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"ABSTRAKTablet lepas lambat merupakan tablet yang didesain untuk melepaskan zat aktif secara perlahan-lahan. Penelitian ini bertujuan untuk membuat dan mengkarakterisasi eksipien sambungsilang dari koproses xanthan gum-gum akasia CL-Ko-XGGA sebagai matriks sediaan tablet lepas lambat dengan gliklazid sebagai model obat. Eksipien CL-Ko-XGGA merupakan hasil sambungsilang dari eksipien koproses xanthan gum-gum akasia Ko-XGGA menggunakan natrium trimetafosfat dengan perbandingan masing-masing eksipien, yaitu 1:2, 1:1, dan 2:1. Eksipien Ko-XGGA dan CL-Ko-XGGA dikarakterisasi secara fisika, kimia, dan fungsional. Eksipien CL-Ko-XGGA 1:2, 1:1, 2:1 memiliki derajat substitisi DS berturut-turut 0,067; 0,082; 0,088, serta kekuatan gel sebesar 14,03; 17,27; 20,70 gF. Eksipien tersebut memiliki sifat alir dan kemampuan mengembang yang lebih baik dibandingkan dengan eksipien Ko-XGGA. Eksipien CL-Ko-XGGA diformulasikan dalam tablet lepas lambat sebagai matriks dengan metode granulasi basah dan seluruh formula memenuhi persyaratan evaluasi tablet. Pelepasan gliklazid dari tablet F1-F6 dalam medium dapar fosfat pH 7,4 natrium lauril sulfat 0,2 selama 12 jam menunjukkan profil pelepasan obat diperlambat dan dapat digunakan selama 8 hingga 32 jam. Dapat disimpulkan bahwa dalam sediaan tablet lepas lambat eksipien CL-Ko-XGGA 2:1 memiliki kemampuan menahan pelepasan obat lebih baik dari eksipien CL-Ko-XGGA 1:2 dan 1:1.

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ABSTRAKSustained release tablet is solid dosage form which is designed to release drugs slowly. This research was intended to prepare and characterize the cross linked excipient of coprocessed xanthan gum acacia gum CL Co XGGA as a matrix of sustained release tablet with gliclazide as the drug model. CL Ko XGGA excipient was cross linked results of coprocessed excipient of xanthan gum acacia gum Co XGGA using sodium trimetaphosphate, in the ratio of each excipient 1 2, 1 1, and 2 1. Co XGGA and CL Co XGGA excipients were characterized physically, chemically, and functionally. The degree of substitution DS of CL Co XGGA 1 2, 1 1, 2 1 excipients were respectively 0.067 0.082 0.088, and gel strength were respectively 14.03 17.27 20.70 gF. Those excipients had improved flow properties and swelling capability compared with the Co XGGA excipients. CL Co XGGA excipients were formulated in sustained release tablet as matrix by wet granulation method and all formulas passed tablet evaluation tests. The release of gliclazide from tablets F1 F6 in phosphate buffer medium pH 7.4 sodium lauryl sulphate 0.2 for 12 hours showed sustained release profile and can be used up to 8 until 32 hours. In conclusion, CL Co XGGA 2 1 excipient have better ability to retain drug release than CL Co XGGA 1 2 and 1 1 excipients in the sustained release tablets."

