Development and evaluation of benzoyl peroxide loaded HPMC film for topical acne treatment

The aim of this study is to develop a new dosage form for benzoyl peroxide (BPO) which is used in acne treatment, within the scope of the QbD approach. Other dosage forms of BPO on the market are available as solutions and gels. The most obvious negative aspects of the available dosage forms are they contain high doses, difficult to apply the exact dose, they may spread to the unwanted areas after application, and they may be misused by patients. For the above reasons, side effects of the drug are frequently observed between users of these dosage forms. Polymeric films that provide regional targeting offer the opportunity to treat acnes with lower doses as well as being easy to use. Hydrophilic polymers that intended to use can provide rapid drug release due to their rapid dispersibility. Polymeric films containing BPO were produced on a laboratory scale by using solvent casting method. As formulation ingredients HPMC E15 was preferred as polymer, PEG and PG as plasticizers, and Tween 80 as surfactant. To determine the design area, the film's target product quality, critical quality characteristics, critical material characteristics and critical process parameters were determined. Using MODDE 12 software, the area design was found, and the optimum formula prepared. Quality-determining analyzes like DSC, FESEM, MTT and others were carried out to the produced optimum formula.