycosides in raw materials has been established. [ABSTRACT FROM AUTHOR]

• This is the first comparative study of Pharmacopoeia and Good Manufacturing Practice (GMP) for herbal medicines. • Quality paramaters vary in Pharmacopoeia of Panax ginseng C.A. Meyer and GMP. • High quality control is a prerequisite for the popularity of herbal medicines. • Harmonization of global quality standards for herbal medicines is needed. The use of herbal medicines is widespread, and ensuring their quality control, as guaranteed by pharmacopoeia and Good Manufacturing Practice (GMP) guidelines, has garnered significant attention. Discrepancies in quality standards across different regulatory agencies challenge the global marketing of herbal medicines and hinder public access to these products. Therefore, this research aims to compare pharmacopeia on Panax ginseng C.A. Meyer (P. ginseng) and GMP guidelines for herbal medicines to provide an evidence-based understanding of quality control standards. Definitions of herbal medicines across regulatory authorities, including the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Union (EU), China, Japan, South Korea, and Vietnam, were collected. Additionally, pharmacopeial standards on Panax ginseng case study were analysed, focusing on aspects such as origin, identification, testing methods, extractives, assay, purity, and drug information. The study also compared GMP requirements for herbal medicines, which included personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection. Definitions of herbal medicines are similar among the WHO, PIC/S, and the EU, while distinct definitions based on scientific evidence and traditional practices were presented in China, Japan, South Korea, and Vietnam. Pharmacopeia standards varied across regulatory agencies, as evidenced by the P. ginseng case study. However, testing methods closely resembled each other between China and Vietnam, as well as between Japan and South Korea. Among pharmacopoeias, the WHO monographs offered the most comprehensive drug information on P. ginseng. In contrast, the European Pharmacopoeia lists such details separately in a P. ginseng assessment report. Regarding GMP requirements, although examined components varied among regulatory agencies, significant resemblances exist between the GMP guidelines of PIC/S, the EU, and South Korea, and between those of the WHO and Vietnam. Disparities in quality standards across jurisdictions highlight the necessity for international collaboration to achieve harmonization. Harmonizing these standards aims to promote the global availability of standardized herbal medicinal products, benefiting public health. [Display omitted] [ABSTRACT FROM AUTHOR]

Ginseng (Panax ginseng C. A. Meyer), a perennial herb, possesses immunostimulatory, anticarcinogenic, antiemetic, and antioxidative biological activities. In recent years, more and more people have paid attention to the extraction methods and quality evaluation of ginseng. China, the United States, Europe, Japan, and Korea have all had the quality standards and content determination methods of ginseng. The different treatment methods are adopted before the determination of ginseng samples and the content limits of the index components, such as ginsenoside Rb1, ginsenoside Rg1, and ginsenoside Re exist differences. The similarities and differences of ginseng content detection methods in pharmacopoeias of different countries have been analyzed by a research group, but the comparison of the effects of different methods on the ginsenoside content and structural transformation has not been reported. In this paper, ginsenosides in ginseng were extracted according to four national pharmacopoeias and analyzed quantitatively and qualitatively by UPLC-Q-Exactive-MS and HPLC-UV. It was illustrated that the pretreatment method has a significant influence on the content determination of ginseng. The yield of rare saponins was increased by heating concluded from both the qualitative and quantitative comparison. Finally, a simple and feasible extraction method was optimized by response surface method at room temperature. The analysis of the preparation method and process optimization of the four pharmacopoeias can provide important reference information for the revision of ginseng standards. [ABSTRACT FROM AUTHOR]