"[ABSTRAKTablet mengapung lepas lambat membutuhkan eksipien yang berfungsi sebagaimatriks yang mampu mengendalikan lepasnya obat dan menfasilitasipengapungan tablet di lambung. Salah satu eksipien yang berpotensi untuk haltersebut adalah eksipien koproses xanthan gum ? gum akasia yang merupakanhasil modifikasi fisik dari 2 jenis polimer alam, yaitu xanthan gum dan gumakasia. Oleh karena itu, penelitian ini bertujuan untuk memperoleh eksipienkoproses xanthan gum ? gum akasia yang kemudian digunakan sebagai matrikspada formulasi tablet mengapung. Pada penelitian ini dibuat eksipien koprosesxanthan gum ? gum akasia dengan perbandingan 1:1, 1:2, 2:1, 1:3 dan 3:1 daneksipien yang diperoleh dikarakterisasi sifat fisik, kimia, danfungsionalnya.Eksipien-eksipien koproses yang dihasilkan tersebut kemudiandiformulasikan menjadi sediaan tablet mengapung dengan menggunakanfamotidin sebagai model obat. Tablet mengapung yang dihasilkan dievaluasi,antara lain uji kemampuan mengapung serta pelepasan obat dalam medium HClpH 1,2 selama 8 jam. Hasil penelitian menunjukkan bahwa eksipien koprosesyang diperoleh berupa serbuk halus tidak berbau dan berwarna putih keabu-abuan.Selain itu eksipien koproses tersebut memiliki kemampuan mengembang yangbaik, viskositas yang cukup besar dan kekuatan gel yang baik yang cocok untukdigunakan sebagai matriks tablet mengapung. Tablet mengapung F2 yang dibuatdengan menggunakan eksipien koproses Ko-XG-GA 1:2 menunjukkankarakteristik yang terbaik dengan floating lag time 8,33± 0,58 menit dankemampuan mengapung hingga 24 jam. Profil pelepasan famotidin dari tabletmengapung yang diformulasikan dengan eksipien koproses Ko-XG-GA (F1 ? F5)menunjukkan profil pelepasan obat terkendali dengan model kinetika pelepasanorde nol dan dapat digunakan untuk pemakaian selama 32 jam. Dari hasilpenelitian ini dapat disimpulkan bahwa eksipien koproses Ko-XG-GA yangdihasilkan dapat diaplikasikan sebagai matriks sediaan tablet mengapung lepasterkendali.

