Optimasi Formula Fast Disintegrating Tablet Parasetamol dengan Superdisintegrant Sodium Starch Glycolate dan Filler-Binder Supertab® 50 ODT

Naela Hana Umaira, Prof. Dr. apt. T. N. Saifullah S., S. Si., M. Si; apt. Farida Nur Aziza, S.Farm., MGMP

2026 | Skripsi | FARMASI

Sediaan parasetamol cair masih banyak digunakan karena kemudahan administrasinya, meskipun memiliki kelemahan mendasar berupa stabilitas yang rendah akibat kerentanan terhadap degradasi. Kondisi ini mendorong pengembangan Fast Disintegrating Tablet (FDT) parasetamol sebagai alternatif yang mampu menggabungkan stabilitas jangka panjang sediaan padat dengan kemudahan administrasi yang selama ini menjadi keunggulan sediaan cair.  Tablet dibuat dengan metode kempa langsung menggunakan Sodium Starch Glycolate (SSG) sebagai superdisintegrant dan Supertab® 50 ODT sebagai filler-binder. Optimasi dilakukan melalui model Simplex Lattice Design (SLD) menggunakan perangkat lunak Design Expert v.13 dengan 8 run formula, di mana proporsi SSG dan Supertab® 50 ODT ditetapkan sebagai variabel bebas. Evaluasi yang dilakukan meliputi pengujian sifat alir serbuk dan karakteristik fisik tablet FDT. Formula optimum diverifikasi menggunakan uji one sample t-test untuk membandingkan hasil eksperimental dengan prediksi model.

Hasil penelitian menunjukkan bahwa SSG memberikan pengaruh signifikan dalam meningkatkan derajat sudut diam, memperlama waktu pembasahan, serta meningkatkan rasio absorpsi air. Supertab® 50 ODT berperan dominan dalam memperbaiki sifat alir, menjaga kekerasan tablet, meningkatkan kerapuhan, dan mempercepat waktu disintegrasi. Formulasi FDT parasetamol dengan karakteristik fisik optimum diperoleh pada kombinasi konsentrasi SSG sebesar 4,146?n Supertab® 50 ODT sebesar 48,054% terhadap bobot tablet. Formula tersebut dinyatakan valid berdasarkan persamaan SLD karena tidak terdapat perbedaan signifikan antara nilai prediksi model dengan hasil pengujian eksperimental.

Liquid paracetamol formulations remain widely used due to their ease of administration, despite a fundamental weakness in low stability caused by susceptibility to degradation. This condition prompted the development of paracetamol Fast Disintegrating Tablets (FDT) as an alternative capable of combining the long-term stability of solid dosage forms with the ease of administration typically associated with liquid forms. The tablets were prepared by the direct compression method using Sodium Starch Glycolate (SSG) as a superdisintegrant and Supertab® 50 ODT as a filler-binder. Optimization was conducted via the Simplex Lattice Design (SLD) model using Design Expert v.13 software with 8 formula runs, where the proportions of SSG and Supertab® 50 ODT were established as independent variables. Evaluations included testing powder flow properties and the physical characteristics of the FDT. The optimum formula was verified using a one-sample t-test to compare experimental results with model predictions.

The results showed that SSG significantly influenced the increase in the angle of repose, prolonged wetting time, and increased the water absorption ratio. Supertab® 50 ODT played a dominant role in improving flow properties, maintaining tablet hardness, increasing friability, and accelerating disintegration time. The paracetamol FDT formulation with optimum physical characteristics was obtained at a combination of 4.146% SSG and 48.054% Supertab® 50 ODT relative to the tablet weight. This formula was declared valid based on the SLD equation as there were no significant differences between the model's predicted values and the experimental test results.

Kata Kunci : Parasetamol, Optimasi, Fast Disintegrating Tablet, Sodium Starch Glycolate, SuperTab® 50 ODT