Sun Pharma Advanced Research Company Limited

Ajay Khopade

Arindam Halder

Subhas Balaram Bhowmick

Ankit Shaileshkumar Shah

Natarajan Arulsudar

Lynne Bui

Ronald Harning

Ravi Patel

Shivam Umeshkumar Upadhyay

Wen Wee Ma

Bhushan Borole

Alex Adjei

Narendra Lakkad

Malay Shah

The present invention relates to a method of increasing the bioavailability and/or prolonging ophthalmic action of a drug, the method comprising instilling into the eye an aqueous suspension comprising reversible clusters of drug loaded nano-resin particles, said clusters having a D50 value of at least 2 micrometer and said drug loaded nano-resin particles have a particle size distribution characterized in that the D90 value is 70 nanometer to 900 nanometer. The present invention further relates to an aqueous suspension comprising reversible clusters of drug loaded nano-resin particles, said clusters have a D50 value of at least 2 micrometers and said drug loaded nano-resin particles have a particle size distribution characterized in that the D90 value is 70 nanometers to 900 nanometers.

Method of increasing bioavailability and/or prolonging ophthalmic action of a drug

The present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day. The present invention also provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives.

Ophthalmic solution of difluprednate

The present invention relates to a lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof. The present invention also relates to an aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures.

Stabilization of phenobarbital sodium for injection

The present invention relates to nano-resin particles that are suitable for pharmaceutical use and their use in the pharmaceutical field. The present invention provides nano-sized resin particles having a particle size distribution characterized in that Dvalue is between 200 nanometers to 900 nanometer and Dvalue is not less than 50 nanometers, wherein the nano-resin particles are in pure form and safe for pharmaceutical use. The present invention further relates to pharmaceutical compositions comprising these purified nano-resin particles and their use in the treatment of diseases. The present invention further provides a process for preparing purified, nano-sized resin particles that are suitable for pharmaceutical use, the process comprising steps of: (i) washing an ion exchange resin and suspending in an aqueous liquid, (ii) subjecting the suspension of (i) to wet milling for a period such that the particles have a particle size distribution characterized in that the Dvalue is between 200 nanometers to 900 nanometers and Dvalue is not less than 50 nanometers, (iii) subjecting the suspension of (ii) to purification to remove impurities, (iv) drying the purified suspension to obtain nano-resin particles in the form of dry powder.

Drug loaded nanoresin particles

A method of treating patients suffering from carcinoma of intrahepatic or extra hepatic bile duct or gall bladder which is locally advanced or metastatic, by intravenously administering to the patient, paclitaxel in the form of a nanodispersion. The nanodispersion comprises particles with a mean particle size less than 300 nm and is free of polyoxyethylated castor oil and free of a protein.

Method of treating carcinoma

The present invention relates to an ophthalmic solution comprising

Ophthalmic solution of bimatoprost

The present invention provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives. Also, the present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day.

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.

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Baroda, India

Ajay Khopade