Octreotide injection

Patent metadata

Field	Value
Publication number	US-10342850-B2
Application number	US-201816124781-A
Country	US
Kind code	B2
Filing date	Sep 7, 2018
Priority date	May 15, 2017
Publication date	Jul 9, 2019
Grant date	Jul 9, 2019

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.

First claim

The invention claimed is:

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.

Assignees

• Sun Pharmaceutical Ind Ltd

Inventors

• Rana Amar
• Thummar Rakesh
• Agrawal Sudeep
• Bhowmick Subhas Balaram
• Thennati Rajamannar

Classifications

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K38/08

  Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)} · CPC title

• A61K47/10

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K9/08 Primary

  Solutions {(composition of solutions A61K47/00)} · CPC title