Abstract

FORMULATION AND EVALUATION OF DAPSONE TOPICAL GEL, 7.5% W/W

Venkateswaran Chidambaram Seshadri*, Packiaraj Jeyachandran Manohari,
Janakiraman Kunchithapatham and Jayanarayan Kulathingal

Abstract

Diaminodiphenyl Sulfone is chemical name of Dapsone and is a BCS Class II drug. Recently USFDA has approved Dapsone Topical Gel (ACZONE®) manufactured by Allergan for the treatment of both inflammatory and non-inflammatory acne vulgaris for the age group of 12 to 65 years. Acne vulgaris is a nearly universal skin disease afflicting 79–95% of the adolescent population. Allergan designed ACZONE® in an airless pump containing a polypropylene bottle with a high density polyethylene piston containing a consortium of solvent like Isohexane; solubilizers / surfactants like Diethylene Glycol Monoethyl Ether and Polysorbate 80; Acrylamide/Sodium Acryloyldimethyl Taurate copolymer as a polymer; Methyl Paraben as preservative and Purified Water as solvent. The aim of the present research is in cost effective manufacturing of once daily Dapsone Gel 7.5% with minimum excipients viz., Diethylene Glycol Monoethyl Ether as solubilizer, Carbomer Homopolymer type C as polymer, Methyl Paraben as preservative, Purified Water as solvent / vehicle and Sodium Hydroxide / Hydrochloric Acid as pH adjusters and packing the final product in conventional laminated tubes. The Physico-chemical properties and stability of the formulated product was found comparable to ACZONE® 7.5%. It is reported that globally about 700 million people across ages get affected by Acne Vulgaris and this research will be a boon combining the once a day dosing of 7.5% strength stabilized in a simple laminated tube packing at a reduced cost.

Keywords: Planetary mixing, Colloid milling, Stability.