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Abuga K, Nyamweya N, King’ondu O. "Quality of alcohol-based hand sanitizers marketed in the Nairobi metropolitan area." East Cent. Afr. J. Pharm. Sci.. 2021;24(1):29-37. Abstract

The emergence of the COVID-19 pandemic has propelled the use of alcohol-based hand sanitizers to the fore as a SARS-CoV-2 control measure. To be effective these products must comply with relevant quality parameters such as alcohol concentration, methanol limits and purity. The current study was designed to determine the quality of alcohol-based hand sanitizer products in the Nairobi metropolitan area. For this purpose, 74 commercially marketed samples were collected and subjected to analysis by gas chromatography. Only three samples (4.1%) complied with the regulatory specifications for alcohol content, methanol limits and pH. Five samples (6.8%) complied with the specification for alcohol content but did not meet methanol or pH limits. A total of 44 (59.5%) samples had methanol levels that exceeded threshold limits. Eleven samples (14.9%) were found with methanol substitution (i.e., methanol, instead of ethanol or isopropanol, was the main alcohol component). The results show that users of alcohol-based hand sanitizers are being exposed to substandard and falsified products which in addition to being non-efficacious pose harm due to unacceptable levels of toxic impurities. Regular, routine post-market surveillance is needed to prevent such products from reaching the market.

Abuga K, Ongarora D, Karumbi J, Olulo M, Minnaard W, Kibwage I. "Sub-Standard Pharmaceutical Services in Private Healthcare Facilities Serving Low-Income Settlements in Nairobi County, Kenya." Pharmacy. 2019;7(4):167. Abstract

Background: Quality pharmaceutical services are an integral part of primary healthcare and a key determinant of patient outcomes. The study focuses on pharmaceutical service delivery among private healthcare facilities serving informal settlements within Nairobi County, Kenya and aims at understanding the drug procurement practices, task-shifting and ethical issues associated with drug brand preference, competition and disposal of expired drugs. Methods: Forty-five private facilities comprising of hospitals, nursing homes, health centres, medical centres, clinics and pharmacies were recruited through purposive sampling. Structured electronic questionnaires were administered to 45 respondents working within the study facilities over an 8-week period.
Results: About 50% of personnel carrying out drug procurement belonged to non-pharmaceutical cadres namely; doctors, clinical officers, nurses and pharmacy assistants. Drug brand preferences among healthcare facilities and patients were mainly pegged on perceived quality and price. Unethical business competition practices were recorded, including poor professional demeanour and waiver of consultation fees veiled to undercut colleagues. Government subsidized drugs were sold at 100% profit in fifty percent of the facilities stocking them. In 44% of the facilities, the disposal of expired drugs was not in conformity to existing government regulatory guidelines. Conclusions: There is extensive task-shifting and delegation of pharmaceutical services to non-pharmaceutical cadres and poor observance of ethical guidelines in private facilities. Strict enforcement of regulations is required for optimal practices.

Abuga KO, Kigera ST, Wanyama M, Nandama WM, Kibwage IO. "Quality Control Results of Pharmaceuticals Analyzed in the Mission for Essential Drugs and Supplies (MEDS) Laboratory During the Period 2013-2017." East Cent. Afr. J. Pharm. Sci.. 2021;24(2):57-66. Abstract

During the 2013-2017 period, the MEDS laboratory received and processed 6853 samples. Samples were sourced from Kenya and other sub-Saharan Africa countries. The samples submitted comprised Kenyan manufactured (31.9%) and internationally manufactured products (67.9%) while nine samples were of unknown origin. Analysis was carried out according to compendial and/or in-house specifications. The non-compliance rate was 5.1% consisting of 1.2 % local and 3.8% imports. The top ten drug classes with high failure rates were antimyasthenics (50.0%), antiseptics/disinfectants (24.7%), anthelminthics (22.0%), thyroid/antithyroid drugs (20.0%), nutrient mixtures (18.5%), uricosurics (12.5%), waters (11.6%), mixed anti-infectives (11.1%), hemostatics (10.0%) and nootropics (10.0%). Full compliance was however, recorded with laxatives, antidiarrheals, antihemorrhoidals, prokinetics, antithrombotics, antithrombocytopenia agents, vasopressors, anti-arrhythmic drugs, anti-anginal drugs, disease modifying antirheumatic drugs, antimigraine drugs, vertigolytics, muscle relaxants, bisphosphonates, joint lubricants, hormones, anticholinergics, osmotic diuretics, hypophosphatemics, lubricants, minerals, amino acids/peptides, immunomodulatory agents, choleretics, antidotes, lozenges, ear drops, proteins/glycoproteins, herbal products, X-ray contrast media, vaccines, environmental monitoring, medical devices/equipment and cleaning validation swabs. A total of 23 substandard and falsified medicines devoid of active ingredients were encountered over the five-year period. The results obtained demonstrate the need to strengthen regulatory stringency in order to curb incidences of substandard and falsified medicines.

