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Guaifenesin (GUA) is determined in dosage forms and plasma using two methods. The spectrofluorimetric technique relies on the measurement of native fluorescence intensity at 302 nm upon excitation wavelength "223 nm". The method was validated according to ICH and FDA guidelines. A concentration range of 0.1–1.1 μg/mL was used, with limit of detection (LOD) and quantification (LOQ) values 0.03 and 0.08 µg/mL, respectively. This method was used to measure GUA in tablets and plasma, with %recovery of 100.44% ± 0.037 and 101.03% ± 0.751. Furthermore, multivariate chemometric-assisted spectrophotometric methods are used for the determination of GUA, paracetamol (PARA), oxomemazine (OXO), and sodium benzoate (SB) in their lab mixtures. The concentration ranges of 2.0–10.0, 4.0–16.0, 2.0–10.0, and 3.0–10.0 µg/mL for OXO, GUA, PARA, and SB; respectively, were used. LOD and LOQ were 0.33, 0.68, 0.28, and 0.29 µg/mL, and 1.00, 2.06, 0.84, and 0.87 µg/mL for PARA, GUA, OXO, and SB. For the suppository application, the partial least square (PLS) model was used with %recovery 98.49% ± 0.5, 98.51% ± 0.64, 100.21% ± 0.36 & 98.13% ± 0.51, although the multivariate curve resolution alternating least-squares (MCR-ALS) model was used with %recovery 101.39 ± 0.45, 99.19 ± 0.2, 100.24 ± 0.12, and 98.61 ± 0.32 for OXO, GUA, PARA, and SB. Analytical Eco-scale and Analytical Greenness Assessment were used to assess the greenness level of our techniques. [ABSTRACT FROM AUTHOR]

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Background: This study aimed to assess the correlation between serum levels of anti-Mullerian hormone (AMH), basal folliclestimulating hormone (FSH), basal luteinizing hormone (LH), and basal estradiol with pregnancy outcomes. Methods: Conducted at Shariati Hospital in Tehran from 2020 to 2021, this prospective cohort study included women under 38 years old with idiopathic recurrent miscarriage (IRM). Individuals with AMH levels below 1 ng/mL were classified as the poor responder group. All participants with IRM received a daily combination of 20 mg prednisolone and 200 mg progesterone vaginal suppositories from the beginning of pregnancy until 12 weeks, along with aspirin and folic acid. Pregnancy was monitored until 36 weeks, and outcomes were evaluated over two years using univariate and multiple logistic regression, with P-values < 0.05 considered significant. Results: The study comprised 128 individuals with a mean age of 36.4 ± 3.9 years. Of these, 80 became pregnant, while 48 did not. Among the pregnant individuals, 34 had terminations before 26 weeks (13 ongoing and 21 clinical), while 46 had pregnancies lasting 26 weeks or longer. Maternal age (RR = 1.23, 95% CI: 1.10 - 1.90, P = 0.001), history of abortion (RR = 1.262, 95% CI: 1.052 - 1.327, P = 0.008), and low serum AMH level (RR = 0.752, 95% CI: 0.227 - 0.934, P = 0.035) were significantly associated with the probability of subsequent pregnancies. Maternal age (RR = 1.108, 95% CI: 1.05 - 1.350, P = 0.025) and history of abortion (RR = 1.097, 95% CI: 1.02 - 1.161, P = 0.042) were the only factors associated with the risk of non-pregnancy. Conclusions: The study findings suggest that AMH levels in women with IRM significantly influence pregnancy outcomes, including abortion and live births at 26 weeks or more. The univariate analysis revealed significant correlations between age, serum AMH levels, previous history of abortion, and the risk of abortion. Additionally, AMH levels were found to relate to follicle storage rather than egg quality, indicating that AMH does not predict live birth after IVF. Overall, this prospective study underscores the importance of maternal age, AMH level, and previous abortion history in predicting pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Objective: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underlying the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Palmitoylethanolamide, Epilobium and Calendula extract in patients with CP/CPPS III. Materials and methods: From June 2023 to July 2023, we enrolled 45 consecutive patients affected by CP/CPPS type III in three different institution. We included patients aged between 18 and 75 years with symptoms of pelvic pain for 3 months or more before the study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 12 point and diagnosed with NIH category III, according to 4-glass test Meares-Stamey test. Patients were then allocated to receive rectal suppositories of PEA, Epilobium and Calendula, 1 suppository/ die for 1 month. All patients have been tested with standard urinalysis in order to assess urinary leukocytes (U-WBC). The primary endpoint of the study was the reduction of NIHCPSI. The secondary outcomes were the change of peak flow, post-void residual (PVR), IIEF-5, VAS score, PSA and decrease of U-WBC. Results: A total of 45 patients concluded the study protocol. At baseline, the median age of all the patients included in the cohort was 49 years, the median PSA was 2.81 ng/ml, the median NIH-CPSI was 18.55, the median IIEF-5 was 18.27, the median U-WBC was 485.3/mmc, the median VAS score was 6.49, the median PVR was 26.5 ml and the median peak flow was 16.3 ml/s. After 1 month of therapy we observed a statistically significant improvement of NIH-CPSI, U-WBC, PSA, IIEF-5, peak flow, PVR and VAS. Conclusions: In this observational study, we showed the clinical efficacy of the treatment with PEA, Epilobium and Calendula, 1 suppository/die for 1 month, in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cells in the urine that could imply a reduction of inflammatory cytokines. These results should be confirmed in further studies with greater sample size. [ABSTRACT FROM AUTHOR]

Background and aims: A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. Methods: Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. Results: Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by −4.6 ± 2.0, −4.4 ± 1.8, and −4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by −7.1 ± 4.5, −6.9 ± 5.4, and −7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. Conclusions: The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results. [ABSTRACT FROM AUTHOR]

No standardized pain management protocol exists for intracavitary brachytherapy, and various methods of analgesia have been used in different countries and institutions. This study aimed to investigate the effects of pain management during intracavitary brachytherapy using nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen suppositories. In this single-center, prospective, observational study, patients undergoing intracavitary brachytherapy for cervical cancer completed a questionnaire survey after each brachytherapy session, which comprised questions regarding pain intensity, satisfaction with analgesia, and desire for effective anesthesia. Data analysis was performed using data from 100 brachytherapy sessions of 27 patients. The median numerical rating scale (NRS; 0–10) score for each intracavitary brachytherapy session was 3–4. The median satisfaction scale score for analgesia (5-point scale, 1–5) for each session was approximately 4. Eight patients (29.6%) answered that they desired anesthesia more effective than suppositories at any session of brachytherapy. A comparison of the high (NRS ≥ 4) and low (NRS ≤ 3) NRS groups during the first session revealed that the high NRS group tended to have higher NRS scores and lower satisfaction with analgesia during all sessions. A positive correlation was observed between tumor size and the NRS score during the first brachytherapy session. The NRS score was approximately 3–4, and satisfaction with analgesia was approximately 4 out of 5 when NSAIDs or acetaminophen suppositories were used as analgesics during intracavitary brachytherapy for cervical cancer. Although the current pain management protocol is clinically acceptable, inadequate analgesia is indicated in approximately 30% of patients. [ABSTRACT FROM AUTHOR]

