TITLE:
Pharmaceutical Quality Evaluation of Vonoprazan Film Coated Tablets: A Newly Approved and Launched First-in-Class Potassium Competitive Acid Blocker Marketed in Bangladesh
AUTHORS:
Shahriyar Tonmoy, Md. Ataur Rahman, Taslima Akter, Rahima Akter, Md. Rafiquzzaman
KEYWORDS:
Vonoprazan Tablets, Potassium-Competitive Acid Blocker (P-CAB), Proton Pump Inhibitor (PPI), Pharmaceutical Quality Assessment, High-Performance Liquid Chromatography (HPLC)
JOURNAL NAME:
Open Access Library Journal,
Vol.12 No.2,
February
28,
2025
ABSTRACT: Context: Vonoprazan fumarate is the first-in-class innovative P-CAB (potassium-competitive acid blocker) authorized and launched in the Bangladeshi pharmaceutical market in June 2023. There is no study yet on the pharmaceutical quality of Vonoprazan fumarate products manufactured and marketed in Bangladesh. Systematic assessment of pharmaceutical quality parameters is a crucial part of the continuous quality improvement and monitoring of pharmaceutical products. It is also an outstanding component of pharmacovigilance and post-marketing surveillance. Objective: This study aims to assess the physicochemical quality parameters of different marketed brands of Vonoprazan fumarate available in Bangladesh. As part of quality factors, uniformity of weight, hardness, moisture content, disintegration time, identification, dissolution, and potency test were considered in the present study. Methodology: Five brands of samples of Vonoprazan fumarate tablets were randomly chosen and purchased from different pharmacies located in Dhaka, Bangladesh. Multiple in vitro tools were used to predict and scrutinize the collected medication formulations to assess and ensure product quality and patient safety. Among others, USP (United States Pharmacopeia), Apparatus 2 (Paddle System), and HPLC (High-Performance Liquid Chromatography) were used for dissolution and potency evaluation, respectively. These tests were considered to measure the actual drug content and physical properties, as well as to forecast how specific products will behave in vivo. Results: During this investigation, it was found that the tested results of the five brands of Vonoprazan fumarate tablets complied with the quality specifications described in USP 43-NF 38 (United States Pharmacopeia 43-National Formulary 38). Conclusion: All five tested samples from the five distinct brands met the acceptability standards. The products may meet patients’ demands and provide the intended therapeutic effects.