Optimasi Formula Fast Disintegrating Tablet (FDT) Parasetamol dengan Metode Effervescent dan Superdisintegrant Crospovidone XL

Zahra Laila Adha Repiyan, Prof. Dr. apt. Teuku Nanda Saifullah Sulaiman, S. Si., M. Si.

2026 | Skripsi | FARMASI

Parasetamol merupakan obat analgesik-antipiretik yang umumnya tersedia dalam bentuk sediaan konvensional seperti tablet dan sirup. Sediaan konvensional memiliki keterbatasan berupa kesulitan menelan dan resiko kontaminasi etilen glikol (EG) dan dietilen glikol (DEG). Fast Disintegrating Tablet (FDT) merupakan bentuk sediaan alternatif yang dapat mengatasi keterbatasan tersebut. Penelitian ini bertujuan untuk mengoptimasi formula FDT parasetamol menggunakan effervescent agent dan crospovidone XL sebagai disintegrating system.

Tablet diformulasi dengan variasi effervescent agent (11-14%) dan crospovidone XL (2-5%) menggunakan metode kempa langsung. Evaluasi sifat fisik FDT yang dilakukan meliputi: kecepatan alir, organoleptik, keseragaman ukuran, kekerasan, kerapuhan, waktu pembasahan, rasio absorpsi air, dan waktu disintegrasi. Penentuan formula optimum dilakukan dengan metode Simplex Lattice Design (SLD) menggunakan software Design-Expert® dan diuji dengan one sample t-test.

Hasil penelitian menunjukkan bahwa kombinasi effervescent agent dan crospovidone XL memberikan pengaruh signifikan terhadap sifat fisik FDT parasetamol. Effervescent agent berpengaruh terhadap peningkatan kerapuhan dan kecepatan alir, sedangkan crospovidone XL berpengaruh terhadap peningkatan kekerasan tablet, rasio absorpsi air, dan penurunan waktu pembasahan serta interaksi keduanya dapat menurunkan waktu disintegrasi tablet. Kombinasi effervescent agent sebanyak 11% (asam tartat 5?n natrium bikarbonat 6%) serta crospovidone XL sebanyak 5?pat menghasilkan formula optimum dengan nilai desirability sebesar 0,901. Formula optimum yang diperoleh memiliki respon yang tidak berbeda signifikan dengan respon prediksi yang dihasilkan oleh software Design-Expert®.

Paracetamol is an analgesic-antipyretic drug that is commonly available in conventional dosage forms such as tablets and syrups. Conventional dosage forms have limitations, including difficulty swallowing and the risk of contamination by ethylene glycol (EG) and diethylene glycol (DEG). Fast Disintegrating Tablet (FDT) is an alternative dosage form that can overcome these limitations. This study aims to optimize the formulation of paracetamol FDT using an effervescent agent and crospovidone XL as the disintegrating system.

The tablets were formulated with variations of effervescent agent (11-14%) and crospovidone XL (2-5%) using direct compression method. The physical properties of the FDTs evaluated included: flow rate, organoleptic properties, size uniformity, hardness, friability, wetting time, water absorption ratio, and disintegration time. The determination of the optimum formula was carried out using the Simplex Lattice Design (SLD) method with Design-Expert® software and tested with a one-sample t-test.

The results showed that the combination of effervescent agent and crospovidone XL had a significant effect on the physical properties of paracetamol FDTs. The effervescent agent influenced the increase in friability and flow rate, while crospovidone XL affected the increase in tablet hardness, water absorption ratio, and reduction in wetting time; their interaction could decrease the disintegration time of the tablet. A combination of 11?fervescent agent (tartaric acid 5% and sodium bicarbonate 6%) and 5% crospovidone XL produced the optimum formula with a desirability value of 0.901. The optimum formula obtained had responses that were not significantly different from the predicted responses generated by the Design-Expert® software.

Kata Kunci : Parasetamol, FDT, Effervescent, Crospovidone, Design-Expert®