The influence of hydro-alcoholic media on hypromellose matrix systems.
Hydrophilic matrices are widely used for extended release drug delivery, with hypromellose (HPMC) being a popular rate-controlling carrier. The FDA has recently issued an alert regarding the potential negative influence of alcohol on extended release dosage forms. The aim of this study was to investigate the hydroalcoholic solution effect on hydration, gel formation and drug release from HPMC matrices. None of the investigated matrix formulations (felodipine, gliclazide, and metformin hydrochloride) resulted in dose-dumping when exposed to ethanol solutions. HPMC compacts made of three different viscosity grades of Methocel showed consistent swelling and gel formation when exposed to hydroalcoholic media.
Levina
Marina
M
Colorcon Limited, Dartford, England. mlevina@colorcon.co.uk
Vuong
Hue
H
Rajabi-Siahboomi
Ali R
AR
D003692:Delayed-Action Preparations / Q000737:chemistry*; D000431:Ethanol / Q000494:pharmacology*; D015736:Felodipine / Q000008:administration & dosage / Q000737:chemistry; D005907:Gliclazide / Q000737:chemistry; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D012995:Solubility; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D000431:Ethanol; D065347:Hypromellose Derivatives; D008747:Methylcellulose; D005907:Gliclazide; D015736:Felodipine