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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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Page(s):  62-64

Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets Page 1
Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets Page 2
Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets Page 3

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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: 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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