Skripsi

OPTIMASI DAN KARAKTERISASI DISPERSI PADAT KLARITROMISIN DENGAN VARIASI JUMLAH NATRIUM ALGINAT, KITOSAN, DAN RASIO BALL-TO-POWDER MENGGUNAKAN DESAIN FAKTORIAL

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This study aims to overcome the solubility and dissolution issues of clarithromycin through a co-grinding solid dispersion system using sodium alginate, chitosan, and variations in the ball-to-powder ratio (BPR). A 23 factorial design via Design-Expert®13 software was applied for the optimization process. The ANOVA results established sodium alginate as the most dominant factor (p < 0.0001) in controlling the micromeritic properties and solubility of the preparation. The optimum formula was achieved at a composition of 70 mg chitosan, 100 mg sodium alginate, and a 1:10 BPR. Characterization confirmed the transition from a crystalline to an amorphous phase (XRD) without incompatible chemical interactions (FTIR), along with modifications in particle morphology (SEM). The optimized solid dispersion provided an increase in saturated solubility to 0.948 mg/mL compared to pure clarithromycin at 0.00033 mg/mL. In vitro, the preparation exhibited an initial burst release with total release reaching 91.54% within 60 minutes compared to the pure substance at 76.66%, controlled by a surface erosion mechanism fitting the Hixson-Crowell model. Although the formulation successfully overcame the thermodynamic barrier of solubility through the formation of a polyelectrolyte complex, thermal stability testing indicated limitations. The amorphous preparation experienced significant progressive degradation upon exposure to repeated temperature fluctuations beyond three cycles, indicating the necessity for strict control over storage conditions. Keywords: chitosan, clarithromycin, sodium alginate, solid dispersion, factorial design.

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Detail Information

Series Title

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Call Number

T1956872026

Publisher

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

Collation

xxv, 141 hlm.; ilus.; 29 cm

Language

Indonesia

ISBN/ISSN

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Classification

615.190 7

Content Type

Text

Media Type

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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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