Optimasi Formula Fast Disintegrating Tablet Parasetamol dengan Superdisintegrant Crospovidone dan Filler-Binder StarLac®

Nadia Mutiara Shandy, Apt. Farida Nur Aziza, S.Farm., MGMP; Prof. Dr. apt. T. N. Saifullah S., S. Si., M. Si

2026 | Skripsi | FARMASI

Parasetamol merupakan obat antipiretik lini pertama untuk anak. Akan tetapi, bentuk sediaan tablet konvensional seringkali menjadi permasalahan karena kondisi kesulitan menelan, terutama pada populasi pediatri. Peristiwa ini dapat menurunkan kepatuhan pengobatan. Oleh karena itu, dikembangkan bentuk sediaan inovatif berupa fast disintegrating tablet (FDT) yang dapat hancur dengan cepat di dalam rongga mulut tanpa perlu air. Penelitian ini bertujuan untuk mengetahui pengaruh proporsi crospovidone sebagai superdisintegrant dan StarLac® sebagai filler-binder terhadap sifat alir serbuk dan sifat fisik FDT parasetamol serta mendapatkan proporsi optimum dari kedua bahan tersebut. FDT dibuat dengan metode kempa langsung. Sifat alir serbuk dievaluasi melalui uji kecepatan alir dan sudut diam. Sedangkan sifat fisik tablet dievaluasi melalui uji keseragaman ukuran, kekerasan, kerapuhan, waktu pembasahan, waktu disintegrasi, dan rasio absorpsi air. Data hasil evaluasi diolah menggunakan metode simplex lattice design pada software Design Expert 13 untuk memperoleh formula optimum dan data prediksi setiap pengujian. Selanjutnya, data prediksi diverifikasi menggunakan Microsoft Excel melalui uji one sample t-test. Hasil penelitian menunjukkan bahwa crospovidone berpengaruh dalam mempercepat waktu pembasahan, mempercepat waktu disintegrasi, dan meningkatkan rasio absorpsi air. Sedangkan StarLac® berpengaruh untuk meningkatkan sifat alir serbuk, meningkatkan kekerasan, dan menurunkan kerapuhan tablet. Formulasi FDT parasetamol dengan karakteristik fisik optimum diperoleh pada kombinasi konsentrasi crospovidone sebesar 5?n StarLac® sebesar 47,31% terhadap bobot tablet. Formula tersebut dinyatakan valid berdasarkan persamaan Simplex Lattice Design (SLD) karena tidak terdapat perbedaan signifikan antara nilai prediksi model dengan hasil pengujian eksperimental.

Paracetamol is a first-line antipyretic drug for children. However, conventional tablet dosage forms often present problems due to difficulty swallowing, especially in the pediatric population. This can reduce medication adherence. Therefore, an innovative dosage form was developed, fast disintegrating tablet (FDT), which can be rapidly destroyed in the oral cavity without the need for water. This study aims to determine the effect of the proportion of crospovidone as superdisintegrant and StarLac® as filler-binder on the powder flow properties and physical properties FDT paracetamol and get the optimum proportion of the two ingredients. FDT were prepared using the direct compression method. The powder flow properties were evaluated through flow rate and angle of repose tests. Meanwhile, the physical properties of the tablets were evaluated through size uniformity, hardness, friability, wetting time, disintegration time, and water absorption ratio tests. The evaluation data were processed using the simplex lattice design on software Design Expert 13 to obtain the optimum formula and predictive data for each test. Next, the predictive data was verified using Microsoft Excel through an one sample t-test. The results of the study show that crospovidone has an effect on accelerating wetting time, accelerating disintegration time, and increasing the water absorption ratio. Meanwhile, StarLac® has an effect on improving powder flow properties, increasing hardness, and reducing tablet friability. The paracetamol FDT formulation with optimum physical characteristics was obtained at a combination of concentrations crospovidone of 5% and StarLac® of 47.31% of the tablet weight. The formula is declared valid based on the equation Simplex Lattice Design (SLD) because there is no significant difference between the model prediction values and the experimental test results.

Kata Kunci : Parasetamol, Fast Disintegrating Tablet, Crospovidone, StarLac®