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Ludwig Hoellein,1 Eliangiringa Kaale,2 Yonah Hebron Mwalwisi,3 Marco H Schulze,4 Carina Vetye-Maler,5 Ulrike Holzgrabe1 1Institute for Pharmacy and Food Chemistry, Julius-Maximilians-Universität Würzburg, Würzburg, Germany; 2Muhimbili University of Health and Allied Sciences, School of Pharmacy, Dar es Salaam, Tanzania; 3Tanzania Medicines & Medical Devices Authority, Dar es Salaam, Tanzania; 4Georg-August-Universität Göttingen, Institut für Krankenhaushygiene und Infektiologie, Göttingen, Germany; 5Apotheker ohne Grenzen Deutschland e.V., München, GermanyCorrespondence: Ulrike Holzgrabe, Institute for Pharmacy and Food Chemistry, Julius-Maximilians-Universität Würzburg, Am Hubland, Würzburg, 97074, Germany, Tel +49 931 31 85460, Email ulrike.holzgrabe@uni-wuerzburg.deAbstract: Medicine quality and methods for its assessment play a major role in the effectiveness of therapies and the treatment of many infectious diseases. However, poor-quality and/or falsified products are circulating in huge amounts in many low- and middle-income countries and are one of the major reasons why more and more resistant bacteria emerge. The development of resistance is additionally triggered by a plethora of antibiotic medicines which is easily available through pharmacies and unofficial sources. The uncontrolled overuse of these products is a huge problem not only in single countries but worldwide. In this review, we aim to demonstrate the factors which are involved in an emerging resistance development and how strong regulatory authorities, routine quality control by means of proficiency testing, and post-marketing surveillance as well as training personnel and patients can be combined to curb the problem.Keywords: medicine quality, falsified, antimicrobial resistance, proficiency testing, post-marketing surveillance, Africa, Latin America

Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient (API). Micromeritics properties: bulk density (BD) and tapped density (TD), compressibility index (Carr’s index), Hauser’s ratio (H), and sieve analysis were performed in order to determine the best excipients to be used in the formulation development of omeprazole magnesium enteric coated tablets. Results show that omeprazole magnesium has fair flow and compressibility properties (BD 0.4 g/mL, TD 0.485 g/mL, Carr’s index 17.5%, Hauser’s ratio 1.2, and sieve analysis time 5 minutes). There were no significant drug excipient interactions except change in colour in all three conditions in the mixture of omeprazole and aerosil 200. Moisture content loss on drying in all three conditions was not constant and the changes were attributed to surrounding environment during the test time. Changes in the absorption spectra were noted in the mixture of omeprazole and water aerosil only in the visible region of 350–2500 nm. Omeprazole magnesium alone and with all excipients showed no significant changes in omeprazole concentration for a 30-day period. Omeprazole magnesium formulation complies with USP standards with regards to the fineness, flowability, and compressibility of which other excipients can be used in the formulation. [ABSTRACT FROM AUTHOR]

Abstract Background Priority setting for artemisinin-based antimalarial drugs has become an integral part of malaria treatment policy change in malaria-endemic countries. Although these drugs are more efficacious, they are also more costly than the failing drugs. When Tanzania changed its National Malaria Treatment Policy in 2006, priority setting was an inevitable challenge. Artemether-lumefantrine was prioritised as the first-line drug for the management of uncomplicated malaria to be available at a subsidized price at public and faith-based healthcare facilities. Methods This paper describes the priority-setting process, which involved the selection of a new first-line antimalarial drug in the implementation of artemisinin-based combination therapy policy. These descriptions were further evaluated against the four conditions of the accountability for reasonableness framework. According to this framework, fair decisions must satisfy a set of publicity, relevance, appeals, and revision and enforcement conditions. In-depth interviews were held with key informants using pretested interview guides, supplemented with a review of the treatment guideline. Purposeful sampling was used in order to explore the perceptions of people with different backgrounds and perspectives. The analysis followed an editing organising style. Results Publicity: The selection decision of artemether-lumefantrine but not the rationale behind it was publicised through radio, television, and newspaper channels in the national language, Swahili. Relevance: The decision was grounded on evidences of clinical efficacy, safety, affordability, and formulation profile. Stakeholders were not adequately involved. There was neither an appeals mechanism to challenge the decision nor enforcement mechanisms to guarantee fairness of the decision outcomes. Conclusions The priority-setting decision to use artemether-lumefantrine as the first-line antimalarial drug failed to satisfy the four conditions of the accountability for reasonableness framework. In our understanding, this is the first study to evaluate priority-setting decisions for new drugs in Tanzania against the accountability for reasonableness framework. In addition to the demand for enhanced stakeholder involvement, publicity, and transparency, the study also calls for the institution of formal appeals, revision, and regulatory mechanisms in the future change of malaria treatment policies.