Three-dimensional (3D) printing has paved the way in pharmaceutical applications. This innovative methodology presents novel and inventive remedies for patients and the pharmaceutical sector. Moreover, the benefits of this approach encompass the mitigation of adverse effects, customization of formulations for patients with rare medical conditions, and enhancement of therapeutic effectiveness. The objective of our review was to offer a comprehensive survey of the advancements observed in the drug delivery systems that were produced. A thorough inspection has assessed the diverse dosage forms developed using the three-dimensional printing technique (3DP), especially in the last five years. The pharmaceutical industry places significant emphasis on the benefits of developing dosage forms with intricate designs and geometries, incorporating multiple active ingredients, and tailored release profiles due to their versatility and related advantages. Drug delivery systems can be classified into different modalities, tablets, capsules, suppositories, transdermal delivery systems, microneedles, vaginal delivery systems, and nanoscale dosage forms. The utilization of our classification system facilitates researchers' task of evaluating publications and effectively pinpointing further opportunities for research exploration. [ABSTRACT FROM AUTHOR]

Introduction: Hemorrhoidal disease is one of the most frequent causes of anal complaints. The general aim of this study was to evaluate the release profile of the encapsulated drug, in order to overcome the limitations of conventional galenic forms, while maintaining their efficacy. Methods: Determination of the active ingredient contained in Landolphia owariensis extract was carried out by UV-Visible spectrophotometry. Release studies were carried out in a continuous flow cell. The dissolution profile of the suppository containing microparticles was compared to the dissolution profile of suppositories containing the unencapsulated extract and to that of Landolphia owariensis extract-based microparticles. Results: The percentage of active ingredient released from suppositories containing microparticles and those containing the extract alone was 69.47% and 80.01% respectively. Flavonoid release from suppositories containing microparticles was slower, with a release rate of 6.31µg/mm, slightly close to the release rate of extract based microparticles (7.37µg/mn); in contrast, in vitro flavonoid release from suppositories containing the extract was faster (19.85µg/mm). Conclusion: Release trials have shown the influence of the sodium alginate matrix system on PA release kinetics. These innovative suppositories will help improve compliance and the treatment of hemorrhoidal crisis. [ABSTRACT FROM AUTHOR]

Background: Cervicitis is a prevalent gynecologic disease, which does not usually respond to conventional treatments. Long-term cervicitis can cause serious health problems such as inflammation, infertility, and cancer. Henna oil, an herbal product in Persian medicine, is recommended for uterine diseases like cervicitis. Objective: This study aims to evaluate the efficacy of Henna oil as a vaginal suppository in combination with an antibiotic regimen in the treatment of cervicitis. Materials and Methods: This randomized placebo-controlled trial, included 92 nonmenopausal women with cervicitis at the Baqaipur Clinic of Shahid Sadoughi hospital in Yazd and the Persian Medicine Health Center in Ardakan, Yazd, Iran. Participants were further divided into either the Henna oil vaginal suppository group or the placebo group (n = 46/each group). During the study, the antibiotic treatment was administered to both groups. Cervicitis symptoms were compared between the groups and within each group. Results: Of 92 included individuals, 41 in each group completed the study. Results revealed that significant differences were observed in some outcomes, including vaginal discharge (p < 0.001), cervical ulcer size (p < 0.001), dyspareunia (p = 0.046), and postcoital bleeding (p < 0.001), indicating that the treatment was more effective in the henna group compared to the placebo group. Conclusion: Findings supported that the vaginal suppository of Henna oil in combination with antibiotic therapy could be effective in the improvement of clinical symptoms of cervicitis regardless of its pathology. [ABSTRACT FROM AUTHOR]

The rectal route for drug administration is becoming attractive to drug formulators because there are no hepatic first-pass effects, it decreases gastrointestinal side effects, and it avoids undesirable food effects on drug absorption. Suppositories are recognized as an alternative to the oral dosage forms in situations such as when the patient is comatose, unable to swallow, nauseous, or vomiting. Effective drug delivery with appropriate pharmaceutical excipients is critical to producing clinically valuable preparations. The high cost of available excipients and other disadvantages have led to exploring potential excipients from natural sources. Allanblackia floribunda butter, a naturally occurring lipid, is used for medicinal, culinary, and cosmetic purposes. The butter was used as a base to formulate Paracetamol and Diclofenac suppositories. Quality control tests were conducted on the formulated suppositories, such as the Weight variation, hardness, disintegration time, and content uniformity. The suppositories passed all the quality control tests as the parameters assessed were within the acceptable range. The melting point ranges for all the suppositories were found to be satisfactory. The cumulative drug release (%) of the suppositories at 45 minutes was 90.19±0.00 (Hot water extract), 93.75±0.00 (Cold press extract), and 98.16±0.00 (Hexane extract) for Paracetamol suppositories. Diclofenac sodium suppositories had a cumulative percentage release of 81.60±0.00 (Hot water Extract), 95.33±0.00 (Cold press extract), and 99.20±0.00 (Hexane Extract). However, the release profiles of the drugs from the bases were similar (f2 > 50). The suppository formulation was successful, and the quality control tests conformed to Pharmacopoeia standards.

The rectal route for drug administration is becoming attractive to drug formulators because there are no hepatic first-pass effects, it decreases gastrointestinal side effects, and it avoids undesirable food effects on drug absorption. Suppositories are recognized as an alternative to the oral dosage forms in situations such as when the patient is comatose, unable to swallow, nauseous, or vomiting. Effective drug delivery with appropriate pharmaceutical excipients is critical to producing clinically valuable preparations. The high cost of available excipients and other disadvantages have led to exploring potential excipients from natural sources. Allanblackia floribunda butter, a naturally occurring lipid, is used for medicinal, culinary, and cosmetic purposes. The butter was used as a base to formulate Paracetamol and Diclofenac suppositories. Quality control tests were conducted on the formulated suppositories, such as the Weight variation, hardness, disintegration time, and content uniformity. The suppositories passed all the quality control tests as the parameters assessed were within the acceptable range. The melting point ranges for all the suppositories were found to be satisfactory. The cumulative drug release (%) of the suppositories at 45 minutes was 90.19±0.00 (Hot water extract), 93.75±0.00 (Cold press extract), and 98.16±0.00 (Hexane extract) for Paracetamol suppositories. Diclofenac sodium suppositories had a cumulative percentage release of 81.60±0.00 (Hot water Extract), 95.33±0.00 (Cold press extract), and 99.20±0.00 (Hexane Extract). However, the release profiles of the drugs from the bases were similar (f2 > 50). The suppository formulation was successful, and the quality control tests conformed to Pharmacopoeia standards. [ABSTRACT FROM AUTHOR]

Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study – where women were offered the dapivirine vaginal ring after two pivotal trials were completed – through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled (n = 60). Access to an effective user-initiated HIV prevention product was one of the main reasons women joined HOPE. Although many participants worried that their male partners might expose them to HIV, they chose to remain in their relationships and avoid conflict or confrontation with their partners by discreetly using the ring to protect themselves. Other reasons for joining were quality healthcare, reimbursement and altruism. Researchers should better understand social and personal motivators behind research participation in order to recognize community sociocultural norms and its influences on product acceptability and adherence challenges. [ABSTRACT FROM AUTHOR]

