Ready-to-administer solution of fentanyl citrate

Patent metadata

Field	Value
Publication number	US-10206872-B2
Application number	US-201615185452-A
Country	US
Kind code	B2
Filing date	Jun 17, 2016
Priority date	Jun 19, 2015
Publication date	Feb 19, 2019
Grant date	Feb 19, 2019

Abstract

A method of treating a patient in need of therapy with fentanyl or a salt thereof, the method comprising providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol and water for injection, the solution having a pH in the range of 3.5 to 7.5, and parenterally administering the solution to the patient.

First claim

We claim:

1. A method of administering anesthesia and/or analgesia to a patient by parenterally administering fentanyl or a salt thereof, said method comprising:
a. providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol, and water for injection, wherein said solution has a pH in the range of 3.5 to 7.5, has a volume from 50 ml to 500 ml in an infusion container, has been sterilized by autoclaving, and is physically and chemically stable when stored at room temperature for at least 12 months; and
b. parenterally administering said solution to a patient selected from the group consisting of a patient undergoing a surgical procedure, a patient in need of fentanyl as an adjunct to regional or general anesthesia, and a patient in need of fentanyl as a general anesthetic,
wherein the solution is directly administered intravenously to the patient and does not require any intervening steps of reconstitution and/or dilution or mixing.

2. The method as claimed in claim 1 , wherein the sugar is selected from the group consisting of dextrose, glucose, fructose or mixtures thereof.

3. The method as claimed in claim 1 , wherein the sugar alcohol is selected from the group consisting of mannitol or sorbitol or mixtures thereof.

4. The method as claimed in claim 1 , wherein the solution is present in one or more containers, and fentanyl or a salt thereof is present in amount ranging from 0.001 mg/ml to 0.1 mg/ml.

5. The method as claimed in claim 4 , wherein fentanyl or a salt thereof is present in an amount ranging from 0.005 mg/ml to 0.075 mg/ml.

6. The method as claimed in claim 4 , wherein the container comprises a polymer of a cyclic olefin.

7. The method as claimed in claim 1 , wherein the infusion container is an infusion bag made from polymeric material.

8. The method as claimed in claim 1 , wherein the polymeric material is a cyclic olefin.

Assignees

• Sun Pharmaceutical Ind Ltd
• Sun Pharmacuetical Ind Ltd

Inventors

• Kumar Samarth
• Kane Prashant
• Bhowmick Subhas Balaram
• Thakkar Milan Natvarbhai
• Dave Kandarp Maheshkumar

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P25/04

  Centrally acting analgesics, e.g. opioids · CPC title

• A61K31/4468

  having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl · CPC title

• A61K9/08

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

• 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