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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."

"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."

"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."

"Eksipien koproses xanthan gum-amilosa tersambungsilang (Ko-CLA-XG) beresiko mengalami degradasi enzimatis oleh α-amilase. Hal ini dapat mempengaruhi pelepasan obat dalam matriks eksipien Ko-CLA-XG. Penelitian ini bertujuan untuk mengetahui degradasi enzimatis eksipien Ko-CLA-XG dan melihat pengaruh α-amilase pada profil disolusi tablet lepas lambat natrium diklofenak dengan matriks eksipien Ko-CLA-XG. Eksipien Ko-CLA-XG merupakan hasil koproses dari amilosa tersambungsilang dengan xanthan gum. Amilosa disambungsilang dengan menggunakan natrium trimetafosfat dalam konsentrasi 6% dan 12%. Eksipien Ko-CLA6-XG dan Ko-CLA12-XG dibuat dengan perbandingan 1:1, 1:2, dan 2:1 kemudian dilakukan uji degradasi enzimatis dengan metode iodin. Selanjutnya eksipien Ko-CLA-XG diformulasikan menjadi tablet lepas lambat dengan metode kempa langsung. Tablet lepas lambat yang dihasilkan dievaluasi dan dipelajari profil pelepasan obat dengan dan tanpa menggunakan α-amilase.Hasil penelitian menunjukkan derajat substitusi CLA6 dan CLA12 adalah 0,204 dan 0,319. Waktu untuk mendegradasi CLA sebanyak 20% dari eksipien Ko-CLA6-XG 1:1, 1:2, dan 2:1 berturut-turut adalah 28 menit, 43 menit, dan 24 menit serta eksipien Ko-CLA12-XG 1:1, 1:2, dan 2:1 berturut-turut adalah 44 menit, 45 menit, dan 36 menit. Seluruh tablet lepas lambat yang diformulasikan memenuhi persyaratan evaluasi tablet. Profil pelepasan tablet dengan matriks eksipien Ko-CLA-XG tidak terpengaruh oleh adanya α-amilase. Oleh karena itu, eksipien Ko-CLAXG dapat digunakan sebagai matriks tablet lepas lambat.

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Coproccessed xanthan gum-crosslinked amylose (Co-CLA-XG) excipients are at risk of enzymatic degradation by α-amylase. It may affect the drug release of tablets with Co-CLA-XG excipients matrices. This study aims to know the enzymatic degradation of Co-CLA-XG excipients and to view α-amylase effect on dissolution profile of sodium diclofenac sustained release tablet with Co-CLA-XG excipients matrices. Co-CLA-XG excipients is the result of crosslinked amylose and coproccessed with xanthan gum. Amylose was crosslinked using sodium trimetaphosphate, which is 6% and 12%. Co-CLA6-XG and Co-CLA12-XG excipients were made with a ratio of 1:1, 1:2, and 2:1 then evaluated for enzymatic degradation using iodine method. Afterward, Co-CLA-XG excipients were formulated into sustained release tablets by direct compression. Tablets were evaluated and studied drug release profile using and without α-amylase.

The results showed substitution degree of CLA6 and CLA12 were 0.204 and 0.319. Time to degrade 20% CLA for Co-CLA6-XG excipients 1:1, 1:2, and 2:1 were 28, 43, and 24 minutes with Co-CLA12-XG excipients 1:1, 1:2, and 2:1 were 44, 45, and 36 minutes. Tablets fulfilled tablet evaluation requirements. The release profile of tablets with Co-CLA-XG excipients matrices were not affected by α-amylase. Therefore, Co-CLA-XG excipients can be used as a sustained-release tablet matrices."

"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."

"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."

