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.

Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases

Author(s):  Teimouri Arezou, Yeung Pollen, Agu Remigius U

Issue:  Jul/Aug 2021 - Volume 25, Number 4
View All Articles in Issue

Page(s):  344-351

Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 1
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 2
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 3
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 4
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 5
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 6
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 7
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases Page 8

Download in electronic PDF format for $75

Abstract:  The objective of this study was to investigate the stability of compounded nifedipine cream in gel and ointment formulations dispensed in white plastic and glass amber jars. Extemporaneously compounded nifedipine cream (Glaxal Base), gel (K-Y Jelly), and ointment (Aquaphor) in white plastic and glass amber jars were stored at 4°C, 23°C, and 40°C. We determined potency on days 0, 7, 14, 30, 60, and 90, and subsequently assigned beyond-use-dates based on United States Pharmacopeia recommendations, organoleptic properties, and pH changes. Nifedipine potency in cream and ointment stored in white plastic jars was within ±10% of initial for 90 days (excluding day 14 for cream). In glass amber jars, potency was outside the acceptable range by day 14 at 23°C but within range for 90 days at 4°C (excluding day 30). Nifedipine potency was maintained for 90 days in both jars at 23°C and 4°C (excluding day 30) and in white plastic jars at 40°C, but 60 days stored in glass amber jars. The pH of formulations was stable with changes of less than 1-unit pH. At 40°C, a significant decrease in apparent viscosity of cream was evident on day 90. There was a decrease in apparent viscosity and phase separation of the ointment at 40°C and an increase in apparent viscosity (difficult to mix) at 4°C on day 14 onwards. Significant organoleptic changes were observed by day 7 at 40°C (decrease in apparent viscosity and abnormal odor by day 90), day 30 at 4°C (thicker consistency), and day 90 at 23°C (abnormal odor). Storage in white plastic jars at 23°C is recommended for compounded topical nifedipine cream and ointment (for 90 days), and for gel (60 days).

Related Keywords: Arezou Teimouri, BSc (Pharm), MSc (Pharm Sci), Pollen Yeung, BSc (Pharm), PhD, Remigius U. Agu, BPharm, MPharm (Pharmacology), MPharm (Pharmaceutics), PhD, nifedipine, topical preparations, calcium channel blocker, wound healing, anal fissures, diabetic ulcers, smooth muscle relaxation, blood perfusion, Glaxal base, K-Y jelly, Aquaphor ointment, storage, chemical stability, drug potency

Related Categories: DERMATOLOGY, EXCIPIENTS, PEER-REVIEWED, WOUND CARE, DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Jul/Aug 2021
Pg. 344-351

Drug-release Assessment of Compounded Topical Nifedipine and Diltiazem in Commonly Used Bases for Wound Healing
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Nov/Dec 2020
Pg. 501-508

Stability of Compounded Diltiazem Hydrochloride in Cream, Ointment, and Gel Formulations for Topical Use
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Nov/Dec 2020
Pg. 482-490

Current Topical Treatments in Wound Healing - Part 1
Helmke Christopher D
Jul/Aug 2004
Pg. 269-274

Compounded Topical Gabapentin for Neuropathic Pain: Does Choice of Base Affect Efficacy?
Shakshuki Ayah
, Agu Remigius U
Nov/Dec 2019
Pg. 496-503

Pathophysiology and Management of Onychomycosis and Novel Approaches for Effective Transdermal Applications
Dharmian Jose Prakash
, Sathiyaseelan Iraniammal, Renganathan Akshaya, Mubees Alamaan Mohamed, Naser Mohammed Yasin Abdul, Ramkrishnan Prakash, Arumugam Somasundaram
Nov/Dec 2023
Pg. 494-502

Stability Assessment of Topical Amitriptyline Extemporaneously Compounded with Lipoderm Base, PLO Gel Mediflo 30, and Emollient Cream
Shakshuki Ayah
, Agu Remigius U
Jan/Feb 2019
Pg. 82-87

Stability of Venlafaxine Immediate-Release Suspensions
Donnelly Ronald F
, Wong Keith, Goddard Rob, Johanson Christel
Jan/Feb 2011
Pg. 81-84

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Evaluation and Comparison of Wound Healing Properties of an Ointment (AlpaWash) Containing Brazilian Micronized Propolis and Peucedanum ostruthium Leaf Extract in Skin Ulcer in Rats
Nani Marcel
, Leone Andréia, Bom Vinícius Pedro, Buszinski Andrei Felipe, Oliveira de Souza Rebeca, Pinheiro Vanessa Alves, Danapoulos Panagiota, Swikidisa Rosita, Marquele-Oliveira Franciane, Cipriani Frade Marco Andrey, Berretta Andresa Aparecida, Nogueira Rodrigo José Lupatini
Mar/Apr 2018
Pg. 154-163

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 for Cold Sores or Fever Blisters
Allen Loyd V Jr
May/Jun 2004
Pg. 206-209

Compounding Pearls -- Wound Care: Base Selection
Riepl Mike
Mar/Apr 2020
Pg. 98-102

Formulation and Pharmaceutical Evaluation of Extemporaneous α-arbutin Creams for the Treatment of Melasma
Teeranachaideekul Veerawat
, Boonsongsawat Worrawee, Asanawittaya Waralee, Jintapattanakit Anchalee, Chantasart Doungdaw, Wongrakpanich Amaraporn
Jan/Feb 2021
Pg. 62-72

Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations
Visser J Carolina
, ten Seldam Inge E J, van der Linden Isabella J, Hinrichs Wouter L J, Veenendaal Reinier F H, Dijkers Eli C F, Woerdenbag Herman J
May/Jun 2018
Pg. 247-251

Chemical Stability of Extemporaneously Compounded Omeprazole Formulations: A Comparison of Two Methods of Compounding
Garg Sanjay
, Svirskis Darren, Al-Kabban Majid, Farhan Samer, Komeshi Mohammed, Lee Jacky, Liu Quincy, Naidoo Sacha, Kairuz Therese
May/Jun 2009
Pg. 250-253

The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013
Lutz Eugene
, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc
Jan/Feb 2014
Pg. 6-12

The Influence of Tablet Formulation, Drug Concentration, and pH Modification on the Stability of Extemporaneously Compounded Levothyroxine Suspensions
Svirskis Darren
, Lin Shao-Wei, Brown Helen, Sangaroomthong Annie, Shin Daniel, Wang Ziqi, Xu Hongtao, Dean Rebecca, Vareed Preetika, Jensen Maree, Wu Zimei
Mar/Apr 2018
Pg. 164-171

In Vitro Permeability, Irritability, and Release Evaluation of Commonly Used Topical Diclofenac Gel Preparations (1%, 5%, and 10%)
Kohan Hamed Gilzad
, Baker David M, Sani Shabnam, Bielecki-Wilken Kathleen A, Ramirez Alfonso
Mar/Apr 2021
Pg. 146-155

Topical Oil-in-Water Cream Bases, Featured Excipient:
Allen Loyd V Jr
Jul/Aug 2002
Pg. 303-304

Return to Top