- Patent Title: Stable protein formulations comprising a molar excess of sorbitol
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Application No.: US15303881Application Date: 2015-04-16
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Publication No.: US11058768B2Publication Date: 2021-07-13
- Inventor: Kala Chandramouli , Rohan Pai
- Applicant: BIOCON LTD. , MYLAN GMBH
- Applicant Address: IN Bangalore; CH Zurich
- Assignee: BIOCON LTD.,MYLAN GMBH
- Current Assignee: BIOCON LTD.,MYLAN GMBH
- Current Assignee Address: IN Bangalore; CH Zurich
- Agency: Olive Law Group, PLLC
- Agent Marianne Fuierer
- Priority: IN1989/CHE/2014 20140416
- International Application: PCT/IB2015/052789 WO 20150416
- International Announcement: WO2015/159254 WO 20151022
- Main IPC: A61K39/395
- IPC: A61K39/395 ; C07K16/32 ; A61K9/19 ; A61K47/26 ; A61K47/10 ; A61K47/20 ; A61J1/20 ; A61J1/06 ; A61J1/14 ; A61K47/18 ; A61K9/00

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.
Public/Granted literature
- US20170028063A1 Stable Protein Formulations Comprising a Molar Excess of Sorbitol Public/Granted day:2017-02-02
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