Abstract

Stability of Ursodiol in SyrSpend SF Cherry Flavored

Author(s): Geiger Christine M, Voudrie Mark A II, Sorenson Bridget

Issue: Nov/Dec 2012 - Volume 16, Number 6

Page(s): 510-512

Download in electronic PDF format for $75
  • Stability of Ursodiol in SyrSpend SF Cherry Flavored Page 1
  • Stability of Ursodiol in SyrSpend SF Cherry Flavored Page 2
  • Stability of Ursodiol in SyrSpend SF Cherry Flavored Page 3

Note: Electronic version includes errata or revisions.

Abstract

Ursodiol is used in the treatment and prevention of certain types of gallstones and for patients with primary biliary cirrhosis. Ursodiol is marketed for this purpose by Watson Pharma, Inc. as ACTIGALL, by Axcan Scandipharm Inc. as URSO 250 and URSO Forte, and by a number of generic manufacturers. Ursodiol is available as capsules of varying strengths. The need for other dose-form options for those patients who cannot take capsules has led compounding pharmacies to seek other alternatives, namely oral solutions and suspensions. Additionally, some patients are unable to tolerate suspending agents containing alcohol or sorbitol. The objective of this study was to determine the stability of ursodiol in SyrSpend SF Cherry Flavored which does not contain sorbitol or alcohol. The studied sample was compounded into a 30-mcg/mL suspension and stored in a low-actinic plastic bottle at temperatures between 2°C and 8°C. Six samples were assayed at each time point out to 66 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced degradation studies. The sample remained within 90% to 110% of the initial concentration throughout the course of the study. The beyond-use date of this product is at least 66 days, based on data collected when refrigerated and protected from light.

Related Keywords

  • ursodiol
  • bile acid
  • gallstones
  • cholelithiasis
  • oral suspension
  • stability

Related Categories

  • EXCIPIENTS
  • GASTROENTEROLOGY
  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • 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 2012
Pg. 510-512
Stability of Ursodiol in SyrSpend SF Cherry Flavored
Author(s): Geiger Christine M, Voudrie Mark A II, Sorenson Bridget
Nov/Dec 2019
Pg. 493
Ursodiol 30 mg/mL in SyrSpend SF Cherry Oral Suspension
Author(s): Allen Loyd V Jr
Jan/Feb 2003
Pg. 48-50
Featured Excipient: Flavor Enhancing Agents
Author(s): Allen Loyd V Jr
Jan/Feb 2019
Pg. 70-76
Stability of Compounded Ursodiol Suspensions in PCCA Base, SuspendIt
Author(s): Pramar Yashoda V, Mandal Tarun K, Bostanian Levon A, Nguyen Anh TQ, Miller Valicia, Morris Tommy C, Graves Richard A
Sep/Oct 2011
Pg. 427
Ursodiol 50-mg/mL Oral Suspension
Author(s): Allen Loyd V Jr
Jul/Aug 2013
Pg. 344-346
Stability of Midazolam in SyrSpend SF and SyrSpend SF Cherry
Author(s): Geiger Christine M, Sorenson Bridget, Whaley Paul A
Jan/Feb 2010
Pg. 82-85
Stability of Oseltamivir Phosphate in SyrSpend SF, Cherry Syrup, and SyrSpend SF (For Reconstitution)
Author(s): Voudrie Mark A II, Allen D Brett
Nov/Dec 2005
Pg. 480
Ursodiol 25-mg/mL Oral Liquid
Author(s): Allen Loyd V Jr
Jul/Aug 2020
Pg. 327-336
Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF pH4
Author(s): Espana B, Joseph-Tornabène F, Jaquet Cécile, Perrot S, Prouillac C
Jul/Aug 2021
Pg. 327
Nifedipine 4.mg/mL in SyrSpend SF pH4 Cherry Flavored
Author(s): Allen Loyd V Jr
Mar/Apr 2022
Pg. 146
Phenobarbital 10 mg/mL in SyrSpend SF pH4, Cherry Flavored
Author(s): Allen Loyd V Jr
Sep/Oct 2015
Pg. 420-427
Stability Assessment of 10 Active Pharmaceutical Ingredients Compounded in SyrSpend SF
Author(s): Geiger Christine M, Sorenson Bridget, Whaley Paul
May/Jun 2020
Pg. 232
Ursodiol 100 mg/mL in Cod Liver Oil, Veterinary
Author(s): Allen Loyd V Jr
Jan/Feb 2020
Pg. 54
Amiodarone Hydrochloride 5 mg/mL in SyrSpend SF pH4 Cherry Flavored
Author(s): Allen Loyd V Jr
Jul/Aug 2012
Pg. 347-349
Stability of Gabapentin in SyrSpend SF
Author(s): Sorenson Bridget, Voudrie Mark A II, Gehrig Dan
Sep/Oct 2003
Pg. 382
Ursodiol 150-mg Capsules
Author(s): Allen Loyd V Jr
Nov/Dec 2008
Pg. 558-564
Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System
Author(s): Vu Nicole T, Aloumanis Vasileios, Ben Michel J, Kupiec Thomas C, Patterson Evelyn K, Radke Joshua, Erickson Martin A III, Schneider Gary
Mar/Apr 1997
Pg. 90-92
Flavors and Flavoring
Author(s): Allen Loyd V Jr
Jul/Aug 2018
Pg. 321
Midazolam 1 mg/mL in SyrSpend SF or SyrSpend SF Cherry
Author(s): Allen Loyd V Jr
Mar/Apr 2016
Pg. 159-163
Stability of Commercially Available Grape and Compounded Cherry Oral Vancomycin Preparations Stored in Syringes and Cups
Author(s): Kirk Loren, Lewis Paul, Luu Yao, Brown Stacy