Topical gel with ethyl cellulose based microsponges loaded with clindamycin hydrochloride for acne treatment

Abstract

This study describes development of a dosage form for acne treatment. A topical semi-solid dosage form—gel with clindamycin-hydrochloride (CM-HCl) loaded ethyl cellulose based microsponges (MSP). Central composite experimental design was used for optimization of the formulation in means of particle size and drug loading. CM-HCl MSP optimal formulation was prepared and characterized in aspect of: particle size (D50-14.9 μm) and particle size distribution (Span-1.979); shape (spherical) and morphology (porous); FTIR spectra; drug content (CM-HCl/polymer (mg/mg)-1.2544) and drug release with mean dissolution time (MDT) of 4.51 h. Chitosan (2%) was used as a gelling agent for the optimal sample formulation. The gel showed pseudoplastic behavior and high value of spreading capacity (263.64% spreading after 5 min). It was translucent without presence of foreign particles and had typical light-yellow colour, pH value of 5.36 ± 0.15 and MDT of 7.17 h. Stability studies performed at 25° ± 2 °C/60% ± 5% RH and 40° ± 2 °C/75% ± 5% RH for a period of 6 months were in favor of the stability of the designed topical semi-solid dosage form.