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OPTIMASI DAN KARAKTERISASI DISPERSI PADAT KLARITROMISIN DENGAN VARIASI JUMLAH NATRIUM ALGINAT, KITOSAN, DAN PENGARUH ALKALIZER MENGGUNAKAN METODE DESAIN FAKTORIAL

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Clarithromycin is a macrolide antibiotic classified as a biopharmaceutical classification system (BCS) class II drug with low solubility, which results in limited bioavailability. This study aimed to enhance the solubility of clarithromycin by formulating it into a solid dispersion system using sodium alginate and chitosan as polymer matrices, with the addition of an alkalizer to modify the microenvironmental pH. The development of the optimum solid dispersion formulation was carried out using Design Expert® software employing a 2³ factorial design, with sodium alginate, chitosan, and alkalizer as factors. The optimum formulation was determined based on the highest desirability value and the best characterization results, including compressibility index, Hausner ratio, assay, solubility, and moisture content. The optimization results showed that the optimum amounts of sodium alginate and chitosan were 100 mg and 70 mg, respectively, without the addition of an alkalizer, as evidenced by XRD analysis showing a reduction in crystallinity to 17.59%, a transformation of clarithromycin crystal morphology into an amorphous form based on SEM analysis, an increase in the percentage dissolved up to 92%, and an increase in percent transmittance in several dissolution media up to 96.68%. Stability testing demonstrated that the solid dispersion system was able to minimize decreases in assay, solubility, pH, and organoleptic properties up to the fifth cycle, while FTIR analysis indicated the absence of chemical bond formation between clarithromycin and the polymer matrices which is supported by the TLC results. Based on these results, the optimum clarithromycin solid dispersion formulation exhibited favorable characteristics and was able to enhance both the solubility and dissolution rate of clarithromycin. Keyword(s): alkalizer, chitosan, clarithromycin, sodium alginate, solid dispersion

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Detail Information

Series Title

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Call Number

T1956742026

Publisher

Indralaya : Prodi Ilmu Farmasi, Fakultas Matematika dan Ilmu Pengetahuan Alam Universitas Sriwijaya., 2026

Collation

xiv, 46 hlm.; ilus.; 29 cm

Language

Indonesia

ISBN/ISSN

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Classification

615.190 7

Content Type

Text

Media Type

-

Carrier Type

-

Edition

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Subject(s)

Prodi Ilmu Farmasi
Klaritromisin

Specific Detail Info

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Statement of Responsibility

TUTI

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