Skripsi

STUDI STABILITAS PROTRANSETOSOM KLINDAMISIN HCL DENGAN LIOPROTEKTAN TREHALOSA MENGGUNAKAN METODE ICH Q1A (R2)

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Penilaian

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Clindamycin HCl as a topical anti-acne drug has low bioavailability due to its hydrophilic nature which is difficult to penetrate the stratum corneum. Propionibacterium acnes, the main pathogen of acne, lives in the sebaceous glands in the dermis, so it requires deeper penetration. Transethosomes can increase penetration because they are classified as lipid nanovesicles with good elasticity and permeability. However, transethosomes have shortcoming in storage stability because they contain phospholipids which are easily degraded. This research aims to improve the stability of clindamycin HCl transethosomes through lyophilization and addition of trehalose as lyoprotectant. Trehalose is added at 5:1 to lipids to protect vesicles during lyophilization which involves extreme temperatures. The characterization results showed that the lyophilized transethosomes with trehalose can significantly improve the entrapment efficiency from 92.700% to 99.556% and the particle size from 343.667 nm to 219.300 nm; and maintain the polydispersity index from 0.513 to 0.547 and the zeta potential from -32.233 mV to -34.933 mV. The formula obtained was continued for ICH Q1A (R2) stability study and in vitro release study. Stability study showed that lyophilization and addition of trehalose can increase the shelf life of transethosomes from 28 days to 208 days at 25°C. Release study showed that protransethosomal gel has better and more sustained penetration than non-transethosomal gel by following zero-order release kinetics. Based on the research results, the development of transethosomes into protransethosomes through lyophilization and addition of trehalose can increase storage stability and penetration of clindamycin HCl into in vitro cell membrane.

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Availability

Inventory Code	Barcode	Call Number	Location	Status
2407000887	T138914	T1389142024	Central Library (References)	Available but not for loan - Not for Loan

Detail Information

Series Title

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Call Number

T1389142024

Publisher

Inderalaya : Prodi Ilmu Farmasi, Fakultas Matematika dan Ilmu Pengetahuan Alam., 2024

Collation

xvii, 99 hlm.; ilus.; 29 cm.

Language

Indonesia

ISBN/ISSN

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Classification

615.107

Content Type

Text

Media Type

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Carrier Type

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Edition

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Subject(s)

Prodi Ilmu Farmasi
Obat-obatan--Farmasi

Specific Detail Info

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Statement of Responsibility

MI

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