In vitro dissolution of oral modified-release tablets and capsules in ethanolic media

In 2005, Palladone, an extended-release capsule, was withdrawn from the market after clinical testing showed subjects who took the product with alcohol had increased levels of drug in their blood. To better understand this phenomenon, we studied the in vitro drug release of 27 oral modified-release...

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Bibliographic Details
Published in:International journal of pharmaceutics 2010-10, Vol.398 (1), p.93-96
Main Authors: Smith, Anjanette P., Moore, Terry W., Westenberger, Benjamin J., Doub, William H.
Format: Article
Language:English
Subjects:
Administration, Oral
Biological and medical sciences
Capsules
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - chemistry
Dissolution
Dose dumping
Ethanol
Ethanol - chemistry
General pharmacology
Medical sciences
Modified release
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Solubility
Tablets and capsules
Tablets, Enteric-Coated
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Summary:In 2005, Palladone, an extended-release capsule, was withdrawn from the market after clinical testing showed subjects who took the product with alcohol had increased levels of drug in their blood. To better understand this phenomenon, we studied the in vitro drug release of 27 oral modified-release products in alcohol-containing media. In 40% alcoholic medium, 9 of 10 capsules and 2 of 17 tablets show accelerated drug release. When a high percentage of the total dose is released in a short period of time, the extended-release product is then performing like an immediate release formulation. Products were also tested in 5% and 20% alcoholic media and in simulated gastric fluid (without enzyme) containing 20% alcohol. No tested capsules or tablets exhibited a significant increase in drug release in media containing only 5% alcohol. The current study indicates that in vitro dissolution may provide evidence regarding the ruggedness of formulations to ingested alcohol.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2010.07.031