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"ABSTRAK Kitosan merupakan polimer alam yang bersifat kationik. Sifat kationik tersebutmembuat kitosan dapat berinteraksi dengan polimer anionik membentukkompleks polielektrolit (KPE). Dalam penelitian ini, pektin digunakan sebagaipolimer anionik yang berinteraksi secara ionik dengan kitosan. Tujuan daripenelitian ini adalah membuat dan mengkarakterisasi KPE kitosan-pektin yangakan digunakan sebagai matriks dalam sediaan tablet mengapung. Larutan kitosandan pektin 0,3% b/v dicampur dengan perbandingan 1:9, 3:7, 1:1, 7:3 dan 9:1pada pH 4,5 dan 5,0. Kondisi terbaik untuk menghasilkan KPE adalah pada pH5,0 dengan perbandingan larutan kitosan dan pektin = 3:7. Perbedaan karakteristikKPE kitosan-pektin dengan polimer asalnya ditunjukkan dengan analisis gugusfungsi, analisis termal, daya mengembang dan kekuatan gel. Selanjutnya KPEdigunakan sebagai matriks dalam sediaan tablet mengapung dengan famotidinsebagai model obat. KPE juga dikombinasikan dengan hidroksipropilmetilselulosa(HPMC) dengan konsentrasi yang berbeda-beda. Hasil uji disolusi menunjukkanbahwa KPE dapat menahan pelepasan famotidin selama 10 jam. Kombinasidengan HPMC dapat membantu KPE menahan pelepasan famotidin hingga 20jam. Tablet yang hanya mengandung KPE sebagai matriks hanya dapat bertahanmengapung hingga 12 jam, sedangkan tablet dengan kombinasi KPE dan HPMCdapat bertahan mengapung hingga 24 jam.

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ABSTRACT Chitosan is a natural cationic polymer. That cationic property makes chitosan can form polyelectrolite complex (PEC) with anionic polymer. In this research, pectin was used as anionic polymer that interact ionically with chitosan. The aim of this research is to produce and characterize chitosan-pectin PEC that would be used as matrix in floating tablet. The solutions of chitosan and pectin 0,3% w/v were mixed in ratio 1:9, 3:7, 1:1, 7:3 and 9:1 with pH of the solution 4,5 and 5,0. The best condition to produce PEC was in pH 5,0 with ratio of chitosan and pectin = 3:7. The differences between chitosan-pectin PEC characteristic and its origin polymer were shown by functional group analysis, thermal analysis, swelling capacity and gel strength. The PEC was then used as matrix in floating tablet with famotidin as a model. PEC was also combined with hydroxypropilmethylcellulose (HPMC) in different concentrations. The results of the dissolution study showed that PEC could retard the release of famotidin for 10 hours. PEC in combination with HPMC could retard the release of famotidin for 20 hours. Tablet that only contains PEC as matrix could remain buoyant for 12 hours while tablet with combination of PEC and HPMC could remain buoyant for 24 hours. "

"ABSTRAK Kombinasi eksipien secara fisika lebih menguntungkan dibandingkan dengan kombinasi secara kimia karena lebih praktis dan memerlukan lebih sedikit persyaratan uji dalam proses pengembangan produk. Koproses merupakan salah satu metode kombinasi eksipien secara fisika untuk meningkatkan sifat fungsional. Penelitian ini bertujuan untuk mengkarakterisasi eksipien hasil koproses antara kitosan dengan sodium starch glycolate (SSG) dan mengaplikasikannya pada sediaan tablet mengapung. Eksipien koproses dibuat dengan mencampur kitosan 5% b/v dalam asam asetat 0,5 N dan SSG 5% b/v dalam akuades suhu 70°C dengan perbandingan 1:1, 1:2, dan 1:3. Campuran dikeringkan dengan double drum dryer. Eksipien koproses digunakan sebagai matriks pada tablet mengapung yang dibuat dengan metode granulasi basah dan menggunakan sistem effervescent. Tablet mengapung juga dibuat dengan matriks kombinasi campuran fisik eksipien koproses dan HPMC dengan perbandingan 1:1, 2:1, dan 3:1. Hasilnya menunjukkan bahwa eksipien koproses kitosan-SSG memiliki daya mengembang yang lebih besar dari masing-masing maupun campuran fisik eksipien penyusunnya. Tablet dengan matriks eksipien koproses memiliki kemampuan menahan pelepasan obat selama 10 jam dan dapat mengapung selama 12 jam. Penambahan HPMC dapat meningkatkan kemampuan menahan pelepasan obat hingga 20 jam dan meningkatkan kemampuan mengapung tablet hingga lebih dari 24 jam.

