1. Modeling and biopharmaceutical evaluate of topical semi – solid dosage forms of fungicidal effect with terbinafine hydrochloride
- Author
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Mostautienė, Vilmantė and Ramanauskienė, Kristina
- Subjects
Terbinafine hydrochloride ,antifungal activity ,biopharmaceutical study in vitro - Abstract
The Aim: to model topical semi – solid dosage forms with terbinafine hydrochloride and to evaluate their quality by carrying out the bio-pharmaceutical tests in vitro. Objectives: 1. To select excipients and to produce topical semi – solid dosage forms with terbinafine hydrochloride. 2. To produce stable topical semi – solid dosage forms with terbinafine hydrochloride and evaluate their quality. 3. To investigate the effect of base on the release of terbinafine hydrochloride from topical semi – solid dosage forms. 4. To investigate the antifungal activity of topical semi – solid dosage forms with terbinafine hydrochloride in vitro. Methods: the quality of topical semi – solid dosage forms with terbinafine hydrochloride is evaluated by determining of rheological features and pH values. Also, by the active substance release study in vitro. The object of the study: topical semi – solid dosage forms with terbinafine hydrochloride. Results: Produced sixteen topical semi – solid dosage forms with terbinafine hydrochloride. Semi-solid formulations for local effects have suitable pH values (5,4 ± 0,01 – 6,2 ± 0,02). The consistency coefficient of semi-solid preparations is influenced by temperature changes. The greatest amount (36,93 ± 0,04 proc. ) of active substance has been released after six hours from emulsion (v-a) cream based on coconut butter and terbinafine hydrochloride concentration 1 proc. The strongest antifungal activity was in formulations with 1% terbinafine hydrochloride concentration. Conclusion: Homogeneous, semi-solid pharmaceutical formulations of different compositions with terbinafin hydrochloride, emulsion-based (v-a) creams and hydrophilic ointment bases have been modeled. The highest amounts of terbinafine hydrochloride released from the foundations, most of which are coconut butter, are released in the smallest amounts from emulsion (v-a) creams with vaseline and anhydrous lanolin. Topical semi – solid dosage forms biopharmaceutical studies in vitro have shown that the active substance release depends on the selected base, active substance concentrations and active substance forms in base. Antifungal activity studies in vitro to Microsporum canis fungus have shown that all formulations have antifungal activity.
- Published
- 2019