Improving medicines regulation can lead to better population health, but how this process works in low- and middle-income countries remains underexplored. Tanzania's pharmaceutical sector is often cited as a successful example of a well-functioning regulatory system in a developing country, attributed to the work of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). This raises the question: how was this regulatory capacity developed, and what lessons can other countries learn from Tanzania's experience? This paper analyzes changes in Tanzania's pharmaceutical regulation over three periods of significant sectoral reform. A desk review was conducted of Tanzania's policies, laws, regulations, guidelines, procedures, and institutional reports. The study reveals that Tanzania's regulatory capacity improved significantly through targeted reforms that addressed challenges in key regulatory areas. The three key periods examined are: 1) The separation of medicines regulation from food safety (1978-2003), 2) The expansion of regulatory domains and the establishment of a semi-autonomous regulatory agency (2003-2011), and 3) The expanded role of the Pharmacy Council to include premises regulation (2011-2020). The development of a well-functioning regulatory system in Tanzania resulted from advancements in four key areas: 1) The evolution of a legal regulatory framework, 2) Strong stakeholder engagement, 3) Continuous capacity building, and 4) Effective organizational leadership. Tanzania's regulatory system has evolved from being relatively ineffective to leading regional harmonization efforts in East Africa. This progress was not linear, requiring sustained effort, collaboration, and support from key development partners such as the Global Fund, WHO, and UNDP. Future efforts to enhance regulatory effectiveness should focus on creating adaptive systems that respond to changing needs, rather than solely prescriptive functions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Fimbo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Paracetamol, also known as acetaminophen, is categorized as an analgesic and antipyretic medication and is available as over the counter (OTC) medication. It is commonly used in conditions associated with pain and fever. There is a tendency for community to prefer using imported paracetamol tablets from Europe and United States than from Asia and Africa worrying of the quality of the products. Safety, effectiveness, and efficacy of a medicine can be guaranteed when its quality is reliable; however, there is limited data on the quality of locally manufactured paracetamol tablets, thus necessitating this study. Aim: This study is aimed at assessing the quality of paracetamol tablets 500 mg manufactured by local companies by evaluating their physical parameters, assay results, and dissolution profiles. The compliance of these tablets with the specifications outlined in the British Pharmacopoeia (BP) was analyzed. Additionally, a comparative dissolution test was conducted to assess dissolution profile for innovator product and generics. Method: Five different brands from East African countries with 76 tablets from each brand were compared with the innovator product regarding weight variation, hardness, friability, assay, and dissolution test based on the BP specifications. Results and discussion: All samples of paracetamol tablets 500 mg from the local manufacturers in this study met the specifications set by the BP for physical parameters, including weight variation, friability, hardness, and disintegration tests. The weight variation test, directly related to drug content variation, demonstrated compliance within the acceptable deviation of 5%. Similarly, the assay test, which determines the concentration of the active pharmaceutical ingredient (API), confirmed that all samples complied with the acceptable concentration range of 90%-110% for paracetamol. The dissolution test, assessing the percentage release of the API within a specified time, demonstrated that at 15 min, two samples (diodol and enamol) exhibited lower concentration releases than the required 80%, indicating potential delays in their bioavailability and onset of action. Conclusion: To conclude, all samples had good quality and they can be used for their therapeutic purposes., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Gerald Marisa et al.)

