Optimasi formula tablet piroksikam menggunakan flowlac, avicel dan compritol secara cetak langsung dengan metode simplex lattice design

SUHESTI, Tuti Sri, Prof. Dr. Achmad Fudholi, DEA., Apt

2009 | Tesis | S2 Ilmu Farmasi

Piroksikam merupakan obat anti inflamasi non steroid (AINS) dengan dosis kecil (10-20 mg/hari) dengan waktu paro (t1/2) eliminasi yang panjang. Formulasi piroksikam diharapkan dapat menghasilkan tablet berkualitas yang memenuhi syarat sifat fisik tablet. Komponen penyusun tablet terdiri dari Flowlac 100 (bahan pengisi), Avicel PH-101 (pengikat) dan Compritol 888 ATO (pelicin). Optimasi dilakukan menggunakan metode simplex lattice design (SLD) dengan 3 komponen yaitu flowlac (A), avicel (B) dan compritol (C), sehingga diperlukan minimal 7 rancangan formula yaitu F1 (100% A), F2 (100% B), F3 (100% C), F4 (50% A & 50% B), F5 (50% B & 50% C), F6 (50% A & 50% C), dan F7 (33,33% A, 33,33% B, 33,33% C). Kecepatan alir massa tablet, kekerasan, waktu hancur, kadar piroksikam dan disolusi (C45) digunakan sebagai parameter optimasi. Berdasar persamaan simplex lattice design, dibuat contour plot dan superimposed contour plot untuk menentukan formula optimum. Berdasarkan superimposed contour plot diperoleh formula optimum dengan proporsi Flowlac (89,6 %), Avicel (7,4 %) dan Compritol (3 %) yang menghasilkan kecepatan alir 21,46 g/detik; kekerasan 6,46 kg; waktu hancur 6,98 menit; kadar piroksikam 10,13 mg dan disolusi (C45) 7,35 mg. Interaksi Flowlac-Avicel-Compritol berpengaruh terhadap sifat fisis dan pelepasan (disolusi) tablet piroksikam. Flowlac merupakan faktor yang paling dominan dalam meningkatkan kecepatan alir, kekerasan, disolusi dan kadar piroksikam yang terlarut. Compritol merupakan faktor yang paling dominan dalam memperlambat waktu hancur tablet.

Piroksikam is a non steroid anti inflammation drugs (NSAID) with small dosis (10-20 mg daily) with a long time (t1/2) elimination. Piroxicam formulation is expected able to yield a good physical properties of tablet. The exipient components of tablet are Flowlac 100 (filler), Avicel PH-101 (binder) and Compritol 888 ATO (lubricant). The research was done with simplex lattice design (SLD) by using 3 component, i.e. Flowlac (A), Avicel (B), and Compritol (C). Seven formula were obtained that are F1 (100% A), F2 (100% B), F3 (100% C), F4 (50% A & 50% B), F5 (50% B & 50% C), F6 (50%A & 50%C),dan F7 (33,33% A, 33,33% B, 33,33% C). The optimization parameters of piroxicam tablets were flow rate of the tablet mass, tablet hardness, disintegration time, piroxicam content and the dissolution (C45), 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 Flowlac (89,6 %), Avicel (7,4 %) and Compritol (3 %).The results of flowability were 21,46 g/second; hardness (6,46 kg); disintegration time (6,98 minutes); drug content (10,13 mg) and dissolution (7,35 mg). The interaction among Flowlac-Avicel-Compritol could influence to the physical properties and the release profile of tablet. Flowlac was the most dominant factor in increasing flowability, hardness and dissolution of tablet. Compritol was the most dominant factor to make a longer time of disintegration tablet.

Kata Kunci : Optimasi,Piroksikam,Flowlac,Avicel,Compritol,Cetak langsung,Simplex lattice design,optimization; piroksikam; Flowlac; Avicel; Compritol; direct compression; simplex lattice design