A quantitative near infrared spectroscopy model for the assay of efavirenz in tablets

Near-infrared-spectroscopy combined with multivariate data analysis represents the most recent and efficient technology in analytical chemistry. The objective of this study was to utilize near infrared spectroscopy as an adapted technology for the quantitative assay of efavirenz. The study developed and validated a quantitative model for estimating the amount of efavirenz in efavirenz uncoated tablets. The quantification was based on the partial least squares algorithm and constructed by cross-validation. A UV spectrophotometric procedure was used as the reference method. Different pre-processing methods were employed in the development of calibration models. The best calibration model was that using partial least squares as the regression algorithm in association with Multiplicative Scattering Correction as the spectrum pre-processing method. The model estimators were: coefficient of determination (R²) 0.9815, standard error of cross validation 2.0346 and a factor of 5. The chosen model correlated well with the prediction results in accordance with the Mahalabinos distance limits. The developed NIR method allows the estimation of the amount of efavirenz in tablets without sample preparation thus proving to be a simple, fast and suitable method for the quantitative assay of efavirenz in uncoated tablets. Hence, NIR coupled with chemometric methods can be used for on-line, in-line or at-line monitoring of the manufacturing process and are helpful in achieving the goals of Process Analytical Technology.Keywords: Near Infrared Spectroscopy, chemometrics, multivariate data analysis, efavirenz, Partial Least Squares, cross validatio

Stability indicating liquid chromatographic method for determination of lamivudine and tenofovir disoproxil fumarate in fixed dose combination formulations

This study describes the development and validation of a stability indicating high performance liquid chromatographic method for the analysis of lamivudine and tenofovir disoproxil fumarate and their degradants. The method uses a Reprosil®-pur basic C18 column (250 mm × 4.6 mm, 5 μm) maintained at 30°C, methanol and a mixture of buffers (2.3 g/L ammonium dihydrogen phosphate and 1.32 g/L of diammonium hydrogen phosphate, pH 3.9) for gradient elution at a flow rate of 1.0 mL/min, and UV detection at 270 nm. Good separation of lamivudine and tenofovir disoproxil fumarate and their potential impurities was achieved. The stability indicating ability of the developed method was validated by subjecting both active ingredients to hydrolytic and oxidative stress conditions and separating the degradation products from their respective intact drugs. The calibration curve was linear over the 80-120 μg/mL concentration range for both active ingredients with r2> 0.99. A recovery rate of 99.8 % for lamivudine and 99.3 % for tenofovir disoproxil fumarate confirmed the accuracy of the method for the simultaneous determination of both drugs in the fixed-dose combination.Keywords: Stability indicating liquid chromatography, lamivudine, tenofovir, validatio

Genetic instability and anti-HPV immune response as drivers of infertility associated with HPV infection

Funding Information: RFBR grant 17–54-30002, Ministry of Science and Higher Education of the Russian Federation (Agreement No. 075–15–2019-1660) to Olga Smirnova. Publisher Copyright: © 2021, The Author(s).Human papillomavirus (HPV) is a sexually transmitted infection common among men and women of reproductive age worldwide. HPV viruses are associated with epithelial lesions and cancers. HPV infections have been shown to be significantly associated with many adverse effects in reproductive function. Infection with HPVs, specifically of high-oncogenic risk types (HR HPVs), affects different stages of human reproduction, resulting in a series of adverse outcomes: 1) reduction of male fertility (male infertility), characterized by qualitative and quantitative semen alterations; 2) impairment of couple fertility with increase of blastocyst apoptosis and reduction of endometrial implantation of trophoblastic cells; 3) defects of embryos and fetal development, with increase of spontaneous abortion and spontaneous preterm birth. The actual molecular mechanism(s) by which HPV infection is involved remain unclear. HPV-associated infertility as Janus, has two faces: one reflecting anti-HPV immunity, and the other, direct pathogenic effects of HPVs, specifically, of HR HPVs on the infected/HPV-replicating cells. Adverse effects observed for HR HPVs differ depending on the genotype of infecting virus, reflecting differential response of the host immune system as well as functional differences between HPVs and their individual proteins/antigens, including their ability to induce genetic instability/DNA damage. Review summarizes HPV involvement in all reproductive stages, evaluate the adverse role(s) played by HPVs, and identifies mechanisms of viral pathogenicity, common as well as specific for each stage of the reproduction process.publishersversionPeer reviewe