Background: Glycaemic control is essential for improving the quality of life in patients with Diabetes Mellitus (DM). Untreated hyperglycaemia can result in numerous severe and life-threatening complications, such as damage to the eyes, kidneys, nerves, heart, and peripheral vascular system. Appropriate glycaemic control and management is fundamental to prevent and delay diabetes complications. Therefore, this study aims to assess the prevalence of poor glycaemic control, its associated factors, and the prevalence of diabetes-related complications among DM patients., Methods: A cross-sectional study was conducted among 340 DM patients treated at Bugando Medical Center from 4th - 30th April 2023 to determine the prevalence of poor glycaemic control and its predictors. Secondary data from 7952 DM patients treated between April 2022 and 30th May 2023 were used to determine DM-related complications. STATA 15 version …was used for analysis., Results: Out of 340 patients, 66.4% had poor glycaemic control with HbA1c or Random Blood Glucose greater than 7% or 7mmol/L, respectively. Older age, duration of DM of more than 10 years, insulin therapy, and those unaware of glycaemic target goals were factors associated with poor glycaemic control. (AOR: 2.46, 95% CI: 1.28-6.01, P = 0.03), (AOR: 3.15, 95% CI: 2.22-6.55, P = 0.016), (AOR: 3.07, 95% CI: 2.10-6.12, P = 0.022) and (AOR: 3.42, 95% CI: 2.17-5.97, P = 0.001), respectively. Of the 7952 patient records reviewed indicated that 44.5% had complications, of which 25.8% had neurological complications and 55.3% had multiple complications., Conclusion: Two-third of DM patients failed to achieve good glycaemic control and about half of the patient's records reviewed indicated they developed diabetic complications. Thus appropriate interventions are necessary to improve glycaemic control and prevent or control complications among DM patients., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Muchunguzi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: Children account for a significant proportion of antibiotic consumption in low- and middle-income countries, with overuse occurring in formal and informal health sectors. This study assessed the prevalence and predictors of residual antibiotics in the blood of children in the Mbeya and Morogoro regions of Tanzania., Methods: The cross-sectional community-based survey used two-stage cluster sampling to include children aged under 15 years. For each child, information on recent illness, healthcare-seeking behaviour, and use of antibiotics, as well as a dried blood spot sample, were collected. The samples underwent tandem mass spectrometry analysis to quantify the concentrations of 15 common antibiotics. Associations between survey variables and the presence of residual antibiotics were assessed using mixed-effects logistic regression., Results: In total, 1742 children were surveyed, and 1699 analysed. The overall prevalence of residual antibiotics in the blood samples was 17.4% (296/1699), the highest among children under the age of 5 years. The most frequently detected antibiotics were trimethoprim (144/1699; 8.5%), sulfamethoxazole (102/1699; 6.0%), metronidazole (61/1699; 3.6%), and amoxicillin (43/1699; 2.5%). The strongest predictors of residual antibiotics in the blood were observed presence of antibiotics at home (adjusted odds ratio [aOR] = 2.9; 95% CI, 2.0-4.1) and reported consumption of antibiotics in the last 2 weeks (aOR = 2.5; 95% CI, 1.6-3.9). However, half (145/296) of the children who had residual antibiotics in their blood, some with multiple antibiotics, had no reported history of illness or antibiotic consumption in the last 2 weeks, and antibiotics were not found at home., Discussion: This study demonstrated a high prevalence of antibiotic exposure among children in Tanzanian communities, albeit likely underestimated, especially for compounds with short half-lives. A significant proportion of antibiotic exposure was unexplained and may have been due to unreported self-medication or environmental pathways. Incorporating biomonitoring into surveillance strategies can help better understand exposure patterns and design antibiotic stewardship interventions., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: Tanzania observed a gradual increase in the number of measles cases since 2019 with a large outbreak recorded during 2022. This study describes the trend of measles in Tanzania over a 5-year period from 2018-2022., Methods: This was a descriptive study conducted using routine measles case-based surveillance system including 195 councils of the United Republic of Tanzania., Results: Between 2018 and 2022 there were 12,253 measles cases reported. Out of 10,691 (87.25%) samples tested by enzyme-linked immunosorbent assay, 903 (8.4%) were measles immunoglobulin M positive. The highest number of laboratory-confirmed measles cases was in 2022 (64.8%), followed by 2020 (13.8%), and 2019 (13.5%). Out of 1279 unvaccinated cases, 213 (16.7%) were laboratory-confirmed measles cases compared to 77/723 (10.6%) who were partially vaccinated and 71/1121 (6.3%) who were fully vaccinated (P < 0.001). Children aged between 1-4 years constituted the most confirmed measles cases after laboratory testing, followed by those aged 5-9 years. There was a notable increase in the number of laboratory-confirmed measles cases in children <1 year and 10-14 years during 2022 compared to previous years. The vaccination coverage of the first dose of measles-containing vaccine (MCV1) was maintained >90% since 2013 while MCV2 increased gradually reaching 88% in 2022., Conclusions: Accumulation of susceptible children to measles due to suboptimal measles vaccination coverage over the years has resulted in an increase in the number of laboratory-confirmed measles cases in Tanzania with more cases recorded during the COVID-19 pandemic. Strengthening surveillance, routine immunization, and targeted strategies are key to achieving the immunity levels required to interrupt measles outbreaks., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Each film coated tablet of amoxicillin/clavulanic acid contains 500 mg of amoxicillin as an active pharmaceutical ingredient and 125 mg of clavulanic acid. Different brands have the same active ingredients but different excipients, which may cause differences in efficacy. With the emergence of generic antibiotics post-patent expiration, the antibiotic activity of generics is in question in comparison to the innovator. This study aims at determining the pharmaceutical quality and in-vitro antimicrobial activity of different brands of amoxicillin/clavulanate., Method: ology: The study was a cross-sectional laboratory-based experimental study conducted at the TMDA (Tanzania Medicines and Medical Devices Authority) Lake Zone laboratory and the CUHAS Microbiology Laboratory from in May 2021. The study samples were four brands of amoxicillin/clavulanate and sixty archived isolates, thirty of which were E. coli and the remaining thirty K. pneumoniae . Determination of minimum inhibitory concentrations, assay and dissolution test results were used to make conclusions for the study., Results: All tablets samples complied with the British pharmacopeia (BP) specifications, however sixty archived isolates which were tested in this study showed resistance towards the standard AMC disc (68 %). The innovator brand (AC1) showed significant mean difference from 2 out of 3 generics (p-values <0.05) while the first generic brand (AC2) showed significant superiority among the generics., Conclusion: Thus, the four samples that were used all complied with the specifications according to BP on dissolution and assay tests but there was an overall resistance towards amoxicillin/clavulanate, and this was moreover seen by generic brands in comparison to the innovator which proved to be of superior activity., Competing Interests: The authors declare that they have no competing interests., (© 2023 The Authors.)

Background: Too few pharmacists receive formal training on substandard and falsified (SF) medical products. Strengthening knowledge across pharmacists is considered a moral and ethical duty of academia, that is, to build the health systems' capacities to combat this global health threat these poor-quality products represent. This study therefore aimed to evaluate whether a dedicated educational course for undergraduate pharmacy students can improve their knowledge on these products., Methods: A survey was conducted at three sub-Saharan universities. Knowledge was assessed through scores on a 20-point questionnaire with questions related to the course content. Scores were compared before and after the course, and a linear mixed-effects model analysis was used to analyse score differences. Students were furthermore asked for feedback and self-assessment. In addition, teachers were interviewed on the context of the course introduction. These data were analysed descriptively., Results: Among 335 out of 355 students who completed the survey (n=41/53 in Cameroon, n=244/252 in Senegal and n=50/50 in Tanzania), knowledge of SF medical products was enhanced, with increase in all countries, overall, by 3.5 (95% CI 3.1 to 3.9) score points. Students improved in all offered modules in each country. Students confirmed their improvement through self-assessment.The course was well received among students and teachers. Barriers included time constraints and access to practical means (equipment availability, room allocation, internet accessibility and affordability). These barriers can be overcome by key enablers such as the support from university leadership and early involvement of the university in the course design., Conclusions: The course improved students' knowledge on SF medical products. These findings encourage further full implementation of this course in existing curricula beyond the pilot and can inform possible future scale-up. This has a potential for reinforcing the capacity of health systems to protect communities from SF medicines, by empowering all pharmacist across the health systems to intervene., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market., Methods: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV's that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review., Results: A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements., Conclusions: The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market., (© 2021. The Author(s).)

Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems., Methods: An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance., Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification., Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: DM and ML are employees of the Bill & Melinda Gates Foundation which funds the EAC MRH initiative.

Introduction: Adequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda., Methodology: An exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure., Results: The average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11), 98.7% (USD 10,302,295.25) and 100% (USD 7,375,802.08) for Zanzibar Food & Drugs Agency (ZFDA), Uganda National Drug Authority (NDA) and Tanzania Medicines and Medical Devices Authority (TMDA) respectively. Governments, industry fees and donors are the major sources of funding across all NMRAs in the EAC region, with TMDA and Uganda NDA relying more on industry fees by 73.20% (USD 4,664,777.59) and 98.25% (USD 8,077,238.20) respectively. While Burundi relies solely on government funding, ZFDA, on the other hand, received on average 50.40% (USD 252,557.22) from government and 40.60% (USD 165,303.34) from industry fees and the remaining 9% from donors and other sources. An overall contribution of funds received from donors by each NMRA was the least among other sources of financing. Observation of expenditure patterns indicated operational costs to be the major expense in the majority of the NMRAs, followed by salaries and infrastructure development. The Kenya NMRA has the highest degree of average expenditure across all three categories, with the least average expenditures being marked by Burundi NMRA. The operational costs on average increased considerably in all the NMRAs during the study period., Conclusion: Evidence from the EAC suggests that government and industry fees are the main sources of funding while donor contributions vary from country to country. Government policy, legal framework, and fees structure are the key enablers of NMRAs funding sustainability., Competing Interests: The authors have declared that no competing interests exist.

Background: Albendazole is an orally administered broad-spectrum anthelmintic. Currently it is mostly used in the treatment of soil transmitted helminthes, hydatidosis and neurocysticercosis caused Taenia solium. Aim of the study. To develop and optimize a formulation of chewable albendazole tablet with improved dissolution rate., Methodology: This study was specifically focused on formulation development which passes compatibility studies and optimization of the developed formulation. The formulations were evaluated on assay, dissolution, friability, hardness, weight variation, disintegration and similarity in comparison with the reference product on the market. Analysis was required to be undertaken by High performance thin layer chromatography (HPTLC) analytical methods. Design of Expert version 7 software was used for selection or making scientific decisions in selecting the best composition of the best formulation., Results: Five formulations out of ten (F-6, F-7, F-8, F-9 and F10) had all parameters in acceptable range. On optimization, one formulation with independent variables, Sodium Laury Sulphate (SLS) 1.911%, polyvinyl pyrrolidone (PVP-K30) 3.128%, and Sodium Cross carmellose (CCM) 4.95% was selected out of ten predictions made with Design expert version 7.0. It was found that assay of the best formulation is 99.23% which was within the in-house assay specification 95-105%. Dissolution single point in 30 min was found to be 91.5% disintegration between 2-5 min and friability 0.45%.The optimized formulation was tested and found to be within the acceptable limits. The formulation was comparable to the reference product on the market with similarity factor (f2) 62 and difference factor (f1) of 6 at pH1.2., Conclusion: A new generic albendazole tablet with improved dissolution rate was formulated, developed and optimized by using a wet granulation method., (© 2019 The Author(s).)

Background: To assess the extent to which foreign pharmaceutical imports vary from year to year and identifying leading generic and branded formulations, key countries and key importers of pharmaceuticals in private sector supply chain., Methodology: A systematic analysis of data for pharmaceutical imports from the Ministry of Health.Data from 2013 to 2016 fiscal years and relevant documents were accessed from the Tanzania Food and Drugs Authority (TFDA). Data cleaning was carried out to remove duplicate entries and to exclude pharmaceutical imports for individual uses, promotion purpose, donations, raw material, medical devices, government institutions and veterinary products., Results: A total of 397 different suppliers imported pharmaceutical in Tanzania mainland from 2013 to 2016 fiscal years. In the 2013-2014 fiscal year, the private sector suppliers imported pharmaceutical worth 216 U.S million dollars. India ranked as the first country for exporting highest value of pharmaceutical into the country. It displays a 54% cumulative market share of total imports from 2013-2016, followed by Egypt (11.7%), Switzerland and the USA hold 4.1% of cumulative market share. By 2020-2021 fiscal years, we forecast for imported pharmaceuticals to reach a total value of 906 U.S million dollars for the private sector supply chain. All analysis in this study and the forecasted figures are limited to private sector pharmaceutical supply chain only and does not include data for government pharmaceutical supply chain., Conclusions: Our result shows that the vast majority of pharmaceutical imports in the private sector supply chain are dominated by imports from India. India is competing with other countries such as Egypt, Switzerland, USA and South Africa among the top importing countries. There was almost an equal distribution of pharmaceutical for both communicable and non-communicable diseases. Data presented shows a growing trend for the market segment for medicines required for the management of non-communicable diseases. Generally, the private sector pharmaceutical market is keeping on rising at a rapid pace. By the year 2021, the growth is forecasted to increase by 28% compared to the current market value. The projected growth rate could be good news for foreign pharmaceutical companies seeking new sources of growth in international pharmaceutical trading. It is also good news to the poor patients if the availability of drugs previously unavailable in the country is significantly increased., Competing Interests: The authors have declared that no competing interests exist.

Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs' capacity in Africa.