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ABSTRACTControlled release floating tablets required excipient which act as a matrix thatcan control the release of active drugs and facilitate the tablet floating in thegastric. One of the potential excipients is a co-processed excipient of xanthan gum? gum acacia, which is a physical modification of 2 natural polymers. Therefore,the aim of this study was to produce co-processed excipients of xanthan gumgumacacia, which were used as matrices in the floating tablet formulations. Inthis study, several co-processed excipients were prepared from xanthan gum andgum acacia in the ratio of 1:1, 1:2, 2:1, 1:3 and 3:1. The obtained excipients werecharacterized physically, chemically, and functionality. The co-processedexcipients were then formulated as the floating tablets using famotidine as a drugmodel. The obtained floating tablets were evaluated in terms of the tablet floatingcapabilities and the drug release in HCl medium pH 1.2 for 8 hours. The resultsshowed the co-processed excipients were fine powder, odorless and greyish whitecolour. The resulted excipients had good swelling index, fairly large viscosity andgood gel strength; hence it was suitable applied as matrices of floating tablets. Thefloating tablets of F2 which was containing the co-processed excipient of Co-XGGA1:2 had shown the best characteristics with 8.33 ± 0.58 minutes of floating lagtime and 24 hours of total floating time. The release study revealed that thefamotidine floating tablets which were using co-processed excipients of Co-XGGA(F1 - F5) as matrices could control drug release with zero order release kineticand could be used for controlled release dosage forms for 32 hours. It can beconcluded that the co-processed excipients of Co-XG-GA could be applied asmatrices in controlled release floating tablets.;Controlled release floating tablets required excipient which act as a matrix thatcan control the release of active drugs and facilitate the tablet floating in thegastric. One of the potential excipients is a co-processed excipient of xanthan gum– gum acacia, which is a physical modification of 2 natural polymers. Therefore,the aim of this study was to produce co-processed excipients of xanthan gumgumacacia, which were used as matrices in the floating tablet formulations. Inthis study, several co-processed excipients were prepared from xanthan gum andgum acacia in the ratio of 1:1, 1:2, 2:1, 1:3 and 3:1. The obtained excipients werecharacterized physically, chemically, and functionality. The co-processedexcipients were then formulated as the floating tablets using famotidine as a drugmodel. The obtained floating tablets were evaluated in terms of the tablet floatingcapabilities and the drug release in HCl medium pH 1.2 for 8 hours. The resultsshowed the co-processed excipients were fine powder, odorless and greyish whitecolour. The resulted excipients had good swelling index, fairly large viscosity andgood gel strength; hence it was suitable applied as matrices of floating tablets. Thefloating tablets of F2 which was containing the co-processed excipient of Co-XGGA1:2 had shown the best characteristics with 8.33 ± 0.58 minutes of floating lagtime and 24 hours of total floating time. The release study revealed that thefamotidine floating tablets which were using co-processed excipients of Co-XGGA(F1 - F5) as matrices could control drug release with zero order release kineticand could be used for controlled release dosage forms for 32 hours. It can beconcluded that the co-processed excipients of Co-XG-GA could be applied asmatrices in controlled release floating tablets.;Controlled release floating tablets required excipient which act as a matrix thatcan control the release of active drugs and facilitate the tablet floating in thegastric. One of the potential excipients is a co-processed excipient of xanthan gum– gum acacia, which is a physical modification of 2 natural polymers. Therefore,the aim of this study was to produce co-processed excipients of xanthan gumgumacacia, which were used as matrices in the floating tablet formulations. Inthis study, several co-processed excipients were prepared from xanthan gum andgum acacia in the ratio of 1:1, 1:2, 2:1, 1:3 and 3:1. The obtained excipients werecharacterized physically, chemically, and functionality. The co-processedexcipients were then formulated as the floating tablets using famotidine as a drugmodel. The obtained floating tablets were evaluated in terms of the tablet floatingcapabilities and the drug release in HCl medium pH 1.2 for 8 hours. The resultsshowed the co-processed excipients were fine powder, odorless and greyish whitecolour. The resulted excipients had good swelling index, fairly large viscosity andgood gel strength; hence it was suitable applied as matrices of floating tablets. Thefloating tablets of F2 which was containing the co-processed excipient of Co-XGGA1:2 had shown the best characteristics with 8.33 ± 0.58 minutes of floating lagtime and 24 hours of total floating time. The release study revealed that thefamotidine floating tablets which were using co-processed excipients of Co-XGGA(F1 - F5) as matrices could control drug release with zero order release kineticand could be used for controlled release dosage forms for 32 hours. It can beconcluded that the co-processed excipients of Co-XG-GA could be applied asmatrices in controlled release floating tablets., Controlled release floating tablets required excipient which act as a matrix thatcan control the release of active drugs and facilitate the tablet floating in thegastric. One of the potential excipients is a co-processed excipient of xanthan gum– gum acacia, which is a physical modification of 2 natural polymers. Therefore,the aim of this study was to produce co-processed excipients of xanthan gumgumacacia, which were used as matrices in the floating tablet formulations. Inthis study, several co-processed excipients were prepared from xanthan gum andgum acacia in the ratio of 1:1, 1:2, 2:1, 1:3 and 3:1. The obtained excipients werecharacterized physically, chemically, and functionality. The co-processedexcipients were then formulated as the floating tablets using famotidine as a drugmodel. The obtained floating tablets were evaluated in terms of the tablet floatingcapabilities and the drug release in HCl medium pH 1.2 for 8 hours. The resultsshowed the co-processed excipients were fine powder, odorless and greyish whitecolour. The resulted excipients had good swelling index, fairly large viscosity andgood gel strength; hence it was suitable applied as matrices of floating tablets. Thefloating tablets of F2 which was containing the co-processed excipient of Co-XGGA1:2 had shown the best characteristics with 8.33 ± 0.58 minutes of floating lagtime and 24 hours of total floating time. The release study revealed that thefamotidine floating tablets which were using co-processed excipients of Co-XGGA(F1 - F5) as matrices could control drug release with zero order release kineticand could be used for controlled release dosage forms for 32 hours. It can beconcluded that the co-processed excipients of Co-XG-GA could be applied asmatrices in controlled release floating tablets.]"

