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"Penelitian ini bertujuan untuk membuat eksipien ko-proses dari campuran kappa dan iota karagenan pada perbandingan tertentu yang dikombinasi dengan pragelatinisasi pati singkong propionat (PPSP), selanjutnya mengkarakterisasi eksipien ko-proses dan menggunakannya dalam formulasi sediaan gastroretentif tablet mengapung.Pada penelitian ini, tablet dibuat dengan metode granulasi basah dan menggunakan famotidin sebagai model obat. Formulasi tablet mengapung dibuat dengan eksipien koproses karagenan dan PPSP dengan perbandingan tertentu. Daya mengembang dan keterapungan tablet mengapung dievaluasi. Pelepasan obat dari tablet mengapung diteliti dan dianalisa dengan menggunakan beberapa model persamaan kinetika.Hasil penelitian menunjukkan bahwa formula A dengan eksipien koproses karagenan : PPSP (1:1) sebanyak 60 % dengan HPMC 10% menghasilkan formula yang terbaik dengan waktu mengapung 11,42 ± 1,53 menit dengan lamanya keterapungan selama 20 jam. Formula tersebut juga menunjukkan profil pelepasan yang terkendali dengan model kinetika Higuchi serta mekanisme difusi non Fickian.

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The aim of this study was to make a coprocess excipients from the mixture of kappa and iota carrageenan on specific comparisons, combined with the pregelatinized cassava starch propionate (PPSP) , further characterized the coprocess excipients and used the formulation in processed gastroretentif preparation of floating tablet.In this study, tablets were made by wet granulation method and using famotidine as a model drug. Some formulations of floating tablets were prepared by varying the composition of the excipients coprossed carragenan with a certain ratio. The swelling and buoyancy of the floating tablets were evaluated. Furthermore, the drug release from the floating tablets were studied and analyzed using several models of kinetic equations.The results showed that formula A with excipients coprocessed carragenan (1:1) as much as 60% with 10% HPMC produce the best formula and floating lag time 11.42 ± 1.53 minutes and total floating time for 22 hours. The formula also revealed a profile of controlled drug release and approached to Higuchi kinetics model and the non Fickian diffusion mechanism."

"Pregelatinisasi pati singkong (PPS) mempunyai kemampuan mengembang yang baik akan tetapi daya ikatnya rendah,sehingga menyebabkan tablet menjadi rapuh, khususnya pada tablet cepat hancur. Untuk mengatasi kekurangan tersebut diantaranya adalah melalui modifikasi PPS dengan metode koproses. Tujuan dari penelitian ini adalah membuat koprosesdari (PPS) dengan hidroksi propil metil selulosa(HPMC) yang selanjutnya digunakan dalam formulasi tablet cepat hancur. Pada penelitian ini eksipien koproses dibuat dengan menggabungkan suspensi PPS dalam air dengan suspensi HPMC dalam air pada perbandingan 6:1, selanjutnya dikeringkan dengan drum dryer. Terhadap eksipien yang dihasilkan dilakukan evaluasi, selanjutnya digunakan dalam formulasi tablet cepat hancur. Proses pembuatan tablet menggunakan metode granulasi basah. Tablet cepat hancur dibuat 4 formula (formula ABCD), tablet yang dihasilkan dievaluasi sifat fisiknya yang meliputi kekerasan, keregasan, waktu pembasahan, waktu hancur sesuai dengan persyaratantablet cepat hancur yang baik. Hasil evaluasi tablet yang dihasilkan menunjukkan hanya formula D yang dapat hancur sesuai dengan ketentuan Farmakope Eropa yaitu kurang dari 3 menit (88,16 ±10,61 detik), serta memiliki karakteristik sebagai berikut; kekerasan 1,73 kp ± 0,32, keregasan 0,69 ± 003,waktu pembasahan 142,66 ± 8,02 detik. Dapat disimpulkan bahwa hanya formula D memenuhi persyaratan tablet cepat hancur,baik sifat fisik maupun waktu hancur tablet.

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Pragelatinized cassava starch (PCS) has a good ability to swelled but low binding capacity in tablet formulation, that causing the tablet to become brittle, especially in fast disintegrating tablets. To overcome the lack of them is through the modification of the PCS with the coprocess method. The purpose of this research was to create coprocess excipient from PCS with hydroxy propyl methyl cellulose (HPMC), then it was used in fast disintegrating tablets formulations by wet granulation method.