The usage of fixed dose combination (FDC) tablets of Lamivudine and Tenofovir Disoproxil Fumarate (TDF) is increasing due to increased incidences of HIV/Hepatitis B and HIV/TB co-infections. This is likely to increase the financial crisis due to limited resources for funding procurement of ready-made products from the pharmaceuticals manufacturing leading countries. Therefore, production of local oral tablets containing Lamivudine and TDF FDC is inevitable. Lamivudine 300 mg/TDF 300 mg tablets were developed and optimized by D-optimal mixture design and produced by direct compression technique. Twenty trial formulations with independent variables, including PVP-CL 1-12.00%, PVP-K30 1-10.00%, starch-1500 2.5-12.5% and Avicel-PH102 2-19.25% were prepared by direct compression technique. The formulations were assessed on assay, dissolution, friability, weight variation and disintegration time. It was found that assay ranged from 98.13-101.95% for Lamivudine, 98.25-102.84 for TDF, both were within the in-house assay specification of 95 to 105%. Dissolution at single point was above 80% for Lamivudine 93.96-100.55% and 95.85-103.15% for TDF, disintegration time was between 1.92-66.33 min and friability 0.06-12.56%. Out of twenty formulation trials, eight formulations had all parameters in proven acceptable range. On optimization, one formulation with independent variables, PVP-CL 5.67%, PVP-K30 1.00%, Starch-1500 5.76% was selected. The optimized formulation was comparable to the reference product on the market with similarity factor (f2) and difference factor (f1) within the acceptable range for both Lamivudine and TDF.

Introduction: The purpose of this study was to investigate the quality of a select group of medicines sold in accredited drug dispensing outlets (ADDOs) and pharmacies in different regions of Tanzania as part of an in-depth cross-sectional assessment of community access to medicines and community use of medicines., Methods: We collected 242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine from selected ADDOs and pharmacies in Mbeya, Morogoro, Singida, and Tanga regions. The analysis included physical examination and testing with validated analytical techniques. Assays for eight of nine products were conducted using high-performance thin-layer chromatography (HPTLC). For ALu tablets, we used a two-tiered approach, where tier 1 was a semi-quantitative Global Pharma Health Fund-Minilab® method and tier 2 was high-performance liquid chromatography (HPLC) as described in The International Pharmacopoeia's monograph for artemether-lumefantrine., Results and Discussion: The physical examination of samples revealed no defects in the solid and oral liquid dosage forms, but unusual discoloration in an injectable solution, ergometrine maleate. For ALu, the results showed that of 38 samples, 31 (81.6%) passed tier 1 testing and 7 (18.4%) gave inconclusive drug content results. The inconclusive ALu samples were submitted for tier 2 testing and all met the quality standards. The pass rate using the HPTLC and TLC/HPLC assays was 93.8%; the failures were the ergometrine maleate samples purchased from both ADDOs and pharmacies. The disintegration testing of the solid dosage forms was conducted in accordance with US Pharmacopeia monographs. Only two samples of paracetamol, 1.2% of the solid dosage forms, failed to comply to standards. The study revealed a high overall rate of 92.6% of samples that met the quality standards. Although the overall failure rate was 7.4%, it is important to note that this was largely limited to one product and likely due to poor distribution and storage rather than poor manufacturing practices., Conclusions: Over 90% of the medicines sold in ADDOs and pharmacies met quality standards. Policy makers need to reconsider ergometrine maleate's place on the list of medicines that ADDOs are allowed to dispense, by either substituting a more temperature-stable therapeutically equivalent product or requiring those sites to have refrigerators, which is not a feasible option for rural Tanzania., Competing Interests: The authors have declared that no competing interests exist.

A simple, cost effective, accurate, and precise RP-HPLC method was developed for the simultaneous determination of sulfalene and sulfadoxine in fixed dose dual combinations with pyrimethamine together with their related substances. Proprietary products containing these combinations are often being prescribed in malaria endemic countries. Quantification of the active compounds and impurity profiling was achieved using two standard C18 columns with a mobile phase being composed of 60% (v/v) of a 0.05M KH2PO4 buffer solution (pH=2.6) and 40% (v/v) of methanol, applying an isocratic elution mode and a detection wavelength of 215nm. The method allows a quick quantitative determination of sulfadoxine and sulfalene and the separation of the respective impurities within a total runtime of approximately 15min and was validated with respect to specificity, linearity, precision, accuracy, limits of detection and quantification, robustness, and stability of the standard and sample solutions. The method is simpler than the corresponding method described in the International Pharmacopoeia and the United States Pharmacopoeia in terms of being easy to apply, being less time consuming, and utilizing reagents and chemicals which are cost efficient., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: There is a great need for physicians in Tanzania. In 2012, there were approximately 0.31 physicians per 10,000 individuals nationwide, with a lower ratio in the rural areas, where the majority of the population resides. In response, universities across Tanzania have greatly increased the enrollment of medical students. Yet evidence suggests high attrition of medical graduates to other professions and emigration from rural areas where they are most needed., Objective: To estimate the future number of physicians practicing in Tanzania and the potential impact of interventions to improve retention, we built a model that tracks medical students from enrollment through clinical practice, from 1990 to 2025., Design: We designed a Markov process with 92 potential states capturing the movement of 25,000 medical students and physicians from medical training through employment. Work possibilities included clinical practice (divided into rural or urban, public or private), non-clinical work, and emigration. We populated and calibrated the model using a national 2005/2006 physician mapping survey, as well as graduation records, graduate tracking surveys, and other available data., Results: The model projects massive losses to clinical practice between 2016 and 2025, especially in rural areas. Approximately 56% of all medical school students enrolled between 2011 and 2020 will not be practicing medicine in Tanzania in 2025. Even with these losses, the model forecasts an increase in the physician-to-population ratio to 1.4 per 10,000 by 2025. Increasing the absorption of recent graduates into the public sector and/or developing a rural training track would ameliorate physician attrition in the most underserved areas., Conclusions: Tanzania is making significant investments in the training of physicians. Without linking these doctors to employment and ensuring their retention, the majority of this investment in medical education will be jeopardized.