Medicinal plants have been used by humans for the treatment of various diseases for thousands of years from past to present. Members of the Lamiaceae family are among the most preferred medicinal plants due to the wide variety of secondary components they contain, particularly essential oils. In this review, Master's and PhD theses and books based on ethnobotanical studies investigated between 1960 and 2021 as well as internationally recognized databases (PubMed, Scopus, Google Scholar, Web of Science, SciFinder, Springer and Elsevier) were used to determine the medicinal uses of Lamiaceae taxa among the people in Turkey. As a result of the study, it was found that a total of 221 taxa (192 species) belonging to 29 genera, 51 of which are endemic, have medicinal/therapeutic uses. The local names of these taxa, the usage which are used among the people, the diseases in which they are used, and the geographical regions given in the present study. The genera of taxa most commonly used for medicinal purposes by the local people are Salvia (37 taxa), Sideritis (25 taxa), Stachys (22 taxa), Thymus (16 taxa) and Origanum (13 taxa). It was observed that the most frequently used two methods while preparing these plants for use was infusion (61%), and decoction (24%). Studies conducted on National (TURK, BHP), Regional (EU) and International Pharmacopoeias (WHO) and various monographs (AHP, COMISSION E, EMA, ESCOP, PDR) have revealed that there are 29 taxa included in these pharmacopoeias and monographs whose purpose of use are similar to the diseases that local people are trying to treat. Diseases that people use plants for therapeutic purposes are grouped into 12 categories. It was determined that these plants were widely used for therapeutic purposes in gastric disorders as well as otolaryngology and respiratory system diseases. This review briefly discusses whether some taxa commonly used by the local people in the treatment of diseases can be useful in the treatment of the disease in question, in the light of scientific studies. [ABSTRACT FROM AUTHOR]

The study assesses and analyze the global "Pharmacopoeia" research output on a set of quantitative and qualitative metrics to explore the status of research activity on pharmacopoeia at global, national, organizational, and also at individual level. The study provides a domain to the most productive countries, institutions or organizations, communication channels, authors, and research themes. Publications data (556 publications) were retrieved using Scopus database for the study timespan 2000–2020. The network visualization maps including research collaboration were created by utilizing the VOSviewer program. The pharmacopoeia research output registered a 15.76% annual average growth and accrued an average of 7.05 citations per paper during the period. The leading role of China was reflected in the analysis as topped country, organization, and leading communication channel. [ABSTRACT FROM AUTHOR]

Itraconazole is a triazole antifungal agent that is synthesised. Itraconazole has been manufactured into a variety of pharmacological formulations and administered in a variety of ways. Itraconazole pills are used to treat pulmonary fungi that can cause fungal infection and spread throughout the body. Because Itraconazole is not yet officially listed in any pharmacopoeia, only a few procedures for quality control and stability testing in pharmaceutical formulations have been published. The goal of this study is to develop a more precise, easy, and cost-effective spectrophotometric approach for analysing Itraconazole in bulk and capsule dosage forms with improved precision, accuracy, and sensitivity. The UV spectroscopic determination was performed with Chloroform as the solvent at an absorption maximum of 267 nm. Linearity over the concentration range in the UV spectroscopic approach. The linearity of Itraconazole over the concentration range was found to be 1-10 g/ml using the UV spectroscopic technique, with a correlation coefficient of 0.999. The findings of the analyses were statistically and the recovery studies have confirmed this. [ABSTRACT FROM AUTHOR]

The Coronavirus Disease (COVID-19) is sweeping around the world at a rapid pace resulting in severe health crises across the globe. The pandemic condition has forced the government, regulatory authorities, bio/pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The race for development of medicines and vaccines for treatment of COVID-19 is well under way and regulatory authorities are making efforts to safely deliver it into hands of public. As ever, pharmacopoeias played an active role in providing a framework of standards for the development, manufacturing, and quality of life-saving COVID-19 related medicines. The COVID-19 crisis has compelled the pharmacopoeias to redefine their role and show unprecedented levels of flexibility in extending their services to the stakeholders, developing new drug standards, and simultaneously ensuring the safety of their staff. During this pandemic, pharmacopoeias operated in a triangular chain system with regulators and pharmaceutical manufacturers to evaluate potential products for treatment of COVID-19. The present article provides an insight on the roles, challenges, and responses of the pharmacopoeias to deal with the current situation due to COVID-19 and emphasizes on new opportunities for collaborations to set standards for COVID-19 related drugs. [ABSTRACT FROM AUTHOR]

