Formulation and in vitro evaluation of Griseofulvin cream for treatment of Tinea Pedis.

Abstract

ABSTRACT Background: Tinea pedis have been treated using Griseofulvin tablet as oral dosage form in part of Africa including Tanzania. In Ghana Griseofulvin was incorporated into shea-butter to make the drug spread easy to infected region of skin. The approach to seek formulation of griseofulvin cream in Tanzania is due to the rising need to reducing side effects induced by griseofulvin tablet, among the primary and secondary school children infected by tinea pedis when administered the drug orally. Objective: To formulate and in vitro evaluate griseofulvin cream for treating Tinea pedis. Material and method: White vaseline from Caesar and Loretz GmbH; Polysorbate 80 (Tween 80) from Sigma Aldrich (Switzerland); Sorbitan oleate (Span 80) from Sigma (USA); distilled water q.s. and Griseofulvin powder was purchased and bought from North Korea, were used in formulation of cream. Toluene, diethyl ether for mobile phase, ethyl acetate for diluent were bought in Dar es salaam. Tests and analysis for rheological properties were determined using Kinexus rheometer (Malvern) at temperature of 25oC, with a geometry spindle CP4/40 SR1454SS (KJ3100277), Potato agar, Trichophyton rubrum, and incubator from ITM-Muhas. Albino rats from school of Pharmacy-Muhas. Physical properties were observed and verified against specifications. pH was measured using electronic pH conductometer in which 1gm was diluted to 100mls of distilled water. Accelerated stability test for cream was done using stability chamber from day 0 to day90, then test performed using HPTLC. Antifungal activity tested against Trichophyton rubrum which causes tinea capitis in which Agar plate diffusion method was done using potato agar and activity studied for 5days. Well diameters were 15mm, cream weight was 100.2mg, control was pure cream. Results: Formulations 1,2 and 3 had desirable trends of rheological properties in term of viscometry, frequency sweep, three step shear rate, creep and recovery. Meanwhile formulation F4 had less desirable viscometry, thixotropic, creep and recovery properties. pH trends were stable, ranging from 5.9 to 7. Formulations were stable from day 0 to 90 under accelerated temperature conditions of 40oC± 5oC and humidity conditions of 75%±5%. The assay trend showed a range from 100.62% on day 0 to 99.68% on day 90. Antifungal activity of Griseofulvin cream had shown a very strong activity against Trichophyton rubrum with zone of inhibition of 37.5mm. Irritation effect of the cream was very slight with an average edema and erythema score of 1.17. Conclusion and recommendations: This was the first formulation of a semisolid griseofulvin product in Tanzania, focusing on essential performance parameters such as rheological and physical properties, pH, and stability behavior. The first three formulations demonstrated desirable rheological properties, with formulation F3 showing the most favorable trend. The pH values adhered to specifications ranging from 5 to 8, and all formulations exhibited a stable shelf-life trend. Formulation showed strong antifungal activity against Tinea pedis. Keywords: Griseofulvin cream, Rheological properties, Hydrophilic lipophilic balance value, physical appearance, pH, Antifungal activity