Claims for Patent: 9,629,852
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Summary for Patent: 9,629,852
Title: | Ophthalmic composition comprising a prostaglandin |
Abstract: | The present invention relates to a pharmaceutical composition suitable for ophthalmic use comprising one or more prostaglandin derivatives or salts, a stabilizing amount of polyethylene glycol hydroxystearate and pharmaceutically acceptable vehicle. |
Inventor(s): | Khopade; Ajay Jaysingh (Baroda, IN), Halder; Arindam (Baroda, IN), Bhowmick; Subhas Balaram (Baroda, IN) |
Assignee: | SUN PHARMA ADVANCED RESEARCH COMPANY LTD. (Mumbai, IN) |
Application Number: | 12/601,429 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 9,629,852 |
Patent Claims: |
1. A pharmaceutical composition suitable for ophthalmic use comprising 0.005% w/v latanoprost or a pharmaceutically acceptable salt therof, 0.15% w/v castor oil, 0.2 to 0.75% w/v of
polyethylene glycol hydroxystearate, a co-solvent, a chelating agent, a preservative, and pharmaceutically acceptable vehicle, wherein the ratio of oil to polyethylene glycol hydroxystearate is less than 1.0, wherein the composition is in the form of a
self-emulsifying micro-emulsion with average droplet size of about 100 nm or less and a zeta potential between -0.1 mV to -20 mV, wherein the composition does not comprise a cationic surfactant, and wherein the composition does not comprise a quaternary
ammonium compound.
2. The pharmaceutical composition as claimed in claim 1 Wherein the emulsion has an average droplet size of less than 100 nanometers in diameter. 3. The pharmaceutical composition as claimed in claim 2, wherein the emulsion has a percent transmission greater than 70%. 4. The pharmaceutical composition as claimed in claim 2, wherein the emulsion has a percent transmission greater than 80%. 5. The pharmaceutical composition as claimed in claim 1 wherein the composition does not show any clinical sign of ocular irritation when tested in rabbits. |