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.

Inflammatory skin conditions are prevalent in the general population and are a source of much concern for those who suffer from them. Acne is an extremely common condition and can significantly impact the quality of life of affected patients. Rosacea is another common dermatological disorder that often affects the face and can present with flushing, irritated skin, and pimples. In addition to being key for acne and rosacea, inflammation can also play a role in prematurely aging skin and contributes to the formation of wrinkles. Given the prevalence and patient impact of dermatological conditions on the face, such as those previously described, there is a demand for personalized medicines to manage these conditions when commercially available options are unsuitable, unavailable, or insufficient to fully resolve the condition. When designing an appropriate personalized therapy for a patient, both the vehicle and the active pharmaceutical ingredient choices are key to the success of the treatment. Cleoderm™ is a topical cream designed for use as a vehicle for the preparation of dermatological treatments by compounding pharmacies. Its ingredient profile was specifically curated to be gentle on the skin, allowing its use as a vehicle for compounded preparations that may be applied to sensitive and affected skin. In this bracketed study, benzoyl peroxide, cyproterone acetate, estriol, metronidazole, niacinamide, progesterone, retinoic acid, spironolactone, and tranexamic acid were selected, due to their known applications for dermatological skin conditions. To evaluate the compatibility and stability of Cleoderm™ in these formulations, high-performance liquid chromatography, followed by antimicrobial effectiveness testing, were performed for 180 days. For most formulations, a beyond-use date of 180 days was observed when stored at room temperature, except for retinoic acid, which had a beyond-use date of 30 days. Through the outcomes of this study, we concluded that Cleoderm™ presents increased convenience for both the compounding pharmacist and the patient, suggesting that it is an adequate candidate vehicle for compounding different dermatological formulations with adequate stability, presenting itself as a good alternative to commercially available treatments that cannot be personalized.