Patent: 7,833,546

Summary for Patent: 7,833,546

Title:	Pharmaceutical dosage form and method for the production thereof
Abstract:	The invention relates to a method for producing a pharmaceutical dosage form as tablets, pellets and/or in the form of an active ingredient-containing matrix, whereby the tablets, pellets and/or active ingredient-containing matrix contain a pharmaceutical active ingredient and a copolymer serving as a coating agent and/or binding agent, and optionally contain a core and pharmaceutically common additives. According to the invention, the copolymer, the pharmaceutical active ingredient, the optionally present core and/or the pharmaceutically common additives are processed using known techniques by melting, injection molding, extrusion, wet granulation, casting, dipping, spreading out, spraying on, or pressing to form tablets, pellets and/or an active ingredient-containing matrix. The inventive method is characterized in that a copolymer is used that consists of 20 to 34 wt. % methacrylic acid, 20 to 69 wt. % methylacrylate and 0 to 40 wt. % ethylacrylate and, optionally, of 0 to 10 wt. % of additional vinylically copolymerizable monomers with the provision that the glass transition temperature of the copolymer is no higher than 60.degree. C. according to ISO 11357-2, Item 3.3.3. The invention also relates to the pharmaceutical dosage form produced according to this method, said copolymer and the use thereof.
Inventor(s):	Petereit; Hans-Ulrich (Darmstadt, DE), Suefke; Thomas (Erzhausen, DE), Meier; Christian (Darmstadt, DE), Schnabel; Michael (Biebesheim, DE), Blesing; Ingrid (Fuerth/Odenwald, DE), Grimm; Stefan (Wintersheim, DE)
Assignee:	Evonik Roehm GmbH (Darmstadt, DE)
Application Number:	10/502,648
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,833,546
Patent Claims:	see list of patent claims

Details for Patent 7,833,546

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2022-02-27
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2022-02-27
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2022-02-27
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2022-02-27
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2022-02-27
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2022-02-27