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Feb 11, 2025Keywords:
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Main Article Content
Post-market monitoring of efficacies and determination of acid-neutralizing capacity of some antacid formulations in Nigeria
Abstract
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.
