Investigation of the effects of hydroalcoholic solutions on textural and rheological properties of various controlled release grades of hypromellose.
Hypromellose (hydroxypropyl methylcellulose, HPMC) matrices are widely used in the formulation of sustained release dosage forms. The integrity and performance of an HPMC matrix formulation depends on rapid hydration and gel formation upon ingestion. Due to the recent alert issued by the Food and Drug Administration regarding the potential negative influence of alcoholic beverages on extended release (ER) formulations, several researchers have evaluated the potential influence of hydroalcoholic media on drug release from ER dosage forms. It has been reported that HPMC matrix formulations do not show "dose dumping" in hydroalcoholic media. The purpose of this study was a fundamental investigation on the effect of hydroalcoholic solutions (0-40% v/v ethanol) on textural and rheological properties of different viscosity grades of neat HPMC, as the functional ingredient within a hydrophilic matrix. In general, hydroalcoholic solutions had little effect on gel formation and mechanical properties of hydrated compacts, while the rheological behavior of HPMC showed dependency on the ethanol content of such solutions.
Missaghi
Shahrzad
S
Colorcon, 415 Moyer Boulevard, West Point, PA 19486, USA. SMissaghi@colorcon.com
Fegely
Kurt A
KA
Rajabi-Siahboomi
Ali R
AR
D000434:Alcoholic Beverages; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D000431:Ethanol / Q000737:chemistry*; D005782:Gels; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D012212:Rheology; D013678:Technology, Pharmaceutical / Q000379:methods*; D014783:Viscosity; D014867:Water / Q000737:chemistry
D003692:Delayed-Action Preparations; D004337:Drug Carriers; D005782:Gels; D014867:Water; D000431:Ethanol; D065347:Hypromellose Derivatives; D008747:Methylcellulose