"Many type of starch from various plants can be exploited as an alternative for additional materials in tablet formulation. One of the source that have been developed as a pharmaceutical excipient is durian seed starch, which relatively easy to find in tropic area such as Indonesia. The objective of this research was to observe theability of durio seed starch as binder in wet granulation of ketoprofen tablet formulation. Durio seed starch obtained by extraction and drying methode. Starch as a paste used in wet granulation as a binder. Tablet made by wet granulation withketoprofen (25%) as a drug model; calcium phosphate dihidrate as a diluent; Avicel® PH 102 as a disintegrant; magnesium stearat (1%) and talc (2%) as a lubricant. Placebo formula with various durio seed starch concentration (5%, 6%, 8%, 10%) in tablet compared to other binder that is cassava starch. Placebo tablet formula withbetter hardness and friability used in ketoprofen tablet formula and compared to cassava starch as a binder with the same concentration. Formula with durio seed starch as binder have smaller hardness and more friable than cassava starch as a binder. Thereby tablet with durio seed starch as binder have faster disintegration time than tablet with cassava starch as a binder. The dissolution test for both ketoprofen formula did not meet the pharmacopeial requirements."

"The determination of pseudoephedrine hydrochloride and triprolidine hydrochloride in influenza syrup medicine has been performed using TLC densitometric method. Pseudoephedrine hydrochloride and triprolidine hydrochloride were extracted using chloroform at pH 12 from the syrup, and separated using HPTLC silica Kieselguhr glass plates 60 F 254, 20x10 cm2 as stationary phase, and a mixture of methanol, ammonia and chloroform (40:2:30) as mobile phase. The plates were analyzed using Camag TLC Scanner 3 with UV-detector at 257 nm for pseudoephedrine hydrochloride and at 290 nm for triprolidine hydrochloride. The results showed that the linearity, limit of detection, and limit of quantitation of the method for pseudoephedrine hydrochloride were 0.9999, 0.0064 ìg, and 0.2124 ìg respectively; while for triprolidine hydrochloride were 0.9999, 0.0076 ìg, and 0.0254 ìg respectively. The coefficient of variance (CV) of repeatability for the two substances were less than 2.0%; and the recovery values for pseudoepherine hydrochloride and triprolidine hydrochloride were 99.98 + 1.05% and 99.73 + 1,54% respectively. The result showed that the samples analysed contained pseudoephedrine hydrochloride 94.36% of the labeled ammount, and triprolidine hydrochloride 94.44% of the labeled ammount."

"Drugs stagnation is an effect of poor logistics systems in the health services industry, partycularly at the Public Health Centre. This was evident as drug stagnation at the "Puskesmas Mentikan KOta Mojokerto" for the 2005 year is stated at 15,44%...."

"Pada kesempatan hari ini yang merupakan tonggak dalam hidup saya, perkenankanlah saya mengemukakan isi hati saya, yang telah mengarahkan dan menggerakkan saya untuk mengabdi pada ilmu yang saya cintai, yaitu Farmakologi.Untuk hadirin yang mungkin tidak semua mengerti apa yang dimaksud dengan ilmu yang disebut Farmakologi ini, perlu saya jelaskan bahwa Farmakologi mempelajari kerja obat, sifat obat dan nasib obat di dalam mahluk hidup. Dengan sendirinya ilmu ini mempersoalkan efek baik dan buruk obat bila digunakan pada manusia maupun hewan. Farmakologi dalam konteks Fakultas Kedokteran (manusia) tentu menaruh tekanan pada pelayanan kesehatan masyarakat. Dengan adanya banyak masalah mengenai obat yang akan saya uraikan kemudian, jelaslah bahwa tidak hanya Farmakologi saja yang hams berperan tetapi pengelolaannya membutuhkan partisipasi dari berbagai instansi pemerintah maupun swasta serta profesi kesehatan dan masyarakat sendiri yang berkepentingan. Namun demikian Farmakologi, inherent dengan ilmu yang dipelajarinya, merupakan ilmu dasar dalam pengelolaan penggunaan obat, dan perlu mendapatkan fokus yang proporsional di Indonesia di masa mendatang."