Optimasi formula tablet vitamin C menggunakan Avicel PH 101, Flowlac 100 dan Starch 1500 secara cetak langsung dengan metode simplex lattice design

WIBOWO, Indro Heri, Prof. Dr. Achmad Fudholi, DEA., Apt

2010 | Tesis | S2 Ilmu Farmasi

Sifat vitamin C tidak tahan terhadap panas, kelembaban serta tidak stabil dengan tekanan yang besar sehingga dalam pembuatannya metode granulasi basah dan granulasi kering relatif kurang menguntungkan dibandingkan metode cetak langsung. Kelemahan metode cetak langsung tidak cocok untuk bahan aktif yang mempunyai sifat alir dan kompaktibilitas yang jelek, salah satunya vitamin C,sehingga dalam pembuatannya memerlukan bahan tambahan yang mampu memperbaiki kelemahan tersebut. Avicel, flowlac dan starch merupakan bahan tambahan yang banyak digunakan dalam formulasi tablet secara cetak langsung,masing-masing bahan mempunyai karakteristik filler binder yang berbeda-beda.Perbedaan sifat ini akan menghasilkan mutu fisik tablet vitamin C yang berbeda pula,sehingga perlu dilakukan penelitian pengaruh bahan tambahan tersebut. Proporsi optimal dari campuran bahan tambahan avicel, flowlac dan starch dapat ditentukan dengan metode Simplex Lattice Design (SLD).Metode SLD dengan 3 komponen yaitu avicel (A), flowlac (B) dan starch (C), memerlukan 7 rancangan formula yaitu F1 (100% A), F2 (100% B), F3 (100% C), F4 (50% A & 50% B), F5 (50% A & 50% C), F6 (50% B & 50% C), dan F7 (33,33% A, 33,33% B, 33,33% C). Kecepatan alir massa tablet, kekerasan, kerapuhan dan waktu hancur digunakan sebagai parameter optimasi. Berdasar persamaan SLD, dibuat contour plot dan superimposed contour plot untuk menentukan formula optimum.Berdasarkan superimposed contour plot diperoleh formula optimum dengan proporsi avicel (36,1 %), flowlac (33,7 %) dan starch (30,2 %) yang menghasilkan kecepatan alir 16,1 g/detik; kekerasan 5,4 kg; kerapuhan 0,34 % dan waktu hancur 5,85 menit. Interaksi Avicel-Flowlac-Starch berpengaruh terhadap sifat fisis tablet vitamin C. Avicel merupakan faktor yang paling dominan dalam meningkatkan kekerasan dan memperlama waktu hancur tablet. Starch merupakan faktor yang paling dominan dalam meningkatkan kecepatan alir dan kerapuhan tablet.

The nature of Vitamin C is not resistant to heat, humidity and are not stable against large pressure, so that the manufacturing method of wet granulation and dry granulation is relatively less profitable than direct compress methods. The Weaknesses of direct compress method is not suitable for active ingredients with bad flowability and compactibility, one of them is Vitamin C, so that in the manufacturing process requires additives to fix it. Avicel, flowlac and starch are additives that are widely used in tablet formulation with direct compress, each ingredient has the different characteristics of filler binder. The differences of this nature will result different physical quality of vitamin C tablets, so necessarily needs a research of this additives influence. The Optimal proportion of the additive mixture of avicel, flowlac and starch can be determined by the method of Simplex Lattice Design (SLD).SLD method by using 3 component, i.e. avicel (A), flowlac (B), and starch (C), seven formula were obtained that are F1 (100% A), F2 (100% B), F3 (100% C),F4 (50% A & 50% B), F5 (50% A & 50% C), F6 (50% B & 50%C),dan F7 (33.33% A, 33.33% B, 33.33% C). The optimization parameters of vitamin C tablets were flow rate of the tablet mass, tablet hardness, friabilition and disintegration time, on SLD model; equations, contour plots, and superimposed of contour plots were obtained, by which the optimum formula was determined.Based on superimposed contour plot optimum formula is obtained with proportion of avicel (36.1 %), flowlac (33.7 %) and starch (30.2 %) and the results of flowability were 16.1 g/second; hardness 5.4 kg; friability 0.34 % and disintegration time 5.85 minutes. Interaction Avicel-Flowlac-Starch could influence the physical properties of tablet. Avicel was the most dominant factor in increasing hardness and time of disintegration tablet. Starch was the most dominant factor in increasing flowability and tablet friability.

Kata Kunci : Optimasi,Vitamin C,Avicel,Flowlac,Starch,Simplex lattice design