More and more people who suffer from chronic diseases such as high blood pressure, diabetes, and disorders of the central nervous system are developing the habit of alcohol consumption. The United States ranks 40th among nations in alcohol consumption, and alcohol use is particularly common in tribal, rural, and poor urban areas of the country. The consumption of alcoholic beverages varies considerably between different countries and between different ethnic groups within a country (1).
Extended-release dosage forms are the drug-delivery systems of choice for managing chronic diseases. Such formulations typically contain a higher dose of drug than instant-release formulations and generally are based on matrix principles or the barrier-membrane coating principle. Excipients such as hypromellose (i.e., hydroxypropyl methylcellulose) and ethyl cellulose control the drug's release rate. Alcohol affects the solubility of these excipients, and consuming alcohol after taking extended-release drug products that contain these excipients may lead to dose dumping.
Depending on the therapeutic indication and the therapeutic index of a drug, dose dumping can raise safety concerns or diminish a drug's efficacy, thus posing a significant risk to patients. Some modified-release oral dosage forms contain drugs and excipients that exhibit higher solubility in ethanolic solutions than they do in water. Such products may exhibit rapid drug dissolution in the presence of ethanol. Therefore, the consumption of alcoholic beverages along with these products might be expected to induce dose dumping.This potential for dose dumping from an oral modified-release dosage form has not attracted much attention in the pharmaceutical literature for many reasons. One possible reason is the general assumption that a clinically insignificant difference in drug-release rate would be expected with ethanol consumption in vivo. A study conducted more than 20 years ago, and the absence of a clear postmarketing signal pointing to alcohol-induced dose dumping, may have reinforced this assumption (2).
Although various drug–drug interactions and drug–food interactions have been discussed widely, no research has evaluated the influence of various alcoholic beverages on the performance of drug products—specifically sustained-release dosage forms. A review of the literature indicates the gap in this field of research. The objective of the present study was to evaluate the influence of alcoholic beverages on the drug-release profile of sustained-released dosage forms.
The authors used standard reagent-grade ethanol (40% v/v, Avantor Performance Materials, Selangor, Malaysia) for their analysis. Kingfisher Strong beer (8% alcohol, Bombay Breweries, Taloja, India), Kingfisher Mild beer (5% alcohol), and rum (40–55% alcohol, South Seas Distilleries and Breweries, Mumbai) were the alcoholic beverages.
The authors studied instant- and sustained-release formulations of metformin (Glycomet 500, Batch No. 13003812, USV, Mumbai, and Glycomet 500 S.R., Batch No. 28002510, USV) and of diclofenac (Voveran 50, Batch No. 107015AD, Novartis, Basel, and Voveran S.R. 100, Batch No. 98033 A, Novartis). The authors chose metformin and diclofenac because they are the most frequently prescribed drugs for diabetes and pain management in India.