Abstract

To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid

Author(s): Chuong Monica C, Taglieri Catherine A, Kerr Stephen G

Issue: Nov/Dec 2017 - Volume 21, Number 6

Page(s): 500-512

Download in electronic PDF format for $75
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 1
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 2
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 3
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 4
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 5
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 6
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 7
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 8
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 9
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 10
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 11
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 12
  • To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid Page 13

Abstract

Omeprazole is a proton pump inhibitor used to treat the symptoms of gastro esophageal reflux disease, ulcers, excess stomach acid, infection with Helicobacter pylori, and to control the gastric side effects of various drugs. The approved dosage forms in the U.S. are powder in compounding kits, delayed-release granules for oral suspension, oral delayed-release tablets, and oral delayed-release capsules. An extemporaneously compounded unsweetened oral liquid method, published in the International Journal of Pharmaceutical Compounding, was found to be commonly used by pharmacists. This project investigated the robustness of the compendium omeprazole high-performance liquid chromatographic assay in evaluating an oral liquid made from commercial delayed-release pellets, the potency of extemporaneously compounded solutions having a 1.125% v/v flavored versus unflavored samples stored at controlled cold temperatures at different time points, and examining the absorption spectrum of the flavoring agent. As part of the study, stability-indication testing was also conducted. The studies indicate that the chromatographic area under the plasma concentration-time curve of both study groups remained over 90% of the label claim during the follow-up period. The flavor did not significantly impact the pH of the oral liquid. This study further identified (1) an increase in resilient foam formation in the flavored liquid, potentially hindering dosing accuracy, (2) omeprazole is oxidized easily by 3% hydrogen peroxide, and (3) flavoring agent absorbs in an ultraviolet visible spectroscopy spectral range often used in assay detectors for quantification of drug molecules, and could interfere with assay protocols of the same.

Related Keywords

  • omeprazole
  • proton pump inhibitors
  • PPIs
  • gastroesophageal reflux disease
  • GERD
  • Helicobacter pylori
  • gastric ulcers
  • stomach acid
  • gastric side effects
  • oral liquid preparation
  • foam formation
  • flavoring agents
  • stability

Related Categories

  • EXCIPIENTS
  • GASTROENTEROLOGY
  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Nov/Dec 2017
Pg. 500-512
To Flavor or Not to Flavor Extemporaneous Omeprazole Liquid
Author(s): Chuong Monica C, Taglieri Catherine A, Kerr Stephen G
Jan/Feb 2003
Pg. 48-50
Featured Excipient: Flavor Enhancing Agents
Author(s): Allen Loyd V Jr
Nov/Dec 2019
Pg. 504-510
Compatibility of Flavoring Agents in Compounding Extemporaneous Omeprazole Oral Liquid
Author(s): Chuong Monica, Taglieri Catherine A, Huang Szu Yu, Sariol Anthony, Kitigawa Reina, Barman Koushik, Mistry Amee, Harris Donna L, Kerr Stephen G
Jan/Feb 2019
Pg. 58
Omeprazole 1 mg/mL and 4 mg/mL in Humco Flavor Sweet Sugar-Free Oral Liquid
Author(s): Allen Loyd V Jr
Mar/Apr 2011
Pg. 124-128
Proton Pump Inhibitor Homogenous Suspensions: A Compounding Solution to Pediatric Gastroesophageal Reflux Disease
Author(s): Corsini Lindsay, Williams LaVonn A
Mar/Apr 1997
Pg. 90-92
Flavors and Flavoring
Author(s): Allen Loyd V Jr
May/Jun 2023
Pg. 250-255
Stability of Omeprazole Extemporaneous Oral Solution in Chopin Base
Author(s): Spennacchio Antonio, Lopedota Angela Assunta, la Forgia Flavia Maria, Fontana Sergio, Denora Nunzio, Lopalco Antonio
Sep/Oct 2006
Pg. 389
Omeprazole 2-mg/mL Oral Liquid
Author(s): Allen Loyd V Jr
Mar/Apr 2020
Pg. 140-147
The Effect of Manufacturer on the Compounding of Omeprazole Suspensions and Their Stability Assessment
Author(s): Meissner Svenja, Bansal Mahima, Dela Cruz Paula Donamae, Hanning Sara, Svirskis Darren
Jul/Aug 2017
Pg. 330-333
Compounded Levofloxacin Triple Therapy is Safe and Effective for Refractory Helicobacter pylori
Author(s): Mah Xian-Jun, Gupta Vikas, Loch Srey Neth, Ahlenstiel Golo, van de Poorten David
Mar/Apr 2007
Pg. 161
Ranitidine Hydrochloride 15-mg/mL Oral Liquid
Author(s): Allen Loyd V Jr
Jan/Feb 2001
Pg. 13-16
Flavoring: Compounding a Treat
Author(s): Kloesel Lawson G
Sep/Oct 2019
Pg. 409
Omeprazole 2 mg/mL in SyrSpend SF Alka (Reconstituted)
Author(s): Allen Loyd V Jr
Sep/Oct 2006
Pg. 391
Pantoprazole Sodium 2-mg/mL Oral Liquid
Author(s): Allen Loyd V Jr
Mar/Apr 2006
Pg. 139
Cimetidine 60-mg/mL Oral Liquid, Alcohol Free
Author(s): Allen Loyd V Jr
Mar/Apr 2012
Pg. 164-166
Stability of Omeprazole in SyrSpend SF Alka (Reconstituted)
Author(s): Whaley Paul A, Voudrie Mark A II, Sorenson Bridget
Jul/Aug 2003
Pg. 288-291
Basics of Compounding for Raynaud's Disease
Author(s): Glasnapp Andrew
Jul/Aug 2003
Pg. 313-319
Stability of Hydralazine HCl in Both Flavored and Nonflavored Extemporaneous Preparations
Author(s): Okeke Claudia C, Medwick Thomas, Nairn Graham, Shaila Khuspe, Grady Lee T
Jan/Feb 2007
Pg. 74
Lansoprazole 3-mg/mL Oral Liquid
Author(s): Allen Loyd V Jr
Sep/Oct 2023
Pg. 386-395
Basics of Compounding: Compounding Foams
Author(s): Allen Loyd V Jr