OPTIMASI CO-PROCESSED EXCIPIENT MIKROKRISTALIN SELULOSA PH 102 DAN POVIDONE K 30 SERTA PENGGUNAANNYA DALAM FORMULASI TABLET PARASETAMOL

ARIS PERDANA KUSUMA, Prof. Dr. Achmad Fudholi, DEA., Apt.

2013 | Tesis | S2 Ilmu Farmasi

Kempa langsung merupakan metode yang paling efisien dalam formulasi sediaan tablet. Bahan tambahan kempa langsung dapat dibuat dengan co-processing melalui metode spray drying. Penelitian ini bertujuan untuk mengetahui pengaruh co-processing dengan spray drying terhadap sifat fisik campuran mikrokristalin selulosa PH 102 dan Povidone® K 30 dengan model simplex lattice design sekaligus untuk mengetahui proporsi optimumnya. Selanjutnya, co-processed excipient ini digunakan sebagai bahan tambahan pada pembuatan tablet parasetamol. Penelitian dilakukan dengan proses spray drying terhadap kombinasi mikrokristalin selulosa PH 102 dan Povidone® K 30 pada berbagai macam proporsi menggunakan model simplex lattice design. Proporsi optimum ditentukan dengan menguji sifat alir dan kompaktibilitasnya yang masing-masing dinyatakan sebagai compressibility index (C.I) dan kekerasan. Co-processed excipient optimum ini digunakan sebagai bahan tambahan kempa langsung tablet parasetamol 500 mg Hasil pengujian menunjukkan bahwa sifat alir berfluktuasi pada berbagai proporsi co-processed excipient sedangkan kompaktibilitas meningkat seiring penambahan proporsi Povidone® K 30. Proporsi optimum dicapai pada 71 % mikrokristalin selulosa PH 102 dan 29 % Povidone® K 30 dengan nilai prediksi teoritis C.I dan kekerasan masing-masing 20,77 % dan 8,20 kg. Hasil uji verifikasi co-processed excipient riil sebesar 16,22 ± 0,39 % untuk C.I dan 7,61 ± 0,12 kg untuk kekerasan berbeda signifikan pada kedua parameter dengan prediksi teoritisnya (p < 0,05). Co-processed excipient optimum menghasilkan tablet parasetamol yang memenuhi semua persyaratan sediaan tablet yakni uji kekerasan, kerapuhan, waktu hancur, dan disolusi.

Direct compression is the most efficient formulation process for tablet dosage form. Excipient for direct compression can be made by co-processing with spray drying method. The aim of the study is to investigate the effect of spray dryed co-processing to the physical properties of mixture microcrystalline cellulose PH 102 and Povidone® K 30 with simplex lattice design as well as to determine the optimum proportions. Furthermore, this co-processed excipient was used as additive in the manufacture of paracetamol tablets. The research was carried out by spray drying process to microcrystalline cellulose PH 102 and Povidone® K 30 at various proportions of mixture using simplex lattice design model. The optimum proportion was determined by examining flow and compactibility properties which expressed as compressibility index (CI) and hardness. The optimum co-processed excipient was used as direct compression excipient of 500 mg paracetamol tablet The test results showed that the flow properties was fluctuated while the compactibility increased in the addition of Povidone® K 30 proportion. Optimum proportion was achieved in 71% microcrystalline cellulose PH 102 and 29% Povidone® K 30 with theoretical predictions of CI and hardness were 20.77% and 8.20 kg respectively. The test result verified that the real co-processed excipient were 16.22 ± 0.39% for CI and 7.61 ± 0.12 kg for hardness, differ significantly for both parameter from the theoretical prediction (p < 0,05). The optimum co-processed excipient produced paracetamol tablets which fulfill all of the test parameters including hardness, friability, disintegration time, and dissolution.

Kata Kunci : co-processed excipients; spray drying; simplex lattice design; mikrokristalin selulosa PH 102, Povidone® K 30