Ifeyinwa C Ezeala, Charles O Nnadi , Cyprian O Onyeji

For correspondence:-  Charles Nnadi   Email: charles.nnadi@unn.edu.ng   Tel:+234-8064947734

Received: 11 June 2024        Accepted: 1 November 2024        Published: 28 November 2024

Citation: Ezeala IC, Nnadi CO, Onyeji CO. Post-market monitoring of efficacies and determination of acid-neutralizing capacity of some antacid formulations in Nigeria. Trop J Pharm Res 2024; 23(11):1819-1826 doi: 10.4314/tjpr.v23i11.3

© 2024 The authors.
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Abstract

Purpose: To investigate post-market monitoring of the efficacy of antacids in different dosage forms available in Nigeria by evaluating the acid-neutralizing capacities (ANCs) of 28 antacid brands. Methods: The active pharmaceutical ingredients (APIs) were collected and the ANC was determined following the US Pharmacopeia monograph which involved reacting a minimum labeled dose (MLD) of the antacid with hydrochloric acid (HCl) and the excess was neutralized with sodium hydroxide (NaOH). All determinations were made using a pH meter at 37 ± 1 °C. Results: The ANC values of all brands ranged from 2.50 ± 0.23 to 28.10 ± 0.16 mEq/MLD. All the brands except one suspension contained simethicone alone and recorded ANC values above the acceptable limit (5 mEq/MLD). Antacids with aluminium hydroxide and magnesium hydroxide at amounts of ≥ 250 mg per 5 mL or tablet were associated with high ANC values. Antacids containing high amounts of single API such as sodium bicarbonate or calcium carbonate also had high ANC values. Conclusion: The ANC values of all the brands except one suspension (containing simethicone alone) are above the acceptable limit (5 mEq/MLD) and as such should be included on the drug labels.