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Abstrak :
ABSTRAK
Rute penghantaran obat transdermal membutuhkan eksipien khusus untuk menghantarkan obat melalui kulit menuju sistemik. Tujuan penelitian ini adalah membuat dan menganalisis kemampuan penetrasi hidrogel transdermal yang dibuat dari eksipien koproses amilosa tersambungsilang6 – xanthan gum (Ko-CLA6-XG) pada perbandingan 1:2 sebagai pembentuk matriks dan natrium diklofenak sebagai model obat. Uji penetrasi in vitro dilakukan menggunakan sel difusi Franz dan dianalisis dengan spektrofotometer UV. Uji penetrasi in vivo dilakukan dengan mengaplikasikan hidrogel transdermal berukuran 1 x 1 cm pada bagian abdomen tikus jantan galur Sprague-Dawley. Analisis hasil uji penetrasi in vivo dilakukan menggunakan kromatografi cair kinerja tinggi (KCKT) dengan detektor photodiode array (PDA). Hasil uji penetrasi in vitro menunjukkan jumlah kumulatif obat yang terpenetrasi selama 12 jam sebesar 7629 ± 2711 µg.cm-2 dengan fluks sebesar 655,23 ± 216,43 µg.cm-2.jam-1. Profil pelepasan natrium diklofenak dari hasil uji penetrasi in vivo memberikan konsentrasi puncak plasma (Cmax) sebesar 4,35 ± 0,94 µg.ml-1 pada 1 jam dengan nilai area di bawah kurva (AUC 0-∞) 54,35 ± 7,55 µg.ml-1.jam. Berdasarkan hasil tersebut, hidrogel transdermal dengan eksipien Ko-CLA6-XG (1:2) mampu mempenetrasikan dan mengendalikan pelepasan natrium diklofenak selama 12 jam.

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ABSTRACT
Transdermal drug delivery needs specific excipient to deliver drug through the skin. The goals of this research were produced and analyzed penetration ability of transdermal hydrogel based on co-processed excipient of xanthan gum and 6-cross-linked amylose (Co-CLA6-XG) in 1:2 composition as matrix-forming and diclofenac sodium as a drug model. In vitro penetration study was evaluated using Franz diffusion cell and analyzed by UV-spectrophotometre. In vivo penetration study was performed by applying a transdermal hydrogel in size of 1 x 1 cm on the abdomen of Sprague-Dawley rats. Plasma concentration of diclofenac was analyzed by high-performance liquid chromatography (HPLC) with photodiode array (PDA) detector. In vitro penetration study showed that the cumulative drug permeated across the skin for 12 hours was 7629 ± 2711 µg.cm-2 with flux 655.23 ± 216.43 µg.cm-2.hours-1. The results of in vivo study showed that maximum plasma concentration (Cmax) was 4.35 ± 0.94 µg.ml-1 during 1 hour and area under curve (AUC 0-∞) was 54.35 ± 7.55 µg.ml-1.hour. According to the results, it can be concluded that transdermal hydrogel based on Co-CLA6-XG (1:2) excipient is able to deliver and penetrate diclofenac sodium release during 12 hours.

