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All Journal Science and Technology Indonesia Pharmaceutical And Biomedical Sciences Journal (PBSJ)
Gumala, Azhoma
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Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Environmental Science Health Professions Materials Science & Nanotechnology Medicine & Pharmacology Physics Public Health

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Amine-Functionalized Mesoporous Silica SBA-15 for Enhanced Solubility and Release Rate of Gliclazide Sayyidina, Fasqina; Gumala, Azhoma; Zaini, Erizal; Hanifa, Dini; Hasanah, Uswatul
Science and Technology Indonesia Vol. 10 No. 3 (2025): July
Publisher : Research Center of Inorganic Materials and Coordination Complexes, FMIPA Universitas Sriwijaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.26554/sti.2025.10.3.963-971

Abstract

Gliclazide (GLI), a sulfonylurea-class antidiabetic drug, exhibits poor aqueous solubility, limiting its bioavailability. This study aimed to enhance gliclazide’s solubility and dissolution rate by adsorbing it into mesoporous silica SBA-15 and amine-functionalized SBA-15 (SBA-15-A). SBA-15 was synthesized using Pluronic® P123 as a template and tetraethyl orthosilicate (TEOS) as the silica precursor, while 3-aminopropyltriethoxysilane (APTES) was used to introduce amine functional groups. Gliclazide was loaded into SBA-15 and SBA-15-A at a 1:3 mass ratio. The materials (GLI, SBA-15, SBA-15-A, GLI-SBA, and GLI-SBA-A) were characterized using nitrogen adsorption-desorption isotherms, differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM), transmission electron microscopy (TEM), and powder X-ray diffraction (PXRD). Characterization revealed that the pore diameters of SBA-15 and SBA-15-A were 6.079 nm and 5.483 nm, respectively. FT-IR confirmed the interaction between gliclazide and the mesoporous carriers. SEM and TEM analysis showed crystalline gliclazide and rod-shaped morphologies for the mesopores samples. DSC and PXRD results indicated that most of the gliclazide had been converted to an amorphous form. Solubility testing over 24 hours showed that GLI-SBA and GLI-SBA-A improved gliclazide solubility by 1.375- and 2.334-fold, respectively, compared to pure gliclazide. Dissolution testing in distilled water revealed a 6.033-fold and 3.887-fold increase in the release rate at 5 minutes for GLI-SBA and GLI-SBA-A, respectively. Both solubility and release rate improvements were statistically significant (p <0.05). These findings suggest that amine functionalization of SBA-15 effectively enhances the solubility and dissolution rate of gliclazide.
Perbandingan Mutu dan Profil Disolusi Tablet Griseofulvin Merek Dagang Generik Gumala, Azhoma; Lucida, Henny; Salman, Salman
Pharmaceutical and Biomedical Sciences Journal (PBSJ) Vol. 4 No. 2 (2022)
Publisher : Pharmaceutical and Biomedical Sciences Journal (PBSJ)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.15408/pbsj.v4i2.29982

Abstract

Abstract: Griseofulvin is an active pharmaceutical ingredient in Biopharmaceutic Classification Systems Class II and the price of the dosage form from commercial brands four times higher than the generic.  A comparative study on physical properties and dissolution profiles between generic and commercial brands of griseofulvin tablets has been conducted to assess whether there is difference between their qualities. The pharmaceutical properties were assessed based on the Indonesian and the United State Pharmacopeias. Results showed that the tablets fulfilled the requirements for size uniformity, weight uniformity (0.5995± 0.0075) gram - (0.6989±0.0080) gram, friability 0.08-1.10 %, hardness (10±0.7746) - (19.6±0.9165) kg/cm2, disintegration time 07.12 - 17.17 minutes with drug content of 94.20 - 99.67%. The commercial brand griseofulvin tablets A1& A2 and generic B1 met the official specification for physical characteristics. Results of dissolution test for commercial brand A1 & A2 and generic B1 showed that griseofulvin had T60min (Q ≤ 70%) and the dissolution test profiles did not follow neither first order, Higuchi, Korsmeyer Peppas, nor Langenbucher kinetic models (r < 0,95). The dissolution test for griseofulvin tablet A1 met the USP specification, T90min (Q ≥ 75%) with the release mechanism follow Langenbucher kinetic model. Abstrak: Griseofulvin merupakan zat aktif golongan Sistem Klasifikasi Biofarmasetik kelas II dengan perbedaan harga antara tablet merek dagang lebih mahal hingga empat kalinya dibandingkan tablet generik. Uji disolusi terbanding dilakukan untuk melihat adakah perbedaan mutu yang signifikan antar tablet tersebut. Metode evaluasi mutu dilakukan sesuai dengan ketentuan Farmakope Indonesia dan USP. Hasil evaluasi mutu fisik tablet meliputi keseragaman ukuran, keseragaman bobot yaitu (0,5995± 0,0075) – (0,6989±0,0080) gram, kerapuhan 0,08 - 1,10%, kekerasan (10±0,7746) - (19,6±0,9165) kg/cm2, & waktu hancur  07.12 - 17.17 menit dan penetapan kadar  94,20 - 99,67%, memenuhi ketentuan Farmakope Indonesia. Profil disolusi tidak mengikuti model kinetika orde satu, Higuchi, Korsmeyer Peppas, ataupun Langenbucher (r < 0,95). Hasil uji disolusi tablet A1 yang dilakukan berdasarkan  USP memenuhi persyaratan T90 min  (Q ≥ 75%) dan memiliki profil disolusi mengikuti  persamaan Langenbucher (r>0,95). Keywords: Profil disolusi, tablet griseofulvin, mutu tablet, model matematika
Co-Authors DINI HANIFA, DINI Erizal Zaini Henny Lucida Salman Salman Sayyidina, Fasqina Uswatul Hasanah, Uswatul