Abstract: The present invention relates to a novel salt of (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione and hydrates thereof, to methods for preparing the novel salt and its hydrates. In one aspect, the present invention provides a compound which is lurasidone dihydrochloride. In another aspect, the present invention provides a process for preparation of lurasidone dihydrochloride comprising: (i) mixing lurasidone free base in an organic solvent system; (ii) subjecting step (i) mixture to acid proton source; and (iii) isolating compound of lurasidone dihydrochloride.
Abstract: Stable non-alcoholic transdermal hydrogel of dexibuprofen was prepared by using a simple manufacturing process, and the experimental trials showed that the pH modifying agent, antioxidant and water miscible solvent are the essential excipients to obtain stable non-alcoholic transdermal hydrogel of dexibuprofen. The dexibuprofen hydrogel prepared using carbopol as a gelling polymer produced an opaque gel, whereas hydrogel prepared using hyroxypropyl methylcellulose (HPMC) as a gelling polymer produced a transparent gel. There was no significant changes observed with respect to physical description, pH, assay and particularly to the related substance values when the hydrogels were subjected to the stability study at accelerated condition (40° C./75% RH) for 3 months in laminated tubes.
Type:
Application
Filed:
August 12, 2015
Publication date:
December 3, 2015
Applicant:
Shasun Pharmaceuticals Limited
Inventors:
Jeffrey Stuart Bergman, Sampathkumar Devarajan, Selvakumar Ramalingam, Anandsenthil Vel Palanisamy
Abstract: The present invention is a solid dosage form for oral administration of ibuprofen comprising a modified release formulation of ibuprofen which provides an immediate burst effect and thereafter a sustained release of sufficient ibuprofen to maintain blood levels at least 6.4 ?g/ml over an extended period of at least 8 hours following administering of a single dose.
Type:
Grant
Filed:
February 16, 2010
Date of Patent:
May 12, 2015
Assignee:
Shasun Pharmaceuticals Limited
Inventors:
Michael Hite, Cathy Federici, Alan Brunelle, Stephen Turner
Abstract: The present invention discloses a non-aqueous solution process for making cross-linked polymers. The cross-linked polymers are characterized by a repeat unit that includes at least one amino group. Amino groups can be part of the polymer backbone (e.g., polyethyleneimine), pendant from the polymer backbone (e.g., polyallylamine), or both types of amino groups can exist within the same repeat unit and/or polymer. The present invention discloses more specifically non-aqueous solution cross-linking to prepare Sevelamer and its salts, Colesevelam and its salts.