Details for Patent: 5,002,776

Summary for Patent: 5,002,776

Title:	Controlled absorption diltiazem formulations
Abstract:	A controlled absorption diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming water insoluble synthetic polymer and optionally a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer, when said water soluble polymer is present, being effective to permit release of diltiazem from the pellet at a rate allowing controlled absorption thereof over not less than a twelve hour period following oral administration. The pellet has a dissolution rate in vitro which when measured in a dissolution apparatus (paddle) according to U.S. Pharmacopoeia XXI in 0.05 M KCl at pH 7.0 results in not more than 35% of the total diltiazem being released after 2 hours of measurement. Not more than 60% of the total diltiazem is released after four hours of measurement and 100% of the diltiazem is released no earlier than after 8 hours of measurement in said apparatus.
Inventor(s):	Edward J. Geoghegan, Seamus Mulligan, Donald E. Panoz
Assignee:	Perrigo Pharma International DAC
Application Number:	US07/273,192
Patent Claim Types: see list of patent claims	Formulation; Compound; Process; Device; Dosage form;

Drugs Protected by US Patent 5,002,776

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 5,002,776

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Ireland	3158/87	Nov 20, 1987
Ireland	822/88	Mar 22, 1988

International Family Members for US Patent 5,002,776

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	241987
Austria	66813
Australia	2377588
Australia	615221
Australia	634660