FORMULATION AND EVALUATION OF MAGISTRAL TOPICAL CREAM AND LOTION CONTAINING CANNABIDIOL FOR USE IN RHEUMATOID ARTHRITIS
FORMULATION AND EVALUATION OF MAGISTRAL TOPICAL CREAM AND LOTION CONTAINING CANNABIDIOL FOR USE IN RHEUMATOID ARTHRITIS

Summary/Abstract: When proprietary medicinal products are no longer available in pharmacies, the compounding of topical individual formulations may represent an effective alternative solution. Specific circumstances, such as rare indications, pediatric use, or intolerance to certain ingredients, often create challenges related to the availability, dosage, and selection of appropriate pharmaceutical formulations. In such cases, magistral preparations provide flexibility and enable personalized therapy tailored to individual patient needs. Prepared magistral formulations can be as effective as proprietary or generic medicinal products while maintaining comparable quality standards. In addition, they allow adaptation of the formulation composition and are often more economically accessible. In many situations, magistral preparations remain the only viable therapeutic option when a medicinal product is unavailable on the market. Cannabis has been used as a medicinal plant for millennia; however, systematic scientific investigations of its main components began in the 1960s. Since then, extensive research has been conducted on cannabinoids and their biological activity. In countries where medicinal cannabis use is approved, strict regulations govern its clinical application. One method of administration is through magistral preparations prescribed by a physician and prepared in facilities that meet quality standards, ensuring controlled levels of tetrahydrocannabinol (THC) and cannabidiol (CBD). The aim of this study was the characterization and evaluation of two topical formulations, a cream and a lotion, containing cannabis oil at a concentration of 10%. The primary objective was the selection of suitable bases according to the solubility of the active substance in order to ensure successful formulation. The prepared formulations were evaluated based on appearance, color, identification, pH value, spreadability, cannabidiol content, viscosity, relative density, and microbiological purity. The obtained results demonstrated satisfactory physicochemical characteristics and compliance with pharmacopoeial requirements, indicating appropriate quality and stability of the formulations. Furthermore, the topical dosage forms showed favorable technological properties relevant for routine pharmaceutical compounding and patient use. The study highlights the importance of appropriate excipient selection and formulation design for achieving consistent quality in magistral preparations. Overall, the findings support the potential role of magistral topical cannabis-based preparations as a complementary therapeutic option in pharmaceutical practice and warrant further investigation of their clinical applicability.

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