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Details for Patent: 6,403,616

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Summary for Patent: 6,403,616

Title:	Chemical process and pharmaceutical formulation
Abstract:	Process for the manufacturing of slightly soluble or less soluble alkaline salts of substituted sulphinyl heterocycles containing an imidazole moiety with formula I ##STR1## preferably alkaline salts of a proton pump inhibitor compound, wherein the process comprises the step of reacting the substituted sulphinyl heterocycle of Formula I with a source of the cation in the presence of a base, characterized by a washing step in which the prepared alkaline salt of the substituted sulphinyl compound is washed with a basic aqueous solvent mixture. The obtained bulk drug substance resulting in a bulk product that in an aqueous suspension of the substituted sulphinyl heterocycle having a pH not significantly lower than that of a saturated water solution of the pure compound prepared. Alternatively, the process for manufacturing a pharmaceutical dosage form comprising the active substance could be adjusted. For instance the pH of an aqueous suspension of the active substance is adjusted to a pH not significantly lower than that of a saturated water solution of the pure compound. The processes are preferably useful in the manufacturing of omeprazole magnesium salt or magnesium salt of one of its single enantiomers used in pharmaceutical dosage forms.
Inventor(s):	Erickson; Magnus (Vastra Frolunda, SE), Gustavsson; Anders (Nykvarn, SE), Josefsson; Lars (Savedalen, SE)
Assignee:	AstraZeneca AB (Sodertalje, SE)
Application Number:	09/485,897
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,403,616
Patent Claim Types: see list of patent claims	Compound; Process; Dosage form; Use;

Drugs Protected by US Patent 6,403,616

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: 6,403,616

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Sweden	9803952	Nov 18, 1998
Sweden	9803953	Nov 18, 1998

PCT Information
PCT Filed	November 15, 1999	PCT Application Number:	PCT/SE99/02093
PCT Publication Date:	May 25, 2000	PCT Publication Number:	WO00/28975

International Family Members for US Patent 6,403,616

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	271556
Australia	1901700
Australia	770633
Brazil	9915421