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(12) PATENT APPLICATION PUBLICATION
(19) INDIA (21) Application No.: 1203/MUM/2004 A
(22) Date of filing of Application: 08/11/2004 (43) Publication Date: 09/06/2006
(54) Title of the invention: A NOVEL PROCESS FOR PREPARATION OF POLYMORPHIC FORM
II OF SERTRALINE HYDROCHLORIDE
(51) International classification : C07C 209/84,
C07C 209/00,
C07C 211/42
(31) Priority Document No : NIL
(32) Priority Date : NIL
(33) Name of priority country : NIL
(86) International Application No : NIL
and Filing Date : NIL
(87) International Publication No : NIL
(61) Patent of addition to :
Application No
NIL
(62)
Filed on : N.A.
Divisional to Application No : NIL
Filed on : N.A.
(71) Name of Applicant:
LUPIN LIMITED
Address of the Applicant:
159, CST ROAD, KALINA,
SANTACRUZ (EAST), MUMBAI-
400098, MAHARASHTRA, INDIA.
(72) Name of the Inventor:
1. BHANU MANJUNATH
NARAYAN
2. JAIN AJINATH MURALIDHAR
3. MAHAJAN DEEPAK
Filed U/S 5(2) before The Patents
(Amendment) Act, 2005: NO
(57) Abstract: A process for making sertraline hydrochloride Form II, frr from any other polymorph, comprises
dissolution of sertraline base or its mandelate salt in methyl isobutyl ketone (MIBK), heating the solution to
60-65ºC, addition of hydrogen chloride gas or a solution of hydrogen chloride to the reaction mixture, maintaining
the reaction temperature at 60-65ºC for 0.5 to 4 hours and cooling the reaction mixture gradually to 25-30ºC in one
hour time followed by isolation of solid by filtration.
Drawing Sheets: NIL
Total Pages: 21.
Fig. Nil
The Patent Office Journal 09/06/2006 10886