Bot Detector
Download FREE Sample Issue or Article
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.

Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets

Author(s):  Sayre Casey L, Cox Christopher, Velazquez Gabriel, Le Minh Thi, Nguyen Amy Hong, Ramos Marjorie, Burrows Anna, Yellepeddi Venkata Kashyap

Issue:  Jan/Feb 2019 - Volume 23, Number 1
View All Articles in Issue

Abstract:  Progesterone is a naturally occurring female sex hormone, which plays an important role in the female reproductive cycle. Progesterone supplementation is used to treat a variety of conditions. When commercial dosage strengths are unavailable, rapid-dissolving tablets may be compounded. The objective of this study was to evaluate the chemical stability of progesterone when compounded in a rapid-dissolving tablet formulation and to establish an evidence-based beyond-use date. Triplicate test samples were prepared by diluting the pulverized progesterone rapid-dissolving tablets with a portion of methanol to a final concentration of 100 µg/mL. Samples were stored in a stability chamber under accelerated conditions at 60°C and 75% relative humidity and were evaluated at appropriate intervals (0, 6 months, and 12 months). Chemical stability was assessed initially and at appropriate intervals during the study periods with stability-indicating high-performance liquid chromatography analytical techniques based on the determination of drug concentrations. The results of high-performance liquid chromatography analysis indicated that the samples remained stable for 6 months at 60°C and 75% relative humidity. The remaining concentration of progesterone rapid-dissolving tablets at 6 months fell within the United States Pharmacopeia accepted limits (±10% of the initial concentration), which was consistent with the recommended beyond-use dating of 6 months for a non-aqueous formulation per United States Pharmacopeia guidelines.

Related Keywords: Casey L. Sayre, PharmD, PhD, Christopher Cox, PharmD, Gabriel Velazquez, MS, Minh Thi Le, PharmD, Amy Hong Nguyen, PharmD, Marjorie Ramos, PharmD, Anna Burrows, BS, Venkata Kashyap Yellepeddi, BPharm, PhD, chemical stability, progesterone, female sex hormone, rapid-dissolving tablets, endometrial hyperplasia, female infertility, assisted reproductive technology, secondary amenorrhea, abnormal uterine bleeding, prevention of miscarriage and preterm delivery, corpus luteum insufficiency, menopause


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets Sayre Casey L, Cox Christopher, Velazquez Gabriel, Le Minh Thi, Nguyen Amy Hong, Ramos Marjorie, Burrows Anna, Yellepeddi Venkata Kashyap Jan/Feb 2019 62-64 Buy
Development and Validation of a Stability-indicating High-performance Liquid Chromatographic Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches Burrows Anna C, Yellepeddi Venkata Kashyap, Snyder Spencer, Wakefield Meagan, Jackson David, Huynh Johnny, Nguyen Khoa, Sayre Casey L Jul/Aug 2019 340-350 Buy
Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon Jul/Aug 2020 322-326 Buy
Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates) Brandin Thibaut, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice Mar/Apr 2022 150-154 Buy
Finding the Right Balance: A Nationwide Study of Student Pharmacist Exposure to and Perceptions of Nonsterile Compounding Fredrickson Mary E, Belcher Faith G, Del Vecchio Kamryn N, Galleher Miranda N, Jugo Leila S, Gothard M David, Pallotta Raneem H, Pallotta Victor A Jr May/Jun 2022 242-247 Buy
Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD Allen Loyd V Jr Nov/Dec 1997 381-385 Buy
Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions Kabiche Djamila, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel Mar/Apr 2017 160-163 Buy
Chemical Stability of Morphine, Ropivacaine, and Ziconotide in Combination for Intrathecal Analgesia Robert Julien, Sorrieul Jérémy, Rossignol Elsa, Beaussart Hélène, Kieffer Hélène, Folliard Caroline, Dupoiron Denis, Devys Catherine Jul/Aug 2017 347-351 Buy
Efficacy and Tolerability of Compounded Bioidentical Hormone Replacement Therapy Vigesaa Kristy A, Downhour Nathan P, Chui Michelle A, Cappellini Linda, Musil John D, McCallian Dennis J Jul/Aug 2004 313-319 Buy
Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal) Garrigue Philippe, Montana Marc, Ventre Christophe, Savry Amadine, Gauthier-Villano Laurence, Pisano Pascale, Pourroy Bertrand Mar/Apr 2016 148-154 Buy