Bioequivalence regulation in emerging countries: Example of Moroccan regulations on immediate release formulations and comparison with international guidelines

Adade, Casimir Adade; Cheikh, Amine; Cherrah, Yahia; Bouatia, Mustapha; Cardot, J

doi:10.7324/japs.2019.91104

Cited by 3 publications

(1 citation statement)

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“…n several countries of Latin America, Africa, and Asia, the pharmaceutical companies are allowed to market drug products after providing evidence of compliance with pharmacopeial quality requirements and good manufacturing practices (1,2). This policy reduces the costs of medicines and increases accessibility but leads to a large presence of similar products that satisfy these requirements but lack evidence of biopharmaceutical quality (i.e., bioequivalence).…”

Section: Introductionmentioning

confidence: 99%

In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions

Imbriago,

Schiavo,

Baptista

et al. 2024

Dissolution Technol.

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Regulatory requirements for drugs approval in several countries allow pharmaceutical companies to market drug products after providing evidence of compliance with pharmacopeial quality requirements and good manufacturing practices, a policy that reduces drug treatment cost and increases accessibility. On the other hand, these policies lead to pharmaceutical markets characterized by a large share of similar drug products that favor price-oriented competition, thereby discouraging pharmaceutical innovation and increasing productrelated variability in therapeutic response, potentially compromising patient outcomes and healthcare costs. Omeprazole, a widely prescribed drug for gastric secretion disorder treatment, has been historically marketed in Uruguay without the requirement of bioequivalence. The performance of omeprazole formulations, particularly the enteric-coated microgranules, have a significant impact on oral bioavailability because omeprazole is highly labile under acidic conditions. In this work, we aimed to assess the biopharmaceutical characteristics of 11 multi-source omeprazole (20-mg) capsules using in vitro biorelevant dissolution testing. The study included evaluations of enteric-coating performance, pH-dependent omeprazole degradation kinetics, and in vitro dissolution testing to simulate single and multiple doses. The findings revealed important variations in the enteric-coating performance among the tested formulations, with some products showing considerable drug release at pH levels under which the drug is rapidly degraded (pH ≤ 4.0). Dissolution testing revealed suboptimal results for several drug products and high formulation-related variability in omeprazole release profiles, which could potentially affect in vivo performance. This study highlights the need for biorelevant assessment of pharmaceutical quality for multi-source drug products.

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Section: Introductionmentioning

confidence: 99%

In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions

Imbriago,

Schiavo,

Baptista

et al. 2024

Dissolution Technol.

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Clinical pharmacokinetics and bioavailability study between generic and branded fluconazole capsules

Al-Mahroos¹,

Al-Tamimi²,

Al-Tamimi³

et al. 2021

J Adv Pharm Educ Res

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Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

Al-Tamimi

Al-Mahroos

Al-Tamimi

et al. 2022

RJPT

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Cefuroxime axetil (CA) is a broad-spectrum second-generation cephalosporin antibiotic resistant to beta-lactamase used for treating different kinds of infections. This study was conducted to compare the pharmacokinetics (PK) and to evaluate the bioequivalence (BE) between a newly formulated generic CA 500mg tablets as a test formula with the same dose of the brand formula as the reference product applying 2-way, 2-treatment, 2-period, 2-sequence, randomized crossover design with six days washout interval between dosing. After overnight fasting for 12 hours, both CA products were administered to 28 healthy male adult Arabic subjects, followed by serial blood samples obtained from each subject before drug dosing (0-hr) and then up to 8 hours post-dosing. The calculated PK parameters Cmax, Tmax, AUC0–t, AUC0–∞, Thalf, MRT, Cl and Vd obtained from each product were statistically compared by ANOVA and 90% confidence interval tests to evaluate the BE between both products. Based on international guidance on bioequivalences like FDA and EMEA, it was concluded from this research that the test and the reference formulas are bioequivalent since the 90% confidence intervals were within the accepted ranges of 80.00-125.00%. All participants tolerated both products well, and they were discharged without any significant alterations in their clinical baseline characteristics. Therefore, the newly formulated generic CA 500mg tablets may be prescribed in clinical practice and used as a safe and effective alternative to the brand product.

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Bioequivalence regulation in emerging countries: Example of Moroccan regulations on immediate release formulations and comparison with international guidelines

Cited by 3 publications

References 0 publications

In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions

In Vitro Characterization of Multi-Source Omeprazole Capsule Dissolution Performance Under Biorelevant Conditions

Clinical pharmacokinetics and bioavailability study between generic and branded fluconazole capsules

Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

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