Objective: This study aims to determine the efficacy of the Acacia arabica (Lam.) Willd. and Cinnamomum camphora (L.) J. Presl. vaginal suppository in addressing heavy menstrual bleeding (HMB) and their impact on participants' health-related quality of life (HRQoL) analyzed using machine learning algorithms. Method: A total of 62 participants were enrolled in a double-dummy, singlecenter study. They were randomly assigned to either the suppository group (SG), receiving a formulation prepared with Acacia arabica gum (Gond Babul) and camphor from Cinnamomum camphora (Kafoor) through two vaginal suppositories (each weighing 3,500 mg) for 7 days at bedtime along with oral placebo capsules, or the tranexamic group (TG), receiving oral tranexamic acid (500 mg) twice a day for 5 days and two placebo vaginal suppositories during menstruation at bedtime for three consecutive menstrual cycles. The primary outcome was the pictorial blood loss assessment chart (PBLAC) for HMB, and secondary outcomes included hemoglobin level and SF-36 HRQoL questionnaire scores. Additionally, machine learning algorithms such as k-nearest neighbor (KNN), AdaBoost (AB), naive Bayes (NB), and random forest (RF) classifiers were employed for analysis. Results: In the SG and TG, the mean PBLAC score decreased from 635.322 ± 504.23 to 67.70 ± 22.37 and 512.93 ± 283.57 to 97.96 ± 39.25, respectively, at postintervention (TF3), demonstrating a statistically significant difference (p < 0.001). A higher percentage of participants in the SG achieved normal menstrual blood loss compared to the TG (93.5% vs 74.2%). The SG showed a considerable improvement in total SF-36 scores (73.56%) compared to the TG (65.65%), with a statistically significant difference (p < 0.001). Additionally, no serious adverse events were reported in either group. Notably, machine learning algorithms, particularly AB and KNN, demonstrated the highest accuracy within cross-validation models for both primary and secondary outcomes. Conclusion: The A. arabica and C. camphora vaginal suppository is effective, costeffective, and safe in controlling HMB. This botanical vaginal suppository provides a novel and innovative alternative to traditional interventions, demonstrating promise as an effective management approach for HMB. [ABSTRACT FROM AUTHOR]

Bacterial vaginosis (BV) can cause vaginal dysbiosis that may influence general vaginal health and pregnancy complications. Balancing vaginal microbiome using Lactobacillus spp. may be a new way to prevent and treat mild BV. We conducted a randomized, double-blind, placebo-controlled pilot study aimed at evaluating the effect of the product VagiBIOM, a multi-Lactobacillus vaginal suppository, on peri- and premenopausal women with BV in restoring vaginal pH and overall vaginal health by resetting the vaginal microbiome composition. Sixty-six peri- and premenopausal women with BV symptoms were randomized with a 2:1 ratio to be treated with VagiBIOM or placebo suppositories. Vaginal pH, VAS itching score, total Nugent score, and vaginal health index (VHI) were measured. Vaginal microbiome changes before and after the treatment were analyzed by 16S rRNA sequencing and bioinformatics analysis. After 4 weeks of intervention with VagiBIOM or a placebo, the mean score for vaginal pH, VAS itching, and total Nugent score was significantly decreased from the baseline. Compared to the baseline scores, the VHI scores improved significantly following 28-day intervention (p < 0.001). Our results revealed two Lactobacillus species, L. hamsteri, and L. helveticus, as indicator species occurring differentially in the VagiBIOM-treated group. Furthermore, the regression and species network analyses revealed significant bacterial associations after VagiBIOM treatment. Lactobacillus hamsteri was positively associated with the Nugent score and negatively associated with vaginal pH. L. iners and L. salivarius were positively and inversely associated with VHI. As is typical, Bacteroides fragilis was positively associated with vaginal pH and negatively associated with the Nugent score. Interestingly, the Lactobacillus spp. diversity improved after VagiBIOM treatment. The VagiBIOM suppository treatment for peri- and premenopausal women with BV significantly relieved vaginal itching by decreasing vaginal pH and Nugent scores and improving the overall VHI after 4 weeks' intervention. This effect was primarily the result of VagiBIOM improving vaginal Lactobacillus diversity. Trial Registration ClinicalTrials.gov registration: NCT05060029, first registration 09/28/2021: Title: A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH. [ABSTRACT FROM AUTHOR]

Vaginal atrophy is often underestimated in the routine practice of an obstetrician-gynecologist, as specialists expect active complaints from postmenopausal patients. At the same time, vaginal or urogenital atrophy can occur in women of any age due to temporary or permanent estrogen deficiency. Research continues to find effective and safe methods of treatment for this pathology in order to alleviate symptoms and improve the quality of life of women. The objective: to study the effectiveness of using vaginal suppositories in eliminating the manifestations of vaginal atrophy in women of reproductive age with primary ovarian insufficiency. Materials and methods. 23 women from 24 to 35 years old with primary ovarian insufficiency (POI) were involved in the study, they were divided into groups depending on the duration of the disease: I group – 8 women with POI duration up to 5 years, II group II – 8 women with POI duration from 5 to 7 years, III group – 7 patients with a duration of POI of more than 7 years. The set of examinations carried out before the start of the study and after treatment included an assessment of the patients’ complaints, speculum examination of the vagina and cervix with the determination of the vaginal health index in points, study of the condition of the vaginal microbiota (pH-metry, bacterioscopic examination of smears of vaginal secretions). Results. Despite receiving systemic menopausal hormone therapy, all patients had varying intensity of vaginal atrophy, while the frequency and severity of disorders increased with increasing duration of the course of POI. As the duration of POI increased, the frequency and severity of vaginal dryness, bloody discharge during intercourse increased, and the frequency of abnormal vaginal discharge decreased. Manifest vaginal atrophy was diagnosed in 12.5% of patients in I group, 37.5% of patients in II group and 71.4% of patients in III group, moderate atrophy in 37.5%, 37.5% and 28.6% of women, respectively. The obtained data indicate a gradual progression of the phenomena of vaginal atrophy in patients with POI. After treatment, there was a tendency to decrease the pH values of the vaginal contents from 5.6–5.8 to 4.7. The dynamics of patients’ complaints showed that the effectiveness of using vaginal suppositories is the highest for the duration of POI up to 5 years, and for a longer duration of vaginal atrophy, it is 80.0%. At the stage of inclusion in the study, no normocenosis was detected in any of the examined patients (100%), the intermediate state of the microbiota prevailed – 73.9%, nonspecific vaginitis was diagnosed in 13.0% of patients, and bacterial vaginosis in 13.0%. After a course of treatment with vaginal suppositories, vaginal normocenosis was diagnosed in 52.2% of patients, an intermediate state of microbiota in 56.5% in the absence of inflammatory and dysbiotic changes. The effectiveness of normalizing the condition of the vaginal microbiota was 73.9%. Conclusions. Vaginal suppositories are an original combination of components with a pronounced reparative, antipruritic, anti-inflammatory effect, which helps to eliminate the inflammatory process in the vulvovaginal area, support intensive regeneration of the vaginal mucosa and its moisture, restore the physiological protective barrier of the mucous membrane, improve local blood microcirculation, eliminate the itching, discomfort and dryness, normalization of the condition of the vaginal microbiota. [ABSTRACT FROM AUTHOR]

Background: Various medications such as opioids and non-steroidal anti-inflammatory drugs (NSAIDs) are used to alleviate discomfort following caesarean surgery. Particular attention has been paid to NSAIDs due to complications of opioids, and doctors use these medications as useful analgesics to manage various forms of pain. This research was conducted to evaluate the effect of either diclofenac suppository, intravenous acetaminophen or their combination on reduction of the severity of postoperative pain in patients undergoing caesarean section spinal analgesia. Methods: This was comparative prospective interventional clinical study in Zagazig University Maternity Hospital during the period from August 2017 to December 2017. Includes 48 patients undergoing caesarean section. Patients were randomly divided (by alternation) into three groups of 16 patients, group A: 100 mg diclofenac suppository, group B: 1000 mg acetaminophen by intravenous infusion injection in 200 ml of 0.9 percent saline, group C: 100 mg diclofenac suppository and 500 mg intravenous acetaminophen. All patients underwent full clinical assessment and 24-hour pain follow-up. At the end of the surgery, pain severity was measured on a VAS scale at various intervals. Results: The lowest mean pain severity was found in the combination group during the study and the highest was observed in the diclofenac group. There was significant difference of times of additional doses of analgesia which high in group diclofenac then group acetaminophen and the least times detected at combination group. Conclusion: The combination of acetaminophen and diclofenac has stronger and longer analgesic effects than the single use of each drug. [ABSTRACT FROM AUTHOR]

