Evaluation of the factors contributing to the stability of the mixture of heparinoid oil-based cream and droplet dispersion-type ointment

Autor: Tatsuo Koide, Emina Miwa, Ayane Ozutsumi, Toshiro Fukami, Yoshihisa Yamamoto
Rok vydání: 2021
Předmět:
Zdroj: Journal of Drug Delivery Science and Technology. 61:102218
ISSN: 1773-2247
DOI: 10.1016/j.jddst.2020.102218
Popis: We tried to clarify the pharmaceutical properties of heparinoid oil-based cream (HPOC) formulations from various aspects, such as rheological properties. Furthermore, the stability of the mixture of droplet dispersion-type betamethasone butyrate propionate ointment (BBPO) formulations and all HPOC formulations at various mixing ratios was evaluated. Next, we prepared a model droplet dispersion-type ointment and evaluated the relationship between the surfactant contained in the droplet dispersion-type ointment and the mixture stability. The present study revealed that two HPOC formulations have a lower viscosity than other HPOC formulations. Bleeding occurred in the mixture of the two HPOC formulations and droplet dispersion-type BBPO formulation at a mixing ratio of 1:1, suggesting that the pharmaceutical properties of the two HPOC formulations influence the stability of the mixture. A study using the time-domain-nuclear magnetic resonance (TD-NMR) revealed that the molecular mobility of water in those mixtures was diverse. When the stability of the mixture of the model droplet dispersion-type ointment and all the HPOC formulations was evaluated, it was stable in all mixtures when the HLB value of the surfactant added to the model ointment formulation was low (approximately 5). In contrast, it was unstable in all the mixtures when the HLB value of the surfactants was high (approximately 16). In the case of surfactants, such as polyoxyethylene hydrogenated castor oil 40, contained in droplet dispersion-type BBPO formulations, where the HLB value is middle (approximately 12), the mixture stability depends on the pharmaceutical properties of HPOC formulations. Therefore, bleeding occurred only in mixtures with the two HPOC formulations. As described above, to predict the stability of a mixture, it is necessary to understand the pharmaceutical properties of both components from various aspects.
Databáze: OpenAIRE