PREGELATINIZED CASSAVA STARCH PHTHALATE AS FILM-FORMING EXCIPIENT FOR TRANSDERMAL FILM OF KETOPROFEN

Abstract

This present study was intended to expand utilization of starch as transdermal film-forming excipient. In the previous study, starch have been physically and chemically modified through complete pregelatinization and phthalatization process in aqueous-alkaline medium (pH 8-10), resulting pragelatinized cassava starch phthalate (PCSPh). The obtained PCSPh possesed the degree of subtitution of 0.0541 ± 0.0019 and showed different physical, chemical, and functional properties compared to pragelatinized cassava starch (PCS). PCSPh showed higher gel strength value than PCS, a good characteristic to be used as film forming for transdermal dosage forms. In this study, transdermal film were produced using PCSPh as film-forming, glycerin and propylenglycol as plasticizer and ketoprofen as drug model. This transdermal film showed good mechanical properties, including folding endurance, elongation and tensile strength. The in-vitro drug release study showed that 71.78 – 107.07% of ketoprofen has been released from transdermal film in 4 hours by diffusion-controlled mechanism. In vitro penetration study using Franz diffusion cell showed that 72.77 – 108.04% of ketoprofen were able to penetrate the skin membran of Spague-Dawley rats with the flux of 1.499 – 2.311 mg/cm².hour in first three hours and 0.865 – 1.301 mg/cm².hour up to 8 hour. Therefore, it was concluded that PCSPh had good characteristics to be applied as film-forming excipient for transdermal dosage form.