Abstract

Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date

Author(s): Pignato Alyssa, Pankaskie Marvin, Birnie Christine

Issue: Nov/Dec 2010 - Volume 14, Number 6

Page(s): 522-525

Download in electronic PDF format for $75
  • Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date Page 1
  • Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date Page 2
  • Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date Page 3
  • Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date Page 4

Abstract

The purpose of this stability study was to determine the beyond-use date of the active ingredient methimazole extemporaneously prepared for transdermal absorption to treat feline hyperthyroidism. The methimazole was prepared in poloxamer lecithin organogel and subjected to a three-month stability study. It was determined that under room temperature conditions (25°C ± 2°/60% RH ± 5%) the methimazole concentration remained above 90% after 62 days. An accelerated condition of 35°C and refrigerated condition of 5°C were also employed to see how temperature affected the stability of the drug. Under all three conditions the methimazole concentration dropped below 90% after day 62. It was observed that the refrigerated conditions appeared to be least stable both physically and chemically. A control sample was also prepared, stored, and packaged similarly to the sample preparations. As a result, the beyond-use date was determined to be 60 days at room temperature. The drug preparation should not be stored in a refrigerated condition.

Related Keywords

  • methimazole
  • topical preparation
  • transdermal administration
  • feline
  • cat
  • hyperthyroidism
  • stability
  • storage conditions
  • temperature
  • formulation

Related Categories

  • FORMULATIONS
  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • VETERINARY
  • DOSAGE FORMS/DRUG CARRIERS
  • STORAGE

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Nov/Dec 2010
Pg. 522-525
Stability of Methimazole in Poloxamer Lecithin Organogel to Determine Beyond-Use Date
Author(s): Pignato Alyssa, Pankaskie Marvin, Birnie Christine
Mar/Apr 2003
Pg. 106-113
Veterinary Transdermal Medications: A to Z
Author(s): Davidson Gigi S
May/Jun 2013
Pg. 247-253
Effect of Formulation pH on Transdermal Penetration of Antiemetics Formulated in Poloxamer Lecithin Organogel
Author(s): Woodall Rachel, Arnold John J, McKay Doug, Abill C Scott
May/Jun 2003
Pg. 170-174
Five Compounds for Treating Diabetes-Related Conditions
Author(s): Meece Jerry
Jan/Feb 2021
Pg. 73-81
Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design
Author(s): Patel Gopesh, Davis Countaney, Liu Yi, Ip Kendice, Debideen Krystal E, Anderson Stephanie, Byrne Robert, Herr Dylan, Rhoads Melissa Merrell, Caputo Ross, Banov Daniel, Bassani August S
May/Jun 2014
Pg. 253-255
Evaluation of the Stability of Fluoxetine in Pluronic Lecithin Organogel and the Determination of an Appropriate Beyond-use Date
Author(s): Peacock Gina F, Sauvageot Jurgita
Jan/Feb 2019
Pg. 56
Methimazole 5 mg/0.1 mL in Pluronic Lecithin Organogel Gel, Veterinary
Author(s): Allen Loyd V Jr
Jul/Aug 2018
Pg. 303-312
Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating
Author(s): Martin Matt
Jul/Aug 2014
Pg. 345-347
Evaluation of the Stability of Promethazine Hydrochloride in Pluronic Lecithin Organogel and the Determination of an Appropriate Beyond-use Date
Author(s): Peacock Gina F, Sauvageot Jurgita
Jul/Aug 2014
Pg. 348-350
Evaluation of the Stability of Ketoprofen in Pluronic Lecithin Organogel and the Determination of an Appropriate Beyond-use Date
Author(s): Peacock Gina F, Sauvageot Jurgita, Addo Richard T
Sep/Oct 2002
Pg. 344-345
Transdermal Methimazole in the Treatment of 16 Cats with Hyperthyroidism
Author(s): Wingate Gary
Nov/Dec 2009
Pg. 569-571
The Release and Transdermal Penetration of Baclofen Formulated in a Poloxamer Lecithin Organogel
Author(s): Arnold John J, Asbill Scott
Jul/Aug 2001
Pg. 282-283
Evaluating Transdermal Medication Forms for Veterinary Patients, Part 3: Methimazole
Author(s): Davidson Gigi S
May/Jun 2010
Pg. 232-238
Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations
Author(s): Okeke Claudia C, Allen Loyd V Jr
May/Jun 2014
Pg. 256-261
Preparation and In Vitro Evaluation of a Pluronic Lecithin Organogel Containing Ricinoleic Acid for Transdermal Delivery
Author(s): Boddu Sai HS, Bonam Sindhu Prabha, Wei Yangjie, Alexander Kenneth
Mar/Apr 2017
Pg. 164-170
Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs
Author(s): Gorman Gregory, Sokom Simara, Coward Lori, Arnold John J
Nov/Dec 2012
Pg. 471-474
Beyond-use Date: Establishment and Maintenance
Author(s): Osteen Richard
Nov/Dec 2008
Pg. 524-528
Quality-Control Analytical Methods: Overview of Beyond-Use Dating for Compounded Sterile Preparations
Author(s): Trissel Lawrence A
Nov/Dec 2014
Pg. 456-460
Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date
Author(s): Thomson Cassandra Marie, Savji Taslim
Jul/Aug 2019
Pg. 281-287
Mean Kinetic Temperature for Controlled Room Temperature Drug Storage: Official Definitions and Example Calculations
Author(s): Newton David W