Testosterone Therapy for Late-Onset Hypogonadism: A Clinical, Biological, and Analytical Approach Using Compounded Testosterone 0.5-20% Topical Gels.

Testosterone is integral to men's sexual and overall health, but there is a gradual decline in the ageing male. The topical administration of testosterone is a valuable option as a supplement (replacement) therapy to alleviate hypogonadal symptoms. The clinical efficacy of a compounded testosterone 5% topical gel was assessed retrospectively in a male patient in his seventies by evaluating the laboratory testing of the serum total testosterone and the results of a validated androgen deficiency questionnaire. After treatment, the patient's hypogonadal symptoms improved and the serum total testosterone level achieved was considered clinically optimal. The skin permeation of the testosterone topical gel (biological testing) was evaluated in vitro using the Franz finite dose model and human cadaver skin, and it is shown that testosterone can penetrate into and through ex vivo human skin. Testosterone therapy is often prescribed for extended periods, and consequently, it is crucial to determine the beyond-use date of the compounded formulations. The analytical testing involved a valid, stability-indicating assay method for compounded testosterone 0.5% and 20% topical gels. This multidisciplinary study shows evidence supporting topically applied testosterone's clinical efficacy and the compounded formulations' extended stability. Personalized, topical testosterone therapy is a promising alternative in current therapeutics for hypogonadal patients.

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids.

The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.

Evaluation of the Efficacy and Stability of Compounded Pentoxifylline-containing XemaTop for Psoriasis.

Psoriasis is an inflammation-mediated skin disorder for which an efficacious topical treatment is yet to be identified. A new compounded topical formulation containing 10% pentoxifylline in XemaTop base was recently developed for psoriasis. Prior to its use in humans, an in vitro evaluation was performed to determine its efficacy in attenuating molecular markers associated with psoriasis using a three-dimensional psoriasis tissue model. After 5 days of topical exposure to the formulation, the levels of inflammatory cytokines IL-1ß, IL-6, and GM-CSF decreased by 20%, 94%, and 96%, respectively. The production of pro-collagen type I and fibronectin essential for cellular proliferation was also significantly inhibited with a concomitant thinning of the epidermis. These results suggest that 10% pentoxifylline in XemaTop is efficacious in inhibiting the biomarkers associated with psoriasis. Pentoxifylline in XemaTop was stable within 91 days when stored under refrigerated or ambient conditions. These biochemical and stability studies suggest that 10% pentoxifylline in XemaTop may be evaluated now in psoriasis patients.

Physical and Chemical Stability of Estriol 0.025% to 1% Vaginal Creams (VersaBase).

Estrogen replacement therapy is often recommended when female patients present with lower than normal physiologic levels, such as patients going through menopause. The physical and chemical stability of estriol 0.25 mg/g and 10 mg/g vaginal creams (VersaBase) was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both vaginal creams were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the estriol 0.025% to 1% vaginal creams (VersaBase), in electronic mortar and pestle plastic jars, is six months at both room temperature and refrigerated conditions.

Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox).

Budesonide is a corticosteroid that has been shown effective in the treatment of eosinophilic esophagitis, but there are currently no commercial medicines to treat this chronic allergic/immune condition, despite its prevalence in the U.S. Therefore, pharmaceutical compounding is the alternative choice to meet the therapeutic need of eosinophilic esophagitis patients. Two budesonide mucoadhesive oral suspensions (1 mg/10 mL and 2 mg/10 mL) were developed using the compounding vehicle MucoLox, a proprietary mucoadhesive polymer blend that promotes mucosal adhesion. The physical and chemical stability of the oral suspensions was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH and density, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both oral suspensions were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the budesonide 1-mg/10-mL and 2-mg/10-mL mucoadhesive oral suspensions (MucoLox), in amber plastic bottles, is six months at both room temperature and refrigerated conditions.