Stabilization of paricalcitol using chlorobutyl or chlorinated butyl stoppers

• US 20070166187A1
• Filed: 01/18/2006
• Published: 07/19/2007
• Est. Priority Date: 01/18/2006
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Song, Jing, Stephens, Dennis
• Application Number:
  US11/334,060
• Publication Number:
  US 20070166187A1
• Time in Patent Office: Days
• US Class Current: 422/40
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

This invention relates to a method of enhancing the stability of paricalcitol solution in a container by using a chlorobutyl or chlorinated butyl stopper in the container.

Claims

1. A method of preventing the decomposition of a pharmaceutical comprising the step of storing the pharmaceutical in a glass vial sealed with a stopper comprising a halogenated butyl polymer selected from the group consisting of chlorobutyl, chlorinated butyl, fluorobutyl and fluorinated butyl for a time and under conditions sufficient to prevent said decomposition.

2. The method according to claim 1, wherein the stopper is comprised of chlorobutyl or chlorinated butyl polymer.

3. The method according to claim 2, wherein the pharmaceutical is in solution.

4. The method according to claim 3, wherein the pharmaceutical is a vitamin D receptor activator.

5. The method according to claim 4, wherein the vitamin D receptor activator is Paricalcitol.

6. The method according to claim 5, wherein the shelf-life of paricalcitol in solution is increased, compared to a solution of paricalcitol stored in a glass vial sealed with a polymer stopper comprising a polymer selected from the group consisting of butyl, bromobutyl, ethylene-propylenediene monomer or polyisoprene.

7. The method according to claim 5, wherein the paricalcitol solution is administered intravenously.

8. A method of preventing decomposition of a solution of paricalcitol in a preloaded syringe comprising adding paricalcitol to a syringe, wherein the syringe stopper is comprised of chlorobutyl or chlorinated butyl polymer, and maintaining said resulting syringe for a time and under conditions sufficient to prevent decomposition of said solution.