Background: Ablation or surgical excision is the typical treatment of anal high-grade squamous intraepithelial lesions (HSIL). Recurrences are common due to the persistence of underlying human papillomavirus (HPV) infection. Additional well-tolerated and effective non-surgical options for HPV-associated anal disease are needed. Methods: This 3+3 dose escalation Phase I clinical trial evaluated the safety and tolerability of artesunate suppositories in the treatment of patients with biopsy-proven HSIL. Results: The maximal tolerated dose was 400 mg, administered in 3 cycles. All adverse events associated with the use 200- and 400-mg artesunate suppositories were Grade 1. At the 600-mg dose, patients experienced clinically significant nausea. Conclusion: Artesunate suppositories are a safe treatment option for anal HSIL. [ABSTRACT FROM AUTHOR]

In this Policy Forum article, James A. Watson and colleagues discuss recent guidelines relating to pre-referral treatment of suspected severe malaria with rectal artesunate suppositories in remote areas. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Recurrent urinary tract infections (rUTIs) are a burden to patients and the health care economy. Vaginal probiotics and supplements have gained significant attention in mainstream media and lay press as a non-antibiotic alternative. We performed a systematic review to determine whether vaginal probiotics are an effective means of prophylaxis for rUTI. Methods: A PubMed/MEDLINE article search was performed from inception to August 2022 for prospective, in vivo use of vaginal suppositories for the prevention of rUTIs. Search terms included: vaginal probiotic suppository (34 results), vaginal probiotic randomized (184 results), vaginal probiotic prevention (441 results), vaginal probiotic UTI (21 results), and vaginal probiotic urinary tract infection (91 results). A total of 771 article titles and abstracts were screened. Results: A total of 8 articles fit the inclusion criteria and were reviewed and summarized. Four were randomized controlled trials, with 3 of the studies having a placebo arm. Three were prospective cohort studies, and 1 was a single arm, open label trial. Five of the 7 articles that specifically evaluated for rUTI reduction with vaginal suppositories did find a decreased incidence with probiotic use; however, only 2 had statistically significant results. Both of these were studies of Lactobacillus crispatus and were not randomized. Three studies demonstrated the efficacy and safety of Lactobacillus as a vaginal suppository. Conclusion: Current data support the use of vaginal suppositories containing Lactobacillus as a safe, non-antibiotic measure, but actual reduction of rUTI in susceptible women remains inconclusive. The appropriate dosing and duration of therapy remain unknown. [ABSTRACT FROM AUTHOR]

Background: Capecitabine (CAP), a BCS class-I drug which is used for the treatment of Colorectal Cancer (CRC). Site specific and enzyme activated drug delivery was achieved by albumin coated nanoparticles. Co-administration of Proton Pump Inhibitors (PPI) with the tablet dosage form of CAP lowers the dissolution of the CAP due to elevated gastric pH, resulting in decreased CAP absorption. To overcome this absorption, issue the albumin coated CAP NPs were administered through rectal route as suppositories dosage form. Materials and Methods: The capecitabine nanoparticles were prepared using different concentrations of Poly Lactic-co-Glycolic Acid (PLGA) polymer by salting-out technique and were characterized. Further, the optimized polymeric nanoparticles were coated with Egg Albumin (EA) using a glutaraldehyde cross-linker and characterized for their particle size, zeta potential, polydispersity index, drug content, SEM, and in vitro drug release. The suppositories were prepared by fusion moulding method using different grades of PEG as a base and evaluated for various parameters and in vitro drug release. Results and Discussion: The particle size of the optimized CAP NPs and the EA coated CAP NPs were determined to be 171.7 nm and 239.6 nm respectively. The in vitro release of CAP from the EA coated NPs and the suppository formulation shows 88.3% and 81.0% respectively. Conclusion: Capecitabine suppositories were formulated and the quality control parameters were assessed for the site specific and enzyme activated drug delivery in the management of colorectal cancer with help of literature references. [ABSTRACT FROM AUTHOR]

Introduction: A 65-year-old female patient could no longer take oral food or medications due to a duodenal occlusion associated with metastatic urothelial carcinoma. Her pre-existing chemotherapy-induced polyneuropathy had been well treated with pregabalin orally. Methods: Since only preparations for oral use of pregabalin are available, pregabalin suppositories were compounded by the hospital pharmacy for rectal use in this patient. Results: With the rectal administration, the treatment was successfully continued; we measured a good increase in serum levels and the symptoms improved significantly. Discussion: Cancer patients often need to be treated with co-analgesics. At the end of life, treatment often cannot be continued due to lack of other than oral administration. Our case adds to the low evidence of pregabalin administered rectally. [ABSTRACT FROM AUTHOR]

Background: Mixed vaginitis is the infection of the vagina by at least two different pathogens at the same time, both of which contribute to an abnormal vaginal environment leading to signs and symptoms. Baicao Fuyanqing suppository (BCFYQ) is a Miao ethnomedicine, used to treat various vaginitis. The aim of this study was to investigate the efficacy and possible mechanism of BCFYQ in the treatment of mixed vaginitis based on 16S rRNA high-throughput sequencing and metabonomics. Methods: Escherichia coli and Candida albicans were used to establish mixed vaginitismodel in SD rats. Three groups of low, mediumand high doses (0.18/0.36/0.64 g.kg-1) were established, and administered vaginally once a day for 6 consecutive days. After the last administration, vaginal pH and IL-1β, IL-2, IL-13 and IgA levels were measured, and the vaginal tissue was examined pathologically. In addition, the vaginal flora was characterised by 16S rRNA, and endogenous metabolites in the vaginal tissue were detected by UHPLC-Q-Exactive MS. Results: Compared with the model group, BCFYQ can reduce the vaginal pH of rats, make it close to the normal group and improve the damaged vaginal epithelial tissue. The results of ELISA showed that BCFYQ decreased the levels of IL-1 β and IL-2 and increased the levels of IL-13 and IgA (P<0.05). In addition, BCFYQ may increase the abundance of vaginal flora, especially Lactobacillus. The differential metabolite enrichment pathway suggests that the therapeutic mechanism of BCFYQ is mainly related to lipid metabolism and amino acid metabolism. Conclusion: Our research shows that BCFYQ has a good therapeutic effect on mixed vaginitis. It repairs the damaged vaginal mucosa by regulating the vaginal flora and lipid metabolism disorders to improve the local immune function of the vagina and inhibit the growth and reproduction of pathogens. [ABSTRACT FROM AUTHOR]

