Optimasi Co-Processed Excipients Amilum Manihot-Polyvinylpyrrolidone (PVP) dengan Metode Extrusion untuk Filler-Binder Orally Disintegrating Tablet

Danendra Rahadeva Agastya, Dr.apt. T.N. Saifullah Sulaiman, M.Si.; Arif Nur Ikhsan, M.Pharm.Sci., Apt.

2023 | Skripsi | FARMASI

Amilum manihot merupakan eksipien yang memiliki fungsi sebagai pengikat dan pengisi pada formulasi tablet namun memiliki sifat alir granul dan kompaktibilitas yang kurang baik. Kekurangan tersebut dapat diatasi dengan melakukan modifikasi co-processing dengan polyvinylpyrrolidone (PVP) yang memiliki sifat alir dan kompaktibilitas yang baik dengan menggunakan teknik ekstrusi. Penelitian ini bertujuan untuk menentukan proporsi optimum dari kombinasi material co-processing amilum manihot dan PVP K30 dengan metode ekstrusi dan pengaruh variasi kedua bahan terhadap sifat fisik material co-processed dan sifat fisik tablet asetosal.

Penentuan proporsi optimum dari material co-processed dilakukan dengan metode desain faktorial. Evaluasi sifat fisik material co-processed meliputi uji pengukuran diameter rata-rata partikel, kecepatan alir, kompaktibilitas, kompresibilitas, daya serap air, sudut diam, dan kelembaban granul. Penentuan proporsi optimum dilakukan menggunakan software Design-Expert versi 13. Material co-processed hasil optimasi digunakan sebagai filler-binder pada pembuatan tablet asetosal. Evaluasi sifat fisik tablet asetosal meliputi uji kekerasan, kerapuhan, waktu hancur, pembasahan tablet, dan rasio absorpsi air.

Variasi dari proporsi kombinasi amilum manihot dan PVP K30 berpengaruh terhadap sifat fisik material co-processed. Peningkatan komposisi amilum manihot dapat meningkatkan daya serap air, kelembaban granul, dan sudut diam. Sedangkan peningkatan komposisi PVP K30 dapat meningkatkan diameter rata-rata partikel, kecepatan alir, kompaktibilitas, dan kompresibilitas. Proporsi optimum dari material co-processed diperoleh dengan kombinasi proporsi amilum manihot sebesar 19,2?n PVP K30 sebesar 5%. Pembuatan tablet asetosal dengan material co-processed hasil optimasi menghasilkan tablet dengan sifat fisik yang memenuhi persyaratan yang ditetapkan.

Cassava starch is an excipient that has a function as a binder and filler in tablet formulations but has poor granule flow properties and compactibility. To overcome these deficiencies, a modification of co-processing can be carried out using polyvinylpyrrolidone (PVP) excipient which has good flow and compactibility properties using an extrusion method. This study aims to determine the optimum proportion of the co-processing material combination of cassava starch and PVP K30 using the extrusion method and the effect of variations of the two materials on the physical properties of the co-processed material and the physical properties of acetosal tablets.

Determination of an optimized formula proportion of the two co-processed materials will be carried out using the factorial design method. Evaluation of the physical properties of the co-processed material included tests measuring the average particle diameter, flow rate, compactibility, compressibility, water absorption, angle of repose, and granule moisture. Optimum proportions were determined using Design-Expert version 13. The optimized co-processed material was used as a filler-binder in the manufacture of acetosal tablets. Evaluation of the physical properties of acetosal tablets included tests of hardness, friability, disintegration time, tablet wetting, and water absorption ratio

Variations in the proportions of the combination of manihot starch and PVP K30 affect the physical properties of the co-processed material. Increasing the composition of manihot starch can increase water absorption, granule moisture, and angle of repose. While increasing the PVP K30 composition can increase the average particle diameter, flow rate, compactibility, and compressibility. The optimum proportion of co-processed material is obtained by combining the proportion of manihot starch of 19.2% and PVP K30 of 5%. Manufacture of acetosal tablets with optimized co-processed materials produces tablets with physical properties that meet the specified requirements. 

Kata Kunci : amilum manihot, PVP K30, co-processed, ekstrusi