Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets.

Autor:	Sayre CL; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah.; Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Salt Lake City, Utah., Cox C; Smith-Rexall Drug, Pleasant Grove, Utah., Velazquez G; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah., Le MT; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah., Nguyen AH; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah., Ramos M; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah., Burrows A; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah., Yellepeddi VK; Division of Clinical Pharmacology, Department of Pediatrics, School of Medicine, University of Utah, Salt Lake City, Utah. venkata.yellepeddi@hsc.utah.edu.; Pharmacy Compounding Research and Education Laboratory, College of Pharmacy, Roseman University of Health Sciences, South Jordan, Utah.
Jazyk:	angličtina
Zdroj:	International journal of pharmaceutical compounding [Int J Pharm Compd] 2019 Jan-Feb; Vol. 23 (1), pp. 62-64.
Abstrakt:	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. (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)
Databáze:	MEDLINE
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