Compatibility of Caffeine Clobetasol Propionate Dutasteride Nicotinamide and Progesterone in TrichoFoam™, a Natural Vehicle for Hair Foams.

BACKGROUND: Alopecia is a chronic dermatological disorder affecting men and women worldwide. Given the high incidence and significant impact on patients' well-being, options for managing and treating alopecia are essential. Topical available options remain limited and oral products may result in adverse effects. TrichoFoam™ is a ready-to-use foaming vehicle developed for compounding pharmacies and formulated with gentle, non-irritating, and sensory-pleasant ingredients. OBJECTIVE: The purpose of this study was to assess topical foams' physicochemical and microbiological stabilities of formulations compounded with TrichoFoam™ as the ready-touse vehicle. METHODS: HPLC analyses were conducted in a bracketed study covering concentrations of 0.1% to 2.0% of caffeine, 0.01% to 0.1% of clobetasol propionate, 0.1% to 0.25% of dutasteride, 0.25% to 0.50% of nicotinamide, and 0.25% to 2.5% of progesterone compounded with TrichoFoam™. Antimicrobial Effectiveness Testing was conducted at the beginning and end of the studies. RESULTS: Most formulations presented a beyond-use date of at least 90-180 days, except for clobetasol propionate, which showed compatibility for 14 days, and dutasteride 0.25%, which showed a BUD of 30 days. CONCLUSION: This validates the stability of the active pharmaceutical ingredients from different pharmacological classes with TrichoFoam™, suggesting that this ready-to-use vehicle can be an excellent alternative for personalized alopecia treatment.

Clinical Safety Profile of TrichoConcept™, a Line of Cosmetic Vehicles for Personalized Treatment of Alopecia.

Alopecia is a chronic dermatological disorder that affects patients worldwide, with a significant impact on quality of life, self-esteem, and psychological wellbeing. However, commercially available options for alopecia treatment are still limited. Considering that topical formulations have a long-term use therapeutic profile, the safety of their ingredients should be closely evaluated to avoid potentially irritant substances. Alternative active ingredients with different mechanisms of action, as well as adequate vehicles, might increase patients' adherence leading to better clinical outcomes. The purpose of this study was to examine the irritation, skin sensitization, photoallergy, and phototoxicity potential of a line of ready-to-use vehicles for producing topical therapies for alopecia treatments, TrichoConcept™. Subjects were selected and randomly assigned to compare the patch test with the study products or to the control solution (sterile 0.9% NaCl solution). No clinical signs of irritation, sensitization, photoallergy or phototoxicity were reported. From the results of this study, it is suggested that the investigated products can be considered safe under the evaluated conditions, and the claims "dermatologically tested", "clinically tested", and "nonirritant" can be supported.

Effectiveness of a New Ultraviolet C Disinfection System to Inactivate Airborne Coronavirus in Different Environmental Conditions.

Airborne infectious diseases have been a major worldwide concern for many years. The sudden and fast spread of the severe acute respiratory syndrome 2, causing the coronavirus disease 2019 in a pandemic form, has intensified the necessity of constant environmental disinfection. Among the possible technologies that can be used for air disinfection is the ultraviolet germicidal irradiation through the use of ultraviolet C light. The main mechanism involved in ultraviolet C light inactivation of microorganisms such as viruses, bacteria, protozoa, fungi, yeasts, and others is mainly due to its capacity to promote dimerization of pyrimidine, disturbing the microorganism's DNA (and RNA) replication and transcription, therefore leading to cell death. The aim of this study was to validate the efficacy of a new ultraviolet C light disinfection system to deactivate viruses such as coronavirus in different environmental conditions. The device was effective in the neutralization of airborne particles containing coronavirus genus samples, presenting >99.99% of inactivation rate in an aerosolization test, simulating the real conditions in which this virus is most transmitted in different environments.

Ensuring Homogeneity in Powder Mixtures for Pharmaceuticals and Dietary Supplements: Evaluation of a 3-Axis Mixing Equipment.

The mixing process plays a pivotal role in the quality of pharmaceuticals and food/dietary supplements, as it can impact the homogeneity of the substances in their dosage form and affect characteristics such as dissolution and stability. Thus, the choice of the right mixing device is paramount for compounding pharmacies. In this paper, we evaluated the mixing efficacy of a new 3-axis mixer device and determined its optimal working conditions. Three different formulations were compounded with the device and a total of 540 individual assays were performed by HPLC or ICP-MS to validate its use, in addition to a direct comparison among it and two alternative mixing methods. The 3-axis mixer device was able to provide homogeneous mixtures and finished capsules with adequate content uniformity with a broad range of conditions of use (mixing times from 2 to 8 min, and speed of rotation from 10 to 100 rpm). In addition, the device was superior to classical mixing methods (such as the use of manually shaken plastic bags) and at least equivalent to well-established ones (Y-shaped mixer). Finally, we proposed a cleaning procedure that was also adequate to prevent cross-contamination among products compounded with the same device.