Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride

Author(s):  Alexander Kenneth S, Thyangarajapuram N

Issue:  Sep/Oct 2003 - After the Women's Health Initiative Trial
View All Articles in Issue

Page(s):  389-393

Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Page 1
Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Page 2
Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Page 3
Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Page 4
Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride Page 5

Download in electronic PDF format for $75

Abstract:  Amiodarone is commercially available as both a tablet and an injectable formulation. It is widely dispensed as an extemporaneously compounded suspension for pediatric and geriatric patients. Extensive stability data at numerous temperatures and a calculated shelf life based on kinetics for such a formulation have not been reported. Refrigeration and room temperature data for finite times have been reported in the literature.

In this study, a stable extemporaneous formulation of amiodarone hydrochloride was formulated using Pacerone tablets. The formulation consisted of 0.75% carboxymethylcellulose and 0.75% Veegum as suspending agents; 25% sucrose, provided as simple syrup; and aqueous strawberry concentrate as flavor. A total of 2.5 L of the formulation was compounded and stored in quantities of 150 mL in 8-oz glass containers. The initial drug content was determined by reverse-phase high-performance liquid chromatography, with a method that was developed in our laboratory. The stability study was carried out by storing three containers at five different temperatures, namely 4, 30, 40, 50 and 60°C. The suspension was analyzed at the end of 2, 6, 12, 24 and 48 hours at 7 days, and, thereafter, at the end of every week for 13 weeks. The percentage of drug remaining was plotted against time for each temperature. The slope of the regression line was obtained for each temperature and the zero-order degradation rate constant obtained. The logarithm of the zero-order degradation rate constants was plotted against the inverse of the temperature in degrees Kelvin to obtain the Arrhenius plot. From the regression line for the Arrhenius plot, the zero-order degradation constant at 25°C was calculated to be 0.0517 day–1. The shelf life for the formulation at 25°C was calculated to be 193.4 days; the shelf life under refrigeration (4°C) was found to be 677.3 days. The degradation products were characterized using high-performance liquid chromatographic-mass spectrometry. Data obtained from the analysis suggested that amiodarone cleaved at its ketone and ether linkages to yield corresponding degradation products.

Related Keywords: Amiodarone hydrochloride, accelerated stability studies, of extemporaneous suspension of, Amiodarone hydrochloride, formulation of extemporaneous suspension of, Amiodarone hydrochloride, stability studies, of extemporaneous suspension of

Related Categories: GERIATRICS, PEDIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride
Alexander Kenneth S
, Thyangarajapuram N
Sep/Oct 2003
Pg. 389-393

Formulation Development and Stability Testing of Extemporaneous Suspension Prepared From Dapsone Tablets
Kaila Nitin
, El-Ries Mohamed, Riga A, Alexander Kenneth S, Dollimore D
May/Jun 2003
Pg. 233-239

Evaluation of the Physicochemical Stability of Amiodarone Hydrochloride in Syringes for the Intensive Care Unit
Lardinois Benjamin
, Dimitriou Alexandre, Delcave Charlotte, Jamart Jacques, Bihin Benoît, Soumoy Laura, Hecq Jean-Daniel, Galanti Laurence M
Mar/Apr 2019
Pg. 163-166

Extemporaneous Formulation and Stability Testing of Mexiletine HCl Solution
Alexander Kenneth S
, Kaushik Sarita
Mar/Apr 2004
Pg. 147-152

Formulation and Stability Study of Eslicarbazepine Acetate Oral Suspensions for Extemporaneous Compounding
Zhao Fang
, Dave Vivek S, Mar Mazin Z, Perri Jonathan R
Sep/Oct 2018
Pg. 433-439

Extemporaneous Formulations: How to Evaluate HPLC Stability Studies
Chan Debora Schotik
Nov/Dec 1999
Pg. 447-451

Amiodarone Hydrochloride 50-mg/mL Injection
Allen Loyd V Jr
Mar/Apr 2012
Pg. 154

Amiodarone Hydrochloride 5 mg/mL in SyrSpend SF pH4 Cherry Flavored
Allen Loyd V Jr
Jan/Feb 2020
Pg. 54

Compatibility of Amiodarone Hydrochloride with Vasopressin During Simulated Y-site Administration
Ramaley Corrine C
, Li Feng, Du Chengan
Sep/Oct 2013
Pg. 436-438

Compatibility of Baclofen, Carvedilol, Hydrochlorothiazide, Mercaptopurine, Methadone Hydrochloride, Oseltamivir Phosphate, Phenobarbital, Propranolol Hydrochloride, Pyrazinamide, Sotalol Hydrochloride, Spironolactone, Tacrolimus Monohydrate, Ursodeoxycholic Acid, and Vancomycin Hydrochloride Oral Suspensions Compounded with SyrSpend SF pH4
Polonini Hudson
, da Silva Sharlene Loures, Brandão Marcos Antônio Fernandes, Bauters Tiene, De Moerloose Barbara, Ferreira Anderson de Oliveira
Nov/Dec 2018
Pg. 516-526

Stability of Azathioprine, Clonidine Hydrochloride, Clopidogrel Bisulfate, Ethambutol Hydrochloride, Griseofulvin, Hydralazine Hydrochloride, Nitrofurantoin, and Thioguanine Oral Suspensions Compounded with SyrSpend SF pH4
Polonini Hudson
, Loures da Silva Sharlene, Neves Cunha Carolina, de Oliveira Ferreira Anderson, Anagnostou Korina, Dijkers Eli
May/Jun 2020
Pg. 252-262

Chemical Stability of Amiodarone Hydrochloride in Intravenous Fluids
Pramar Yashoda V
Sep/Oct 1997
Pg. 347-348

Physicochemical Stability of the Extemporaneous Ibuprofen Oral Suspension in "Wagner" Base
Spennacchio Antonio
, Lopedota Angela, la Forgia Flavia, Fontana Sergio, Franco Massimo, Denora Nunzio
Jan/Feb 2023
Pg. 72-77

A Pilot Stability Study of Dehydroepiandrosterone Rapid-dissolving Tablets Prepared by Extemporaneous Compounding
Rush Steven D
, Vernak Charlene, Zhao Fang
Jan/Feb 2017
Pg. 83-87

Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF pH4
Espana B
, Joseph-Tornabène F, Jaquet Cécile, Perrot S, Prouillac C
Jul/Aug 2020
Pg. 327-336

Preparation and Stability Evaluation of Extemporaneous Oral Suspension of Valsartan Using Commercially Available Tablets
Zaid Abdel Naser
, Assali Mohyeddin, Qaddomi Aiman, Ghanem Mashhour, Zaaror Yara Abu
Mar/Apr 2014
Pg. 169-174

Stability of Hydralazine HCl in Both Flavored and Nonflavored Extemporaneous Preparations
Okeke Claudia C
, Medwick Thomas, Nairn Graham, Shaila Khuspe, Grady Lee T
Jul/Aug 2003
Pg. 313-319

Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution
Zaid Abdel-Naser
, Zaaror Yara Abu, Qaddumi Aiman, Ratrout Ala, Ahmad Ayda, Hamad Emad, Kittana Naim
Nov/Dec 2021
Pg. 523-527

Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes
Xu Quanyun A
, Trissel Lawrence A, Pham Lien
Jan/Feb 2002
Pg. 66-69

Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Bupivacaine Hydrochloride Packaged in Plastic Syringes
Trissel Lawrence A
, Xu Quanyun A, Pham Lien
Jan/Feb 2002
Pg. 70-73

Return to Top