Pharmaceutical compositions comprising boronic acid compounds

• US 10,293,048 B2
• Filed: 03/01/2013
• Issued: 05/21/2019
• Est. Priority Date: 03/02/2012
• Status: Active Grant

• Current Assignee: Dr. Reddy's Laboratories Ltd.
• Original Assignee: Dr. Reddy's Laboratories Ltd.
• Inventors: Vaya, Navin, Prabhakar Bhagwatwar, Harshal, Bandichhor, Rakeshwar, Khati, Nirmal, Shaik, Riyaz Ahmed, Bhise, Rahul, Asalla, Yakaswamy, Shinde, Rajkumar Bhimrao
• Primary Examiner(s): Ramachandran, Umamaheswari
• Application Number:
  US14/382,347
• Publication Number:
  US 20150051172A1
• Time in Patent Office: 2,272 Days
• 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 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/497 containing further heterocyclic rings
• CPC Class Codes: A61K 31/69 Boron compounds
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07F 5/025 Boronic and borinic acid compounds

Abstract

A pharmaceutical composition and preparing processes thereof. The composition comprises bortezomib or pharmaceutically acceptable salt or solvate thereof, tromethamine and an organic carboxylic acid, and the pH of the composition is from about 3.0 to 6.0.

Claims

1. A lyophilized pharmaceutical composition comprising Bortezomib or pharmaceutically acceptable salt or solvate thereof, tromethamine and citric acid or a salt thereof;

wherein the pH of the composition is from about 3.0 to 6.0 upon reconstitution.

2. The composition according to claim 1, wherein the pH is from about 3.5 to 5.5.

3. The composition according to claim 2, wherein the pH is from about 4.0 to 4.5.

4. The composition according to claim 1, wherein the molar ratio of Bortezomib, tromethamine and citric acid is 1:

1 to 15;

1 to 11.

5. The composition according to claim 4, wherein the molar ratio of Bortezomib, tromethamine and citric acid is 1:

4 to 10;

4 to 8.

6. The composition according to claim 5, wherein the molar ratio of Bortezomib, tromethamine and citric acid is 1:

7 to 8;

5 to 6.

7. The composition according to claim 1, wherein the composition is reconstituted with water for injection or 0.9% sodium chloride.