Quality Control and Physical and Chemical Stability of Hydrocortisone Oral Suspension: An Interlaboratory Study

Santoveña, A; Llabrés, M; Fariña, JB

Abstract

Quality Control and Physical and Chemical Stability of Hydrocortisone Oral Suspension: An Interlaboratory Study

Author(s): Santoveña A, Llabrés M, Fariña JB

Issue: Sep/Oct 2010 - Supporting Quality Pharmaceutical Compounding World Wide

View All Articles in Issue

Page(s): 430-435

Download in electronic PDF format for $75

Abstract

There were two objectives of this study, one of which was to ensure that different 1-mg/mL hydrocortisone oral suspensions that were prepared as compounded preparations in four accredited laboratories using the same standard operating procedure were in accordance with the general quality controls of these disperse systems and the specific requirements of the European Pharmacopeia, the Royal Spanish Pharmacopeia, and the United States Pharmacopeia. The other objective was to confirm the shelf-life of 90 days that was established for this type of compounded preparation. All the suspensions were in accordance with the organoleptic controls and with the theoretically calculated volume per unit of the preparation, but the amount of active ingredient per volume of the preparations were smaller than the theoretically expected. This result was attributed to the standard operating procedure because no significative differences between laboratories and days were detected, in which an excess of active ingredient is necessary to include in the process to ensure the declared dose. By high-performance liquid chromatography, it was possible to confirm the 90 days of stability of the drug at 5°C.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
Sep/Oct 2010 Pg. 430-435	Quality Control and Physical and Chemical Stability of Hydrocortisone Oral Suspension: An Interlaboratory Study Author(s): Santoveña A, Llabrés M, Fariña JB
Sep/Oct 2021 Pg. 431-439	Physicochemical and Microbiological Stability of Extemporaneously Compounded Hydrocortisone Oral Suspensions in PCCA Base, SuspendIt Author(s): Pramar Yashoda V, Mandal Tarun K, Bostanian Levon A, Kader Cyndy, Morris Tommy C, Graves Richard A
Jul/Aug 2017 Pg. 322-329	Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox) Author(s): Ip Kendice, Carvalho Maria, Shan Ashley, Banov Daniel
Jan/Feb 2018 Pg. 66-75	Stability of an Alcohol-free, Dye-free Hydrocortisone (2 mg/mL) Compounded Oral Suspension Author(s): Manchanda Arushi, Laracy Melissa, Savji Taslim, Bogner Robin H
Sep/Oct 2014 Pg. 427-431	Physicochemical and Microbiological Stabilities of Hydrocortisone in InOrpha Suspending Agent Studied Under Various Condition Author(s): Bourget Philippe, Amin Alexandre, Vidal Fabrice, Pieyre Manon, Dosso El Ourmar, Beauvais Raphaelle, Loeuillet Richard
Sep/Oct 2003 Pg. 389-393	Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Author(s): Alexander Kenneth S, Thyangarajapuram N
May/Jun 2007 Pg. 259-261	Chemical Stability of Hydrocortisone in an Oral Liquid Dosage Form without Suspending Agents Author(s): Gupta Vishnu D
Jul/Aug 2021 Pg. 325	Hydrocortisone 2-mg/mL in Oral Mix Suspension Author(s): Allen Loyd V Jr
Mar/Apr 2017 Pg. 160-163	Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions Author(s): Kabiche Djamila, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel
Jan/Feb 2023 Pg. 72-77	Physicochemical Stability of the Extemporaneous Ibuprofen Oral Suspension in "Wagner" Base Author(s): Spennacchio Antonio, Lopedota Angela, la Forgia Flavia, Fontana Sergio, Franco Massimo, Denora Nunzio
May/Jun 2018 Pg. 240-246	Investigation of the Physical, Chemical, and Microbiological Stability of Oral Solutions Compounded with Herbals Author(s): Khokhlova Kateryna O, Zdoryk Oleksandr A
Jan/Feb 2010 Pg. 76-77	Chemical Stability of Hydrocortisone in Humco Simple Syrup and Ora-Sweet Vehicle Author(s): Gupta Vishnu D
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
Jan/Feb 2004 Pg. 10-14	Women's Oral Health: Is There a Hormonal Link? Author(s): Preckshot John
Jan/Feb 2001 Pg. 9-12	Stability Issues for Compounding Extemporaneously Prepared Oral Formulations for Pediatric Patients Author(s): Schotik Debora
Sep/Oct 2015 Pg. 428-431	Stability of Levothyroxine, Doxycycline, Hydrocortisone, and Pravastatin in Liquid Dosage Forms Stored at Two Temperatures Author(s): Nahata Milap C
Nov/Dec 2021 Pg. 523-527	Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution Author(s): Zaid Abdel-Naser, Zaaror Yara Abu, Qaddumi Aiman, Ratrout Ala, Ahmad Ayda, Hamad Emad, Kittana Naim
Jul/Aug 2020 Pg. 315	Hydrocortisone Hemisuccinate 2 mg/mL or Hydrocortisone Sodium Phosphate 2 mg/mL in SyrSpend SF pH4 Author(s): Allen Loyd V Jr
Mar/Apr 2024 Pg. 151-155	Physical-chemical Stability of the Extemporaneous Paracetamol Oral Suspension in Puccini Base Author(s): Lacassia Chiara, Spennacchio Antonio, Lopedota Angela Assunta, la Forgia Flavia Maria, Fontana Sergio, Denora Nunzio, Lopalco Antonio
Mar/Apr 2014 Pg. 169-174	Preparation and Stability Evaluation of Extemporaneous Oral Suspension of Valsartan Using Commercially Available Tablets Author(s): Zaid Abdel Naser, Assali Mohyeddin, Qaddomi Aiman, Ghanem Mashhour, Zaaror Yara Abu