"Sustained release tablet is solid oral dosage form which is designed to release drugs slowly in the body. This research was conducted to make and characterize the cross-linked excipient of coprocessed polyvinyl alcohol-amylose as matrix for sustained release tablet with diclofenac sodium as the model drug. Cross-linked excipient of coprocessed polyvinyl alcohol-amylose (CL6 Co-PVA-A) was resulted from coprocessed excipient of polyvinyl alcohol-amylose (Co-PVA-A) that have been crosslinked with sodium trimetaphosphate. Meanwhile, Co-PVA-A was originated from two excipients, which are polyvinyl alcohol and amylose that have been coprocessed with ratio 1:2, 1:1, and 2:1. Co-PVA-A and CL6 Co-PVA-A properties were characterized physically, chemically, and functionally. Co-PVA-A and CL6 Co-PVA-A were formulated with dry granulation method in sustained release tablet as matrix. Furthermore, the sustained release tablets were evaluated and the drug release profiles were studied. As results, substitution degree of CL6 Co-PVA-A 1:2, 1:1, and 2:1 are respectively 0.080; 0.069; and 0.086. Those excipients have good swelling capability and gel strength that are 5.02; 5.22; and 5.12 gf. All sustained release tablet passed the requirement of weight variation, hardness, friability, and assay. CL6 Co-PVA-A as matrices (F1, F2, and F3) showed first order (F1) and zero order (F2 and F3) drug release kinetics. This study suggested that the tablets can be applied as sustained release tablets and retard drug release up to 16 hours.

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Sustained release tablet is solid oral dosage form which is designed to release drugs slowly in the body. This research was conducted to make and characterize the cross-linked excipient of coprocessed polyvinyl alcohol-amylose as matrix for sustained release tablet with diclofenac sodium as the model drug. Cross-linked excipient of coprocessed polyvinyl alcohol-amylose (CL6 Co-PVA-A) was resulted from coprocessed excipient of polyvinyl alcohol-amylose (Co-PVA-A) that have been crosslinked with sodium trimetaphosphate. Meanwhile, Co-PVA-A was originated from two excipients, which are polyvinyl alcohol and amylose that have been coprocessed with ratio 1:2, 1:1, and 2:1. Co-PVA-A and CL6 Co-PVA-A properties were characterized physically, chemically, and functionally. Co-PVA-A and CL6 Co-PVA-A were formulated with dry granulation method in sustained release tablet as matrix. Furthermore, the sustained release tablets were evaluated and the drug release profiles were studied. As results, substitution degree of CL6 Co-PVA-A 1:2, 1:1, and 2:1 are respectively 0.080; 0.069; and 0.086. Those excipients have good swelling capability and gel strength that are 5.02; 5.22; and 5.12 gf. All sustained release tablet passed the requirement of weight variation, hardness, friability, and assay. CL6 Co-PVA-A as matrices (F1, F2, and F3) showed first order (F1) and zero order (F2 and F3) drug release kinetics. This study suggested that the tablets can be applied as sustained release tablets and retard drug release up to 16 hours."

"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."

"Tablet lepas lambat merupakan tablet yang mampu memperlama pelepasan obat dalam saluran cerna untuk memperpanjang durasi kerja obat dengan menggunakan matriks sebagai salah satu komponen utamanya Penelitian ini bertujuan untuk memperoleh eksipien koproses polivinil alkohol amilosa tersambung silang ko PVA CLA6 sebagai matriks pada tablet lepas lambat Ko PVA CLA6 dihasilkan dengan cara koproses PVA dengan CLA6 dengan perbandingan 1 1 1 2 dan 2 1 Ko PVA CLA6 yang telah diperoleh dikarakterisasi sifat fisik kimia dan fungsionalnya Ko PVA CLA6 memiliki derajat subtitusi fosfat 0 0681 kemampuan mengembang yang cukup baik memiliki viskositas yang cukup besar tetapi dengan kekuatan gel yang lemah Tablet dengan matriks ko PVA CLA6 diformulasikan dengan metode granulasi kering dan seluruhnya memenuhi persyaratan evaluasi tablet Profil pelepasan natrium diklofenak dari tablet yang mengandung matriks ko PVA CLA6 dengan perbandingan 1 1 F1 1 2 F2 dan 2 1 F3 dalam medium basa dapar fosfat selama 8 jam menunjukkan profil pelepasan obat yang diperlambat Q 20 45 dengan kinetika pelepasan orde nol Oleh karena itu formula F1 F2 dan F3 dapat diaplikasikan sebagai formula sediaan tablet lepas lambat untuk pemakaian selama 32 jam.

