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

ALZAHRA, DITA FATIMAH and Apriani, Elsa Fitria and Ahmadi, Adik (2024) STUDI STABILITAS PROTRANSETOSOM KLINDAMISIN HCL DENGAN LIOPROTEKTAN MANITOL MENGGUNAKAN METODE ICH Q1A (R2). Undergraduate thesis, Sriwijaya University.

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Abstract

The topical anti-acne preparation clindamycin HCl has low bioavailability (5-8%) because its hydrophilic makes it difficult to penetrate the stratum corneum where Propionibacterium acnes resides. Efforts have been made to increase the bioavailability of clindamycin HCl through development into transethosomes, but clindamycin HCl transethosomes have less than optimal stability (shelf life <30 days). This research focuses on increasing the stability of clindamycin HCl transethosomes through lyophilization and adding the lyoprotectant mannitol so that it transforms into clindamycin HCl protransethosomes. The addition of 5% mannitol aims to minimize the stress the nanovesicles experience during lyophilization because extreme temperatures are used in the process. Characterization showed significant differences, with transethosomes (F1) having a particle size ≤ 300 nm and polydispersity index ≤ 0,3, while protransethosomes (F2) and protransethosomes with mannitol (F3) were the opposite. The zeta potential of the three formulas did not different significantly. The results of the ICH Q1A (R2) stability test using the accelerated test method for 42 days showed that the shelf life of F3 (596,311 days) was longer than F1 (19,823 days) and F2 (172,982 days) at a temperature of 25°C. The results of the in vitro penetration test showed that the protransethosome gel had better penetration and faster release (release kinetics model zero-order) than the nonprotransethosome gel (release kinetics model Higuchi). Based on the research results, the clindamycin HCl protransethosome and the addition of mannitol had a positive influence on the characterization, stability, and penetration of the clindamycin HCl transethosome into in vitro cell membrane.

Item Type:	Thesis (Undergraduate)
Uncontrolled Keywords:	Kinetika pelepasan, klindamisin HCl, manitol, protransetosom, stabilitas
Subjects:	R Medicine > RS Pharmacy and materia medica > RS192-199 Pharmaceutical technology R Medicine > RS Pharmacy and materia medica > RS400-431 Pharmaceutical chemistry
Divisions:	08-Faculty of Mathematics and Natural Science > 48201-Pharmacy (S1)
Depositing User:	Dita Fatimah Alzahra
Date Deposited:	25 Jan 2024 02:06
Last Modified:	25 Jan 2024 02:06
URI:	http://repository.unsri.ac.id/id/eprint/139730

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