A LUBRICANT FORMULATION OF CARBAMOYLETHYL KATIRA AND A PROCESS FOR PREPARATION THEREOF

• US 20180235873A1
• Filed: 08/05/2016
• Published: 08/23/2018
• Est. Priority Date: 08/07/2015
• Status: Active Grant

• Current Assignee: Council of Scientific & Industrial Research
• Original Assignee: Council of Scientific & Industrial Research
• Inventors: RANA, VIKAS, Sharma, Radhika, Kamboj, Sunil, Singh, Kuldeep, Suresh, Sarasija
• Granted Patent: US 10,639,274 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears

Abstract

A lubricant formulation of carbamoylethyl katira and a microwave assisted process for the preparation of the lubricant formulation of carbamoylethyl katira. The lubricant formulation of carbamoylethyl katira having antibacterial activity useful for eye lubricant based formulations, treatment of dry eye disease syndrome, etc.

Claims

1. A lubricant formulation of carbamoylethyl katira comprising katira gum in the range of 5% w/v to 10% w/v carbamoylethyl in the range of 5% w/v to 10% w/v and additives.

2. The lubricant formulation as claimed in claim 1, wherein katira gum is obtained from Cochlospermum religiosum.

3. The lubricant formulation as claimed in claim 1, wherein additives are selected from the group consisting of a surfactant, emulsifier, and combinations thereof, in a water based emulsion.

4. The lubricant formulation as claimed in claim 1, wherein said formulation shows antibacterial activity against Staphylococcus aureus.

5. The lubricant formulation as claimed in claim 1, wherein said formulation is for use in treatment of dry eye disease.

6. A process for the preparation of a lubricant formulation of carbamoylethyl katiraas claimed in claim 1, wherein said process comprises of the following steps:

a) soaking gum katira in water for a time period of 14 to 20 hrs to obtain homogenized gel;

b) stirring the homogenized gel obtained in step (a) for 30 to 45 minutes followed by addition of 25 ml of 28% w/v to 44% w/v ice cold sodium hydroxide solution with stirring and additional stirring for 30 min after the addition of ice cold sodium hydroxide to obtain basic reaction mixture;

c) adding 11% w/v to 18% w/v of acrylamide to the basic reaction mixture obtained in step (b) with constant stirring for 1 hr to obtain reaction mixture;

d) irradiating the reaction mixture obtained in step (c) in a microwave reactor at 450 watt for a time period of 0.5 to 1 min followed by a cooling cycle for a time period of 1 to 2 min at a temperature of 4°

C. to 10°

C. in ice bath;

e) repeating the step (d) for 3 to 7 times followed by neutralization with dilute glacial acetic acid to obtain neutralized reaction mixture;

f) precipitating the neutralized reaction mixture obtained in step (e) with solvents followed by washing with precipitating solvent to obtain precipitate of carbamoylethylkatira;

g) filtering and drying the precipitates of carbamoylethylkatira obtained in step (f) to obtain carbamoylethyl katria;

h) dissolving 2.5% to 10% w/v of carbamoylethylkatira obtained in step (g) in luke warm sterile water for injection followed by filtration through 0.22μ

filtration system;

i) sterilizing the lubricant formulation of carbamoylethylkatira obtained in step (h) at a temperature in the range of 121°

C. to 118°

C. for a time period of 20 to 40 minutes to obtain sterilized lubricant formulation.

7. The process as claimed in claim 6, wherein the ratio of glacial acetic acid and water in step (e) is 1:

1 for neutralization of reaction.

8. The process as claimed in claim 6(g), wherein drying of carbamoylethylkatira in step (g) is carried out using lyophilization at a temperature in the range of −

80°

C. for a time period of 72 to 96 hour or oven drying at a temperature selecting in the range of 45 to 55°

C. for a time period selected in the range of 3.5 to 4.5 days or 60°

C. for a time period selected in the range of 1.5 to 2.5 days to obtain the formulation of carbamoylethylkatira.