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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
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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

Related Categories: HRT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE

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