Water soluble cellulose acetate: a versatile polymer for film coating.
The objective of this study was to investigate the use of water soluble cellulose acetate (WSCA) as a film coating material for tablets. Aspirin (ASA) tablets were prepared by direct compression and coated with either WSCA or HPMC (hydroxypropyl methylcellulose) dispersions. Coatings of 1-3%, depending on the intended application, were applied to the model drug (ASA) tablets employing a side-vented coating pan. Free films of WSCA, prepared by cast method, are crystal clear and, depending on the viscosity grade, are flexible, strong and durable. WSCA has the capability of forming free films without plasticizers and the films dry at room temperature. Glass transition temperature, Tg, was determined by differential scanning calorimetry. The Tg of WSCA is significantly higher relative to HPMC. Inclusion of plasticizer lowers the Tg of WSCA and effective plasticizers were PEG 400 and glycerin. Low viscosity WSCA was more soluble in water (25-30%) relative to medium viscosity WSCA (10-15%). WSCA solutions exhibited no increase in viscosity with an increase in temperature. Samples of coated (WSCA and HPMC) tablets and uncoated ASA cores were packaged for stability studies at room and elevated temperature storage. Physical stability of ASA tablets coated with 2:1 LV: MV (low viscosity: medium viscosity) WSCA formulations was better when compared to tablets coated with HPMC. Dissolution stability of WSCA coated ASA was similar to the physical stability results. After three months at elevated temperature (35 and 45 degrees C), the WSCA coated tablets complied with USP dissolution requirements for ASA, while the HPMC coated tablets did not. There was no difference in moisture (weight) gain of ASA tablets coated with either WSCA or HPMC. The WSCA coated tablets were not sticky or tacky, while the HPMC coated tablets were tacky and stuck together.
Wheatley
Thomas A
TA
FMC BioPolymer, PO Box 8, Princeton, NJ 08543, USA. TAWheatley@MSN.Cm
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin; D001672:Biocompatible Materials / Q000737:chemistry*; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004355:Drug Stability; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D012995:Solubility; D014783:Viscosity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001672:Biocompatible Materials; C005062:acetylcellulose; D065347:Hypromellose Derivatives; D002482:Cellulose; D008747:Methylcellulose; D001241:Aspirin