Stable pharmaceutical composition

Patent metadata

Field	Value
Publication number	US-2019284282-A1
Application number	US-201716068294-A
Country	US
Kind code	A1
Filing date	Jan 11, 2017
Priority date	Jan 12, 2016
Publication date	Sep 19, 2019
Grant date	—

Abstract

This present invention relates to a method of stabilizing an aqueous pharmaceutical preparation susceptible to de-gradation by formulating in a dual buffer system wherein the individual buffers are selected from phosphate, aspartate, glutamate, and succinate buffer.

First claim

1 ) A stable aqueous pharmaceutical formulation for an antibody comprising a dual buffer system comprising buffers selected from the group consisting of phosphate, aspartate, succinate, and glutamate.

2 ) The formulation of claim 1 , wherein the formulation further comprises pharmaceutically acceptable excipients such as amino acids, sugars, polyols, salts or surfactants.

3 ) The formulation of claim 1 , wherein the antibody is a therapeutic antibody.

4 ) The formulation of claim 1 , wherein the antibody is stable under at least one of the following accelerated stability conditions such as 25° C. for 3 months or 37° C. for 4 weeks or 40° C. for 2 weeks or 50° C. for 1 week.

5 ) The formulation of claim 1 , wherein the antibody is stable when subjected to multiple freeze-thaw cycles.

6 ) A stable aqueous pharmaceutical formulation of adalimumab comprising a dual buffer selected from the group consisting of phosphate-glutamate buffer or succinate-glutamate buffer.

7 ) (canceled)

8 ) A stable aqueous pharmaceutical formulation of tocilizumab comprising succinate-aspartate buffer, and wherein the formulation inhibits a reduction in monomer content and main peak content of the antibody composition.

9 ) A stable aqueous pharmaceutical formulation of trastuzumab comprising a dual buffer system selected from succinate-glutamate or phosphate glutamate buffer, and wherein the formulation inhibits a reduction in monomer content of the antibody composition.

10 ) The formulation according to claim 1 , wherein the dual buffer system has a pH between 5-7.

11 ) The formulation according to claim 1 , wherein the antibody concentration is at least 20 mg/ml.

12 ) The formulation according to claim 1 , wherein the antibody concentration is at least 100 mg/ml.

13 ) The formulation according to claim 6 , wherein the dual buffer system has a pH between 5-7.

14 ) The formulation according to claim 6 , wherein the antibody concentration is at least 20 mg/ml.

15 ) The formulation according to claim 6 , wherein the antibody concentration is at least 100 mg/ml.

16 ) The formulation according to claim 6 , wherein the formulation inhibits a reduction in monomer content and main peak content of the antibody composition.

17 ) The formulation according to claim 6 , wherein the formulation is stable when subjected to at least three freeze-thaw cycles.

18 ) The formulation according to claim 8 , wherein the antibody concentration is at least 20 mg/ml.

19 ) The formulation according to claim 8 , wherein the antibody concentration is at least 100 mg/ml.

20 ) The formulation according to claim 9 , wherein the antibody concentration is at least 20 mg/ml.

21 ) The formulation according to claim 9 , wherein the antibody concentration is at least 100 mg/ml.

Assignees

• Dr Reddys Laboratories Ltd

Inventors

• Jayaraman Murali
• Nair Pravin
• Kanakadurga Lakshmi
• Kaur Navneet
• Thumbrahalli Deepak

Classifications

• A61P35/00

  Antineoplastic agents · CPC title

• A61K47/183

  Amino acids, e.g. glycine, EDTA or aspartame · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title