East and Central African Journal of Pharmaceutical Sciences

Quality control outcomes of pharmaceuticals and allied products analyzed in the Mission for Essential Drugs and Supplies (MEDS) laboratory: 2018-2020

Kennedy O Abuga — 2024-06-25

Quality control data was compiled for samples analyzed in the Mission for Essential Drugs and Supplies (MEDS) laboratory in the 2018-2020 period. During this interval, the laboratory received and processed 6,059 samples from Kenya and international sources. These samples comprised domestic (31.9%) and internationallymanufactured (67.0%) products while 1.1% were of undeclared origin. Analysis was performed using compendial and/or in-house specifications. The non-compliance rate was 8.0% consisting of 3.2 % local, 4.5% imports and 0.3% for samples of unknown origin. The top 20 drug classes with high failure rates were: environmental monitoring samples (100.0%), joint lubricants (50.0%), dialysis solutions (50.0%), microscopy stains (50.0%), herbal preparations (43.2%), nootropics (33.3%), solvents (33.3%), waters (32.0%), antiseptics/disinfectants (29.8%), medical devices (28.4%), hormones (23.7%), nutrient mixtures (20.9%), disease modifying antirheumatic drugs (20.0%), anti-incontinence drugs (16.7%), uterotonics (13.8%), vitamins (13.0%), anti-ulcer drugs (12.6%), vasopressor agents (12.5%), anthelmintics (12.2%) and hypolipidemics (10.8%). Full compliance was however, recorded with antiflatulants, digestive enzymes, antidiarrheals, prokinetics, anti-arrhythmics, anti-anginals, choleretics, antimycobacterials, anaesthetics, antimigraine drugs, bisphosphonates, antimyaesthenics thyroid/antithyroid drugs, erectile dysfunction drugs, ovulants, uricosurics, osmotic diuretics, vaginal lubricants, tocolytics, histaminics, lozenges, ear drops, detergents, radiopharmaceuticals, proteins, probiotics, acaricides, sterilization validation swabs and excipients. There was a significant increase in the overall non-compliance rate compared to the previous report for 2013-2017. These results add impetus towards the need for regulatory stringency to curb the occurrence of substandard and falsified products in the market.

Quality evaluation of ciprofloxacin, metronidazole, albendazole tablets and amoxicillin suspension, marketed in Mwanza, Tanzania: A cross sectional study

Emmanuel Kimaro — 2024-06-25

In Tanzania, essential medicines like amoxicillin, ciprofloxacin, metronidazole, and albendazole face potential quality challenges due to the risk of substandard and falsified drugs in the market. This study was carried out in Mwanza town, Tanzania to assess the quality of these drugs in order to address concerns about antimicrobial resistance and public safety. For this purpose, physical parameters, assay, and dissolution tests were conducted on samples of various brands according to the USP and BP monographs. All samples met USP standards for physical parameters and assay. But one brand of amoxicillin suspension failed assay test. Ciprofloxacin met dissolution criteria, but only one albendazole sample complied. About 47.6% of samples failed the quality tests performed. These results provide vital insights into pharmaceutical quality, safety and efficacy in the study area.

Quality evaluation of commercial alcohol-based hand sanitizers in Nairobi, Kenya: A post COVID-19 pandemic survey

Catherine N Maingi — 2024-06-25

The global public health impact of COVID-19 necessitated multifaceted approaches such as use of alcohol-based hand sanitizers (ABHS) to control transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study evaluated compliance with Kenya Bureau of Standards (KEBS) specification of commercially available alcohol-based hand sanitizers purchased from selected retail outlets in the Nairobi metropolitan area. Out of the 122 samples analyzed, 63% met KEBS specifications based on visual inspection, while gas chromatography-mass spectrometry (GC-MS) identified methanol as a contaminant in 26% of samples. Quantification of the permitted alcohols, ethanol and isopropanol, using gas chromatography with flame ionization detector (GC-FID) revealed that 44.3% had an alcohol content within the specified range of 60 - 95% v/v, with 5.7% containing neither alcohol. Furthermore, only 10% of samples from local manufacturers met KEBS specifications. These results highlight the need for strict monitoring and regulation of alcohol-based hand sanitizers, particularly in the context of the COVID-19 pandemic. Moreover, the presence of methanol and variations in alcohol content underscore the importance of implementing comprehensive quality control measures to ensure the effectiveness and safety of these highly important public health tools.

Quality of commercial alcohol-based hand sanitizers marketed in Kampala, Uganda during the COVID-19 pandemic

Oscar P Okello Okidi — 2024-06-25

In the year 2020, coronavirus disease-2019 (COVID-19) became a global public health emergency. The World Health Organization recommended wearing of masks, regular hand washing with soap or use of alcohol-based hand sanitizers to prevent human-to-human transmission of the disease. As a result, there was a rapid proliferation of hand sanitizers in the market, leading to concerns about the quality of these products. This study aimed to conduct a qualitative and quantitative evaluation of commercial alcohol-based hand sanitizers marketed in Kampala, Uganda. Commercial products (130) were sampled from five divisions of Kampala city and assessed for appearance, packaging, labelling and conformity with regulator’s mark of quality. Additionally, the pH of the samples was determined. Gas chromatography coupled with mass spectrometry and flame ionization detectors were used for qualitative and quantitative analysis of the alcohol-based hand sanitizers, respectively. Only 15 samples (12%) met all the specifications for appearance, packaging, labelling, and regulation characteristics assessed. Alcohol was detected in 128 samples (98%). The permitted alcohols detected in the samples were ethanol (86%), isopropyl alcohol (4%) and ethanol/isopropyl alcohol admixture (3%). However, samples containing methanol, either alone (4%) or mixed with ethanol (1.5%) were encountered. Isopropyl alcohol was found as a denaturant in only one sample contrary to the label claims in seven samples. Twenty-two samples (17%) had a different alcohol from that declared on the label. Seventy-eight samples (60%) had alcohol content within the requisite range of 60-95% v/v while forty-two had less than 60% v/v alcohol, and one contained more than 95% v/v. Sixty-seven samples did not comply with the specifications for pH. The results obtained from the study underscore the need for market surveillance of these products.

Poor quality alcohol based hand sanitizers: The pitfall in infection control

Kennedy O Abuga — 2024-06-25

Ever since the serendipitous discovery of alcohol through fermentation c. 10000 BC, the substance has attracted utility and abuse in equal measure. The initial use of alcohol as beverage in social functions, later diversified to medicinal and spiritual applications. Alcohol discovery however, cannot be traced to a single source but diverse geographical sites, although its use for beverage purposes seems universal. Distillation of fermented liquors to produce spirits dates back to c. 2000 BC in China, Egypt, and Mesopotamia for medicinal, cosmetic and spiritual purposes. The invention of the alembic as a distillation apparatus has several claims towards Arabic, Jewish, Egyptian and European origins with accompanying nomenclature