Title of Invention	A BOTTLE WITH A HINGED LID
Abstract	N/A

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FORM 2 THE PATENTS ACT 1970 (Act 39 of 1970) COMPLETE SPECIFICATION (SECTION 10, rule 13) "PROCESSES FOR THE PREPARATION OF ALPHA POLYMORPH OF PERINDOPRIL ERBUMINE" Glenmark Pharmaceuticals Limited, an Indian Company, registered under the Indian company's Act 1957 and having its registered office at B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road Post Box No. 26511 Mumbai- 400 026, India THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119 to Provisional Application No. 60/572,402, filed May 19, 2004 and entitled "Process for the PREPARATION of ALPHA POLYMORPHS OF PERINDOPRIL ERBUMINE", and from Indian Provisional Application Number 531/MUM/2004, filed May 07, 2004, the contents of which are incorporated by reference herein BACKGROUND OF THE INVENTION BACKGROUND OF THE INVENTION 1. Technical Field The present invention generally relates to improved processes for the preparation of the alpha crystalline form of perindopril erbumine. 2. Description of the Related Art The present invention relates to a process for the preparation of perindopril erbumine (also known as (2S,3^S,7|iS)-l-[(S)-N-[(S)-I-carboxy-butyI]aIanyI]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1)) of Formula I: The tert-butylamine salt of perindopril, also known as perindopril erbumine, is the form commercially sold under the trade name Aceon®. Perindopril is the free acid form of perindopril erbumine and is an ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril is a pro-drug and is metabolized in vivo by hydrolysis of the ester group to form perindoprilat, the biologically active metabolite. Perindopril is ordinarily used to treat hypertension. 2 It is believed that perindoprilat lowers blood pressure primarily through inhibition of ACE activity. ACE is a peptidyl dipeptidase that catalyzes conversion of the inactive decapeptide, Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity and decreased aldosterone secretion. The latter results in diuresis and natriuresis and may be associated with a small increase of serum potassium. WO 01/87835 and U.S. Patent Application Publication No. 2005/0059609 disclose the alpha form of perindopril erbumine and a process for its preparation, the contents of which are incorporated by reference herein. The process includes using ethyl acetate as a solvent for crystallization. Problems associated with this process includes (1) low yield of the alpha polymorph of perindopril erbumine due to impurities; (2) extra crystallization using ethyl acetate to get acceptable yields of the alpha form of perindopril erbumine; and (3) a relatively large number of impurities are formed during the erbumine salt formation in ethyl acetate at reflux temperature. Accordingly, there remains a need for improved processes for preparing the alpha crystalline form of perindopril erbumine to provide better yields and fewer impurities than the prior art processes in a convenient and more cost efficient manner on a commercial scale. SUMMARY OF THE INVENTION In accordance with one embodiment of the present invention, a process for the preparation of the alpha crystalline form of perindopril erbumine of formula I: is provided comprising: (a) forming a solution comprising perindopril erbumine of formula I in one or more ketones; (b) heating the solution to reflux; and, 3

Documents:

531-mum-2002-cancelled pages(29-1-2008).pdf

531-mum-2002-correspondence 1(18-7-2005).pdf

531-mum-2002-correspondence 2(31-1-2005).pdf

531-mum-2002-correspondence(ipo)-(8-5-2006).pdf

531-mum-2002-form 1(20-5-2004).pdf

531-mum-2002-form 1(7-5-2004).pdf

531-mum-2002-form 2(granted)-(29-1-2008).doc

531-mum-2002-form 2(granted)-(29-1-2008).pdf

531-mum-2002-form 3(17-6-2004).pdf

531-mum-2002-form-pct-isa-210(7-5-2004).pdf