madman
Super Moderator
Bracketed Testosterone 0.02-25% in VersaPro™ Gel Base
Testosterone is an essential hormone that is produced endogenously and is critical for sexual, cognitive, and body function, including maintenance of bone density, fat distribution, muscle strength and mass, facial and body hair, red blood cell production, sex drive, and sperm production (in men). Although Testosterone levels tend to gradually decline with age, congenital or acquired conditions, such as Klinefelter syndrome, hemochromatosis, pituitary disorders, inflammatory disease, obesity, cancer treatment and injury to the testes can lead to diminished production of Testosterone, referred to as hypogonadism.1,2 Studies have shown topical administration of Testosterone to be an effective means for helping to restore Testosterone levels through Testosterone Restoration Therapy (TRT).3 Short-term treatment with androgens in postmenopausal women has also been reported to improve libido and mood and reduce hot flashes.4 Compounded Testosterone for topical application offers ease of administration and flexible dosing in order to provide patients with much-needed customized treatment. Determining the stability of a compounded medication is best practice and is a highly sought-after analytical data.
In this study, we evaluated the physical, chemical, and microbiological stability over time of two different concentrations of Testosterone (0.02% and 25% w/w) compounded in VersaPro™ Gel Base (MEDISCA). The formulations underwent forced degradation studies to develop validated, stability indicating methods. The stability of the formulations was evaluated using tightly-closed, light-resistant containers stored at controlled room temperature (25°C). Physicochemical characteristics were analyzed at predetermined time points (0, 30, 60, 90, 120, 150, and 180 days) and each formula tested had the organoleptic properties inspected, the pH and viscosity measured, and the Testosterone concentration assayed using a validated stability-indicating HPLC-UV method. The antimicrobial effectiveness of the preservative system was also tested using a validated method based on USP <51>. Our results showed that the concentration of the bracketed Testosterone formulations remained within the United States Pharmacopeia specification (90 to 110%) for at least 180 days at the tested condition. No changes in organoleptic properties were observed and there was no significant change in pH or viscosity (Table 1). The antimicrobial effectiveness of the preservative system also met the USP requirements for both concentrations (Table 2).
In conclusion, Testosterone in VersaPro™ Gel Base with a bracketed range of 0.02 – 25% was found to be physically, chemically, and microbiologically stable for up to 180 days when stored at room temperature in tightly-closed light-resistant containers. Therefore, an extended beyond-use date of 180 days can be assigned to this bracketed range of Testosterone concentrations if the same vehicle and conditions are respected.
Testosterone is an essential hormone that is produced endogenously and is critical for sexual, cognitive, and body function, including maintenance of bone density, fat distribution, muscle strength and mass, facial and body hair, red blood cell production, sex drive, and sperm production (in men). Although Testosterone levels tend to gradually decline with age, congenital or acquired conditions, such as Klinefelter syndrome, hemochromatosis, pituitary disorders, inflammatory disease, obesity, cancer treatment and injury to the testes can lead to diminished production of Testosterone, referred to as hypogonadism.1,2 Studies have shown topical administration of Testosterone to be an effective means for helping to restore Testosterone levels through Testosterone Restoration Therapy (TRT).3 Short-term treatment with androgens in postmenopausal women has also been reported to improve libido and mood and reduce hot flashes.4 Compounded Testosterone for topical application offers ease of administration and flexible dosing in order to provide patients with much-needed customized treatment. Determining the stability of a compounded medication is best practice and is a highly sought-after analytical data.
In this study, we evaluated the physical, chemical, and microbiological stability over time of two different concentrations of Testosterone (0.02% and 25% w/w) compounded in VersaPro™ Gel Base (MEDISCA). The formulations underwent forced degradation studies to develop validated, stability indicating methods. The stability of the formulations was evaluated using tightly-closed, light-resistant containers stored at controlled room temperature (25°C). Physicochemical characteristics were analyzed at predetermined time points (0, 30, 60, 90, 120, 150, and 180 days) and each formula tested had the organoleptic properties inspected, the pH and viscosity measured, and the Testosterone concentration assayed using a validated stability-indicating HPLC-UV method. The antimicrobial effectiveness of the preservative system was also tested using a validated method based on USP <51>. Our results showed that the concentration of the bracketed Testosterone formulations remained within the United States Pharmacopeia specification (90 to 110%) for at least 180 days at the tested condition. No changes in organoleptic properties were observed and there was no significant change in pH or viscosity (Table 1). The antimicrobial effectiveness of the preservative system also met the USP requirements for both concentrations (Table 2).
In conclusion, Testosterone in VersaPro™ Gel Base with a bracketed range of 0.02 – 25% was found to be physically, chemically, and microbiologically stable for up to 180 days when stored at room temperature in tightly-closed light-resistant containers. Therefore, an extended beyond-use date of 180 days can be assigned to this bracketed range of Testosterone concentrations if the same vehicle and conditions are respected.
