Biopharmaceutical Performance of DiluCap: A Line of Functional Excipients Enhancing Dissolution Profiles of Minoxidil, Finasteride, Melatonin, and Naltrexone.

Abstract

Hardshell capsules are favored in individualized formulations due to their flexibility and convenience. However, excipient selection is crucial to ensure the active pharmaceutical ingredient (API) maintains stability, compatibility, and efficacy. Excipients, while typically inert, play a vital role in enhancing the manufacturing process, stability, and dissolution of APIs. Fagron's DiluCap® line is composed of six functional excipients designed to optimize capsule formulations. This study evaluates the dissolution profiles of hard-shell capsules containing minoxidil (1 mg and 2.5 mg) in DiluCap® SLD, finasteride (1 mg and 5 mg) in DiluCap® PSD, minoxidil + finasteride (2.5 mg + 1 mg) in DiluCap® SLD, melatonin (2 mg) in DiluCap® SR, and naltrexone (1.5 mg) in DiluCap® SR. Dissolution tests were conducted under gastrointestinal-simulating conditions. Minoxidil and finasteride capsules achieved rapid dissolution, while melatonin and naltrexone capsules demonstrated controlled release, highlighting the suitability of DiluCap® excipients for multiple purposes in compounding pharmacies. The findings underline the importance of selecting appropriate excipients to ensure API performance, enhance bioavailability, and streamline compounding processes.