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"ABSTRAKTablet lepas lambat merupakan tablet yang di desain untuk melepaskan obatsecara perlahan – lahan di dalam saluran cerna, dengan menggunakan matrikssebagai salah satu komponen utama. Penelitian ini bertujuan untuk memperoleheksipien koproses xanthan gum – amilosa tersambungsilang (Ko-CLA6-XG danKo-CLA12-XG); (CL6-Ko-A-XG dan CL12-Ko-A-XG) sebagai matriks tabletlepas lambat natrium diklofenak. Eksipien Ko-CLA6-XG dan Ko-CLA12-XGmerupakan hasil koproses xanthan gum dengan CLA6 dan xanthan gum denganCLA12. Eksipien CL6-Ko-A-XG dan CL12-Ko-A-XG dihasilkan dengan carasambungsilang dari hasil koproses xanthan gum dan amilosa menggunakannatrium 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-XGyang dihasilkan dikarakterisasi sifat fisik, kimia dan fungsional. Ko-CLA6-XGdan 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 tersebutmempunyai kemampuan mengembang yang baik, viskositas yang cukup besar dankekuatan gel yang baik. Tablet dengan matriks Ko-CLA6-XG, Ko-CLA12-XG,CL6-Ko-A-XG dan CL12-Ko-A-XG diformulasikan dengan metode cetaklangsung dan seluruhnya memenuhi persyaratan evaluasi tablet. Profil pelepasannatrium 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 profilpelepasan obat diperlambat dengan kinetika pelepasan orde nol (F1 – F6, F9, F11)dan Korsmeyer-Peppas (F7, F8, F10, F12). Oleh karena itu, F1 – F6 dapatdigunakan untuk sediaan lepas lambat selama 16 jam sedangkan F7 – F12 dapatdigunakan untuk sediaan lepas lambat selama 32 jam.

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ABSTRACTSustained release tablet was solid dosage form which was designed to releasedrugs slowly in gastrointestinal tract. This present research was intended toproduce 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 forsustained release tablet of sodium diclofenac. Co-CLA6-XG and Co-CLA12-XGwere produced by coprocessing xanthan gum with CLA6 and xanthan gum withCLA12. CL6-Co-A-XG and CL12-Co-A-XG were produced from thecoprocessed xanthan gum and amylose then were crosslinked with sodiumtrimethaphosphate. 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 werecharacterized 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 ofCL6-Co-A-XG 1:1, 1:2 and 2:1 were respectively 0,077; 0,081 and 0,083. The DSof CL12-Co-A-XG 1:1, 1:2 and 2:1 were respectively 0,113; 0,119 and 0,122. Allexcipients had good swelling index, high viscosity and good gel strenght. Tabletswith Co-CLA6-XG, Co-CLA12-XG, CL6-Co-A-XG and CL12-Co-A-XG matrixwere 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 thesustained release profile followed zero order kinetics (F1 – F6, F9, F11) andKorsmeyer-Peppas (F7, F8, F10, F12). Thus, F1 – F6 tablet formulations could beapplied as sustained release tablet formulas and could retard drug release up to 16hours. Then F7 – F12 could be applied as sustained release tablet formula andcould retard drug release up to 32 hours."

"Sistem penghantaran obat transdermal saat ini banyak digunakan sebagai alternatif terhadap terapi konvensional (oral) untuk menghindari masalah seperti efek samping, metabolisme lintas pertama, dan kurangnya kepatuhan pasien.Penelitian ini bertujuan untuk mengembangkan sediaan hidrogel transdermal yang mengandung natrium diklofenak serta mengevaluasi penetrasi perkutan secara in vitro dan in vivo. Matriks sediaan hidrogel dibuat dari eksipien sambungsilang-6 dari koproses amilosa dan xanthan gum (CL6-Ko-A-XG). Hidrogel yang dibuat diuji penetrasinya secara in vitro melewati kulit tikus dengan menggunakan metode sel difusi Franz. Selanjutnya, dilakukan uji penetrasi secara in vivo menggunakan tikus Sprague-Dawley jantan (n=6) selama 12 jam. Analisis kadar natrium diklofenak dalam plasma tikus dilakukan dengan menggunakan kromatografi cair kinerja tinggi (KCKT). Berdasarkan hasil uji penetrasi secara in vitro, diperoleh jumlah kumulatif natrium diklofenak yang terpenetrasi 5890 ± 0,8 μg/cm2 dan fluks pada kondisi tunak 528 ± 72,5 μg/cm2/jam. Selanjutnya, dari hasil uji penetrasi in vivo diperoleh nilai area di bawah kurva (AUC0-t) natrium diklofenak yakni 47,94 ± 16,5 μg/mL jam. Maka, dapat disimpulkan bahwa hidrogel yang terbuat dari eksipien CL6-Ko-A-XG dapat menghantarkan natrium diklofenak hingga sirkulasi sistemik d.

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Transdermal drug delivery system can be an alternative to conventional (oral) therapy in order to avoid problems such as side effects, first pass metabolism, and poor patient compliance. The purpose of this study was to develop transdermal hydrogels containing diclofenac sodium and evaluate the in vitro and in vivo percutaneous penetration. The hydrogels matrices were prepared from 6-crosslinked of co-processed amylose-xanthan gum (CL6-Ko-A-XG). The hydrogels were subjected to in vitro penetration through rat skin using Franz diffusion cell. Furthermore, in vivo penetration study was carried out in male Sprague-Dawley rats (n=6) during 12 hours. In vivo drug plasma concentrations were determined using high performance liquid chromatography (HPLC). Based on the results of the in vitro study, the cumulative amount of diclofenac sodium penetrated was 5890 ± 0.8 μg/cm2 and flux at steady state condition was 528 ± 72.5 μg/cm2 hour. Moreover, the results of in vivo study showed that the area under curve (AUC0-t) was 47.94 ± 16.5 μg/mL hr. In conclusions, hydrogels which were formulated using CL6-Ko-A-XG could deliver diclofenac sodium into systemic circulation. According to the results, CL6-Ko-A-XG has a potential to be developed as matrices in transdermal system."