In this study an excipient coprocess was made by combining of PPS suspension in water with of HPMC suspension in water at a ratio of 6: 1, then dried with drum dryer. The excipient product was characterized of physical properties. After that, it used in fast disintegrating tablets formulations. The process of making the tablets was by wet granulation method in 4 formula (ABCD formula). The fast disintegrating tablets product was evaluated physical properties which include hardness, friability, wetting time, disintegrating time, in accordance with the requirements of a good fast disintegrating tablets.

The results of the evaluation of the resulting tablets indicate only formula D that can be disintegrated in accordance with the European Pharmacopoeia, which is less than 3 minutes (88,16 ± 10,61second), beside that another properties were; hardness 1.73 ± 0.32 kp, friability ± 0.69 003, wetting time 142,66 ± 8.02 seconds. The conclusion is formula D eligible as fast disintegrating tablets, not only physical properties but also disintegrating time."

"Pregelatinisasi pati singkong propionat (PPSP) merupakan hasil modifikasi fisika dan kimia pati singkong, yang diperoleh dengan mereaksikan pregelatinisasi pati singkong dengan asam propionat anhidrida. Penelitian ini bertujuan untuk mengetahui karakteristik eksipien koproses yang dihasilkan dari kombinasi PPSP dengan campuran kappa dan iota karagenan (1:1) dapat digunakan sebagai eksipien dalam sediaan farmasi. Karakteristik yang dilakukan adalah karakteristik fisika, kimia dan fungsional. Koproses PPSP dengan karagenan dibuat dari campuran kappa dan iota karagenan (1:1) dengan tiga perbandingan yaitu koproses A (1:1), B (2:1), dan C (3:1) kemudian dikarakterisasi. Berdasarkan evaluasi, koproses C (PPSP: [karagenan kappa: iota karagenan = 1:1] (3:1)) dapat digunakan sebagai eksipien sediaan lepas terkendali.

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Pregelatinized cassava starch propionic (PPSP) is a result of physical and chemical modification of cassava starch, which is obtained by reacting cassava starch with propionic anhydride acid. The aimed of this study is to know the characterictics of coprocessed exipient which is produced from combining pregelatinized cassava starch propionic with carrageenan (kappa:iota (1:1)) can be used as an excipient in pharmaceutical dosage forms. The characterictics of being done is characteristic of physical, chemical and functional. Coprocess ppsp with carrageenan (kappa:iota (1:1)) was made with three ratio A (1:1), B (2:1), and C (3:1), after that coprocessed is characterictics. Based on the evaluation, coprocess C (PPSP: [carrageenan kappa:iota carrageenan = 1:1] (3:1)) can be used as a controlled release dosage excipient."

"[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.]"

"Sediaan tertahan di lambung (gastroretentive) merupakan sediaan yang didesain untuk dapat memperpanjang waktu tinggal sediaan di lambung yang merupakan salah satu tempat terjadinya absorbsi obat di dalam tubuh. Sistem penghantaran mukoadhesif merupakan salah satu bentuk sediaan tersebut dengan mekanisme penempelan pada mukosa lambung. Oleh karena itu pengembangkan eksipien baru untuk bentuk sediaan tersebut perlu untuk dilakukan.Penelitian ini bertujuan untuk melihat kemampuan eksipien koproses pragelatinasi pati singkong propionat (PPSP) dan karagenan sebagai matriks sediaan mukoadhesif tertahan di lambung. Pembuatan eksipien koproses ini didahului dengan pembuatan PPSP menggunakan anhidrida asam propionat sebagai agen pensubtitusi gugus alkilnya. Kemudian di koproses dengan campuran kappa-iota karagenan (1:1) dengan perbandingan campuran kappa-iota karagenan (1:1) : PPSP 1:1, 1:2 dan 1:3.Hasil karakterisasi eksipien koproses menunjukan peningkatan viskositas dan kemampuan bioadhesif dibandingkan dengan eksipien penyusunnya. Eksipien koproses yang dihasilkan tersebut kemudian dibuat sediaan granul mukoadhesif. Granul mukoadhesif berbahan dasar eksipien koproses (F1, F2 dan F3) dan berbahan dasar PPSP (F4) serta karagenan (F5) dapat menempel pada mukosa lambung dan mengatur pelepasan obat hingga 32 jam untuk F1, F2, F3 dan F5, sedangkan 16 jam untuk F4. Granul F3 yang berbahan dasar eksipien koproses C memiliki kekuatan mukoadhesif pada mukosa lambung paling besar yaitu 5,2 gF dan dapat bertahan selama 10 jam pada uji bioadhesif in vitro dan 3 jam pada uji wash off, serta memiliki kadar obat dalam lambung tertinggi pada jam ke-1, 2 dan 4 yaitu berturut-turut 92,19%; 76,84%; 47,33% pada uji bioadhesif in vivo. Sebagai kesimpulan, penelitian ini memberikan gambaran bahwa eksipien koproses C yang merupakan campuran PPSP dengan karaginan kappa-iota (1:1) dengan ratio 3:1 berpotensi untuk digunakan sebagai polimer bioadhesif.