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Sustained release tablet is the tablet which can retard drug release in gastro intestinal track to increase duration of drug effect This present research was intended to produce coprocessed excipient polivinyl alcohol cross linked amylose co PVA CLA6 as matrix for sustained release tablet Co PVA CLA6 was produced by coprocessing between PVA and CLA6 with a ratio of 1 1 1 2 and 2 1 The obtained coprocessed PVA CLA6 was characterized physically chemically and funtionally Coprocessed PVA CLA6 has subtitution degree of phosphate 0 0681 had good enough swelling index also high enough viscosity but low gel strenght Tablets with coprocessed PVA CLA6 as matrix was formulated by dry granulation method and passed tablet evaluations test The release profile of sodium diclofenac from tablet which contained matrix from coprocessed PVA CLA6 with a ratio 1 1 F1 1 2 F2 and 2 1 F3 in base medium of phosphate buffer for 8 hours showed the sustained release profile Q 20 45 which follow the zero order kinetic Thus F1 F2 and F3 tablets formulation could be applied as sustained release tablet formula and could retard drug release up to 32 hours."

"Tablet lepas lambat merupakan tablet yang didesain untuk dapat melepaskan zat aktif secara perlahan di dalam tubuh. Penelitian ini bertujuan untuk membuat dan mengkarakterisasi eksipien protein kedelai tersuksinilasi yang digunakan sebagai matriks dalam formulasi tablet lepas lambat dengan propranolol hidroklorida sebagai model obat. Konsentrat protein kedelai suksinat (PKS 1) diperoleh melaui cara esterifikasi konsentrat protein kedelai (PK) dengan anhidrida suksinat 100% b/b pada kondisi basa. PK dan PKS 1 dikarakterisasi secara fisik, kimia dan fungsional, kemudian diformulasikan menjadi matriks tablet lepas lambat dengan metode granulasi basah. Tablet lepas lambat yang dihasilkan dievaluasi dan dipelajari profil pelepasan obatnya. Hasil penelitian menunjukkan pita serapan pada bilangan gelombang 1653,05 cm-1; 1697,41 cm-1; 2359,02 cm-1 dan derajat substitusi PKS 1 sebesar 35,74 ± 0,38%. Eksipien tersebut menunjukkan kemampuan mengembang yang baik sebesar 35,38 ± 2,08% dalam HCl pH 1,2 dan 66,36 ± 2,12% dalam dapar fosfat pH 7,5. Profil pelepasan propranolol hidroklorida dari tablet lepas lambat yang mengandung PKS 1 sebagai pembentuk matriks (F1, F2, dan F3) menunjukkan profil pelepasan obat yang mengikuti persamaan Higuchi. Dari penelitian ini, dapat disimpulkan bahwa PKS 1 dapat digunakan sebagai eksipien pembentuk matriks pada tablet lepas lambat dan dapat digunakan untuk pemakaian 24 jam.

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Sustained release tablet is solid oral dosage form which is designed to release drugs slowly in the body. This research was conducted to produce and characterize the succinylated excipient of soybean protein as matrix for sustained release tablet formulation with propranolol hydrochloride as model drug. Soybean protein succinate (SPS 1) was obtained by esterification of soybean protein (SP) with anhydride succinic 100% b/b in alkaline solution. SP and SPS 1 were characterized physically, chemically, and functionally, then were formulated as matrix in sustained release tablet by wet granulation method. Furthermore, the sustained release tablets were evaluated and the drug release profiles were studied.

Characterization of excipient results showed a peak at the wave number 1653,05 cm-1; 1697,41 cm-1; 2359,02 cm-1 and substitution degree of PKS 1 is 35,74 ± 0,38%. That modified excipient show good swelling capability that are 35,38 ± 2,08% in medium HCl pH 1,2 and 66,36 ± 2,12% in medium buffer phosphate pH 7,5. Drug released profil of Propranolol hydrochloride from sustained release tablet which contain PKS 1 as matrices (F1, F2, and F3) showed Higuchi drug release kinetics. This study suggested that the PKS 1 can be applied as matrix for sustained release tablets and extend drug release up to 24 hours."

