The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Jul. 13, 2021
Filed:
Apr. 16, 2015
Applicants:
Biocon Ltd., Bangalore, IN;
Mylan Gmbh, Zurich, CH;
Inventors:
Kala Chandramouli, Bangalore, IN;
Rohan Pai, Nipani, IN;
Assignees:
Attorneys:
Primary Examiner:
Int. Cl.
CPC ...
A61K 39/395 (2006.01); C07K 16/32 (2006.01); A61K 9/19 (2006.01); A61K 47/26 (2006.01); A61K 47/10 (2017.01); A61K 47/20 (2006.01); A61J 1/20 (2006.01); A61J 1/06 (2006.01); A61J 1/14 (2006.01); A61K 47/18 (2017.01); A61K 9/00 (2006.01);
U.S. Cl.
CPC ...
A61K 39/39591 (2013.01); A61J 1/06 (2013.01); A61J 1/1412 (2013.01); A61J 1/2006 (2015.05); A61K 9/19 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); C07K 16/32 (2013.01); A61K 9/0019 (2013.01); C07K 2317/24 (2013.01);
Abstract
A stable pharmaceutical formulation comprising a protein of interest, sorbitol and polyethylene glycol (PEG). The sorbitol and protein is present in a molar ratio of 550 to 700 mole of sorbitol:1 mole of protein and the PEG to protein is present in the molar ratio of 2-50:1. The formulation optionally comprising buffer. The formulation in lyophilised form is stable for at least 4 years at 2-8° C. Also provided is a process for preparing the composition and a pharmaceutical kit comprising the same.