Abstract: Compositions comprising a mixture of at least two types of particles wherein a) the first type of particles comprise dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof; and b) the second type of particles comprise at least one pharmaceutically acceptable organic acid, use of said compositions in the reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and/or in the prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery and processes for the preparation of said compositions.

Abstract: Compositions comprising a mixture of at least two types of particles wherein a) the first type of particles comprise dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof; and b) the second type of particles comprise at least one pharmaceutically acceptable organic acid, use of said compositions in the reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and/or in the prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery and processes for the preparation of said compositions.

Abstract: Herein disclosed are novel compositions comprising: Bempedoic acid and Bempedoic acid and Ezetimibe, kits, methods of using and processes for making said novel compositions. Notably, the formulations herein provide pharmaceutical compositions having excellent stability and release properties for both drug products. These improved formulations are useful in the treatment and prevention of cardiovascular disease.

Abstract: Compositions comprising a mixture of at least two types of particles wherein a) the first type of particles comprise dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof; and b) the second type of particles comprise at least one pharmaceutically acceptable organic acid, use of said compositions in the reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and/or in the prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery and processes for the preparation of said compositions.

Abstract: Compositions comprising a mixture of at least two types of particles wherein a) the first type of particles comprise dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof; and b) the second type of particles comprise at least one pharmaceutically acceptable organic acid, use of said compositions in the reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and/or in the prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery and processes for the preparation of said compositions.

Abstract: Herein disclosed are novel compositions comprising: Bempedoic acid and Bempedoic acid and Ezetimibe, kits, methods of using and processes for making said novel compositions. Notably, the formulations herein provide pharmaceutical compositions having excellent stability and release properties for both drug products. These improved formulations are useful in the treatment and prevention of cardiovascular disease.

Abstract: The present invention provides extended release pharmaceutical formulations of valsartan with controlled impurity levels. Particularly, the present invention provides extended release valsartan formulation which is substantially free of valsartan R-isomer impurity.

Abstract: The present invention relates to methods and composition for treatment of hypertension. Particularly the present invention provides a method of treating hypertension comprising orally administering once a day to a human patient in need thereof the compound valsartan in an extended release dosage form, wherein said extended release valsartan dosage form reduces mean systolic and diastolic blood pressure in a patient during a time period of about 20 hours to about 24 hours after administration to a greater extent than an immediate release formulation of valsartan.

Abstract: The present invention relates to methods for treatment of cardiovascular conditions selected from high blood pressure, heart failure, or heart attack. The present invention further relates to a method of treating cardiovascular conditions comprising orally administering once a day to a human subject in need thereof the compound valsartan in an extended release dosage form, wherein the ratio of mean plasma concentration of valsartan provided by the extended release dosage form to the mean plasma concentration of valsartan provided by an immediate release dosage form of valsartan over 8 hour to 24 hour period after administration is greater than 1 in a single dose human pharmacokinetic study.

Abstract: The present invention relates to stable solid formulations of vitamin D3 and to processes for preparation of the same. The present invention provides stabilized compositions comprising vitamin D3 at least one lipophilic dispersant, one or more antioxidants, at least one adsorbent and one or more pharmaceutically acceptable excipients and further coated with a barrier coating.

Abstract: The present invention provides extended release pharmaceutical formulations of valsartan with controlled impurity levels. Particularly, the present invention provides extended release valsartan formulation which is substantially free of valsartan R-isomer impurity.

Abstract: The present invention relates to coated extended release pharmaceutical formulations of valsartan comprising a core comprising valsartan and at least one coating layer over the core. The present invention further relates to extended release pharmaceutical formulations comprising (a) a core comprising valsartan and at least one hydrophilic swelling polymer and (b) at least one coating layer over the core wherein the coating layer in contact with the core is applied from an organic solvent based system.

Abstract: The present invention provides extended release pharmaceutical formulations of valsartan with controlled impurity levels. Particularly, the present invention provides extended release valsartan formulation which is substantially free of valsartan R-isomer impurity.

Abstract: The present invention relates to coated extended release pharmaceutical formulations of valsartan comprising a core comprising valsartan and at least one coating layer over the core. The present invention further relates to extended release pharmaceutical formulations comprising (a) a core comprising valsartan and at least one hydrophilic swelling polymer and (b) at least one coating layer over the core wherein the coating layer in contact with the core is applied from an organic solvent based system.

Abstract: The novel sustained release dosage form comprising an active agent and a combination of a non-swelling pH dependent release retardant and a non swelling pH independent release retardant polymer which provides pH-independent drug release for a considerable period of time after administration.

Abstract: A solvent free process of obtaining an insoluble fiber rich fraction from Trigonella Foenum-graceum seeds is disclosed. The multifunctional fiber rich fraction (FRF) and highly purified FRF are useful as excipients for pharmaceutical dosage forms for various routes of administration. These excipients can be used as binder, disintegrant, filler, dispersing agent, coating agent, film forming agent, thickener and the like, for preparation of variety of dosage forms. FRF and highly purified FRF can also be used in a controlled release, targeted release and other specialized delivery systems, as well as in food and cosmetics formulation.

Abstract: The present invention relates to stable solid formulations of vitamin D3 and to processes for preparation of the same. The present invention provides stabilized compositions comprising vitamin D3 at least one lipophilic dispersant, one or more antioxidants, at least one adsorbent and one or more pharmaceutically acceptable excipients and further coated with a barrier coating.

Abstract: The novel sustained release dosage form comprising an active agent and a combination of a non-swelling pH dependent release retardant and a non swelling pH independent release retardant polymer which provides pH-independent drug release for a considerable period of time after administration.

Abstract: The present invention relates to controlled release pharmaceutical formulations of direct thrombin inhibitors and processes for preparing such compositions. Particularly the present invention relates to oral controlled release pharmaceutical compositions comprising dabigatran etexilate or pharmaceutically acceptable salts thereof.

Abstract: Compositions comprising a mixture of at least two types of particles wherein a) the first type of particles comprise dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof; and b) the second type of particles comprise at least one pharmaceutically acceptable organic acid, use of said compositions in the reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and/or in the prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery and processes for the preparation of said compositions.