THE EFFECT OF BANGGAI YAM (DIOSCOREA ALATA L.) MODIFICATION ON FILM CHARACTERISTICS AS A FILM COATING MATERIAL FOR MODIFIED RELEASE DOSAGE FORMS
Objective: This study aims to determine the effect of modification of Banggai yam (Dioscorea alata L.) as a coating agent in modified release drug.
Methods: Banggai yam starch was physically modified to produce pregelatinized Banggai yam starch (PGBYS) powder as well as chemically to produce pregelatinized Banggai yam starch phthalate (PGBYSP). Powder obtained was each physically and chemically characterized including organoleptics, morphology, tapped density, water content content and degree of substitution. Furthermore, the formulation was made to produce film-coated drug with the same coating agent concentration in 2 formulas: F1 (PGBYSP 6%) and F2 (PGBYS 6%).
Results: The results were then evaluated including organoleptics, film thickness, morphology, mechanical strength, and film dissolution. Results of evaluation showed that film thickness values for both formulas, F1 and F2 respectively, were 0.13±0.020 mm and 0.18±0.005 mm. Mechanical strength included tensile strength consecutively at values of F1= 0.08±0.005 MPa and F2= 0.27 ± 0.05 Mpa; % elongation of F1= 114.16±11.8% and F2= 164.06±57, 94%; Young's modulus of F1= 7.3×104±9.8×10-5 MPa and F2= 1.8×103±7.9×10-4 MPa. The dissolution of the film-coating in HCl pH 1.2 medium for F1 was 7.9±1.92% and F2 was 25.8±2.42%. In pH 6.8 medium, F1 was 8.6±2.27% and F2 was 11.6±1.44%, while in pH 7.4 medium, F1 was 19.1±5.46% and F2 was 13.1±1.78%. Both film-coated formulas were soluble in alkaline medium, but F2 could not maintain its conditions in acid medium. This proves that the chemical modification product by esterification to form a film can withstand acidic medium.
Conclusion: Therefore, PGBYSP has potential to be used as a coating agent in controlled release drug.
Keywords: Dioscorea alata L., starch phthalate, film-coated, characterization
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