Most important quality attributes of any radiopharmaceutical (RPh) are its radiochemical purity (RCP) or content of radiochemical impurities (RCIs) that have to comply with respective norms and limits. However, at present, there is no unified approach to validation of analytical methods in the context of highly radioactive samples.The aim of the study was to develop an approach to validation of methods for determination of RCI content in RPhs.Materials and methods: the authors determined the content of RCIs in a radiopharmaceutical formulation containing a complex of technetium-99m and methylenediphosphonic acid by the radiometric method after isolation of impurities from the main compound by thin-layer chromatography using silica gel and methyl ethyl ketone (for sodium pertechnetate determination) and silica gel and 13.6% sodium acetate solution (for determination of hydrolysed reduced technetium-99m). The radioactivity was registered by a chromatogram scanner with a detector of gamma-rays with energies from 0.05 to 1.5 MeV.Results: the paper analyses existing official approaches to validation of analytical procedures and compares them with the results of experimental studies described in available publications. It assesses the validation parameters for compliance with the acceptance criteria set forth in the current regulations and substantiates selectivity of chromatographic determination of impurities under the selected test conditions. Coefficients of variation for repeatability, reproducibility, and accuracy did not exceed 4.5, 2.8, and 8.9%, respectively, given the relative error of not more than 10.5%. The study demonstrated signal linearity for the 10-fold dilution of the standardised sodium pertechnetate solution, it also demonstrated correspondence between the applied and detected radioactivity when performing the test in the impurity content range of 0.5–5%. The validation procedure was associated with significant radiation burden for the personnel of the quality control laboratory.Conclusions: the authors suggested a methodological approach to validation of methods for determination of RCI content in technetium-99m-based RPhs. This approach may be used in the development of a guideline on validation of analytical methods for RCP/RCI determination in RPhs, or for introduction of relevant sections into existing documents.

The introduction of monographs on new types of herbal substances, which were not included in the previous editions of the State Pharmacopoeia of the Russian Federation (Ph. Rus.), and the introduction of the new powder dosage form of herbal medicinal products require alignment of requirements for the degree of fineness of medicinal products. The aim of the study was to compare Russian and foreign pharmacopoeial requirements for the degree of fineness of herbal substances and herbal medicinal products. The analysis demonstrated that in the case of cut herbal substances and powder, the Ph. Rus., XIV edition, establishes limits for the percent of particles that pass through and particles that are retained by a sieve with a specified pore diameter. In the case of whole herbal substances, the Ph. Rus. establishes limits for the percent of particles that pass through a sieve with a specified pore diameter. The monographs of the world leading pharmacopoeias include general requirements for the size of particles in all powders produced from chemically synthesized substances, as well as from naturally occurring and mineral substances, while individual monographs have no requirements for the degree of fineness of herbal substances. The national pharmacopoeias of the Eurasian Economic Union member states also include requirements for the degree of fineness of herbal substances, but they are not sufficient. The results of the analysis of the established limits demonstrate the need to change the controlled size of small and large particles for some types of herbal substances.

Background: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification., Methods: To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods., Results: We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content., Conclusions: Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: Parenteral drug products should be essentially free from visible particulate contamination. To ensure this, every batch produced must be subject to a 100% visual inspection. Monograph 2.9.20 of the European Pharmacopoeia (Ph. Eur.) describes a method for visual inspection of parenteral drug units in front of a black and white panel using a white light source. Nevertheless, several Dutch compounding pharmacies rely on an alternative method for visual inspection by means of polarised light. The objective of this study was to compare the performance of both methods., Methods: Trained technicians in three different hospitals inspected a predetermined set of samples using both methods for visual inspection of parenteral drugs., Results: The results of this study show that the alternative method for visual inspection yields a higher recovery than the Ph. Eur. method, while no significant difference in false positive results was found., Conclusions: Based on these findings, it can be concluded that the alternative method for visual inspection by means of polarised light can very well replace the Ph. Eur. method in pharmacy practice, provided that local validation of the alternative method is performed., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)