Nirmal Vasant Mulye

6946146, Sep 20, 2005

Apr 18, 2002

10/124869

Nirmal Mulye - Princeton NJ, US

Nostrum Pharmaceuticals Inc. - Princeton NJ

A61K009/30
A61K009/32
A61K009/36
A61K009/38

424479, 424474, 424475, 424477, 424480, 424482, 424491, 424493, 424494, 424495, 424497

The present invention is directed to a coating composition for coating a solid dosage form of a medicament, where the coating composition controls the release of the medicament, said coating composition comprising (a) at least 50% (w/w) by dry weight of a water insoluble polymer insoluble in both acidic, basic and neutral pH, present in the form of an aqueous latex dispersion, (b) a water soluble non-polymeric component present in a weight ratio of about 5 to about 50% (w/w) by dry weight of the coating, having a molecular weight of less than about 15,000 daltons and water solubility in excess of 5 grams per 100 grams of water at room temperature at 1 atm pressure, said water soluble non-polymeric component being organic and either solid or liquid; said ratio of water insoluble polymer to water soluble non-polymeric component ranging from about 95:5 to about 1:1, the solid content in the coating composition ranges from about 5% to about 25%, said water soluble component being completely dissolved in the aqueous latex dispersion. The present invention is also directed to a system for the controlled release of an active medicament comprising a substrate and a coating, said substrate comprising a therapeutically effective amount of a medicament in association with a pharmaceutical carrier in solid unit dosage form, said substrate being uniformly coated with the aforesaid coating composition.

7052706, May 30, 2006

Jun 10, 2002

10/167368

Nirmal Mulye - Princeton NJ, US

Nostrum Pharmaceuticals, Inc. - Princeton NJ

A61K 6/00
A61K 7/00

424401

The present invention is directed to a sustained release pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a lactose or hydrophobic carbohydrate polymer, said medicament being present in an amount greater than about 25% of the pharmaceutical composition and having a water solubility greater than about 1 gram per 10 mL of water at 25 C. , said hydrophobic material having a melting point ranging from at least about 40 C. to about 100 C. at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than the of the medicament, and said hydrophobic material not being present in coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of or melting the hydrophobic material or the use of high shear mixer. The present invention is also directed to a method of preparing said pharmaceutical composition.

7179486, Feb 20, 2007

May 18, 2001

09/861321

Nirmal Mulye - Princeton NJ, US

Nostrum Pharmaceuticals, Inc. - Edison NJ

A61K 9/20
A61K 9/22
A61K 9/26
A61K 9/28

424465, 424464, 424468, 424470, 424474

The present invention is directed to the process of preparing a sustained release niacin tablet and the product prepared therefrom.

7897179, Mar 1, 2011

Aug 6, 2004

10/913048

Nirmal Mulye - Princeton NJ, US

Nostrum Pharmaceuticals, Inc. - Edison NJ

A61J 1/00
A61K 9/16
A61K 9/50

424490, 427 219

The present invention is directed to a process of preparing beads coated with a water soluble drug for incorporation into a pharmaceutical composition comprising: (a) preparing a supersaturated drug solution containing a desired amount of drug, which is completely saturated at a first temperature but which is supersaturated at a second temperature which is below the first temperature; and (b) coating inert beads with the drug solution, said drug solution being maintained at or below the first temperature but above the second temperature, and said beads maintained at a second temperature, wherein the second temperature is less than the first temperature and wherein the solution containing the drug is supersaturated at the second temperature, as well as to the pharmaceutical compositions containing same.

8507000, Aug 13, 2013

May 6, 2004

10/555849

Nirmal Mulye - Kendall Park NJ, US

Nostrum Pharmaceuticals, Inc. - Kendall Park NJ

A61K 9/22
A61K 31/70

424468, 514 29

The present invention is directed to a controlled release formulation in tablet form comprising a pharmaceutically effective amount of an erythromycin derivative and a lubricating effective amount of a lubricant in the absence of material selected from the group consisting of alginic acid or salts thereof or hydrophilic sustained release polymers in amounts effective to retard the release of the erythromycin derivatives in the pharmaceutical composition. It is also directed to a method for facilitating the release of erythromycin derivative from a pharmaceutical composition comprising a therapeutically effective amount of a lubricating effective amount of a lubricant said method comprising adding to said composition an release promoter in tablet disintegrating effective amounts to facilitate the release of the erythromycin derivative from the tablet.

8545882, Oct 1, 2013

Feb 16, 2006

11/355346

Nirmal Mulye - Princeton NJ, US

Nostrum Pharmaceuticals, Inc. - Princeton NJ

A61K 9/20
A61K 9/28

424464, 424474

The present invention is directed to a sustained release pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a lactose or hydrophobic carbohydrate polymer, said medicament being present in an amount greater than about 25% of the pharmaceutical composition and having a water solubility greater than about 1 gram per 10 mL of water at 25 C. , said hydrophobic material having a melting point ranging from at least about 40 C. to about 100 C. at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than the of the medicament, and said hydrophobic material not being present in coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of or melting the hydrophobic material or the use of high shear mixer. The present invention is also directed to a method of preparing said pharmaceutical composition.

20040224017, Nov 11, 2004

Mar 15, 2004

10/800984

Nirmal Mulye - Princeton NJ, US

A61K009/22

424/468000, 514/058000, 514/057000

The present invention relates to a novel process for preparing sustained release tablets containing medicinal compounds and the products prepared by said process. The present invention is directed to a method of preparing a sustained release pharmaceutical composition having a predetermined drug release profile, but which is deviated therefrom by adding a tableting effective amount of a water insoluble or partially insoluble cellulose, to said pharmaceutical composition comprised of a drug in a therapeutically effective amount, and sustained release carrier present in amounts effective retard the release of the drug from the pharmaceutical composition and said cellulose, the latter being present in an aqueous system, the improvement comprising adding to the composition an effective amount of maltodextrin to retard the increase on the rate of release of the drug from the addition of said cellulose thereto.

20110071137, Mar 24, 2011

Aug 20, 2010

12/860032

Nirmal Mulye - Princeton NJ, US

NOSTRUM PHARMACEUTICALS, INC. - Princeton NJ

A61K 31/55
A61K 31/415
A61K 31/155

514217, 514398, 514635

The present invention relates to a novel process for preparing sustained release tablets containing medicinal compounds and the products prepared by said process. The present invention is directed to a method of preparing a sustained release pharmaceutical composition having a predetermined drug release profile, but which is deviated therefrom by adding a tableting effective amount of a water insoluble or partially insoluble cellulose, to said pharmaceutical composition comprised of a drug in a therapeutically effective amount, and sustained release carrier present in amounts effective retard the release of the drug from the pharmaceutical composition and said cellulose, the latter being present in an aqueous system, the improvement comprising adding to the composition an effective amount of maltodextrin to retard the increase on the rate of release of the drug from the addition of said cellulose thereto.