OPTIMASI FORMULA TABLET TEOFILIN MENGGUNAKAN CO-PROCESSED EXCIPIENTS CAMPURAN LAKTOSA DAN AVICEL

Hj. HAYATUS SAADAH, Prof. Dr. Achmad Fudholi, DEA., Apt.

2011 | Tesis | S2 Ilmu Farmasi

Eksipien tablet pada metode kempa langsung harus mempunyai sifat alir dan kompaktibilitas yang baik. Peningkatan fungsi eksipien dapat dilakukan dengan co-processing, yaitu mengkombinasikan dua atau lebih eksipien dengan proses tertentu. Material co-processed excipients campuran laktosa dan avicel dibuat dengan teknik spray drying untuk digunakan sebagai filler-binder dalam formulasi tablet teofilin. Material co-processed excipients yang dihasilkan dievaluasi sifat fisiknya yaitu: distribusi ukuran partikel dan diameter rata-rata, berat jenis, sifat alir, kompaktibilitas dan daya serap air. Optimasi terhadap sifat alir, kompaktibilitas dan daya serap air dilakukan dengan simplex lattice design. Hasil penelitian menunjukkan proporsi campuran laktosa dan avicel yang memenuhi persyaratan sifat fisik serbuk yang optimum ditetapkan dengan perbandingan 1:1 dengan respon waktu alir 8,79 ± 0,02 detik, kompaktibilitas 5,61 ± 0,08 kg dan daya serap 61,30 ± 0,40 mg/mnt. Superimposed contour plot untuk optimasi formula tablet teofilin menggunakan co-processed excipients sebagai filler-binder dengan desain faktorial ditetapkan dengan proporsi optimum magnesium stearat dan eksplotab (1:3,74) dengan respon kekerasan 5,54 ± 0,042 kg, kerapuhan 0,303 ± 0,015 %, waktu hancur 1,83 ± 0,115 menit dan DE20 85,66 ± 0,35 %.

Tablet excipients in direct compression should have good flowability and compactibility. Improvement of excipients properties may be obtained by co-processing. Co-processing is defined as combining two or more excipients by an appropriate process. Co-processed excipients of lactose and avicel, which were fabricated by spray drying technique, would be used as filler-binder in theophylline tablet formulation. The co-processed excipients were evaluated for their physical properties, i.e; particle size distribution, average diameter, density, flowability, compactibility and water absorption. Simplex lattice design was used for optimizing flowability, compactibility and water absorption of co-processed excipients. The results showed that proportion of lactose and avicel with optimum physical properties was determined by the ratio 1:1 with a response of flowability was 8.79 ± 0.02 seconds, compactibility was 5.61 ± 0.08 kg and water absorption was 61.30 ± 0.40 mg/min. Superimposed contour plot of theophylline tablet formulation using co-processed excipients as filler-binder by factorial design was determined by the optimum proportion of magnesium stearate and explotab (1:3.74) with the response of hardness was 5.54 ± 0.042 kg, friability was 0.303 ± 0.015%, disintegration time was 1.83 ± 0.115 minutes and DE20 was 85.66 ± 0.35%.

Kata Kunci : tablet teofilin; co-processed excipients; laktosa; avicel