Sustained release theophylline formulations, excipient systems and methods of production
Patent 6171615 Issued on January 9, 2001. Estimated Expiration Date: July 6, 2018. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
A stable sustained release theophylline formulation is prepared by incorporating theophylline into a semi-solid matrix comprising polyglycolized glycerides (GELUCIRE.RTM. excipient) and a mixture of nucleation enhancers. Theophylline is admixed with molten GELUCIRE to make the sustained release formulation. The nucleation enhancer composition is then incorporated in the admixture to make the sustained release formulation resistant to changes in dissolution upon aging. Orally administrable compositions are prepared by filling gelatin capsules with the formulation. The polyglycolized glycerides (GELUCIRE) and the nucleation enhancer composition also can be used as an excipient system for preparing sustained release pharmaceutical compositions.
Other References
Modelling of Theophylline Compound Released from Hard Gelatin Capsules Containing Gelucire Matrix Granules, Drug Development and Industrial Pharmacy, 17(10), 1267-1277 (1991)
"The Physical Characterisation of Complex Glyceride Mixtures", Sutananta, Chapter 5, The School of Pharmacy, University of London, Mar., 199
July 6, 2018. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
