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 and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt

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

Issue:  Jul/Aug 2022 - Volume 26, Number 4
View All Articles in Issue

Page(s):  342-351

Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 1
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 2
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 3
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 4
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 5
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 6
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 7
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 8
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 9
Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt Page 10

Download in electronic PDF format for $75

Abstract:  Amitriptyline hydrochloride is indicated for the relief of symptoms of depression. A review of the therapeutic uses of amitriptyline hydrochloride reveals the need for flexibility in dosing. This flexibility is readily achieved using an oral liquid dosage form. However, no commercial liquid dosage form of amitriptyline currently exists. Amitriptyline hydrochloride is commercially available only as 10-mg, 25-mg, 50-mg, 75-mg, 100-mg, and 150-mg tablets. An extemporaneously compounded suspension from pure drug powder would provide a flexible, customizable option to meet unique patient needs with convenient and accurate dosing options. The purpose of this study was to determine the physicochemical and microbiological stability of extemporaneously compounded amitriptyline hydrochloride suspensions 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 amitriptyline hydrochloride concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability- indicating high-performance liquid chromatographic assay for the determination of the chemical stability of amitriptyline hydrochloride in PCCA SuspendIt was developed and validated. Suspensions of amitriptyline hydro- chloride were prepared in PCCA SuspendIt at 1-mg/mL and 5-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in amber plastic prescription bottles at two temperature conditions (5°C and 25°C). Samples were assayed initially, and on the following time points (days): 7, 14, 28, 49, 63, 91, 119, and 185. Physical data such as pH, viscosity, and appearance were also noted. Microbiological stability was tested. 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 and is protected against microbial growth. The study showed that amitriptyline hydrochloride concentrations did not go below 99.8% of the label claim (initial drug concentration) at both temperatures studied. No microbial growth was observed. The pH values remained constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that amitriptyline hydrochloride is physically, chemically, and microbiologically stable in PCCA SuspendIt for 185 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for amitriptyline 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, Cyndy Kader, PharmD Student, Tommy C. Morris, PhD, Richard A. Graves, MS, amitriptyline hydrochloride, physical stability, chemical stability, microbial contamination, depression, viscosity, thixotropic indices

Related Categories: EXCIPIENTS, MENTAL HEALTH, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, INFECTIOUS DISEASE

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
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 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

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

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 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 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 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

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

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

Chemical Stability of Amitriptyline Hydrochloride in Oral Liquid Dosage Forms
Gupta Vishnu D
Sep/Oct 2009
Pg. 445-446

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

Stability of Oral Liquid Dosage Forms of Ethacrynic Acid
Gupta Vishnu D
, Ling Jie
May/Jun 2001
Pg. 232-233

Physicochemical and Microbiological Stabilities of Hydrocortisone in InOrpha Suspending Agent Studied Under Various Condition
Bourget Philippe
, Amin Alexandre, Vidal Fabrice, Pieyre Manon, Dosso El Ourmar, Beauvais Raphaelle, Loeuillet Richard
Sep/Oct 2014
Pg. 427-431

Stability of Oral Liquid Dosage Forms of Glycopyrrolate Prepared with the Use of Powder
Gupta Vishnu D
Sep/Oct 2003
Pg. 386-388

Chemical Stability of Perphenazine in Two Commercially Available Vehicles for Oral Liquid Dosage Forms
Gupta Vishnu D
Jul/Aug 2008
Pg. 372-374

Chemical Stability of Cyproheptadine Hydrochloride in an Oral Liquid Dosage Form
Gupta Vishnu D
Jul/Aug 2007
Pg. 347-348

Long-term Stability of Zonisamide, Amitriptyline, and Glycopyrrolate in Extemporaneously Prepared Liquid-dosage Forms at Two Temperatures
Nahata Milap C
Mar/Apr 2016
Pg. 164-166

Return to Top