Abstract

IMPACT OF ALCOHOLIC BEVERAGES ON IN VITRO DRUG RELEASE OF ORAL TABLETS WHEN CO-ADMINISTERED WITH BEER, TEQUILA AND WINE

MD. Betzabeth Jaime-Escalante, PhD Horacio Sandoval, MD. Zacnite Sánchez and PhD. Luz María Melgoza*

ABSTRACT

Oral tablets are designed to be taken with water; however, often they are ingested with alcoholic beverages. In this study, it was analyzed on in vitro drug release of three over-the-counter oral dosage forms: immediate-release acetylsalicylic acid (ASA), immediate-release metformin hydrochloride (Met-HCl) and extended-release sodium diclofenac (DCL-Na) co-administered with beer, tequila and wine. It was compared the effect of these alcoholic beverages and ethanol on drug-releasing profiles too. Appropriate dissolution media (Pharmacopeia) for ASA and Met-HCl (500 mg) and sodium diclofenac (Na-DCL) (100 mg) were supplemented with beer, tequila, or white wine, at a proportion of 13 g of pure ethanol. Furthermore, the results were compared with the FDA proposed method (40% ethanol). It was shown release ASA tablets were significantly different (P<0.05) to FDA, beer and wine. While DCL-Na dosage forms dissolution profiles have a significant difference (P<0.05) respect to all alcoholic beverages and ethanol. Moreover Met-HCl dosage forms dissolution profiles showed significant difference (P<0.05) in FDA, ethanol and tequila dissolution profiles. Nonetheless, comparing only ethanol effect on dissolution profiles, ethanol showed a significant difference (P<0.05) to FDA, beer and wine dissolution profiles in all cases, whereas ethanol vs tequila showed no significant difference, except on DCL-Na dosage forms dissolution profiles.

Keywords: Acetylsalicylic acid, alcohol consumption, alcoholic beverages, diclofenac sodium, drug dissolution, metformin hydrochloride.