Thin-layer chromatography (TLC) has a myriad of separation applications in chemistry, biology, and pharmacology due to its simplicity and low cost. While benchtop laboratory sample application and detection systems for TLC provide accurate quantitation of TLC spot positions and densities, there are many applications where inexpensive and portable instruments would greatly expand the applicability of the technology. In this work, we demonstrate identity verification and concentration determination of pharmaceutical compounds via TLC using a custom 3D-printed cradle that interfaces with an ordinary mobile phone. The cradle holds the mobile phone's internal, rear-facing camera in a fixed position relative to a UV lamp and a TLC plate that includes a phosphor in the stationary phase. Analysis of photographs thus reveals the locations and intensities of principal spots of UV--absorbing drugs. Automated image analysis software determines the center location and density of dark spots, which, using integrated calibration spots of known drug compounds and concentrations, can be used to determine if a drug has been diluted or substituted. Two independent image processing approaches have been developed that may be selected based upon the processing capabilities of the smartphone. Each approach is able to discern 5% drug concentration differences. Using single-component solutions of nevirapine, amodiaquine, and paracetamol that have been manually applied, the mobile phone-based detection instrument provides measurements that are equivalent to those obtained with a commercially available lab-based desktop TLC densitometer., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Objective: To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme., Methods: Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations)., Results: Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance., Conclusions: This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost-effective than traditional pharmaceutical testing techniques., (© 2015 John Wiley & Sons Ltd.)

In this paper, a reliable stability-indicating generic MEEKC method for the analysis of five commonly used fluoroquinolones (FQs) has been developed and optimized by a central composite circumscribed experimental design. The separation was carried out using a fused silica capillary (60.2 cm total length) and a microemulsion (ME) composed of 81.75% (w/w) of a 125 mM NaH 2 PO 4 solution having a pH of 2.75, 2.65% (w/w) SDS, 1.00% (w/w) n-octanol, 6.60% (w/w) n-butanol and 8.00% (w/w) 2-propanol. A voltage of 28 kV was applied in a reverse polarity mode. A linear relationship was established from 0.04 to 0.48 mg/ml with R 2 values higher than 0.98 for all five FQs. Both repeatability and intermediate precision were less than 3% and accuracy ranging from 97 to 100%. Of note, ciprofloxacin impurity A and ofloxacin impurity A could be separated from the respective drug substance in a single run which cannot be achieved using the official HPLC method from the European Pharmacopoeia. Forced degradation of all FQs under heat, in acidic and alkaline medium, in the presence of oxidizing agents and under neutral hydrolysis conditions was investigated. The highest yield of degradation products was observed using oxidative hydrogen peroxide. Hence, the proposed MEEKC method can be used for the quantitative determination of the five FQs and their potential impurities within a total runtime of 20 min., (© 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Objective: To assess the sustainability, robustness and economic advantages of high-performance thin layer chromatography (HPTLC) for quality control of pharmaceutical products., Method: We compared three laboratories where three lots of cotrimoxazole tablets were assessed using different techniques for quantifying the active ingredient., Result: The average assay relative standard deviation for the three lots was 1.2 with a range of 0.65-2.0., Conclusion: High-performance thin layer chromatography assessments are yielding valid results suitable for assessing product quality. The local pharmaceutical manufacturer had evolved the capacity to produce very high quality products., (© 2014 John Wiley & Sons Ltd.)

This review article discusses the sustainability and robust advantages of planar chromatography that are critical to the successful performance of product quality assessments in resource limited areas including field applications. Because of the robustness and ease of use, the training required for successful performance of the high performance thin layer chromatography (HPTLC) assessments is much lower than that of other technologies with comparable reproducibility such as high performance liquid chromatography (HPLC). Some of the successful applications of planar chromatography in resource limited countries are presented. It should be noted that these planar chromatographic technologies have much lower plate counts and therefore separation power than column technologies such as HPLC and gas liquid chromatography (GLC). However in finished pharmaceutical products there are generally few active ingredients which are assessed making the HPTLC adequate for these analyses. In addition at this time there is a much wider array of detection technologies available for HPLC and GLC., (Copyright © 2010 Elsevier B.V. All rights reserved.)

Two laboratories extensively investigated the use of HPTLC to perform assays on lamivudine-zidovudine, metronidazole, nevirapine, and quinine composite samples. To minimize the effects of differences in analysts' technique, the laboratories conducted the study with automatic sample application devices in conjunction with variable-wavelength scanning densitometers to evaluate the plates. The HPTLC procedures used relatively innocuous, inexpensive, and readily available chromatography solvents used in the Kenyon or the Global Pharma Health Fund Minilabs TLC methods. The use of automatic sample applications in conjunction with variable- wavelength scanning densitometry demonstrated an average repeatability or within-laboratory RSD of 1.90%, with 73% less than 2% and 97% at 2.60% or less, and an average reproducibility or among-laboratory RSD of 2.74%.