"Berdasarkan penelitian sebelumnya, eksipien sambung silang koproses xanthan gum-amilosa (CL-Ko-A-XG) berpotensi sebagai matriks dalam formulasi tablet lepas lambat. Penelitian ini bertujuan untuk mengetahui jumlah eksipien yang terdegradasi oleh α-amilase dan pengaruh α-amilase terhadap profil disolusi dari tablet lepas lambat yang menggunakan matriks CL-Ko-A-XG. Eksipien disambungsilang dengan dua konsentrasi natrium trimetafosfat, yaitu 6% (CL6-Ko-A-XG) dan 12% (CL12-Ko-A-XG). Tiap eksipien dibuat dengan tiga perbandingan amilosa-xanthan gum, antara lain 1:1, 1:2 dan 2:1. Uji degradasi enzimatik dilakukan dilakukan terhadap serbuk eksipien selama 60 menit. Selain itu, eksipien digunakan sebagai matriks tablet lepas lambat dan diformulasi dengan metode kempa langsung. Kemudian, dilakukan uji disolusi dalam medium dapar fosfat pH 7,4 dengan dan tanpa α-amylase selama 8 jam. Hasil penelitian ini menunjukkan bahwa eksipien CL6-Ko-A-XG dan CL12-Ko-A-XG terdegradasi sebesar 20% berturut-turut selama 10 dan 30 menit. Selain itu, tablet F1-F6 menunjukkan profil pelepasan obat diperlambat yang mengikuti kinetika pelepasan orde nol dan Korsmeyer-Peppas, dan tidak terpengaruh dengan adanya α-amylase. Dari penelitian ini, dapat disimpulkan bahwa eksipien CL-Ko-A-XG lebih tahan terhadap degradasi enzimatik dibandingkan amilosa. Oleh karena itu, eksipien ini berpotensi sebagai matriks tunggal tablet lepas lambat.

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Based on previous studies, cross-linked of coprocessed xanthan gum-amylose excipient (CL-Co-A-XG) has potential as a matrix in a sustained release tablet formulation. This study aims to determine amount of excipient that is degraded by α-amylase and influence of α-amylase to the dissolution profile of sustained release tablet that used matrix CL-Co-A-XG. Excipient is cross-linked with two concentration of sodium trimetaphospate, which is 6% (CL6-Co-A-XG) and 12% (CL12-Co-A-XG). Each excipient was made with ratio 1:1, 1:2 and 2:1 amylose-xanthan gum. Enzymatic degradation testhas been performed on excipient powder for 60 minutes. Beside that, sustained release tablet with CL-Co-A-XG excipient as matrix was formulated by direct compression method. Then, performed drug dissolution test in phosphate buffer pH 7.4 using and without α-amylase as medium for 8 hours. The results of this study showed that CL6-Co-A-XG and CL12-Co-A-XG were degraded 20% for 10 and 30 minutes. In addition, the release profile of F1-F6 tablets showed the sustained release profile which follow zero-order and Korsmeyer-Peppas kinetic, and not affected by presence of α-amylase. From this study, it can be concluded that the CL-Ko-A-XG excipients is more resistant from enzymatic degradation than amylose. Therefore, this excipient potential as a single matrix sustained release tablets."

"ABSTRAKKitosan merupakan polimer alam yang potensial untuk digunakan sebagai eksipien farmasi karena sifatnya yang biodegradabel dan tidak toksik. Penggunaan kitosan sebagai pembawa obat terbatas karena sifat kelarutannya yang hanya larut dalam asam. Untuk meningkatkan kelarutannya, dalam penelitian ini dilakukan modifikasi kimia terhadap kitosan menggunakan anhidrida suksinat. Kitosan suksinat yang diperoleh digunakan sebagai matriks pada sediaan tablet enterik dengan menggunakan natrium diklofenak sebagai model obat. Derajat substitusi kitosan suksinat yang diperoleh sebesar 3,65 mol/gram. Kitosan suksinat dapat larut dalam medium basa (pH ≥6,8) sehingga terbukti bahwa sintesis yang dilakukan memperluas kelarutan kitosan. Formulasi tablet natrium diklofenak dengan matriks kombinasi kitosan suksinat dan HPMCP (3,5 : 1) serta perbandingan jumlah zat aktif dengan polimer = 1:3, memenuhi persyaratan tablet enterik dan dapat digunakan untuk sediaan lepas lambat selama 32 jam.

