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(12) PATENT APPLICATION PUBLICATION(21) Application No. : 567/MUMNP/2006
(19) INDIA
(22) Date of filing of Application :15/05/2006(43) Publication Date : 18/05/2007
       Journal No. - 20/2007
 
(54) Title of the invention : PHARMACEUTICAL COMPOUNDS AND COMPOSITIONS
 
(51) International classification :C07C213/00
(31) Priority Document No :1356/MUM/2004
(32) Priority Date :17/12/2004
(33) Name of priority country :India
(86) International Application No
        Filing Date
:PCT/GB2005/004935
:19/12/2005
(87) International Publication No :WO2006/064283
(61) Patent of Addition to Application Number
        Filing Date
:NA
:NA
(62) Divisional to Application Number
        Filing Date
:NA
:NA
 
(71)Name of Applicant :
   1)CIPLA LIMITED

      Address of Applicant :289 Bellasis Road, Mumbai Central, Mumbai - 400 008, Maharashtra India
(72)Name of Inventor :
   1)LULLA, Amar
(India)
   2)MALHOTRA, Geena (India)
   3)RAo, Dharmaraj Ramchandra (India)
   4)KANKAN, Rajendra, Narayanrao (India)
   5)CHAUDHARY, Alka (India)
(57) Abstract :
The invention provides three polymorphic forms of crystalline levosalbutamol sulphate designated herein as Forms I, II and III. Crystalline levosalbutamol sulphate Form I is characterised by a powder XRD pattern with peaks at 10.8,11.9, 13.0, 18.3,28.5 ± 0.2 degrees 2 theta. Crystalline levosalbutamol sulphate Form II is characterised by a powder XRD pattern with peaks at 8.7, 9.6,15.2, 15.7, 19.1, 27.2, 30.7 ± 0.2 degrees 2 theta. Crystalline levosalbutamol sulphate Form III is characterised by a powder XRD pattern with peaks at 5.5, 6.9, 7.3, 18.7 ± 0.2 degrees 2 theta. Processes for making the new polymorphic forms and pharmaceutical compositions comprising them are also provided. A pharmaceutical composition comprises a therapeutically effective isomer of salbutamol or a salt, solvate, ester, derivative or polymorph thereof, a glucocorticoid and a pharmaceutically acceptable carrier or excipient and optionally one or more other therapeutic agents. Preferably the composition is an aerosol formulation comprising the drugs, a propellant and optionally one or more other ingredients, such as a surfactant, cosolvent, or bulking agent. Alternatively, DPI or inhalation suspensions may be used.

 

Number of Pages = 59