Dissolution Profiles of Three Brands of Lamivudine and Zidovudine Combinations in the Nigerian Market

Ochekpe, Nelson A.; Ngwuluka, Ndidi C.; Owolayo, H.; Fashedemi, Titilayo T.

doi:10.14227/dt130406p12

Cited by 13 publications

(8 citation statements)

References 2 publications

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“…Zidovudine in SIF showed a steady release of drug as the profile appeared flat over the 60 min period. One study by Ochekpe et al investigated the dissolution profile of Zidovudine combination with Lamivudine in the Nigerian market and demonstrated zidovudine to release less than 85% of drug in SIF (pH 6.8 buffer) at 30 min, which is the cut-off time for rapidly dissolving products [42]. Hence, it was concluded that Combivir® was not similar to the other products and was therefore not considered to be interchangeable with the other formulations.…”

Section: Zidovudinementioning

confidence: 99%

Investigating the Dissolution Profiles of Amoxicillin, Metronidazole, and Zidovudine Formulations used in Trinidad and Tobago, West Indies

2014

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Abstract. Trinidad and Tobago is a twin-island Republic in the Caribbean and like many developing countries, it has included generic drugs on the national drug formulary to decrease the financial burden of pharmaceutical medications. However, to ensure that medications received by patients are beneficial, generic drugs need to be interchangeable with the innovator which has demonstrated safety, efficacy, and quality. The objective of the study was to compare the dissolution profiles and weight variations for different formulations of amoxicillin, metronidazole, and zidovudine that are on the national drug formulary and marketed in Trinidad and Tobago. All the products investigated are categorized as class 1 drugs according to the Biopharmaceutics Classification System (BCS) and the dissolution profiles were assessed according to the World Health Organization (WHO) criteria for interchangeability between products. The similarity factor, f 2 , was used to determine sameness between the products. No generic formulation was found to be similar to Amoxil® 500-mg capsules. The two generic products for metronidazole 200-mg tablets demonstrated more than 85% drug release within 15 min in all three of the buffers; however, their 400-mg counterparts did not fulfill this requirement. The zidovudine 300-mg tablet complied with the requirements in buffer pH 4.5 and simulated gastric fluid (SGF) but not for simulated intestinal fluid (SIF). Some Class 1 pharmaceutical formulations may possess the same active ingredient and amount of drug but may show significant differences to in vitro equivalence requirements. Nevertheless, the dissolution process is suitable to detect these variations.

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Section: Zidovudinementioning

confidence: 99%

Investigating the Dissolution Profiles of Amoxicillin, Metronidazole, and Zidovudine Formulations used in Trinidad and Tobago, West Indies

2014

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“…Two drug release profiles are stated to be similar, if f 1 values are lower than 15 (acceptable range of similarity is 0-15), and f 2 values are greater than 50 (acceptable range of similarity is 50-100) [20,21]. From Table 2B, it can be observed that drug release profiles of the lyophilized polymer/polymer blends matrices were dissimilar to those of the dry polymer/polymer blends.…”

Section: Discussionmentioning

confidence: 99%

Eudragit E100 and Polysaccharide Polymer Blends as Matrices for Modified-Release Drug Delivery II: Swelling and Release Studies

Ngwuluka¹,

Nep²,

Ochekpe³

et al. 2016

Trop. J. Pharm Res

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“…These product attributes have been the focus of several product evaluations after release into the market [1][2][3][4]. Chemical analysis and visual assessment have been used to identify poor-quality drugs prevalent in Asian and sub-Saharan African countries [5,6].…”

Section: Introductionmentioning

confidence: 99%

Quality attributes of twenty-nine brands of ciprofloxacin: post-marketing in vitro analyses, microbiological assay and in vivo simulation

Muhammad¹,

Okpe²,

Olorunfemi³

et al. 2021

J. Pharm Bio.

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Ciprofloxacin is a fluoroquinolone antibiotic employed to treat infections. There are over three hundred registered generic brands of ciprofloxacin in Nigeria. There has been an observed marked variation in therapeutic or clinical outcome with change in brands by health professionals and patients. In a previous study of six (6) brands we had reported a high degree of inequivalence. In this study, twenty-nine (29) brands of ciprofloxacin were extensively evaluated against compendia requirements. Microbial sensitivity against two test organisms was conducted. In-vitro drug release and in-vivo simulation were established. Analysis of the data generated indicated that all brands passed qualitative test using TLC and disintegration test, six failed hardness test, one failed friability, nine failed antimicrobial assay and six failed percentage content assay. Conclusions drawn from the study for evidence-based clinical decisionwould include the fact that three brands only were found to be bioequivalent to the innovator brand, Ciproxin; while eight brands were bio-inequivalent using the three models of similarity factor (f2), and difference factor (f1) in two media and dissolution efficiency (DE) in pH 4.5. The three brands (Cipro-All, Cifran And Ciprogem) may confidently be used interchangeably with the innovator brand Keywords: Bioequivalence; Ciprofloxacin Drug quality; Generic substitution; Post-marketing surveillance

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Dissolution Profiles of Three Brands of Lamivudine and Zidovudine Combinations in the Nigerian Market

Cited by 13 publications

References 2 publications

Investigating the Dissolution Profiles of Amoxicillin, Metronidazole, and Zidovudine Formulations used in Trinidad and Tobago, West Indies

Investigating the Dissolution Profiles of Amoxicillin, Metronidazole, and Zidovudine Formulations used in Trinidad and Tobago, West Indies

Eudragit E100 and Polysaccharide Polymer Blends as Matrices for Modified-Release Drug Delivery II: Swelling and Release Studies

Quality attributes of twenty-nine brands of ciprofloxacin: post-marketing in vitro analyses, microbiological assay and in vivo simulation

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