Background: The emergence of antimicrobial resistance to antifungals has made vulvovaginal candidiasis a concern. Coconut oil has antimycotic properties that could have a synergistic effect when combined with antifungals. Thus, clotrimazole suppositories were prepared using coconut oil as a base to improve its use and delivery in antimycotic treatment and the suppositories were evaluated for their physicochemical, mechanical, and drug release properties, and the antimycotic effect of clotrimazole and coconut oil was examined singly and in combination, as well as their formulations using the agar-well diffusion method in comparison with polyethylene glycol (PEG), and cocoa butter bases. Using the fusion method, coconut oil was solidified with beeswax (20–50%) to prepare 100 mg clotrimazole suppositories. Surfactants (4% w/w); Tween 20®, Span 20®, sodium lauryl sulphate, and their combinations (3% w/w ratio 1:1 of Tween 20® and Span 20®) were used to improve the rate of drug release from the suppository. Results: The suppositories had a pH of 4.1–6.0 and crushing strengths of 0.53 ± 0.07–32.56 ± 5.42 N. Suppositories containing surfactants and those prepared from PEG had significantly (p < 0.05) lower disintegration times ranging from 35 to 90 min than those without surfactants ranging from 305 to 388 min. Drug release (t80) was the fastest from the suppositories containing 40% coconut oil, Tween 20, and PEG. Using the Korsmeyer–Peppas' model, suppositories made from PEG had a non-Fickian diffusion, while those containing 40% coconut oil, and Tween 20 had a super case II transport mechanism. The combination of clotrimazole and coconut oil gave higher zones of inhibition against Candida species compared to either clotrimazole or coconut oil alone. The formulations had higher antimycotic activities against Candida albicans than Candida krusei and Candida tropicalis. Conclusion: The optimized formulation with the desired physicochemical and drug release properties was obtained with coconut oil (40% w/w) solidified with beeswax (50% w/w) as a base. Coconut oil appeared to possess a synergistic antimycotic effect on clotrimazole. Thus, clotrimazole vaginal suppositories with coconut oil as a base in the treatment of vulvovaginal candidiasis showed potential against C. albicans and other Candida species. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema in the treatment of anal sinusitis and its influence on pain mediators, immune function and recurrence rate. Methods: 100 patients with anal sinusitis who were diagnosed in our hospital from January 2020 to July 2021 were selected. According to the random number table method, they were divided into control group (treated with Puji Zhichuang suppository, 50 cases) and experimental group (Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema treatment, 50 cases). Changes in efficacy, traditional Chinese medical syndrome score, pain mediators, immune function and recurrence rate in the two groups were compared. Results: The total effective rate in the experimental group was higher than that in the control group (P<0.05). After 2 courses of treatment, the scores of fallen anus and dull pain, anal incomplete defecation, and anal dampness in the experimental group were lower than those of the control group (P<0.05). CD8+ in the experimental group after 2 courses of treatment was lower than that in the control group. CD3+, CD4+, CD4+ /CD8+ in the experimental group were higher than those of the control group (P<0.05). After 2 courses of treatment, prostaglandin E2 (PGE2), Substance P (SP), dopamine (DA) and 5-hydroxytryptamine (5-HT) in the experimental group were lower than those of the control group (P<0.05). The recurrence rate in the experimental group at 4 months and 6 months after treatment were lower than those in the control group (P<0.05). Conclusion: Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema in the treatment of anal sinusitis can promote the improvement of clinical symptoms, and reduce the recurrence rate, which may be related to reducing the pain mediators level and regulating the immune function of the body. [ABSTRACT FROM AUTHOR]

Ulcerative colitis (UC) is a refractory inflammatory bowel disease, and the outcomes of conventional therapies of UC, including 5-aminosalicylic acid, glucocorticoids, immunosuppressants, and biological agents, are not satisfied with patients and physicians with regard to adverse reactions and financial burden. The abnormality of the intestinal mucosal barrier in the pathogenesis of UC was verified. Qingchang Suppository (QCS) is an herbal preparation and is effective in treating ulcerative proctitis. The mechanism of QCS and its active ingredients have not been concluded especially in mucosal healing. This review elucidated the potential mechanism of QCS from the intestinal mucosal barrier perspective to help exploring future QCS research directions. [ABSTRACT FROM AUTHOR]

Rectal drug administration could offer advantages in the delivery of medicines for children by avoiding swallowability issues, improving stability and enabling administration by caregivers. This study aimed to evaluate the rectal bioavailability of hollow-type suppositories (HTS) and understand the effect of two chemical forms of amoxicillin: amoxicillin sodium (AS) or amoxicillin trihydrate (AMT). HTS were prepared by incorporating a lipophilic core containing the antibiotic with a polyethylene glycol (PEG) shell. Formulations were characterised in vitro, and the absolute bioavailability was determined in a rabbit model, while drug–base interactions were evaluated using X-ray diffraction crystallography (XRD), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy. The in vitro amoxicillin release from AMT HTS was delayed, taking 27.3 ± 4.9 h to release 50% drug compared with 1.7 h for the AS HTS, likely due to solubility differences between AMT and AS. The presence of orthorhombic AMT and anhydrous AS crystals in respective HTS was confirmed via XRD and DSC. PEG shells were able to protect the drug chemical stability when stored at 25 °C/60% RH. Despite the difference in their in vitro release rates, a similar rectal bioavailability was found in both forms of amoxicillin (absolute bioavailability 68.2 ± 6.6% vs. 72.8 ± 32.2% for AMT HTS and AS HTS, respectively; p = 0.9682). Both HTS formulations showed little or no irritation to the rectal mucosa following a single dose. [ABSTRACT FROM AUTHOR]

Introduction: Laxative suppository agent is oftenly used for patient with constipation due to its effectiveness and rapid onset. However, beside the benefit of the drugs, it could cause several side effects which could lead to life-threatening complication. In this report, we present a rare case of laxative's side effect that leads to fatal complication in pediatric patient with history of hydrocephalus and ventriculo-peritoneal (VP) shunt placement. Case report: An 11 years old boy admitted with general weakness, low nutrition intake, and constipation for 4 days. Patient had a history of VP shunt surgery at half months old due to congenital hydrocephalus. Abdominal X-ray found colon dilatation and fecal material collection. Laxative suppository agent was given to the patient. An hour after the treatment, patient had an abdominal pain followed by defecation, and 30 min after defecation, patient was unresponsive with irregular breathing followed by cardiac arrest. Code blue was activated and resuscitation was done for about 40 min, and patient did not respond to resuscitation and pronounced dead 2.5 h after drug's administration. Discussion: The pathophysiology of this complication is related with elevated intraabdominal pressure that caused abdominal compartment syndrome (ACS), and this condition could lead to several organ dysfunction such as cardiopulmonary and abdominal organ dysfunction inducing central nervous system impairment through raised intracranial pressure (ICP). Pediatric patient with history of hydrocephalus on VP shunt could have a low brain compliance and very susceptible to fatal complication due to acute raised of ICP. Conclusion: Laxative suppository agent on pediatric patient with hydrocephalus on VP shunt could lead to fatal complication through ACS and acute elevated ICP pressure. Oral laxative agent should be chosen in constipated patient with neurologic preexisting condition, and patient should be closely monitored if suppository agent is given. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the clinical effect of a combination of sodium bicarbonate sitz bath prescription and vaginal nystatin suppository in the treatment of patients with fungal vaginitis. Methods: Ninety patients with mycotic vaginitis admitted to Tianchang Hospital of Traditional Chinese Medicine from April 2018 to April 2019 were selected and divided into control group (vaginal sitz bath with 5 % sodium bicarbonate solution, n = 45) and study group (vaginal nystatin suppository in addition to vaginal sitz bath with 5 % sodium bicarbonate solution, n = 45) based on the order of admission. The therapeutic effectiveness of the two treatments was compared with respect to time of relief of various clinical indicators, incidence of adverse reactions, rate of recurrence after 3 and 6 months of drug withdrawal, and vaginal pH. Results: The time taken to relieve itching was longer in the control group (5.21 ± 2.12 days) than in the study group (3.74 ± 2.03 days; p <0 .05). There was a higher recurrence rate of itching in the control group after drug withdrawal for 3 and 6 months than in the study group (p < 0.05). Total treatment effectiveness was significantly higher in the study group than in the control group (p <0 .05). However, the incidence of adverse reactions was comparable in the two groups (p > 0.05). Vaginal pH significantly improved (less acidic) in the study group, when compared to the control group (p < 0.05). Conclusion: Application of a combination of vaginal sitz bath using 5 % sodium bicarbonate solution and vaginal nystatin suppository is effective in the treatment of fungal vaginitis. The combination produces a favorable vaginal pH environment and low recurrence of infection. However, the combined treatment should be subjected to further clinical trials prior to application in clinical practice. [ABSTRACT FROM AUTHOR]

Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18–35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting "high acceptability" was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide. [ABSTRACT FROM AUTHOR]

Glaucoma is the leading cause of irreversible blindness, and its treatment is attracting widespread attention. Drug-loaded lacrimal suppositories can effectively treat xerophthalmia, but there is little research on the treatment of glaucoma with drug-loaded lacrimal suppositories. This article explored and expanded the non-pharmacological model of lacrimal suppository therapy for glaucoma by using a combination of lacrimal suppository and medication. The drug-loaded lacrimal suppository was rationally designed through the conjugation of gelatin with polyamide (PAM) via the formation of amide linkages, followed by Schiff base reaction grafting with latanoprost. In vitro drug release studies showed that latanoprost released from drug-loaded lacrimal embolus had sustained-release properties with a release time of 33 days and a drug release volume of 82.6%. The biological evaluation of drug-loaded lacrimal thrombus was carried out by IOP test, retinal potential test, and retinal H&E staining. The results showed that the IOP decreased to 27.125 ± 1.1254 mmHg, and the a and b waves of retinal potential increased to 4.39 ± 0.16 μV and 67.9 ± 2.17 μV, respectively. It indicated that latanoprost lacrimal suppository has a good therapeutic effect on glaucoma. [ABSTRACT FROM AUTHOR]

Introduction: Despite the benefits of analgesic suppositories, there remains controversy around their administration. The perceptions of the parents and caregivers regarding this are unknown in our population. We investigated the perceptions of parents/caregivers towards the use of analgesic suppositories in elective paediatric surgery. We also explored whether parents/caregivers perceived a need for additional consent for the administration of suppositories. Materials and Methods: This was a prospective cross-sectional study conducted at Charlotte Maxeke Johannesburg Academic Hospital, South Africa. The primary outcome was to describe perceptions of parents/caregivers towards analgesic suppositories. Questionnaire-guided interviews were conducted with parents/caregivers of children presenting for elective paediatric surgery. Results: Three hundred and one parents/caregivers were enrolled in the study. Two hundred and sixty-two (87%) were female and 174 (13%) were male. Two hundred and seventy-six (92%) were parents and 24 (9%) were caregivers. There was a high level of acceptability of suppository use in 243 (81%) parents/caregivers. Majority (235, 78%) felt that they should be asked for permission before their child was given a suppository, and more than half (134, 57%) expressed that it should be in a written consent format. The parents/caregivers did not believe that suppositories would cause pain (unadjusted odds ratio [uOR]: 2.49; 95% confidence interval [CI]: 1.29–4.79; P = 0.006) but were unsure whether they would relieve post-operative pain (uOR: 0.25; 95% CI: 0.11–0.57; P = 0.001). Those who had previously used a suppository themselves were significantly more likely to accept the use of suppositories in children (uOR: 4.34; 95% CI: 1.56–12.07; P = 0.005). Conclusion: There was a high level of acceptability of the use of analgesic suppositories. Our population showed a unique preference for written consent over verbal consent. There was a strong positive association between previous use of suppositories by parents/caregivers and acceptance for use in children. [ABSTRACT FROM AUTHOR]

"Pro re nata" (PRN) or "as needed" medicine administration and usage is a relatively neglected area in medication management (pharmacotherapy/pharmaceutical care) which contributes to error‐prone use of medications and is unsafe for patients. In this case, we report the incident of diclofenac toxicity in a 51‐year‐old woman due to a prescription of 100 mg diclofenac suppositories PRN, or as needed, for postoperative pain control without explanation of the maximum daily dose (150 mg daily), which led to arbitrary consumption of 3 g of diclofenac over 5 days (600 mg daily) by the patient, and subsequent development of metabolic acidosis, acute kidney injury, and sudden cardiac arrest. The implementation of practical guidelines and training programs for health care workers to appropriately prescribe, dispense, and administer PRN medicines are necessary, and should at least include providing clarification for their indication, dose and frequency, as well as any cautionary instructions to ensure safe and effective use of such medicines. [ABSTRACT FROM AUTHOR]

Pentobarbital is a drug of choice to limit motion in children during paediatric procedural sedations (PPSs). However, despite the rectal route being preferred for infants and children, no pentobarbital suppositories are marketed, and therefore they must be prepared by compounding pharmacies. In this study, two suppository formulations of 30, 40, 50, and 60 mg of pentobarbital sodium were developed using hard-fat Witepsol® W25 either alone (formulation F1) or with oleic acid (formulation F2). The two formulations were subjected to the following tests described in the European Pharmacopoeia: uniformity of dosage units, softening time, resistance to rupture, and disintegration time. The stability of both formulations was also investigated for 41 weeks of storage at 5 ± 3 °C using a stability-indicating liquid chromatography method to quantify pentobarbital sodium and research breakdown product (BP). Although both formulae were compliant to uniformity of dosage, the results were in favour of a faster disintegration of F2 compared to F1 (−63%). On the other hand, F1 was found to be stable after 41 weeks of storage unlike F2 for which several new peaks were detected during the chromatographic analysis, suggesting a shorter stability of only 28 weeks. Both formulae still need to be clinically investigated to confirm their safety and efficiency for PPS. [ABSTRACT FROM AUTHOR]

Etodolac is a non-steroidal anti-inflammatory drug that is categorized as a BCS class-II drug due to its low aqueous solubility and high permeability. Frequent dosing, extensive liver metabolism, and low dissolution rates are major limitations of etodolac. The present study focuses on the designing of novel suppository base blends for providing an effective delivery of etodolac. The oils (Caprylic/capric triglyceride, isopropyl isostearate, and isopropyl palmitate) were added to Witepsol® H15 to form suppository base blends. White, odorless, and torpedo-shaped suppositories were developed by using two parts of Witepsol® H15 and one part of the oil. All of the suppositories prepared with different blends were found uniform in weight and content. The mechanical strength of all suppositories was in an acceptable range for suppositories (2.0 – 3.8 kg/cm²). The suppositories showed a disintegration time between 13 and 19 minutes. First-order release kinetics were observed after the in vitro release studies. The suppository base blends released 85%- 90% of etodolac in the first hour while 60% of etodolac was released from Witepsol® H15 base alone. Prolonged drug release was achieved after 2 hours all of the formulations reached the plateau levels. The oil blends exhibited higher release percentages (96% - 99%) than plain Witepsol® H15 base (89%). Therefore novel suppository base blends could be a promising formulation ingredient for the etodolac suppositories. [ABSTRACT FROM AUTHOR]