Abuga K, Nyamweya N. "Alcohol-Based Hand Sanitizers in COVID-19 Prevention: A Multidimensional Perspective." Pharmacy. 2021;9(1):64. Abstract

The global use of alcohol-based hand sanitizers (ABHS) as an important means of controlling the transmission of infectious disease has increased significantly as governments and public health agencies across the world advocated hand hygiene as a preventative measure during the COVID-19 pandemic. Although the performance of these products is most commonly defined as a function of their alcohol concentration, they are multifaceted products in which an interplay of several factors is important in determining efficacy. This paper discusses the interplay between ABHS input (formulation) factors and output (product performance) factors in the context of a multidimen-sional perspective using a novel representative paradigm. In the model, represented in the form of a three-dimensional tetrahedron, each of the faces represents inputs in the manufacturing of the ABHS product, which are the type and amount of alcohol, the inactive ingredients, the formulation and the manufacturing practices. The four corners of the tetrahedron represent the product per-formance factors which include product efficacy, sensory characteristics, usage and compliance and product safety. The multidimensional approach to the formulation and evaluation of ABHS shows that several factors contribute to the effectiveness and utility of these products. The paradigm provides a useful framework for manufacturers of ABHS and related healthcare products.

Abuga KO, Amugune BK, Ndwigah SN, Kamau FN, Thoithi GN, Ogeto JO, Okaru AO, Nguyo JM, King'ondu OK, Mugo HM, Kibwage IO. "Quality Performance of Drugs Analyzed in the Drug Analysis and Research Unit (DARU) during the Period 2006-2010." East Cent. Afr. J. Pharm. Sci.. 2013;16(2):33-43. Abstract

During the period 2006-2010, the Drug Analysis and Research Unit analyzed 583 samples. The samples comprised 50.6% local and 49.4% imported products. Samples were subjected to compendial or in-house specifications. The failure rate was 12.2% for local products and 14.2% for imports. Antibacterial products recorded the highest failure rate (21.6%) while anticancers and drugs acting on the gastrointestinal, respiratory and reproductive systems all passed in the tests performed. The failure rate for antiprotozoals, antimalarials, antifungals, anthelminthics and analgesics was 14.3%, 12.5%, 11.8%, 8.9% and 11.5%, respectively.

Abuga KO, Ndwigah SN, Amugune BK, Ongarora DB, Njogu PM, Okaru AO, Kibwage IO. "Quality Control Report of Drugs Analyzed in the Drug Analysis and Research Unit during the Period 2011-2015." East Cent. Afr. J. Pharm. Sci.. 2020;23(3):79-86. Abstract

During the period 2011-2015, the Drug Analysis and Research Unit (DARU) analyzed 1972 drug samples. The samples consisted of 21.5% locally manufactured and 78.2% imported products while the origin of 0.3% of products was indeterminate. Samples were subjected to compendial and/or in-house analytical specifications. The overall non-compliance rate was 4.5% comprising 2.5% local products and 2.0% imports. High failure rates were recorded for uterotonics (37.5%), hemostatics (33%), anthelmintics (17%) and anticancers (10.5%) while ophthalmic, immunomodulatory, musculoskeletal and endocrine drugs all complied with the quality acceptance criteria. Erectile dysfunction drugs, received by the laboratory for the first time, all complied with specifications. The results obtained demonstrate an improvement in the quality of samples submitted to DARU when compared to previous performance.

Aluda AT, Amugune BK, Abuga KO, Kamau FN. "Development and Validation of a Gas Chromatographic Method for Determination of Menthol in Cold-Cough Syrups." PJK. 2018;23(3):90-93. Abstract

Background
Common cold is the most common infection of the upper respiratory tract and cold-cough syrups are often prescribed. Although menthol is one of the common constituents of these syrups, quality checks on cold-cough syrups normally target the major active pharmaceutical ingredients without regard to menthol content.

Objective
To develop and validate a gas chromatography method for determination of menthol in cold-cough syrups.

Methods
A simple, rapid, robust, accurate and reliable Gas Chromatography method was developed and validated for the determination of menthol in cold-cough syrups that may also contain ambroxol, chlorpheniramine, guaifenesin, bromhexine and salbutamol.

Results
Optimized chromatographic conditions were: A ZB-WAXplus 60m ×0.25mm; 0.25μm fused silica capillary column. Oven temperature program of 110 0C (2 min), ramp 10 0C/min to 190 0C (2 min). Injector port temperature maintained at 240 0C. Injection volume of 1.0 μl split in the ratio of 50:1. Carrier gas as nitrogen at 1.0mL/min which also serves as make up gas (30 mL/min) in the flame ionization detector (260 0C). Other detector gases were hydrogen (30 mL/ min) and industrial air (300 mL/ min) and the diluent for samples and standards was grade chloroform.
From recovery studies, 97.56 to 102.97 % recovery was reported. Repeatability studies had a coefficient of variation of 0.55 while intermediate precision was 0.32. The method was linear over a range of 0.042 to 0.169 mg/mL with a coefficient of determination (R2) 0.9986.
Of the 21 samples analyzed, only 10 samples (47.6 %) complied with assay specifications of 90.0 to 110.0 % label claim for finished products according to the United States Pharmacopeia 2016.

Conclusion and recommendation
A gas chromatographic method was developed and validated for the determination of menthol in cold-cough syrups in Kenya. This method can be used together with a validated high-performance liquid chromatography method to assay cold-cough syrups that may also contain ambroxol, bromhexine, chlorpheniramine maleate, guaifenesin and salbutamol.
This method can be useful in routine analysis such as pre-registration studies as well as post market surveillance to curb substandard and counterfeit cold-cough syrups.

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