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Gastroretentive dosage form has been designed to prolong gastric residence time of drug delivery system, mucoadhesive is one of of kind of them which is retained dosage form on the stomach with adhesiveness, so development in excipient for gastroretentive dosage form is needed.The purpose of the present study was to develop and characterize coprocessed excipient pregelatinized cassava starch propionate (PCSP) and carrageenan. Coprocessed excipient product consists of carrageenan (kappa-iota = 1:1) and PCSP in ratio 1:1, 1:2 and 1:3. PCSP was prepared with propionic anhydride in aqueous medium. The product was mixed with carragenan (kappa-iota = 1:1), and characterized physicochemical and functional properties. After that, the coprocessed excipient was used as mucoadhesive granules. Granules F1, F2 and F3 were made from coprocessed excipient while granules F4 and F5 were made from PCSP and carrageenan respectively.The result of these studies indicated that coprocessed excipient carrageenan-PCSP is suitable material for gastroretentive dosage form and drug controlled release. All formula of granules can adhere to gastric mucus and can controlled drug release for 32 hours for F!, F2, F3 and F3, while 16 hours for F4. The F3 granules were made from excipient coprocessed C have highest mukoadhesive properties on stomach, still remain for 10 hours in bioadhesive in vitro test and 3 hours in wash off test and also have highest percentage drug on the stomach at 1st, 2nd and 4th hours with values 92,19%; 76,84%; 47,33% respectively.pada uji bioadhesif in vivo. These results suggested that excipient coprocessed C were a promising polimer for gastroretentive dosage form."

"ABSTRAKFilm bukal merupakan alternatif bagi sediaan oral yang membutuhkan polimer pembentuk film dengan sifat mekanik dan mukoadesif yang baik. Penelitian ini bertujuan untuk mendapatkan eksipien koproses dari pragelatinisasi pati singkong fosfat PPSF dan karaginan dengan perbandingan terbaik; serta memformulasi dan mengkarakterisasi film bukal yang dibuat dari eksipien koproses tersebut. PPSF merupakan eksipien modifikasi dari pati singkong yang digelatinisasi sebagian dan kemudian fosforilasi pada kondisi basa pH 9-10 . Selanjutnya PPSF bersama karaginan dibuat menjadi eksipien koproses dengan perbandingan 1:1; 2:1; 3:1; dan 1:2. Hasil penelitian menunjukkan bahwa eksipien koproses PPSF-karaginan 1:1 memiliki sifat mukoadesif yang baik, dengan kekuatan mukoadesif 5,94 1.128 gF dan waktu mukoadesif 118,3 2,22 menit. Selanjutnya eksipien koproses PPSF-karaginan 1:1 tersebut digunakan sebagai pembentuk film bukal dengan salbutamol sebagai model obat. Karakteristik film bukal salbutamol yang dihasilkan yaitu ketebalan 11,23 0,21 m, kekuatan peregangan 0,18 N/mm2 dan elongasi 81,38 15,03 . Selain itu, pelepasan salbutamol sulfat dari film bukal mencapai 72,93 1,81 selama 19 menit. Dapat disimpulkan bahwa eksipien koproses PPSF-karaginan yang dihasilkan dapat digunakan sebagai eksipien pembentuk film bukal dengan pelepasan obat segera.