The current study describes a suppository base composed of aqueous gelatin solution emulsifying oil globules with probiotic cells dispersed within. The favorable mechanical properties of gelatin to provide a solid gelled structure, and the tendency of its proteins to unravel into long strings that interlace when cooled, lead to a three-dimensional structure that can trap a lot of liquid, which was exploited herein to result in a promising suppository form. The latter maintained incorporated probiotic spores of Bacillus coagulans Unique IS-2 in a viable but non-germinating form, preventing spoilage during storage and imparting protection against the growth of any other contaminating organism (self-preserved formulation). The gelatin–oil–probiotic suppository showed uniformity in weight and probiotic content (23 ± 2.481 × 108 cfu) with favorable swelling (double) followed by erosion and complete dissolution within 6 h of administration, leading to the release of probiotic (within 45 min) from the matrix into simulated vaginal fluid. Microscopic images indicated presence of probiotics and oil globules enmeshed in the gelatin network. High viability (24.3 ± 0.46 × 108), germination upon application and a self-preserving nature were attributed to the optimum water activity (0.593 aw) of the developed composition. The retention of suppositories, germination of probiotics and their in vivo efficacy and safety in vulvovaginal candidiasis murine model are also reported. [ABSTRACT FROM AUTHOR]

Aims and objectives: To identify the prevalence and determinants of medication administration errors (MAEs). Background: Insight into determinants of MAEs is necessary to identify interventions to prevent MAEs. Design: A prospective observational study in two Dutch hospitals, a university and teaching hospital. Methods: Data were collected by observation. The primary outcome was the proportion of administrations with one or more MAEs. Secondary outcomes were the type, severity and determinants of MAEs. Multivariable mixed‐effects logistic regression analyses were used for determinant analysis. Reporting adheres to the STROBE guideline. Results: MAEs occurred in 352 of 2576 medication administrations (13.7%). Of all MAEs (n = 380), the most prevalent types were omission (n = 87) and wrong medication handling (n = 75). Forty‐five MAEs (11.8%) were potentially harmful. The pharmaceutical forms oral liquid (odds ratio [OR] 3.22, 95% confidence interval [CI] 1.43–7.25), infusion (OR 1.73, CI 1.02–2.94), injection (OR 3.52, CI 2.00–6.21), ointment (OR 10.78, CI 2.10–55.26), suppository/enema (OR 6.39, CI 1.13–36.03) and miscellaneous (OR 6.17, CI 1.90–20.04) were more prone to MAEs compared to oral solid. MAEs were more likely to occur when medication was administered between 10 a.m.–2 p.m. (OR 1.91, CI 1.06–3.46) and 6 p.m.–7 a.m. (OR 1.88, CI 1.00–3.52) compared to 7 a.m.–10 a.m. and when administered by staff with higher professional education compared to staff with secondary vocational education (OR 1.68, CI 1.03–2.74). MAEs were less likely to occur in the teaching hospital (OR 0.17, CI 0.08–0.33). Day of the week, patient‐to‐nurse ratio, interruptions and other nurse characteristics (degree, experience, employment type) were not associated with MAEs. Conclusions: This study identified a high MAE prevalence. Identified determinants suggest that focusing interventions on complex pharmaceutical forms and error‐prone administration times may contribute to MAE reduction. Relevance to clinical practice: The findings of this study can be used to develop targeted interventions to improve patient safety. [ABSTRACT FROM AUTHOR]

Background and Objective: Patients with clinical feature of small bowel obstruction and present of previous abdominal surgery should be suspected of adhesive small bowel obstruction especially midline incision. Previous study of oral laxative drug with digestive agent was a conservative treatment that this approach is associated with the hospital stays and risk of delayed surgery. The aims of the present randomized controlled trial study were to investigate a combining standard conservative treatment using Bisacodyl suppository with intravenous metoclopramide for partial adhesive small bowel obstruction comparing with the control group which nothing by mouth, intravenous hydration and nasogastric tube decompression. Materials and Methods: 120 patients admitted between January 2019 - December 2020 with symptom and sign suggestive of partial adhesive small bowel obstruction were randomized to receive either the control group (nothing by mouth, intravenous hydration and nasogastric tube decompression) or treatment group (Bisacodyl suppository and intravenous metoclopramide). The primary outcome included time to first flatus and defecation, number of successfully treatment without surgery, and length of hospital stay were recorded. Results: A total of 120 patients were included in this study, 60 patients in each treatment group and control group. The treatment group was more effective than the control group in the time of flatus and defecation (p < 0.001), and lower number surgical need than another group with statistic significantly (p < 0.05). Also, average length of hospital stay in the treatment group was shorter than the control group with statistically significant at p < 0.001. There were no statistically significant differences between patients in both groups in terms of age, gender, and type of previous surgical incision as baseline. Conclusion: Bisacodyl suppository and metoclopramide intravenous injection was safe and effective without complication to use in patients. It was effective in hastening the resolution of conservatively treated partial adhesive small bowel obstruction and shortening the hospital stay. [ABSTRACT FROM AUTHOR]

Background: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion.Study Design: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires.Results: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy.Conclusions: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens.Clinicaltrials: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735. [ABSTRACT FROM AUTHOR]

We present a case of an infant born to a mother with COVID-19, who at 24 hours of life was treated with a glycerin suppository for failure to pass meconium and went on to develop bilious emesis and abdominal distention as feeding continued over the next several hours. After a barium enema identified the distal obstruction, the pediatric surgical team used rectal irrigation to remove a large meconium plug, which mimicked the appearance of the descending colon on plain film, in a case of small left colon syndrome. Although intestinal obstruction in the newborn is rare, it is imperative that it is promptly diagnosed and treated appropriately to avoid negative outcomes; which, even in perhaps the mildest form of functional distal obstruction, meconium plug syndrome, can lead to an impressive clinical illness with risk of intestinal perforation and subsequent meconium peritonitis if the obstruction is not relieved. [ABSTRACT FROM AUTHOR]

Objectives: To compare the analgesic effects of rectal suppository morphine (RSM) with intramuscular morphine (IMM) in patients suffered from renal colic referred to emergency ward (EW). Methods: In a controlled, randomized, clinical trial, 74/90 patients with renal colic referred to the EW between March 2016 and March 2017 were randomly enrolled into two groups of RSM (10 mg) and IMM (10 mg/mL). Vital signs and severity of pain were recorded at admission time (0), 15, 30 and 60 min after treatment. Results: The results showed that there was a significant decrease in VAS score of RSM group compared to IMM group after 30 and 60 min of administration (P < 0.05). Furthermore, no significant difference was recorded in vital signs, except there was a significant decrease in heart rate (15 and 60 min) and respiratory rate (60 min) of RSM group compared to IMM group (P < 0.05) and no side effects were recorded during the investigation. Conclusion: In conclusion, the use of rectal route of morphine had higher efficiency compared to the IM route of morphine in relieving pain of patients with renal colic. Although, decreased heart and respiratory rates were recorded, the values were in normal range. As well, no major complications were recorded for each method. [ABSTRACT FROM AUTHOR]

Ibuprofen is classified as a BCS class II because of its low solubility and high permeability. Inclusion complex formation using ß-cyclodextrin is one method to increase a drug's solubility. In addition to the method of increasing the solubility, the choice of dosage form and route of administration has a big role in the success of therapy because it can increase the onset of action of drugs while avoiding side effects. Rectal suppositories can provide a faster antipyretic effect than oral preparations. The purpose of this study was to determine the effect of inclusion complexes formation with ß-cyclodextrin in increasing the dissolution rate and release characteristics of ibuprofen suppositories. The suppository formulation used various concentrations of cetylalcohol to increase the consistency of the cocoa butter base. The release characteristics of ibuprofen in suppositories were evaluated, including, organoleptic, melting time, weight diversity, dissolution rate and dissolution efficiency, by comparing ibuprofen inclusion complex suppositories with ß-cyclodextrin all three mole ratios, namely 1:1, 1:2 and 2:1, to pure ibuprofen suppositories. The inclusion complex of ibuprofen with ß-cyclodextrin at a mole ratio of 2:1 showed to increase the solubility and dissolution rate of ibuprofen in suppositories with good physical and release characteristics. [ABSTRACT FROM AUTHOR]

