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.

Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt

Author(s):  Graves Richard A, Mandal Tarun K, Bostanian Levon A, Nguyen Anh TQ, Swopes Demikka, Morris Tommy C, Pramar Yashoda V

Issue:  Nov/Dec 2019 - Volume 23, Number 6
View All Articles in Issue

Page(s):  519-527

Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 1
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 2
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 3
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 4
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 5
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 6
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 7
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 8
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt Page 9

Download in electronic PDF format for $75

Abstract:  Amlodipine besylate is an antihypertensive agent recommended for the management of hypertension in children and adolescents. The commercially available 2.5-mg, 5-mg, and 10-mg amlodipine besylate tablets do not provide the necessary flexibility in dosing needed for treating children. This flexibility is readily achieved using an oral, liquid dosage form. However, no commercial liquid dosage form of amlodipine currently exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets would provide a convenient option to meet unique patient needs. The purpose of this study was to determine the physicochemical stability of extemporaneously compounded amlodipine besylate suspensions in the PCCA Base, SuspendIt. This base is a sugar-free, paraben-free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. The study design included two amlodipine besylate concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stabilityindicating high-performance liquid chromatographic assay for the determination of the chemical stability of amlodipine besylate in SuspendIt was developed and validated. Suspensions of amlodipine were prepared in SuspendIt at 0.5-mg/mL and 10.0-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in plastic amber prescription bottles at two temperature conditions (5°C and 25°C). Samples were assayed initially, and at the following time points: 7 days, 14 days, 29 days, 46 days, 60 days, 90 days, 120 days, and 180 days. Physical data such as pH, viscosity, and appearance were also noted. All measurements were obtained in triplicate. A stable extemporaneous product is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period. This study demonstrates that amlodipine besylate is physically and chemically stable in SuspendIt for 90 days in the refrigerator and 7 days at room temperature, retaining 90% of the label claim (initial drug concentration) at both concentrations. The pH values did not change significantly. The viscosity of the refrigerated samples at both concentrations decreased slightly, while that of the room temperature samples showed a marked increase in viscosity. This study provides a viable, compounded alternative for amlodipine in a liquid dosage form, with an adequate beyond-use-date to meet patient needs. The study further provides stability documentation over a bracketed amlodipine concentration range of 0.5 mg/mL to 10.0 mg/mL, allowing compounding pharmacists more flexibility in customizing their formulations.

Related Keywords: Richard A. Graves, MS, Tarun K. Mandal, PhD, Levon A. Bostanian, PhD, Anh T.Q. Nguyen, Demikka Swopes, BS, Tommy C. Morris, PhD, Yashoda V. Pramar, PhD, amlodipine besylate, antihypertensive, hypertension, high blood pressure, physical stability, chemical stability, long-acting calcium channel blocker

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, CARDIOLOGY

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt
Graves Richard A
, Mandal Tarun K, Bostanian Levon A, Nguyen Anh TQ, Swopes Demikka, Morris Tommy C, Pramar Yashoda V
Nov/Dec 2019
Pg. 519-527

Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Nguyen Anh TQ, Morris Tommy C, Graves Richard A
Mar/Apr 2019
Pg. 157-162

Physicochemical Stability of Compounded Allopurinol Suspensions in PCCA Base, SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Le Giang, Morris Tommy C, Graves Richard A
Sep/Oct 2020
Pg. 413-419

Physicochemical and Microbiological Stability of Extemporaneously Compounded Hydrocortisone Oral Suspensions in PCCA Base, SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Kader Cyndy, Morris Tommy C, Graves Richard A
Sep/Oct 2021
Pg. 431-439

Stability of Compounded Ursodiol Suspensions in PCCA Base, SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Nguyen Anh TQ, Miller Valicia, Morris Tommy C, Graves Richard A
Jan/Feb 2019
Pg. 70-76

Physicochemical and Microbiological Stability of Compounded Metronidazole Suspensions in PCCA SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Le Giang, Morris Tommy C, Graves Richard A
Mar/Apr 2021
Pg. 169-175

Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt
Pramar Yashoda V
, Mandal Tarun K, Bostanian Levon A, Kader Cyndy, Morris Tommy C, Graves Richard A
Jul/Aug 2022
Pg. 342-351

Physicochemical and Microbiological Stability of Pyrimethamine in Paraben-free PCCA Base, SuspendIt
Pramar Yashoda V
, Mandal Tarum K, Bostanian Levon A, Kader Cyndy, Morris Tommy C, Graves Richard A
Mar/Apr 2023
Pg. 160-168

Physiochemical and Microbiological Stability of Azathioprine Suspensions in PCCA Base, SuspendIt
Pramar Yahoda V
, Mandal Tarun K, Bostanian Levon A, Kader Cyndy, Morris Tommy C, Graves Richard A
Jul/Aug 2023
Pg. 330-339

Stability of Spironolactone Oral Suspension in PCCA Base, SuspendIt
Graves Richard
, Phan Kelly V, Bostanian Levon A, Mandal Tarun K, Pramar Yashoda V
Jul/Aug 2017
Pg. 334-338

Stability of Clindamycin Hydrochloride in PCCA Base SuspendIt
Pramar Yashoda V
, Graves Richard A, Ledet Grace A, Phan Kelly V, Bostanian Levon A, Mandal Tarun K
Sep/Oct 2016
Pg. 421-425

Physicochemical Stability of an Oral Suspension of Trimethoprim 20 mg/mL in Combination with Sulfadiazine 200 mg/mL in PCCA Base SuspendIt
Graves Richard A
, Phan Kelly V, Bostanian Levon A, Mandal Tarun K, Pramar Yashoda V
Sep/Oct 2017
Pg. 430-435

Amlodipine Besylate 0.5-mg/mL to 10-mg/mL in SuspendIt Oral Suspension
Allen Loyd V Jr
Jan/Feb 2021
Pg. 43

Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh
Allen Loyd V Jr
Nov/Dec 2003
Pg. 449-450

Amlodipine Besylate 1 mg/mL Veterinary Suspension
Allen Loyd V Jr
Sep/Oct 2009
Pg. 429

Transdermal Amlodipine Besylate in Lipoderm for the Treatment of Feline Hypertension: A Report of Two Cases
Mixon William
, Helms Scott R
Sep/Oct 2008
Pg. 392-397

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

Investigation of the Effects of Excipients in the Compounding of Amlodipine Besylate Orally Disintegrating Tablets
Azmi Nurual Hanisah Saiful
, Ming Long Chiau, Uddin A.B.M. Helal, Sarker Zaidul Islam, Bin Liew Kai
Jan/Feb 2022
Pg. 80-87

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

Physicochemical and Microbiological Stability of Vancomycin 10-mg/mL Intravitreal Syringes
Bartoll Aaron Puplà
, Bellés Medall Maria Dolores, Peñarrocha Josep Edo, Escrig Laura Solaz, Clemente Ruben Eguren, Azuara Julia Bodega, Piqueres Raul Ferrando
Jul/Aug 2022
Pg. 330-335

Return to Top