Abstrak :
ABSTRAK
Tablet lepas lambat merupakan tablet yang di desain untuk melepaskan obat secara perlahan – lahan di dalam saluran cerna, dengan menggunakan matriks sebagai salah satu komponen utama. Penelitian ini bertujuan untuk memperoleh eksipien koproses xanthan gum – amilosa tersambungsilang (Ko-CLA6-XG dan Ko-CLA12-XG); (CL6-Ko-A-XG dan CL12-Ko-A-XG) sebagai matriks tablet lepas lambat natrium diklofenak. Eksipien Ko-CLA6-XG dan Ko-CLA12-XG merupakan hasil koproses xanthan gum dengan CLA6 dan xanthan gum dengan CLA12. Eksipien CL6-Ko-A-XG dan CL12-Ko-A-XG dihasilkan dengan cara sambungsilang dari hasil koproses xanthan gum dan amilosa menggunakan natrium trimetafosfat dengan perbandingan masing – masing eksipien yaitu 1:1, 1:2 dan 2:1. Ko-CLA6-XG, Ko-CLA12-XG, CL6-Ko-A-XG dan CL12-Ko-A-XG yang dihasilkan dikarakterisasi sifat fisik, kimia dan fungsional. Ko-CLA6-XG dan Ko-CLA12-XG mempunyai derajat substitusi 0,070 dan 0,110. Eksipien CL6- Ko-A-XG 1:1, 1:2 dan 2:1 berturut – turut 0,077; 0,081 dan 0,083 serta CL12-Ko- A-XG 1:1, 1:2 dan 2:1 berturut – turut 0,113; 0,119 dan 0,122. Eksipien tersebut mempunyai kemampuan mengembang yang baik, viskositas yang cukup besar dan kekuatan gel yang baik. Tablet dengan matriks Ko-CLA6-XG, Ko-CLA12-XG, CL6-Ko-A-XG dan CL12-Ko-A-XG diformulasikan dengan metode cetak langsung dan seluruhnya memenuhi persyaratan evaluasi tablet. Profil pelepasan natrium diklofenak dari tablet yang mengandung matriks Ko-CLA6-XG (F1 – F3), Ko-CLA12-XG (F4 – F6), CL6-Ko-A-XG (F7 – F9) dan CL12-Ko-A-XG (F10 – F12) dalam medium dapar fosfat selama 8 jam, menunjukkan profil pelepasan obat diperlambat dengan kinetika pelepasan orde nol (F1 – F6, F9, F11) dan Korsmeyer-Peppas (F7, F8, F10, F12). Oleh karena itu, F1 – F6 dapat digunakan untuk sediaan lepas lambat selama 16 jam sedangkan F7 – F12 dapat digunakan untuk sediaan lepas lambat selama 32 jam.

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ABSTRACT
Sustained release tablet was solid dosage form which was designed to release drugs slowly in gastrointestinal tract. This present research was intended to produce coprocessed excipient of xanthan gum-crosslinked amylose (Co-CLA6- XG and Co-CLA12-XG); (CL6-Co-A-XG and CL12-Co-A-XG) as matrix for sustained release tablet of sodium diclofenac. Co-CLA6-XG and Co-CLA12-XG were produced by coprocessing xanthan gum with CLA6 and xanthan gum with CLA12. CL6-Co-A-XG and CL12-Co-A-XG were produced from the coprocessed xanthan gum and amylose then were crosslinked with sodium trimethaphosphate. All excipient had a ratio 1:1, 1:2 and 2:1. The obtained Co- CLA6-XG, Co-CLA12-XG, CL6-Co-A-XG and CL12-Co-A-XG were characterized physically, chemically and functionally. The degree of substitution (DS) of Co-CLA6-XG and Co-CLA12-XG were 0,070 and 0,110. Then the DS of CL6-Co-A-XG 1:1, 1:2 and 2:1 were respectively 0,077; 0,081 and 0,083. The DS of CL12-Co-A-XG 1:1, 1:2 and 2:1 were respectively 0,113; 0,119 and 0,122. All excipients had good swelling index, high viscosity and good gel strenght. Tablets with Co-CLA6-XG, Co-CLA12-XG, CL6-Co-A-XG and CL12-Co-A-XG matrix were formulated by direct compression method and passed tablet evaluation tests. The release profile of sodium diclofenac which contained matrix from Co-CLA6- XG (F1 – F3), Co-CLA12-XG (F4 – F6), CL6-Co-A-XG (F7 – F9) and CL12-Co- A-XG (F10 – F12) in phospate buffer medium for 8 hours, showed that the sustained release profile followed zero order kinetics (F1 – F6, F9, F11) and Korsmeyer-Peppas (F7, F8, F10, F12). Thus, F1 – F6 tablet formulations could be applied as sustained release tablet formulas and could retard drug release up to 16 hours. Then F7 – F12 could be applied as sustained release tablet formula and could retard drug release up to 32 hours.