Background: Malaria is a highly debilitating and frequently fatal disease of wide distribution. Improper drug storage and rampant self-medication are some of the factors that may contribute to an increase in the development of drug resistance by malaria parasites towards antimalarials., Objectives: To determine the extent of antimalarial drugs storage, sources and associated factors at household level at Kiromo ward in Bagamoyo, Coast region, Tanzania after the introduction of SP replacing chloroquine as first line., Methods: A total of 300 households from three villages making up Kiromo ward were included in this study. Swahili version of the questionnaire and a checklist were used in data collection., Results: Of the 300 households visited 25 (8.3%) were found to store antimalarials. The most commonly stored antimalarials were amodiaquine (30.8%) and quinine (34.6%). Most of these were in tablet form (76.9%). The source of these drugs was mostly from dispensaries. Kiromo was the only dispensary in the ward and others were outside the ward. These drugs were stored in special containers for safety. Frequent episodes of illness in the family were given as the most (56%) common reasons for drug storage in the families, followed by distance (20%). There was a statistically significant (p<0.05) association between storage of antimalarial drugs and number of children in the family and presence of a family member with febrile illness. The study further showed that out of 26 different types of antimalarials stored, only 7 (26.9%) had expiry dates on the containers because these were original containers of the drugs., Conclusion: The study revealed that few households store antimalarial drugs with amodiaquine and quinine being the most stored. The majority of the households obtained antimalarial drugs from dispensaries. Health education should be given not only to the patients but also the entire general public on the appropriate drug use, safety, expiry dates and appropriate storage. A model dispensary like Kiromo should be implemented in other rural areas.

We describe the development of a capillary electrophoresis method for the determination of gentamicin C1, C1a, C2a, and C2 components in human serum. Using a weak cation-exchanger with 20 mM phosphate buffer, pH 7.4, 200 mM borate buffer, pH 9.0, and ammonia/methanol, solid-phase extraction (SPE) of gentamicin components from the human sera was performed. The extract was derivatized with 1,2-phthalic dicarboxaldehyde/mercaptoacetic acid reagent. The derivatives were separated with a background electrolyte comprising 60 mM 2-(N-cyclohexylamino)ethanesulfonic acid (CHES) buffer at pH 9.5 containing 31.6% m/v methanol, and quantified with UV-light absorption detection at 230 nm. The identity of the gentamicin components was confirmed by mass spectrometry. The SPE recovery of the gentamicin ranged from 78% to 93%. The calibration curves were linear from the concentration limit of quantitation (LOQ) to 30 mg/L for the gentamicin mixture. The LOQ for gentamicin C1 was 0.33 mg/L, for C2a 0.23 mg/L, C2 0.25 mg/L, C1a 0.27 mg/L and the concentration limit of detection (LOD) for C1 was 0.15 mg/L, C2a 0.11 mg/L, C2 0.12 mg/L, C1a 0.13 mg/L. Intra-assay relative standard deviation (RSD) values were for C1 (5%), C1a (7%), C2 (6.5%) and C2a (9%); inter-assay RSD values were for C1 (11%), C1a (13.3%), C2 (15%) and C2a (14%). The Pearson's correlation between capillary electrophoresis and immunoassay revealed a linear relationship between these two techniques with r = 0.9. This method for determination of gentamicin C1, C1a, C2a, and C2 in human serum can thus be used in the entire therapeutic concentrations range of gentamicin.

Aminoglycoside antibiotics are widely used to treat serious Gram-negative and Gram-positive bacterial infections. The lack of a UV chromophore presents a problem in the analysis of aminoglycosides. Derivatization with 1,2-phthalic dicarboxaldehyde (OPA) in the presence of a thiol made it possible to introduce a UV chromophoric thioisoindole moiety. A qualitative mass spectrometry study was carried out to confirm the molecular identity of the products formed. The conditions described earlier to derivatize gentamicin and kanamycin yielded products in which all primary amino groups are fully derivatized. On the other hand, with tobramycin and amikacin, there was also formation of incompletely derivatized products that contained one thioisoindole group less than the fully derivatized product. This study has therefore brought an additional insight into the nature of the OPA-aminoglycoside derivatives studied., ((c) 2005 John Wiley & Sons, Ltd.)

A method based on solid-phase extraction (SPE) and capillary zone electrophoresis (CZE) for the analysis of tobramycin in human serum is presented. An off-line SPE employing a carboxypropyl bonded phase (CBA) cartridge was used for the extraction of tobramycin from human serum. Adsorbed tobramycin was eluted from the CBA cartridge using a mixture of NH(3) (25%, w/v)-methanol (30:70, v/v). After evaporation, the analyte was reconstituted and derivatized with o-phthaldialdehyde (OPA)/3-mercaptopropionic acid (MPA). The resulting tobramycin-OPA/MPA derivative was purified, and then identified by mass spectrometry. The tobramycin-OPA/MPA derivative was then analysed by CZE with a background electrolyte (BGE) comprising of 30 mM sodium tetraborate pH 10.0-acetonitrile (ACN) (80:20, v/v) with ultraviolet detection at 230 nm. A linear response was observed in the range of 0.3-30 microg/ml with r(2) = 0.992. The sensitivity of the method was determined by its limit of quantitation (LOQ) and limit of detection (LOD) of 0.3 microg/ml and 0.1 microg/ml, respectively. SPE recovery ranged from 68 to 79% at the trough levels to 98% at the peak levels found in serum. Furosemide has been added as internal standard (IS) to improve precision. For the therapeutic range of tobramycin in serum (2-10 microg/ml) the relative standard deviation (R.S.D.) was less than 11% for the entire SPE/CE process. The method demonstrated excellent selectivity as shown by the lack of interference from a total of 20 drugs investigated. The method was then used in therapeutic drug monitoring of patients receiving the drug.

