Pharmaceutical composition

• US 9,095,514 B2
• Filed: 01/08/2010
• Issued: 08/04/2015
• Est. Priority Date: 01/09/2009
• Status: Expired due to Fees

• Current Assignee: Sun Pharma Advanced Research Company Limited (Shanghvi Finance Pvt Ltd.)
• Original Assignee: Sun Pharma Advanced Research Company Limited (Shanghvi Finance Pvt Ltd.)
• Inventors: Namdeo, Alok B., Bhowmick, Subhas Balaram, Subramanian, Narayanaswamy
• Primary Examiner(s): ZAREK, PAUL E
• Application Number:
  US13/143,808
• Publication Number:
  US 20110275597A1
• Time in Patent Office: 2,034 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/133 having hydroxy groups, e.g. sphingosine
• CPC Class Codes: A61K 31/69 Boron compounds
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The present invention relates to a parenteral pharmaceutical composition comprising therapeutically effective amounts of N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronic acid or its salts or its derivatives and tromethamine wherein the composition is stable.

Claims

1. A method of preparing a lyophilised composition of N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronic acid, said method consisting of:

(a) dissolving N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronic acid having a total impurity of less than 0.51%, tromethamine and a bulking agent in water, wherein the N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronic acid and tromethamine are present in a molar ratio of at least about 1;

3;

(b) adjusting the pH of the solution obtained in step (a) to about 6.8 to 7.2;

(c) subjecting the solution obtained in step (b) to sterilization;

(d) filling the solution obtained in step (c) into vials and lyophilizing the solution.

2. A lyophilized composition obtained by the method of claim 1.

3. The method according to claim 1, wherein the bulking agent is selected from the group consisting of potassium chloride, sodium chloride, lactose, sucrose, maltose, trehalose and mixtures thereof.