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ABSTRACTChitosan is a potential natural polymer for application as a pharmaceutical excipient due to its biodegradable and not toxic characteristics. However, the use of chitosan as drug carriers is limited due to its solubility properties. In this study, chitosan succinate (CS) was synthesized from chitosan using succinic anhydride to improve the solubility. Then, CS was used as matrix in enteric tablet using diclofenac sodium as a model drug. The degree of substitution of CS was 3,65 mol / gram. The solubility study showed that CS could be dissolved in alkaline medium (pH ≥ 6,8). So, these study revealed that CS could increase the solubility of chitosan. The in vitro release study showed that the enteric tablet of F5 formulation could retarded drug release up to 32 hours. The enteric tablet of F5 was formulated using CS: HPMCP (3,5:1) matrix, which was 3 fold amount of drug. The result suggested that the formula have the potential to be applied as enteric and sustained release tablet. "

"ABSTRAKInsulin oral adalah alternatif pemberian insulin yang ideal karena nyaman bagi pasien. Kendala pada pemberian insulin oral adalah bioavailabilitas yang rendah. Bioavailabilitas insulin oral dapat ditingkatkan dengan penggunan nanopartikel berbasis polimer alami. Nanopartikel ini dapat diperoleh dari polimer sambungsilang gom xantan dan gom akasia dengan natrium trimetafosfat. Tujuan penelitian ini untuk mendapatkan sediaan insulin oral dari nanopartikel gom xantan dan gom akasia tersambungsilang. Pada penelitian ini nanopartikel insulin diperoleh dengan mencampur koloid gom xantan dan gom akasia dengan perbandingan 1:1 yang kemudian direaksikan dengan natrium trimetafosfat dalam suasana basa. Larutan insulin dalam HCl dimasukkan ke dalam koloid polimer dan dikeringkan dengan metode kering beku, sehingga diperoleh serbuk nanopartikel insulin. Serbuk nanopartikel insulin dikarakterisasi meliputi derajat substitusi DS , diameter partikel, efisiensi penjerapan, daya mengembang, uji pelepasan obat di in vitro, uji stabilitas dan uji in vivo. Hasil penelitian menunjukkan bahwa nanopartikel insulin yang terbentuk memiliki DS: 0,08 ndash; 0,10 dengan kadar obat 26,11 - 48,73 . Selain itu, nanopartikel insulin yang diperoleh memiliki nilai Dv90: 547 nm ndash; 746 nm, dan daya mengembang sebesar 2,9 kali dan 3,4 kali di dalam HCl pH 1,2 dan dapar fosfat pH 6,8. Hasil uji disolusi menunjukkan bahwa dalam 3 jam telah dilepaskan insulin sebanyak 78,42 - 85,67 . Hasil uji stabilitas pada suhu 4 oC menunjukkan bahwa kadar insulin dalam nanopartikel adalah 68,82 - 80,19 pada minggu ke-12. Hasil uji invivo menunjukkan bahwa pemberian nanopartikel insulin dapat menurunkan kadar gula darah sebesar 29,72 pada menit ke-120 dan memiliki bioavailabilitas sebesar 83,33 . Dari penelitian ini dapat disimpulkan bahwa nanopartikel gom xantan dan gom akasia tersambungsilang berpotensi untuk digunakan sebagai sistem penghantaran insulin oral.

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ABSTRACTOral insulin is an ideal alternative of insulin delivery method because it is convenient for the patient. One obstacle to the oral administration of insulin is its low bioavailability. Oral insulin bioavailability can be enhanced by the use of natural polymer based nanoparticles. Nanoparticle drug delivery system could be prepared by a cross linked polymer, which was composed of xanthan gum and acacia gum, and a cross linking agent of sodium trimetaphosphate. The aim of the present study was to produce insulin nanoparticles using the cross linked polymer of xanthan gum and acacia gum for oral delivery. In this study, insulin nanoparticles were prepared by mixing xanthan gum and acacia gum colloid with the ratio 1 1 and using sodium trimetaphosphate as a cross linking agent in bases condition. Afterwards, insulin solution in HCl was added into the colloid, and then dried to produce the insulin nanoparticles. Insulin nanoparticles powder was characterized in terms of degree of substitution DS , entrapment efficiency, particle size, swelling ability, in vitro release study, stability and in vivo study. The results showed that the substitution degree of the croslinked polymer of insulin nanoparticles was 0.08 ndash 0.10 and the entapment efficiency was 26.11 48.73 . Moreover, Dv90 of insulin nanoparticles was 547 nm 726 nm and the swelling ability was 2.9 and 3.4 fold in HCl solution pH 1.2 and phosphate buffer pH 6.8, respectively. According to the release study, the insulin nanoparticles provided the insulin release of 78.42 85.67 within 3 hours. Furthermor, the stability study at 4 oC showed that the remaining insulin was 68.82 80.19 during 12 weeks. Insulin nanoparticles could reduced glucose blood level on diabetic rat model up to 29.72 at minute 120 after treatment and had bioavailability of 83.33 . In conclusion this work demonstrate that the insulin nanoparticles composed of the cross linked polymer of xanthan gum acacia gum might be a potential oral insulin delivery. "

