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 Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt

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

Issue:  Mar/Apr 2019 - Volume 23, Number 2
View All Articles in Issue

Page(s):  157-162

Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 1
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 2
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 3
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 4
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 5
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt Page 6

Download in electronic PDF format for $75

Abstract:  Naltrexone hydrochloride is an orally active narcotic antagonist used to facilitate rapid transition from methadone maintenance. The dosing schedule of naltrexone hydrochloride in detoxification protocols needs to be flexible to permit precise, customized dose titration for individual patients. This flexibility is readily achieved using an oral liquid dosage form. However, no commercial liquid dosage form of naltrexone hydrochloride currently exists. Naltrexone hydrochloride is commercially available as a scored, filmcoated, 50-mg tablet. 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 naltrexone hydrochloride solutions in 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 naltrexone hydrochloride concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability-indicating HPLC assay for the determination of the chemical stability of naltrexone hydrochloride in SuspendIt was developed and validated. Solutions of naltrexone hydrochloride were prepared in SuspendIt at 0.5-mg/mL and 5.0-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, 44 days, 61 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 preparation is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period. The study showed that naltrexone hydrochloride concentrations did not go below 94% of the label claim (initial drug concentration) at both temperatures studied. Viscosity and pH values also did not change significantly. This study demonstrates that naltrexone hydrochloride is physically and chemically stable in SuspendIt for 180 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for naltrexone hydrochloride in a liquid dosage form, with an extended beyond-use date to meet patient needs.

Related Keywords: Yashoda V. Pramar, PhD, Tarun K. Mandal, PhD, Levon A. Bostanian, PhD, Anh T.Q. Nguyen, PharmD Student, Tommy C. Morris, PhD, Richard A. Graves, MS, naltrexone hydrochloride, narcotic antagonist, opioid detoxification, oral liquid dosage forms, physical stability, chemical stability

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, NEUROLOGY

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/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
Pg. 157-162

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 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 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

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

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 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

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

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

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

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

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

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

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

Naltrexone Hydrochloride 0.5 mg/mL and 5.0 mg/mL in SuspendIt Suspension
Allen Loyd V Jr
May/Jun 2021
Pg. 233

Chemical Stability of Naltrexone Hydrochloride Injection
Gupta Vishnu D
May/Jun 2008
Pg. 274-275

Compounded Low-dose Naltrexone for the Treatment of Guttate Psoriasis: A Case Report
Muller George
, Grieshaber Robert, Talley J Floyd, Riepl Mike, Fellows Don
Jul/Aug 2018
Pg. 270-278

Basics of Compounding: Excipients Used in Nonsterile Compounding, Part 10: Rectal Suppository Bases
Allen Loyd V Jr
Jul/Aug 2021
Pg. 304-309

Naltrexone Hydrochloride 50-mg Capsules
Allen Loyd V Jr
May/Jun 2013
Pg. 235

Return to Top