Sun Pharmaceutical Industries Limited

Pharmaceutical Industries Limited

Sudeep Kumar Agrawal

Subhas Balaram Bhowmick

Rajamannar Thennati

Satyashodhan Babasaheb Patil

Prashant Kane

Alpesh Goyani

Deepak Singodia

Bhaskar Pallerla

Amar Rana

Rakesh Thummar

Jaydip Joshi

A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter. The injector is configured to provide at least one audible feedback during the rotation. The method further includes operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject. The injector is provided with multiple surface portions.

Method of injecting octreotide acetate into the body

A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25&#xb0; C. and 60% relative humidity for at least three months.

Parenteral unit dosage form of dihydroergotamine

A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 &#x3bc;g/mL. The method further includes providing, on the injector, a plurality of indicia only at prescribed doses of 50 &#x3bc;g, 100 &#x3bc;g, 150 &#x3bc;g and 200 &#x3bc;g settable via the dose setter without indicia between said prescribed doses; and permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter, wherein the injector is configured to provide at least one audible feedback during the rotation.

A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25&#xb0; C. and 60% relative humidity for at least three months. 

The present invention provides a stable, aqueous injectable solution comprising epinephrine or its pharmaceutically acceptable salt, a sulfite antioxidant, butylated hydroxyl anisole, an organic acid and a chelating agent, wherein the solution is free of an inorganic acid and an inorganic base. The invention also provides a method of treating the septic shock by intravenous administration of stable aqueous injectable solution comprising epinephrine or its pharmaceutically acceptable salt, a sulfite antioxidant, butylated hydroxyl anisole, an organic acid and a chelating agent, wherein the solution is free of an inorganic acid and an inorganic base.

Stable aqueous injectable solution of epinephrine

The present invention relates to a sterile solution comprising: octreotide in the form of a pharmaceutically acceptable salt, present at a concentration equivalent to 2.0 mg/ml to 2.5 mg/ml of octreotide base, and at least one preservative in a pharmaceutically acceptable vehicle, wherein the sterile solution is present in an injection device.

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Baroda, India

Sudeep Kumar Agrawal