Pengaruh Sistem Effervescent Dan Noneffervescent Terhadap Profil Disolusi Kapsul Floating Drug Delivery System (Fdds) Ranitidin

Palupi, RatriSeptyaning (2016) Pengaruh Sistem Effervescent Dan Noneffervescent Terhadap Profil Disolusi Kapsul Floating Drug Delivery System (Fdds) Ranitidin. Sarjana thesis, Universitas Brawijaya.

Abstract

Ranitidin merupakan antagonis reseptor histamin-2 yang memiliki bioavailabilitas absolut 50%, metabolismenya terjadi di kolon, waktu paruh 2,5-3 jam, serta dapat terjadi fluktuasi plasma pada pemberian dosis alternatif 300 mg (setara 336 mg ranitidin HCl). Karakteristik ini menyebabkan ranitidin perlu diformulasi menjadi sediaan lepas lambat, yaitu sistem penghantaran obat terapung (floating drug delivery system/FDDS). Penelitian ini bertujuan untuk mengetahui pengaruh sistem effervescent dan noneffervescent terhadap profil disolusi ranitidin HCl pada kapsul FDDS. Natrium alginat digunakan sebagai matriks polimer penghambat pelepasan obat dan natrium bikarbonat digunakan sebagai bahan pembentuk gas. Uji disolusi ranitidin HCl dari kapsul FDDS dilakukan menggunakan alat uji disolusi tipe 2 dengan media simulasi cairan lambung selama 8 jam. Durasi waktu terapung formula F1 dan F2 adalah 8 jam. Pelepasan ranitidin HCl formula F1 dan F2 pada jam ke delapan masing-masing adalah 97,813 ± 3,915% dan 110,311 ± 6,525%. Kinetika pelepasan obat formula F1 dan F2 cenderung mengikuti kinetika model Higuchi dan model Korsmeyer-Peppas. Hasil analisis statistik independent t-test menunjukkan bahwa terdapat perbedaan yang signifikan (p < 0,05) pada jumlah kumulatif ranitidin HCl yang dilepaskan dari jam ke-1 hingga ke-8 antara sistem effervescent dan noneffervescent. Disimpulkan bahwa kapsul FDDS ranitidin HCl dengan sistem effervescent lebih menghambat disolusi ranitidin HCl secara signifikan jika dibandingkan dengan sistem noneffervescent.

English Abstract

Ranitidine is a histamine-2 antagonist receptor that has 50% absolute bioavailability, metabolism mechanism that happens in the colon, half-life that is about 2,5-3 hours, and an alternative dose of 300 mg (equal to 336 mg ranitidine HCl) which can lead to plasma fluctuations. These characteristics make ranitidine needs to be formulated as sustained-release preparation, which is floating drug delivery system (FDDS). The purpose of this research was to find out the influence of effervescent and noneffervescent system to the dissolution profile of ranitidine FDDS capsules. Sodium alginate was used as polymer matrix drug release retardant and sodium bicarbonate was used as gas generating agent. Ranitidine HCl dissolution testing was determined using dissolution testing apparatus 2 with medium simulated gastric fluid for 8 hours. The floating time of formula F1 and F2 were 8 hours. The ranitidine HCl released percentage of formula F1 and F2 at eighth hours consequently were 97,813 ± 3,915% and 110,311± 6,525%. The drug release kinetics of formula F1 and F2 tend to follow Higuchi model and Korsmeyer-Peppas model. Independent t-test statistical analysis of the cumulative percentage of released ranitidine HCl from first to eighth hours showed a significant difference (p < 0,05) between effervescent and noneffervescent system. It can be concluded that compared to the noneffervescent system, ranitidine HCl FDDS capsule with effervescent system retarded more of ranitidine HCl dissolution.

Item Type: Thesis (Sarjana)
Identification Number: SKR/FK/2016/600/ 051610644
Subjects: 600 Technology (Applied sciences) > 615 Pharmacology and therapeutics > 615.1 Drugs (materia medica)
Divisions: Fakultas Kedokteran > Farmasi
Depositing User: Kustati
Date Deposited: 19 Oct 2016 13:31
Last Modified: 19 Oct 2016 13:31
URI: http://repository.ub.ac.id/id/eprint/126312
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