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Odoyo AO, Abuga KO, Mugo HN, Mang’oi JS. "Quality of metronidazole benzoate suspension products marketed in Nairobi County, Kenya." East Cent. Afr. J. Pharm. Sci.. 2021;24(3):131-135. Abstract

Metronidazole benzoate is an ester derivative of metronidazole utilized in the formulation of oral suspensions owing to its palatability. The drug is liable to hydrolytic degradation during shelf life which could lower assay values and increase free metronidazole content. A medicine quality survey study was carried out in Nairobi County whereby 32 metronidazole benzoate samples representing 13 brands were collected from retail pharmacies. The samples were subjected to British Pharmacopoeia specifications for pH, free metronidazole content and assay. From the results obtained, only nine samples (28.1%) passed all the quality tests performed while five (15.6%), seven (21.9%) and 18 (56.3%) did not comply with pH, metronidazole content and assay specifications respectively. The results obtained demonstrate the existence of substandard metronidazole benzoate products in the market. This underscores the need for regular post market surveillance surveys and execution of appropriate regulatory actions.

Okaru AO, Abuga KO, Kibwage IO, Hausler T, Luy B, Kuballa T, Rehm J, Lachenmeier DW. "Aflatoxin contamination in unrecorded beers from Kenya – A health risk beyond ethanol." Food Control. 2017;79:344-348. Abstract

Samples of unrecorded opaque beers (n=58; 40 based on maize, 5 on sorghum and 13 on other plants) and recorded wines (n=8) in Kenya were screened for aflatoxins using a rapid ELISA technique followed by confirmation using liquid chromatography-tandem mass spectrometry. Six of the maize beers were obtained from Kibera slums in Nairobi County. Aflatoxin contamination was detected in six unrecorded beers (10%), but in none of the recorded wines. Remarkably, three of the aflatoxin positive samples were from the Kibera slums.
The concentration of aflatoxins in the positive samples had a mean of 3.5 µg/L (range 1.8–6.8 µg/L), corresponding for an average consumption of 500 mL (1 standard drink) to a margin of exposure (MOE) of 36 (range: 15–58), which is considered as risk. On the other hand, the alcoholic strength of the aflatoxin positive samples had a mean of 4.3% vol (range 3.5-4.8%) corresponding to a MOE of 2.5 (range of 2.2-3.0) for the equivalent consumption volume. While aflatoxins pose a risk to the consumer, this risk is about 10 times lower than the risk of ethanol.
The Joint FAO/WHO Expert Committee on Food Additives sets no acceptable daily intake for aflatoxins since they are genotoxic carcinogens and instead recommends for the reduction of aflatoxin dietary exposure as an important public health goal, particularly in populations who consume high levels of any potentially aflatoxins contaminated food. Nevertheless, ethanol still posed a considerably higher risk in the unrecorded beers examined. However, consumers should be informed about aflatoxins, as these are an involuntary and unknown risk to them. In addition, producers should be educated about measures to reduce aflatoxins.

Okaru AO, Abuga KO, Kibwage IO, Lachenmeier DW. "High Ethanol Contents of Spirit Drinks in Kibera Slums, Kenya: Implications for Public Health." Foods. 2017;6:89. Abstract

Cheap licit and artisanal illicit spirit drinks have been associated with numerous outbreaks of alcohol poisoning especially with methanol. This study aimed to evaluate the quality of cheap spirit drinks in Kibera slums in Nairobi County, Kenya. The samples consisted of cheap licit spirits (n = 11) and the artisanal spirit drink, ‘chang’aa’, (n = 28). The parameters of alcoholic strength and volatile composition were used as indicators of quality and were determined using gas chromatography with flame ionization detection (GC-FID) and gas chromatography-mass spectrometry (GC-MS) respectively. The ranges for alcoholic strength were 42.8–85.8% vol and 28.3–56.7% vol for chang’aa and licit spirit drinks respectively, while the pH ranges were 3.3–4.2 and 4.4–4.8 for chang’aa and licit spirit drinks respectively. The majority of volatiles were found in artisanal spirits and they included higher alcohols, ethyl esters and carbonyl compounds. The alcoholic strength of all the artisanal spirits (100%) and 91% of the licit spirits was above the 40% vol of standard spirits such as vodka. The high ethanol content of the alcohol products was the only element of public health significance in this study.