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ABSTRACT Physical combination ofexcipients is more benefit than chemical one because it is more practical and needs less stages of regulatory during the development phase Co-processing is one of physical combination method to improve the functional characteristics of excipients. The aims of this research were to characterize excipient resulted from co processing chitosan with sodium starch glycolate (SSG) and to apply the excipient on floating tablet. The co-processed excipientwas made by mixing chitosan 5% w/v in acetic acid 0,5 N with SSG 5% w/v in 7o°C aquadest. The mixture was dried by double drum dryer. The co-processedexcipient was used as matrix in floating tablet prepared by wet granulation method and effervescent system. The floating tablet was also made with matrix of physical mixture combination of the co-processed excipient and HPMC in ratio 1:1, 2:1, and 3:1. The result showed that the co-processed excipient has greaterswelling capacity compared with both its individual and physical mixture of the comprising materials. The tablet with co-processed excipient matrix has ability to retard drug release for 10 hours and could float for 12 hours long. HPMC notonly could improve the ability to retard drug release for 2o hours but also improve+hofioat nti124h "

"Sediaan mengapung multi unit famotidin dikembangkan untuk memperpanjang waktu tinggal obat di dalam lambung yang ditujukan untuk pengobatan tukak lambung. Formulasi beads mengapung ini dibuat dengan cara mendispersikan famotidin dan kalsium karbonat ke dalam campuran larutan natrium alginat dan hidroksipropilmetilselulosa (HPMC). Larutan tersebut kemudian diteteskan ke dalam larutan 5% CaCl2 yang mengandung 10% asam asetat dengan menggunakan syringe needle dengan ukuran 22-G, 25-G, dan 27-G. Beads kalsium alginat terbentuk karena terjadinya gelasi ion dengan adanya ion kalsium, sedangkan gas karbon dioksida terbentuk karena terjadinya reaksi antara garam karbonat dengan asam asetat. Terbentuknya gas ini akan menghasilkan poros dan menyebabkan beads dapat mengapung. Pada penelitian ini, beads yang dihasilkan dapat mengapung selama lebih dari 24 jam. Beads dengan ukuran 22-G memiliki penjerapan dan daya mengembang terbesar. Persentasi penjerapan beads 22-G adalah sebesar 11,41% dan mampu mengembang hingga 4 kalinya. Namun sediaan yang dihasilkan tidak dapat dijadikan sebagai sediaan lepas lambat karena profil pelepasan obatnya yang sangat cepat.

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A multiple-unit-type oral floating dosage form of famotidine was developed to prolong gastric residence time, target peptic ulcer. The floating beads formulations were prepared by dispersing famotidine together with calcium carbonate into a mixture of sodium alginate and hydroxypropyl methylcellulose (HPMC) solution. The resulting solution was dropped through 22-G, 25-G, and 27-G syringe needle into 5% CaCl2 solution containing 10% acetic acid. Calcium alginate beads were formed, as alginate undergoes ionotropic gelation by calcium ions and carbon dioxide develops from the reaction of carbonate salts with acetic acid. The evolving gas permeated, leaving pores, which provided the beads buoyancy. The result of this study, the prepared beads have excellent floating ability over period of 24 hours. The 22-G beads have the largest entrapment efficiency and swelling ability. The percent entrapment efficiency of 22-G beads was 11,41% and swelling up to 4 times. Nevertheless, these beads cannot be used as sustained release dosage form due to its rapidly in releasing drugs."

"[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.]"