	US 12,472,273 B2
	Sterilization process of timolol gel forming solution through aseptic filtration
Manish Kumar Singh, Haryana (IN); Sai Kiran Jana, Haryana (IN); Mallinath Harwalkar, Haryana (IN); Kishor Deo, Haryana (IN); and Deepak Bahri, Haryana (IN)
Assigned to Sentiss Pharma Private Limited, New Delhi (IN)
Appl. No. 17/995,071
Filed by SENTISS PHARMA PRIVATE LIMITED, New Delhi (IN)
PCT Filed Mar. 30, 2021, PCT No. PCT/IB2021/052635 § 371(c)(1), (2) Date Sep. 29, 2022, PCT Pub. No. WO2021/198911, PCT Pub. Date Oct. 7, 2021.
Claims priority of application No. 202011014180 (IN), filed on Mar. 31, 2020.
Prior Publication US 2023/0143595 A1, May 11, 2023
Int. Cl. A61K 31/5377 (2006.01); A61K 9/00 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 47/36 (2006.01); A61L 2/00 (2006.01)

CPC A61L 2/0017 (2013.01) [A61K 9/0024 (2013.01); A61K 9/0048 (2013.01); A61K 31/5377 (2013.01); A61K 47/18 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01)]

6 Claims

1. A process for preparing a sterile ophthalmic composition, the process comprising:

a) Collecting hot water in a manufacturing vessel at a temperature of about 40° C. to about 60° C.;

b) Preparing a solution by adding and dissolving in the hot water Mannitol, Tromethamine, Timolol Maleate, Benzododecinium Bromide and Gellan Gum under continuous stirring and making up the volume to 100%;

c) Heating the solution of step (b) at a temperature of about 105° C. to about 115° C. by passing steam through a jacket of the manufacturing vessel for a period of about 1 hrs to 3 hrs to reduce the viscosity of the solution to a desired range of 70 cps to 110 cps;

d) Cooling down the solution of step (c) to 25±5° C.;

e) Increasing the temperature of the solution of step (d) to about 60° C. to about 75° C. to obtain a viscous solution;

f) Aseptically filtering the viscous solution of step (e) through a 0.45 μm clarification filter (pre-filter) followed by a 0.2μ sterilizing grade filter to sterilize the viscous solution; and

g) Aseptically filling the filtered solution of step (f) into 3-piece vials,

wherein the process does not include autoclaving.