Download in electronic PDF format for $25

Kalchem International - Chemicals and Compounding Supplies

Search the Complete Journal Archives

Stability of Spironolactone Oral Suspension in PCCA Base, SuspendIt

Author(s):  Graves Richard, Phan Kelly V, Bostanian Levon A, Mandal Tarun K, Pramar Yashoda V

Issue:  Jul/Aug 2017 - Volume 21, Number 4
View All Articles in Issue

Abstract:  Spironolactone (Aldactone) is a potassium-sparing diuretic used to treat hypertension and heart failure and may also be used to treat edema resulting from kidney disease, low potassium levels, or excess aldosterone. No commercial liquid dosage form of spironolactone exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets would provide an alternative option to meet unique patient needs. The purpose of this study was to determine the physicochemical stability of spironolactone 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. It thickens upon standing to minimize settling of any insoluble drug particles and becomes fluid upon shaking to allow convenient pouring during administration to the patient. A robust stability-indicating highperformance liquid chromatographic assay for the determination of spironolactone in PCCA base SuspendIt was developed and validated. This assay was used to determine the chemical stability of the drug in SuspendIt. Samples were prepared and stored under three different temperature conditions (5°C, 25°C, 40°C) and assayed using the high-performance liquid chromatographic assay at pre-determined intervals over an extended period of time as follows: 0, 7, 14, 29, 46, 60, 90, 120, and 180 days at each designated temperature. Physical data such as pH, viscosity, and appearance were also monitored. The study showed that drug concentration did not go below 90% of the label claim (initial drug concentration) at all three temperatures studied. Viscosity and pH values also did not change significantly. This study demonstrates that spironolactone is physically and chemically stable in SuspendIt for 180 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for spironolactone in a liquid dosage form, with an extended beyond-use date to meet patient needs.

Related Keywords: Richard A. Graves, MS, Kelly V. Phan, Levon A. Bostanian, PhD, Tarun K. Mandal, PhD, Yashoda V. Pramar, PhD, spironolactone, potassium-sparing diuretic, hypertension, high blood pressure, edema, congestive heart failure, stability-indicating assay, physical stability, chemical stability, storage

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ALLERGY/IMMUNOLOGY/INFLAMMATION, CARDIOLOGY, UROLOGY/URINARY TRACT

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/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
Spironolactone 5 mg/mL in SuspendIt Oral Suspension Allen Loyd V Jr Nov/Dec 2017 496 Buy
Spironolactone 5-mg/mL in Suspendit Oral Suspension Allen Loyd V Jr Mar/Apr 2018 152 Buy
Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under In-use Conditions with Different Administration Materials Mueller Claudia, Dietel Elde, Heynen Severin R, Nalenz Heiko, Goldbach Pierre, Mahler Hanns-Christian, Schmidt Johannes, Grauschopf Ulla, Schoenhammer Karin May/Jun 2015 261-267 Buy
Congestive Heart Failure and Other Medical Facts About Ferrets; Scout's Story: A Case Report on Treating Congestive Heart Failure in a Ferret Williams LaVonn A, Riley Kari Sep/Oct 2009 367-371 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs Gorman Gregory, Sokom Simara, Coward Lori, Arnold John J Mar/Apr 2017 164-170 Buy
Metolazone 10-mg/mL Injection Allen Loyd V Jr Mar/Apr 2010 157 Buy