Pharmaceutical compounding using the molding technique is the currently applied method for the on-demand manufacturing of suppositories and pessaries. Potential errors of this method are difficult to detect, and the possibilities of individualization of size and shape of the suppositories are limited. In this study, a syringe-based semi-solid 3D printing technique was developed for the manufacturing of suppositories in three different printing designs with the suppository bases polyethylene glycol (PEG) and hard fat (HF). The 3D printed suppositories were analyzed for their visual appearance, uniformity of mass and content, diametrical dimension, breaking force and release behavior and compared to suppositories of the same composition prepared by a commonly used molding technique. The results showed no adverse properties for the 3D printed suppositories compared to the molded ones. Moreover, the easy adaptation of shape using the 3D printing technique was demonstrated by the printing of different sizes and infill structures. Thus, 3D printing has great potential to complement the available manufacturing methods for compounded suppositories, as it represents an automated system for the individualized manufacturing of suppositories that meet patients' needs. [ABSTRACT FROM AUTHOR]

Thermosensitive liquid suppositories (LSs) carrying the model antihypertensive drug metoprolol tartrate (MT) were developed and evaluated. The fundamental purpose of this work was to produce, for the first time, liquid MT suppositories based on biodegradable nanoparticles and optimize their rheological and mechanical properties for prospective rectal administration. The nanoparticle system was based on a biodegradable copolymer synthesized by ring opening polymerization (ROP) of glycolide (GL) and L,L-lactide (LLA). Biodegradable nanoparticles loaded with the model drug were produced by the o/o method at the first stage of the investigation. Depending on the concentration of the drug in the sample, from 66 to 91% of MT was released over 12 h, according to first-order kinetics. Then, thermosensitive LSs with MT-loaded biodegradable nanoparticles were obtained by a cold method and their mechanical and rheological properties were evaluated. To adjust the thermogelling and mucoadhesive properties for rectal administration, the amounts of major formulation components such as poloxamers (P407, P188), Tween 80, hydroxypropylcellulose (HPC), polyvinylpyrrolidone (PVP), and sodium alginate were optimized. The in vitro release results revealed that more than 80% of the MT was released after 12 h, following also first-order kinetics. It was discovered that the diffusion process was dominant. The drug release profile was mainly governed by the rheological and mechanical properties of the developed formulation. Such a novel, thermosensitive formulation might be an effective alternative to hypertension treatment, particularly for unconscious patients, patients with mental illnesses, geriatric patients, and children. [ABSTRACT FROM AUTHOR]

Bacterial vaginosis, a polymicrobial clinical syndrome characterized by a shift in healthy vaginal microbiota due to bacterial colonization, is characterized by high recurrence rates after conventional treatment with an antimicrobial agent. This has necessitated the need to develop a formulation that has the potential to ensure Lactobacilli viability and bacterial clearance. This study seeks to develop and optimize a layered suppository using a five-level central composite design to ensure optimized metronidazole release and lactic acid viability. Layered suppositories were formulated using the fusion method using polyethylene glycol blend 1500/4000 and Ovucire® as suppository bases. Lactobacillus fermentum was incorporated in the molten mass before molding the solid body suppositories into the cavity of hollow-type suppositories and sealing the molten excipients. Artificial neural network model predictions for product optimization showed high predictive capacity, closely resembling experimental observations. The highest disintegration time recorded was 12.76 ± 0.37 min, with the optimized formulations showing lower times of 5.93 ± 0.98 min and an average weight of 1.17 ± 0.07 g. Histopathological observations determined high compatibility of suppositories with vaginal cells with no distortion or wearing of the vagina epithelium. This optimized formulation provides a safe and promising alternative to conventional suppositories in the treatment and prevention of the recurrence of bacterial vaginosis. [ABSTRACT FROM AUTHOR]

Infections with Candida species represent a large percentage of the total number of fungal infections in the vaginal mucosa. Conventional treatments with antifungal medicinal substances have proven to be low in efficiency, so we are currently looking for alternative products based on plant extracts (these being more effective according to existing studies but also non-toxic). Our study aimed to obtain the oil of Origanum vulgare L. and its characterization from the point of view of antimicrobial activity, known for its rich composition in active principles such as carvacrol (a compound with proven antifungal activity). Also, the plant Origanum vulgare L. was characterized from a macro- and microscopic point of view. The oregano oil obtained was included in the liposomal formula and characterized from the point of view of appearance, surface electric charge, and size, respectively. The liposomal oil was also included in the formula for the preparation of vaginal suppositories. These were characterized organoleptically and from the point of view of the release of active principles. The future perspectives are to test the formulated pharmaceutical forms in vitro and then in vivo. [ABSTRACT FROM AUTHOR]

Background: The combined mixture of miconazole nitrate (MIC) and nystatin (NYS) has proven its efficiency as a prodigious remedy to cure women's frequent infections: vaginal mycosis and vaginal candidiasis. Objective: A novel green spectrophotometric technique, namely the Fourier self-deconvolution method (FSD), was employed for the quantitative determination of MIC and NYS in their pure and pharmaceutical forms without prior separation. Moreover, the proposed technique was first employed to study the dissolution profile of the cited drugs in their pharmaceutical formulation according to FDA recommendations without excipient interference. Method: The FSD method is based on a simple mathematical manipulation of zero-order spectra of the cited drugs, which suffered from severe overlapping, so zero-order spectra of the cited drugs were deconvoluted using the Fourier wavelet function in spectrophotometer software. The deconvoluted amplitudes for MIC and NYS were measured at 255nm and 320nm, respectively. Results: Linearity ranges were 70-700 mg/mL for MIC and 1-25 mg/mL for NYS. The greenness of the proposed technique was assessed using two assessment tools, namely eco-scale scoring and green analytical procedure index (GAPI), revealing the excellent greenness of this technique. The proposed technique was validated consistent with ICH guidelines and statistically compared to the reported method with no significant differences between them. Conclusions: The proposed technique has advantages of being simple, time-saving, and noting need any modification to be suitable for quantitative analysis of MIC and NYS in both pharmaceutical and laboratory mixtures. Highlights: An innovative FSD method was developed for quantitative analysis of MIC and NYS in their synthetic and pharmaceutical mixtures and applied for in vitro dissolution testing of their pharmaceutical mixture, producing satisfactory results. [ABSTRACT FROM AUTHOR]

Nimesulide is a poorly water-soluble, non-steroidal anti-inflammatory drug for both systemic and topical application. The study aimed to assess the influence of the type of base and surfactants (Tween80, Span80, soy lecithin, sodium lauryl sulfate) on drug release from rectal suppositories. Suppositories were prepared in the Unquator® using Cacao butter, Witepsol H15, and PEG1500:PEG400 as a base. All formulations were evaluated for uniformity of mass, uniformity of content, hardness, disintegration, and dissolution time. The physicochemical properties of the prepared suppositories were in accordance with Pharmacopoeia's requirements. The in vitro release test been shown that the addition of 2% surfactant to lipophilic base suppositories, significantly increased the amount of nimesulide released from all the investigated formulae. Among the formulations containing surfactants, only Witepsol H15 with Span 80 released a nearly complete drug for 210 minutes. The results indicate that the First-Order model is the best fit with the nimesulide in-vitro release from lipophilic and PEG suppositories. The stability test showed no significant changes in the physical properties of suppositories and also API release profiles into the acceptor fluid after 12 weeks of storage at room temperature. [ABSTRACT FROM AUTHOR]