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.

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

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




Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author 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 519-527 Buy
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 157-162 Buy
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 70-76 Buy
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 334-338 Buy
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 430-435 Buy
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 421-425 Buy
Transdermal Amlodipine Besylate in Lipoderm for the Treatment of Feline Hypertension: A Report of Two Cases Mixon William, Helms Scott R Sep/Oct 2008 392-397 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
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 66-69 Buy
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 70-73 Buy