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

摘要

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 pr agelatinized 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 pr agelatinized 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 hour s 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/cm 2 . hour in first three hours and 0.865 – 1.301 mg/cm 2 .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.