OPTIMASI FORMULA FAST DISINTEGRATING TABLET PROMETHAZINE-HCl TERINKLUSI β-SIKLODEKSTRIN MENGGUNAKAN KOMBINASI SUPERDISINTEGRANT SODIUM STARCH GLYCOLATE DAN CROSPOVIDONE

MARIA NOVENA SUKMA AGASTYA, Drs. Mufrod, M.Sc, Apt.

2016 | Skripsi | S1 FARMASI

Promethazine-HCl merupakan antihistamin golongan Phenotiazine yang efektif digunakan untuk mengatasi mual muntah akibat mabuk perjalanan (motion sickness). Promethazine-HCl umumnya tersedia dalam bentuk tablet konvensional yang memiliki kelemahan yaitu aksi obat lambat, biovailabilitas rendah, serta tidak nyaman digunakan untuk pasien pediatric. FDT Promethazine-HCl merupakan pilihan tepat bagi pasien pediatric dengan onset cepat dan rasa yang menyenangkan. Rasa pahit dari Promethazine-HCl ditutupi mengunakan agen penginklusi β-siklodekstrin. Penelitian ini bertujuan untuk mendapatkan formula FDT Promethazine-HCl yang memiliki sifat fisik optimum dengan kombinasi superdisintegrant Sodium Starch Glycolate (SSG) dan Crospovidone. Delapan run FDT Promethazine-HCl dibuat menggunakan metode kempa langsung menggunakan kombinasi superdisintegrant SSG dan Crospovidone dalam berbagai konsentrasi. Evaluasi sifat fisik FDT dilakukan dengan menguji beberapa parameter antara lain kekerasan, kerapuhan, waktu disintegrasi, waktu pembasahan, rasio absorbsi air, dan disolusi. Optimasi formula FDT Promethazine-HCl dilakukan dengan metode Simplex Latice Design menggunakan software Design Expert® version 10.0.0 (trial). Hasil penelitian menunjukkan bahwa kombinasi SSG dan Crospovidone berpengaruh terhadap sifat fisik FDT Promethazine-HCl. Peningkatan proporsi SSG dapat meningkatkan kekerasan, memperlama waktu disintegrasi dan waktu pembasahan. Sedangkan, peningkatan proporsi Crospovidone dapat meningkatkan kerapuhan dan rasio absorbsi air. Proporsi SSG 2% dan Crospovidone 6% terhadap bobot tablet memberikan sifat fisik optimum pada FDT Promethazine-HCl.

Promethazine-HCl is an antihistamine drug, which is classified into Phenotiazine group, used to treat motion sickness effectively. Promethazine-HCl generally available in tablet dosage form which has the disadvantages such as slow action, low bioavailability, and inconvenience for pediatric patients. FDT Promethazine-HCl is the right choice for pediatric patients with rapid onset and a pleasant taste. The bitter taste of Promethazine-HCl was covered using β-siklodekstrin by forming inclusion complex. This study aims to determine the formula of FDT Promethazine-HCl which is giving the optimum physical properties with combination of superdisintegrant Sodium Starch Glycolate (SSG) dan Crospovidone. Eight runs of FDT Promethazine-HCl were made using direct compression method, with the combination of SSG and Crospovidone in various concentration. Evaluation of the physical properties including hardness, friability, disintegration time, wetting time, water absorption ratio, and drug dissolution. Optimization of FDT Promethazine-HCl formula were analyzed using Simplex Lattice Design method with Design Expert® software version 10.0.0 (trial). The results shows that the combination of Sodium Starch Glycolate and Crospovidone is effecting the physical properties of FDT Promethazine-HCl. Increasing proportion of SSG may increase hardness, prolong the disintegrating time and the wetting time. Whereas, increasing the proportion of Crospovidone may increase the friability and water absorption ratio. The proportion of 2 % SSG and 6 % Crospovidone against the weight of the tablet provides optimum physical properties of FDT Promethazine-HCl.

Kata Kunci : Fast Disintegrating Tablet, Promethazine-HCl, Sodium Starch Glycolate, Crospovidone, β-siklodekstrin.