Okaru AO, Abuga KO, Kamau FN, Ndwigah SN. "HPLC Analysis of Azithromycin Suspensions and Tablets.". In: Optimizing medicine use to improve patient outcomes. College of Health Sciences, UoN, Nairobi, Kenya; 2014.
Okaru AO, Abuga KO, Kamau FN, Ndwigah SN, Lachenmeier DW. "A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions." Pharmaceutics. 2017;9(1):11. Abstract

A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was
developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The
optimum chromatographic conditions for separation were established as a mobile phase comprised
of acetonitrile-0.1 M KH2PO4 pH 6.5-0.1 M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59
v/v/v/v) delivered at a flow rate of 1.0 mL/min. The stationary phase consisted of reverse-phase
XTerra® (250 mm × 4.6 mm i.d., 5 μm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50%–150% (r2 = 0.997). The limits of detection and quantification were found to be 0.02% (20 μg) and 0.078% (78 μg), respectively, with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose of drug stability confirmation.

Omweri LG, Okaru AO, Abuga KO, Ndwigah SN. "Quality of povidone-iodine and chlorhexidine-based oral care products in Nairobi, Kenya." F1000Research. 2022;11:343. Abstract

Background: The oral cavity harbors many microbes that may cause diseases, including dental caries and periodontal diseases. Progressive inflammation from periodontal diseases may lead to gum detachment from the teeth. Povidone-iodine and chlorhexidine mouth rinses and gargles are broad-spectrum antimicrobial products that effectively manage dental caries and periodontal diseases and eliminate plaques. This study was conducted in Nairobi County, Kenya to establish the quality of povidone-iodine and chlorhexidine oral care products by determining the content of the active pharmaceutical ingredient and compliance with labeling requirements.
Methods: A total of 34 samples (from 15 brands) of povidone-iodine and 15 samples (from nine brands) of chlorhexidine were collected from retail pharmacies using convenience sampling. All samples were subjected to labeling analysis, identity, and assay tests. Potentiometric titration was used to assay povidone-iodine in the samples, while chlorhexidine was assayed using high-performance liquid chromatography (HPLC) according to British Pharmacopeia 2017 specifications.
Results: All samples complied with identification tests. Moreover, 47.1% of povidone-iodine and 66.7% of chlorhexidine products complied with pharmacopoeial assay specifications. Five povidone-iodine (14.7%) and four chlorhexidine (26.7%) samples had missing label information on the storage conditions and the address of the manufacturer.
Conclusions: Strict adherence to current Good Manufacturing Practices (cGMP) by manufacturers of povidone-iodine and chlorhexidine mouthwashes/gargles is necessary to guarantee quality assured products in the market. Regular post-market surveillance and regulatory enforcement of standards are instrumental in minimizing the circulation of poor-quality products.

Ongarora D, Karumbi J, Minnaard W, Abuga K, Okungu V, Kibwage I. "Medicine prices, availability, and affordability in private health facilities in low-income settlements in Nairobi county, Kenya." Pharmacy. 2019;7(2):40. Abstract

Medicine prices are a major determinant of access to healthcare. Owing to low availability of medicines in the public health facilities and poor accessibility to these facilities, most low-income residents pay out-of-pocket for health services and transport to the private health facilities. In low-income settlements, high retail prices are likely to push the population further into poverty and ill health. This study assessed the retail pricing, availability, and affordability of medicines in private health facilities in low-income settlements within Nairobi County. Medicine prices and availability data were collected between September and December 2016 at 45 private healthcare facilities in 14 of Nairobi’s low-income settlements using electronic questionnaires. The International Medical Products Price Guide provided international medicine reference prices for comparison. Affordability and availability proxies were calculated according to existing methods. Innovator brands were 13.8 times more expensive than generic brands. The lowest priced generics and innovator brands were, on average, sold at 2.9 and 32.6 times the median international reference prices of corresponding medicines. Assuming a 100% disposable income, it would take 0.03 to 1.33 days’ wages for the lowest paid government employee to pay for treatment courses of selected single generic medicines. Medicine availability in the facilities ranged between 2% and 76% (mean 43%) for indicator medicines. Prices of selected medicines varied within the 14 study regions. Retail medicine prices in the low-income settlements studied were generally higher than corresponding international reference prices. Price variations were observed across different regions although the regions comprise similar socioeconomic populations. These factors are likely to impact negatively on healthcare access.

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