A comparative study of the dissolution rate and Acid-Neutralizing capacity of Aceproxyvon with other marketed drugs

Abstract

Quality is one of the most important issues in the pharmaceutical industry. Drugs must be marketed as safe and therapeutically effective formulations whose performance is consistent and foreseeable. evaluation verifies and ensures their quality, bioavailability, and optimum therapeutic activity. Aceclofenac and Paracetamol (acetaminophen) are commonly used for the relief of headaches and pain. The combination of these two drugs is available in different brands in the Indian market. The main objective of the present study was to conduct a comparative dissolution release test and acid neutralizing capacity test (ANC) of Test products versus Reference products. Brands that are similar in both composition and concentration were used in the study to compare the in vitro dissolution profile and ANC in different pH buffer solutions. Three marketed brands of Aceclofenac 100 mg and Paracetamol 325 mg, i.e., Aceproxyvon (test product Brand A), Brand B, and Brand C (Reference products), were used in the study. Brand D being an antacid was used as a reference product to compare the acid-neutralizing capacity of the drugs. The dissolution rates of paracetamol were similar across all formulations at various pH mediums. Aceclofenac showed a higher dissolution rate in Brand A as compared to Brand B and C at pH 4.5, while the dissolution rates of aceclofenac were comparable in all formulations using pH 6.8 and pH 7.5 phosphate media. The ANC of Brand A was found to be higher (7.42 mEq/g) compared to Brand B (6.74 mEq/g) and Brand C (7.18 mEq/g). Brand A showed faster dissolution and higher acid neutralizing capacity as compared to reference products. This enhancement in dissolution rate may further result in a rapid onset of action and better therapeutic efficacy.