Abstract:
This invention relates to a process for preparing a formulation of edaravone or a pharmaceutically acceptable salt thereof, concretely an aqueous injectable formulation, which contains low amounts of a certain impurity. This process comprises heat-sterilization of an aqueous formulation of edaravone or pharmaceutically acceptable salt thereof, which comprises bisulfite anions (HSO3-) and contains less than 1 ppm of oxygen.
Abstract:
The present invention relates to oral pharmaceutical compositions comprising quetiapine fumarate which comprise coated discrete units. The composition of the invention is chemically and physically stable, has a good in vitro dissolution rate thereby showing good bioavailability and resulting bioequivalent to marketed Seroquel® tablets.
Abstract:
The present invention relates to a process for determining the suitability for distribution of a batch of rivaroxaban or of a pharmaceutical composition thereof. In particular, it also relates to two impurities of rivaroxaban, to their use as reference markers to determine the purity of a sample of rivaroxaban or a composition thereof, to analytical methods for determining the purity of a sample of rivaroxaban or a composition thereof and to a process of preparing rivaroxaban or pharmaceutical compositions thereof which are free or substantially free of such impurities.
Abstract:
The invention relates to 2-{2-amino-3-[hydroxy(phenyl)methyl]phenyl} acetamide, a process for its preparation, and its use as a reference marker and reference standard for analyzing the purity of nepafenac.
Abstract:
Disclosed is a process for preparing the malic acid salt of sunitinib comprising reacting malic acid with an acid addition salt of sunitinib, which is a cancer treatment agent, wherein the acid addition salt of sunitinib is an acid weaker than malic acid. Also disclosed are acid addition salts of sunitinib wherein the acid is an acid weaker than malic acid.
Abstract:
Disclosed are new forms of the anticancer agent sunitinib of formula (I), and pharmaceutically acceptable salts thereof, including amorphous form sunitinib malate and sunitinib malate Form III. Also disclosed is a process for preparing and pharmaceutical compositions comprising amorphous form sunitinib malate.
Abstract:
Disclosed is a process for preparing purified ranolazine of formula (I), which is indicated for the chronic treatment of angina, comprising reacting l-[(2,6- dimethylphenyl)aminocarbonyl]piperazine with l-phenoxy-2,3-epoxypropane in an inert solvent followed by precipitating the ranolazine.
Abstract:
The present invention is related to processes suitable for industrial synthesis of pregabalin from (i?)-(-)-3-(carbamoylmethyl)-5-methylhexanoic using sodium hypochlorite as described herein. In addition, the present invention is related to pregabalin which is substantially free of impurities and pharmaceutical compositions comprising pregabalin.
Abstract:
The invention relates to improved methods for preparing polymorph Form I of 2,3- dihydro-5,6-dimethoxy-2-[[ 1 -(phenylmethy l)-4-piperidinyl]methyl- 1 H -inden- 1 -one hydrochloride (i.e., donepezil hydrochloride).