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ABSTRACTBuccal film is an alternative oral dosage form which is required film forming polymer with a good mechanical and mucoadhesive properties. The purposes of present study were to optimize the best ratio of pregelatinized cassava starch phosphate and carrageenan to obtain coprocess excipient, as well as formulate and characterize the film based on the coprocess excipent. Pregelatinized cassava starch phosphate PCSP is a physically and chemically modified excipient with partial gelatinization and phosphorylation in alkaline condition pH 9 10 . Then, PCSP was co processed with carrageenan in the ratio 1 1, 2 1 3 1, and 1 2. The results showed that tensile strength and mucoadhesion time of the coprocess excipient of PCSP Carrageenan 1 1 were 5.94 1.128 gF and 118.3 2.22 minutes, respectively. It revealed that the coprocess excipient had good mucoadhesive properties. Moreover, the coprocess excipient of PCSP Carrageenan 1 1 was used as film forming in buccal film formulation and salbutamol as a drug model. The resulted film had the thickness, the tensile strength, and the elongation were 11.23 0.21 m, 0.18 N mm2, 81.38 15.03 , respectively. Furthermore, the release profile of salbutamol sulfate from the films showed the fast release, which was 72.93 1.81 released during 19 minutes. It is concluded that the coprocess excipient of PCSP Carrageenan could be applied as an excipient of buccal film for immediate release purpose."

"Koproses merupakan suatu konsep baru dari dua atau lebih eksipien yang berinteraksi pada tingkat subpartikel. Tujuan koproses adalah meningkatkan fungsionalitas bahan secara sinergis dan menutupi sifat yang tidak diinginkan dari masing-masing eksipien. Pada penelitian ini tujuan dilakukannya koproses adalah untuk meningkatkan fungsi pati sebagai bahan penyalut dalam industri farmasi dikombinasi dengan Na-CMC untuk menghasilkan sediaan lepas terkendali. Koproses PPS-CMC dibuat dengan cara mengkombinasikan PPS dan Na-CMC dengan rasio 2:1, 3:1, dan 4:1 kemudian dikarakterisasi. Koproses PPS-CMC yang dipilih sebagai bahan penyalut adalah perbandingan 4:1. PPS-CMC koproses 4:1 dapat digunakan sebagai bahan penyalut yang mengendalikan pelepasan obat selama 6 jam pada tiga kali penyalutan.

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Coprocessing is a novel concept involves interactions of two or more excipients at the subparticle level. The aimed of coprocessed are providing a synergy of functionality improvements as well as masking the undesirable properties of the individual excipients. The aimed of this study is using coprocessed to improve starch function as a film former combine with sodium carboxymethylcellulose (SCMC) to make controlled release products.

Coprocessed pregelatinized starch-SCMC is the result of combining pregelatinized starch and SCMC in ratio 2:1, 3:1, and 4:1, after that the coprocessed is characterized. The well-chosen coprocessed as a film former is ratio 4:1. Coprocessed pregelatinized starch-SCMC 4:1 can be used as film former to controlling the release of drugs for 6 hours for three times coating."

"Koproses merupakan suatu konsep baru dari dua atau lebih eksipien yang berinteraksi pada tingkat subpartikel. Tujuan koproses adalah meningkatkan fungsionalitas secara sinergis dan menutupi sifat tidak diinginkan dari masing-masing eksipien. Koproses dapat dilakukan untuk meningkatkan fungsi pati sebagai bahan penyalut dalam industri farmasi dikombinasi dengan etil selulosa untuk menghasilkan sediaan lepas terkendali. Eksipien koproses pragelatinisasi pati singkong (PPS) - etil selulosa (EC) dibuat dengan cara mengkombinasikan PPS dan EC dengan rasio 2:1, 3:1, dan 4:1 kemudian dikarakterisasi. Eksipien koproses PPS-EC yang dipilih sebagai bahan penyalut adalah perbandingan 4:1. Eksipien koproses PPS-EC 4:1 dapat digunakan sebagai bahan penyalut yang mengendalikan pelepasan obat.

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Co-process is a new concept of two or more excipients that interact at the level of sub-particles. The purpose of co-process is to improve the functionality co-process synergistically and cover unwanted nature of each excipients. Co-process can be done to improve the function of starch as an ingredient in the pharmaceutical industry coated combined with ethyl cellulose to produce off the preparation of control. Pregelatinized cassava starch (PCS) - ethyl cellulose (EC) co-process excipients is made by combining PCS and EC by a ratio of 2:1, 3:1, and 4:1 and characterized. PCS-EC co-process excipients selected as coated material is 4:1 ratio. PCS-EC co-process excipients 4:1 can be used as a coating tablet."

"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."