CONSUMER SURVEY OF MALARIA FACT CARD:AN EDUCATIONAL AND COMMUNICATION TOOL IN TANZANIA

Objective: To determine the usefulness of the malaria fact card as a health educational and communication tool in Dare s Salaam. Methods: A prospective consumer survey pilot study on the malaria fact card, a health educational and communication tool was carried out between January and February 2004 in Dar Es Salaam, Tanzania. Parameters studied include consumers understanding of the malaria fact card, consumer behavioural responses and awareness of malaria prevention and treatment. A total of 131 respondents from 10 randomly selected community pharmacies in which malaria fact cards were distributed since 2003 participated in the study. Data were collected using structured and semi structured questionnaires. Results: It was found that 95% of respondents reported that the fact card was easy to read and understand. The study revealed that 64.6% (n=127) responses acknowledged getting new information on correct treatment of malaria using Sulphadoxine-Pyrimethamine (SP), while 8.6% acquired new information about prevention strategies. Only 33% of the consumers surveyed indicated to visit the pharmacies on regular basis. Further, results indicated that 84% of respondents asked the pharmacists for health information and/or advice when purchasing antimalarial medicines. Of all responses 38% (n=179) related to prevention strategies and 26.8% related to correct use of SP medications. Conclusion: We conclude that the malaria fact card is useful as a health educational and communication tool . It is recommended that pharmacists should provide quality and educative information through use of communication tools such as updated malaria fact cards

Quality of antiretroviral drugs, stavudine and indinavir capsules available in the Tanzanian market

Background: The number of antiretroviral drugs (ARVs) available to HIV/AIDS patients in Tanzania is increasing due to a number of intervention programs such as PEPFAR and the Clinton Foundation. These ARVs are imported from a number of countries. However, currently there are no reports on the quality of these medicines imported into Tanzania. The sale of substandard and counterfeit drugs has been well documented particularly in developing countries. The marketing of counterfeit and substandard antiretroviral drugs has also been widely reported in Africa. It is therefore important to closely monitor the quality of ARVs marketed in Tanzania to ensure that substandard or fake products are uncovered before great harm is done to public health. Objective: To assess the quality of ARVs marketed in Tanzania. Methodology: A total of five samples of two generic drugs (stavudine and indinavir) from different manufacturers were randomly collected from various retail pharmacies. Assessment of package inserts and labels was carried out using the Tanzania Food and Drugs Authority (TFDA) specifications. The capsules were analyzed for the content of the active components using validated in-house methods Results: All samples of Indinavir and Stavudine investigated conformed to the packaging and labeling specifications. However, all Indinavir samples were found to contain excess amount of active ingredient (112.6% - 118%) compared to the official limit of 95 – 105%. One sample of stavudine capsules failed the dissolution test, releasing only 56% instead of the specified 80% of the active ingredient. Conclusion: The results of this study emphasize the need for careful monitoring of the quality of drugs to ensure their safety and efficacy. Keywords: Antiretroviral drugs, Quality, Substandard drugs. Tanzania Medical Journal Vol. 21 (1) 2006: pp. 8-1

National Antibiotics Utilization Trends for Human Use in Tanzania from 2010 to 2016 Inferred from Tanzania Medicines and Medical Devices Authority Importation Data

Antimicrobial use (AMU) is one of the major drivers of emerging antimicrobial resistance (AMR). The surveillance of AMU, which is a pillar of AMR stewardship (AMS), helps devise strategies to mitigate AMR. This descriptive, longitudinal retrospective study quantified the trends in human antibiotics utilization between 2010 and 2016 using data on all antibiotics imported for systemic human use into Tanzania’s mainland. Regression and time series analyses were used to establish trends in antibiotics use. A total of 12,073 records for antibiotics were retrieved, totaling 154.51 Defined Daily Doses per 1000 inhabitants per day (DID), with a mean (±standard deviation) of 22.07 (±48.85) DID. The private sector contributed 93.76% of utilized antibiotics. The top-ranking antibiotics were amoxicillin, metronidazole, tetracycline, ciprofloxacin, and cefalexin. The DIDs and percentage contribution of these antibiotics were 53.78 (34.81%), 23.86 (15.44), 20.53 (13.29), 9.27 (6.0) and 6.94 (4.49), respectively. The time series model predicted a significant increase in utilization (p-value = 0.002). The model forecasted that by 2022, the total antibiotics consumed would be 89.6 DIDs, which is a 13-fold increase compared to 2010. Government intervention to curb inappropriate antibiotics utilization and mitigate the rising threat of antibiotic resistance should focus on implementing AMS programs in pharmacies and hospitals in Tanzania