Drug and Alcohol Rehabilitation: The Physicochemical Equivalence of Eight Brands of Amlodipine Tablets in Lagos, Nigeria.

The physicochemical equivalence of eight brands of amlodipine tablets in lagos, Nigeria.

Filed under: Drug and Alcohol Rehabilitation

West Afr J Med. 2012 Jul-Aug; 31(3): 154-9
Olayemi SO, Akinleye MO, Awodele EO, Idris O, Oladimeji-Salami J

Amlodipine is a dihydropyridine calcium channel antagonist that is useful in the treatment of hypertension and angina pectoris. In addition to the innovator brand of this molecule, several generic brands are marketed in Nigeria.To evaluate the physicochemical equivalence of eight brands of amlodipine tablets marketed in Lagos, Nigeria.Physicochemical properties such as identity, weight uniformity, friability, hardness test, disintegration test, dissolution test and assay of active ingredients were performed using the methods described in the British and the United States Pharmacopoeia. Ultra-violet spectrophotometric and High performance liquid chromatographic methods were used for assay of the labelled amount of amlodipine in the products.All the products passed weight uniformity and disintegration tests. Only one brand failed the friability test. Two brands had mean crushing strength less than 4kg/cm2; while only 4 brands passed dissolution test by releasing >75% of the labelled amlodipine within 45 minutes. One brand failed both assay and dissolution tests by returning less than official specifications in the general monograph for conventional tablets. In all, four of the eight sample products analyzed passed all the tests. These can be said to be physicochemically equivalent and may be clinically interchangeable or substituted.This study further highlights the concerns over the quality of drug products marketed in a developing country.
HubMed – drug

Screening for Drug-Induced Hepatotoxicity in Primary Mouse Hepatocytes Using Acetaminophen, Amiodarone, and Cyclosporin A as Model Compounds: An Omics-Guided Approach.

Filed under: Drug and Alcohol Rehabilitation

OMICS. 2013 Jan 11;
Van Summeren A, Renes J, Lizarraga D, Bouwman FG, Noben JP, van Delft JH, Kleinjans JC, Mariman EC

Abstract Drug-induced hepatotoxicity is a leading cause of attrition for candidate pharmaceuticals in development. New preclinical screening methods are crucial to predict drug toxicity prior to human studies. Of all in vitro hepatotoxicity models, primary human hepatocytes are considered as ‘the gold standard.’ However, their use is hindered by limited availability and inter-individual variation. These barriers may be overcome by using primary mouse hepatocytes. We used differential in gel electrophoresis (DIGE) to study large-scale protein expression of primary mouse hepatocytes. These hepatocytes were exposed to three well-defined hepatotoxicants: acetaminophen, amiodarone, and cyclosporin A. Each hepatotoxicant induces a different hepatotoxic phenotype. Based on the DIGE results, the mRNA expression levels of deregulated proteins from cyclosporin A-treated cells were also analyzed. We were able to distinguish cyclosporin A from controls, as well as acetaminophen and amiodarone-treated samples. Cyclosporin A induced endoplasmic reticulum (ER) stress and altered the ER-Golgi transport. Moreover, liver carboxylesterase and bile salt sulfotransferase were differentially expressed. These proteins were associated with a protective adaptive response against cyclosporin A-induced cholestasis. The results of this study are comparable with effects in HepG2 cells. Therefore, we suggest both models can be used to analyze the cholestatic properties of cyclosporin A. Furthermore, this study showed a conserved response between primary mouse hepatocytes and HepG2 cells. These findings collectively lend support for use of omics strategies in preclinical toxicology, and might inform future efforts to better link preclinical and clinical research in rational drug development.
HubMed – drug

Antiretroviral Drug Resistance Profiles and Response to Second-Line Therapy Among HIV Type 1-Infected Ugandan Children.

Filed under: Drug and Alcohol Rehabilitation

AIDS Res Hum Retroviruses. 2013 Jan 11;
Musiime V, Kaudha E, Kayiwa J, Mirembe G, Odera M, Kizito H, Nankya I, Ssali F, Kityo C, Colebunders R, Mugyenyi P

Abstract We sought to determine the pattern of resistance-associated mutations (RAMs) among HIV-1-infected children failing first-line antiretroviral therapy (ART) and ascertain their response to second-line regimens in 48 weeks of follow-up. The design involved a cohort study within an HIV care program. We studied records of 142 children on ART with virological failure to first-line ART and switched to second-line ART with prior genotypic resistance testing. The pattern of RAMs was determined in frequency runs and the factors associated with accumulation of?3 thymidine analogue mutations (TAMs) and K103N were determined using multivariate logistic models. Changes in weight, height, CD4, and viral load at weeks 24 and 48 after switch to second-line therapy were determined using descriptive statistics. The children were mean age 10.9±4.6 years and 55.6% were male. The commonest nucleoside reverse transcriptase inhibitor (NRTI) RAM was M184V in 129/142 (90.8%) children. TAMs,?3 TAMs, 69 insertion complex, K65R/N, and Q151M were observed in 43.0%, 10.6%, 18.3%, 2.8%, and 2.1% of the children, respectively. The commonest nonnucleoside reverse transcriptase inhibitor (NNRTI) RAM was K103N in 72/142 (50.7%) children. The starting ART regimen was associated with accumulation of both?3 TAMs (p=0.046) and K103N (p<0.0001), while a history of poor adherence was associated with K103N accumulation (p=0.0388). After 24 weeks and 48 weeks of follow-up on lopinavir-ritonavir based second-line ART, 86/108 (79.6%) and 84.5% (87/103) of the children had viral loads<400 copies/ml, respectively. The mean CD4 absolute count increased by 173 cells/?l and 267cells/?l at weeks 24 and 48, respectively. Increments were also observed in mean weight (1.6?kg and 4.3?kg) and height (1.8?cm and 5.8?cm) at weeks 24 and 48, respectively. Multiple RAMs were observed among HIV-1-infected children with virological failure on first-line ART with M184V and K103N most frequent. The children responded favorably to boosted PI-based second-line ART. HubMed – drug

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