Recent developments in the use of capillary electrophoretic techniques for the in-line study of enzyme reactions and derivatization protocols are reviewed. The article is divided into two parts: (i) in-line enzyme reactions and (ii) in-line derivatization. The first part introduces electrophoretically mediated microanalysis (EMMA) and discusses and illustrates the different modes of EMMA. A literature overview is provided, starting from 1996, and the investigated enzymes are classified into two tables based on the mode of engagement (i.e., continuous or transient) of the developed EMMA-based assay. The second part starts with an introduction of the procedures and the nomenclature used in the area of in-line derivatization protocols based on EMMA. Reported derivatization procedures are discussed and classified in tables, according to the functional group that is derivatized.

An electrophoretically mediated microanalysis (EMMA) approach, used to perform on-line chemistry between two small molecules, has been characterized and optimized. The plug-plug type EMMA method involved electrophoretic mixing and subsequent reaction of nanoliter plugs of kanamycin-containing samples and 1,2-phthalic dicarboxaldehyde and mercaptoacetic acid within the confines of the capillary column, which acts as a microreactor. Analyses were performed by pressure-injecting a plug of kanamycin sandwiched in two reagent plugs. A potential of 375 Vcm(-1) was then applied to electrophoretically mix the two reactants, and an incubation time of up to 5 min allowed the reaction to proceed prior to the application of a separation potential of 588 Vcm(-1). UV detection was at 335 nm. The background electrolyte was 30 mM sodium tetraborate at pH 10.0, containing 16% of methanol. The method was validated in terms of linearity, limits of quantitation and detection, and precision. The method allows determination of kanamycin in bulk samples as a fully automated procedure.

A reversed-phase liquid chromatography (LC) method has been developed, optimised and validated for the separation and quantitation of capsaicin (CP) and dihydrocapsaicin (DHCP) in a topical cream formulation. Sample preparation involves liquid-liquid extraction prior to LC analysis. The method uses a Hypersil C(18) BDS, 5 micrometer, 250x4.6 mm I.D. column maintained at 35 degrees C. The mobile phase comprises methanol, water, acetonitrile (ACN) and acetic acid (47:42:10:1, v/v/v/v) at a flow rate of 1.0 ml/min. Robustness was evaluated by performing a central composite face-centred design (CCF) experiment. The method shows good selectivity, linearity, sensitivity and repeatability. The conditions allow the separation and quantitation of CP and DHCP without interference from the other substances contained in the cream.

One of the major drawbacks in the analysis of aminoglycoside antibiotics is their lack of UV chromophore and/or fluorophore. Tobramycin, a representative member of this group, was examined in this study. To overcome the detection hurdle, a precapillary derivatization followed by capillary electrophoresis analysis with direct UV detection was investigated. A central composite design was applied to optimize the method and three parameters were selected in this study: buffer pH, temperature and % acetonitrile (ACN). Selectivity between tobramycin main component and its adjacent peaks as well as the peak efficiency and symmetry factors were established as responses. For each response, a model was obtained by a second-order mathematical expression. Successful results were obtained with a simple background electrolyte (BGE) containing 30 mM sodium tetraborate, pH 10.2, and ACN (75:25 v/v). Under these conditions, baseline separation of tobramycin from its adjacent kanamycin B and an unknown peak was achieved. A temperature of 20 degrees C and applied voltage of 28.0 kV were used. The method showed good validation data in terms of precision, limits of quantitation and detection, specificity and linearity and was found to be suitable for analysis of tobramycin bulk pharmaceutical samples.

This paper describes a system for integration of a one-step-microscale chemical derivatization and analysis by a methodology known as electrophoretically mediated microanalysis (EMMA). Differential electrophoretic mobility between an analyte, reagent, and their product offers EMMA a unique capability to selectively carry out electrophoretic mixing, control product formation, and separation. This system was successfully applied to perform derivatization and separation of the multicomponent aminoglycoside antibiotic gentamicin using 1,2-phthalic dicarboxaldehyde and mercaptoacetic acid as labeling reagents. A multivariate approach based on central composite experimental design was used to optimize the derivative yield. Full automation of the derivatization and analytical procedure, high derivatization efficiency, high sample throughput, and precision are the excellent features of the present method. In addition, this methodology offers short analysis time, as well as selectivity and sensitivity suitable for impurities determination. Separation of gentamicin C1, C1a, C2, C2a, C2b, sisomicin, and several minor components was achieved. For the first time separation and identification of three impurities, namely garamine, 2-deoxystreptamine, and paromamine are described.

A selective, sensitive, and rapid pre-capillary derivatization method for determination of the multicomponent aminoglycoside antibiotic gentamicin is described. The derivatization reagents 1,2-phthalic dicarboxaldehyde and mercaptoacetic acid were used and the thioisoindole derivative was UV detected at 330 nm. A central composite experimental design was performed to optimize selectivity and derivatization conditions. Baseline separation of gentamicin C1, C1a, C2, C2a, C2b, sisomicin and several minor components was achieved with a background electrolyte containing 30 mM sodium tetraborate, 7.5 mM beta-cyclodextrin and 12.5% (v/v) methanol at pH 10. Quantitative analysis was performed and illustrated the potential use of capillary electrophoresis for the identification and quantitation of gentamicin as an alternative to methods prescribed in the United States Pharmacopeia and European Pharmacopoeia.