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Part-I - Controller General of Patents Designs and Trademarks

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(12) PATENT APPLICATION PUBLICATION (21) Application No.2597/MUM/2010 A<br />

(19) INDIA<br />

(22) Date <strong>of</strong> filing <strong>of</strong> Application :17/09/2010 (43) Publication Date : 21/06/2013<br />

(54) Title <strong>of</strong> the invention : SUSTAINED RELEASE PHARMACEUTICAL COMPOSITIONS COMPRISING PREGABALIN<br />

(51) International classification<br />

:a61k<br />

31/197;<br />

a61k<br />

9/52<br />

(31) Priority Document No :NA<br />

(32) Priority Date :NA<br />

(33) Name <strong>of</strong> priority country :NA<br />

(86) International Application No<br />

:NA<br />

Filing Date<br />

:NA<br />

(87) International Publication No : NA<br />

(61) Patent <strong>of</strong> Addition to Application Number :NA<br />

Filing Date<br />

:NA<br />

(62) Divisional to Application Number<br />

:NA<br />

Filing Date<br />

:NA<br />

(71)Name <strong>of</strong> Applicant :<br />

1)PANACEA BIOTEC LIMITED<br />

Address <strong>of</strong> Applicant :PLOT NO. GEN - 72/3, TTC<br />

INDUSTRIAL AREA, OPP. MILLENNIUM BUSINESS<br />

PARK GATE NO.2, MAHAPE, NAVI MUMBAI 400 710<br />

MAHARASHTRA, INDIA<br />

(72)Name <strong>of</strong> Inventor :<br />

1)JAIN, RAJESH<br />

2)SINGH, SARABJIT<br />

3)PUTHLI,SHIVANAND<br />

(57) Abstract :<br />

The present invention relates to stable once daily sustained release pharmaceutical compositions comprising pregabalin or<br />

pharmaceutically acceptable salts there<strong>of</strong> <strong>and</strong> a pharmaceutically acceptable excipient wherein pharmaceutical composition is<br />

bioequivalent to conventional immediate release formulation <strong>of</strong> pregabalin administered twice daily. The present invention further<br />

relates to a composition comprising pregabalin <strong>and</strong> sugar esters as release retarding agent for maintaining uniform release rate <strong>of</strong><br />

the drug <strong>and</strong> process for the preparation <strong>of</strong> such oral sustained release formulations.<br />

No. <strong>of</strong> Pages : 28 No. <strong>of</strong> Claims : 17<br />

The Patent Office Journal 21/06/2013 13579

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