Claims for Patent: 10,342,850

Summary for Patent: 10,342,850

Title:	Octreotide injection
Abstract:	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.
Inventor(s):	Amar RANA, Rakesh THUMMAR, Sudeep AGRAWAL, Subhas Balaram Bhowmick, Rajamannar Thennati
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US16/124,781
Patent Claims:	1. A sterile solution comprising: octreotide in the form of a pharmaceutically acceptable salt, present at a concentration equivalent to 2.5 mg/ml of octreotide base, mannitol in an amount ranging from about 20 mg/ml to about 25 mg/ml and at least one preservative in a pharmaceutically acceptable vehicle, wherein the sterile solution is present in an injection device. 2. The sterile solution according to claim 1, wherein the volume of solution contained in the injection device is in the range of 2.8 ml to 3 ml. 3. The sterile solution according to claim 1, wherein the preservative is selected from the group consisting of phenol, benzyl alcohol, m-cresol, methyl parabens, propylparabens, butylparabens, chlorbutanol, thimerosal, phenylmercuric salts and mixtures thereof. 4. The sterile solution according to claim 1, wherein the solution comprises mannitol in an amount of about 22.5 ng/ml. 5. The sterile solution according to claim 1, comprising: Ingredients Concentration in mg/ml octreotide base in the 2.5 form of its salt lactic acid 3.4 mannitol 22.5 wherein the pH of the sterile solution is in the range from 3.9 to 4.5. 6. The sterile solution according to claim 1, wherein the injection device is configured to inject 20 μl to 250 μl of the sterile solution per injection. 7. The sterile solution according to claim 6, wherein the injection device is configured to inject 20 μl to 80 μl of the sterile solution per injection. 8. The sterile solution according to claim 1, wherein the injection device is a pen injection device.