"Transdermal drug delivery system (TDDS) adalah sistem penghantaran obat yang digunakan pada permukaan kulit dengan tujuan sistemik. Untuk itu, diperlukan suatu eksipien pembentuk matriks transdermal yang dapat menghantarkan obat masuk ke dalam kulit. Penelitian ini bertujuan untuk mengembangkan eksipien koproses xanthan gum dan amilosa tersambungsilang-6 (Ko-CLA6-XG) sebagai matriks sediaan transdermal, kemudian dilakukan uji penetrasi secara in vitro dan in vivo. Ko-CLA6-XG diformulasikan dalam bentuk hidrogel dengan model obat natrium diklofenak. Uji penetrasi in vitro dilakukan menggunakan sel difusi Franz yang kemudian dianalisis dengan spektrofotometer UV. Uji in vivo dilakukan dengan cara mengaplikasikan satu gram hidrogel dengan luas aplikasi 1,13 cm2 di atas kulit tikus bagian abdomen, kemudian sampel darah dikumpulkan melalui sinus orbitalis mata dan dianalisis menggunakan kromatografi cair kinerja tinggi (KCKT). Hasil uji penetrasi in vitro menunjukkan jumlah kumulatif obat yang terpenetrasi ke dalam kulit hingga 12 jam sebanyak 1435 ± 180 µg cm-2 dengan fluks total sebesar 118,55 ± 23,01 µg cm-2 jam-1 (r=0,0994) dan waktu tunda selama 48,6 ± 15,6 menit. Profil pelepasan natrium diklofenak selama 12 jam pada uji in vivo mencapai konsentrasi puncak plasma sebesar 2236 ± 398 ng/ml pada 0,86 ± 0,21 jam dengan AUC sebesar 25273 ± 4133 ng ml-1 jam. Kedua hasil uji memberikan gambaran bahwa hidrogel mengandung natrium diklofenak dengan Ko-CLA6-XG sebagai matriks dapat dikembangkan untuk sediaan transdermal.

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Transdermal drug delivery system (TDDS) is the administration of therapeutic agents through the skin for systemic effect. Therefore, it requires an excipient for transdermal matrix-forming that can deliver drug across the skin. This present research was intended to develop the utilization of coprocessed excipient of xanthan gum and 6-cross-linked amylose (Co-CLA6-XG) as a matrix for transdermal and then evaluate the in vitro and in vivo penetration. Co-CLA6-XG was formulated as hydrogel with sodium diclofenac as a drug model. In vitro penetration study was evaluated using Franz diffusion cell analysed with spectrophotometre UV. The in vivo experiment was performed by applied one gram of hydrogel spread over 1,13 cm2 to the rat abdoment skin, then the blood samples were obtained from sinus orbitalis and analysed with high-performance liquid chromatography (HPLC). In vitro study records the cumulative drug permeated across the skin for 12 hours ranged 1435 ± 180 µg cm-2 and shows the transdermal flux 118,55 ± 23,01 µg cm-2 hours-1 (r = 0,994) with the lag time value ranged 48,6 ± 15,6 min. The release profile of sodium diclofenac for 12 hours in vivo reached a maximum peak of 2236 ± 398 ng/ml at 0,86 ± 0,21 hours with the AUC value was 25273 ± 4133 ng ml-1 hour. Thus diclofenaccontaining hydrogel using Co-CLA6-XG as a matrix could be developed as transdermal drug delivery."