Claims for Patent: 6,838,093

Summary for Patent: 6,838,093

Title:	System for osmotic delivery of pharmaceutically active agents
Abstract:	An osmotic system for delivering a pharmaceutically active agent which comprises a core portion, a layer portion enclosing the core portion, and a semipermeable wall portion enclosing the core portion and the layer portion. The core portion includes the pharmaceutically active agent at a first concentration. The pharmaceutically active agent is present in the layer portion at a second concentration. The second concentration is greater than the first concentration. Such a system provides for the osmotic release of the pharmaceutically active agent in release profile other than a zero order release profile, and wherein the release profile is similar to or approaches or reaches a first order release profile.
Inventor(s):	Flanner; Henry H. (Montgomery Village, MD), McKnight; Lisa C. (Fairfax, VA), Burnside; Beth A. (Bethesda, MD)
Assignee:	Shire Laboratories, Inc. (Rockville, MD)
Application Number:	09/872,173
Patent Claims:	1. An osmotic system for delivering a pharmaceutically active agent, comprising: a core portion, wherein said core portion includes said pharmaceutically active agent at a first concentration; a layer portion enclosing and directly adjacent to said core portion, wherein said layer portion includes said pharmaceutically active agent at a second concentration, said second concentration being greater than said first concentration; and a semipermeable wall portion enclosing said core portion and said layer portion. 2. The system of claim 1 wherein said pharmaceutically active agent is a protein or peptide. 3. The system of claim 1 wherein said semipermeable wall portion is formed from cellulose acetate. 4. The system of claim 1 wherein said pharmaceutically active agent is present in said portion in an amount of about 60 wt. %. 5. The system of claim 1 wherein said pharmaceutically active agent is present in said layer portion in an amount of about 90 wt. %. 6. The system of claim 1 wherein said pharmaceutically active agent is pseudoephedrine or its salts. 7. An osmotic system for delivering a first pharmaceutically active agent and a second pharmaceutically active agent, comprising: a core portion, wherein said core portion includes said first pharmaceutically active agent at a first concentration; a first layer portion enclosing and directly adjacent to said core portion, wherein said layer portion includes said first pharmaceutically active agent at a second concentration, said second concentration being greater than said first concentration; a semipermeable wall portion enclosing said core portion and said first layer portion; and a second layer portion including a second pharmaceutically active agent, said second layer enclosing said semipermeable wall portion. 8. The system of claim 7 wherein said first pharmaceutically active agent is present in said core portion in an amount of about 60 wt. %. 9. The system of claim 7 wherein said first pharmaceutically active agent is present in said first layer portion in an amount of about 90 wt. %. 10. The system of claim 7 wherein said second pharmaceutically active agent is present in said second layer portion in an amount of from about 2 wt. % to about 99 wt. %. 11. The system of claim 10 wherein said second pharmaceutically active agent is present in said second layer portion in an amount of from about 60 wt. % to about 95 wt. %. 12. The osmotic system of claim 1, wherein said pharmaceutically active agent is an antitussive, antihistamine, expectorant or decongestant. 13. The osmotic system of claim 12, wherein said pharmaceutically active agent is chlorpheneramine or its salts, diphenhydramine, or dimenhydramine. 14. The osmotic system of claim 1, wherein said pharmaceutically active agent is cyctosporin, carmustine, carbamazepine, desmopreson, dihydroergotamine, fluorouracil, heparin sodium, ribavirin, sumitriptan succinate, flutamide, naltrexone HCl, terbutaline sulfate, triamterene, terazosin, parazosin, nifedipine, calcitonin, parathyroid hormone, or GLP-1. 15. The osmotic system of claim 7, wherein said first pharmaceutically active agent is an antitussive, antihistamine, expectorant or decongestant. 16. The osmotic system of claim 15, wherein said first pharmaceutically active agent is chlorpheneramine or its salts, diphenhydramine, or dimenhydramine. 17. The osmotic system of claim 15, wherein said first pharmaceutically active agent is pseudoephedrine or its salts. 18. The osmotic system of claim 7, wherein said first pharmaceutically active agent is cyclosporin, carmustine, carbamazepine, desmopreson, dihydroergotamine, fluorouracil, heparin sodium, ribavirin, sumitriptan succinate, flutamide, naltrexone HCl, terbutaline sulfate, triamterene, calcitonin, insulin, parathyroid hormone, or GLP-1. 19. The osmotic system of claim 15, wherein said second pharmaceutically active agent is loratidine, desloratidine, astemizole, norastemizole or ebastine. 20. The osmotic system of claim 7, wherein said first pharmaceutically active agent is pseudoephedrine or its salts, and said second pharmaceutically active agent is loratidine.

Details for Patent 6,838,093

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	06/04/2004		2039-02-26
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	06/13/2008		2039-02-26
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-02-26