Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules

Author(s):  Dijkers Eli, Nanhekhan Valerie, Thorissen Astrid, Polonini Hudson

Issue:  Mar/Apr 2017 - Volume 21, Number 2
View All Articles in Issue

Page(s):  171-175

Download in electronic PDF format for $65

Abstract:  The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for all active pharmaceutical ingredients were taken throughout a 90-day period and the content was determined. In total, 5,190 different samples were analyzed for 74 different active pharmaceutical ingredients at room (15°C to 25°C) or controlled refrigerated temperature (2°C to 8°C). Each of these datasets was analyzed according to the United States Pharmacopeia Content Uniformity monograph, corrected for the sample number. The mean acceptance values were well within specifications. In addition, all suspensions complied with the criteria defined by the British Pharmacopoeia monograph for Content Uniformity of Liquid Dispersions for both room and controlled refrigerated temperature. In previous studies, it was found that a routine weight variation check is often not sufficient for quality assurance of extemporaneous prepared capsules. Compounded oral liquids show little variation in content for 74 different active pharmaceutical ingredients; therefore, compounded oral liquids are a suitable alternative when compounding individualized medications for patients.

Related Keywords: Eli Djikers, PharmD, PhD, Valerie Nanhekhan, MSc, Astrid Thorissen, PharmD, Hudson Polonini, Bpharm, PhD, elderly, children, infants, drug bioavailability, dysphagia, swallowing disorder, oral suspensions, United States Pharmacopeia monograph, USP, uniformity of content, content uniformity, weight variation, aged, active pharmaceutical ingredients, acceptance value

Related Categories: GERIATRICS, PEDIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules
Dijkers Eli
, Nanhekhan Valerie, Thorissen Astrid, Polonini Hudson
Mar/Apr 2017
Pg. 171-175

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested
Dijkers Eli
, Polonini Hudson, de Oliveira Ferreira Anderson
Sep/Oct 2020
Pg. 408-412

Updated Stability Data for Midazolam, Oseltamivir Phosphate, and Propranolol Hydrochloride in SyrSpend SF and Minoxidil in Espumil
Dijkers Eli
, Nanhekhan Valerie, Thorissen Astrid
May/Jun 2017
Pg. 240-241

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

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

Compatibility of Estradiol, Estriol, Estrone, Progesterone, and Testosterone Single Formulation in Fitalite, Versatile, or HRT Supreme Cream Base
Polonini Hudson C
, Dijkers Eli, Ferreira Anderson O, Zander Clark, Taylor Sarah
Jul/Aug 2021
Pg. 336-343

Basics of Compounding: Summary of the Official United States Pharmacopeia Monographs for Compounded Preparations
Allen Loyd V Jr
Mar/Apr 2019
Pg. 135-143

Particle Measuring Systems - USP <797> Environmental Monitoring Solutions