IN VITRO DRUG RELEASE STUDY OF CHLORAMPHENICOL IN SITU GEL WITH BASES MIXTURE OF POLOXAMER 407 AND HPMC BY OPTIMIZATION WITH FACTORIAL DESIGN

INSAN SUNAN KURNIAWANSYAH; TAOFIK RUSDIANA; HURIYATUS TSANIYAH; HANDRIAN RAMOKO; HABIBAH A. WAHAB; ANAS SUBARNAS

doi:10.22159/ijap.2021.v13s4.43829

Authors

INSAN SUNAN KURNIAWANSYAH Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
TAOFIK RUSDIANA Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
HURIYATUS TSANIYAH Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
HANDRIAN RAMOKO Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
HABIBAH A. WAHAB School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pulau Pinang, Malaysia
ANAS SUBARNAS Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia

DOI:

https://doi.org/10.22159/ijap.2021.v13s4.43829

Keywords:

Chloramphenicol, In situ gel, In vitro diffusion, Poloxamer 407, HPMC, Franz diffusion, Factorial design, Critical process parameters

Abstract

Objective: The objective of this study was to find the best base mixture composition (poloxamer 407 and HPMC) of chloramphenicol in situ gel formula based on in vitro property (Cumulative amount of drug release).

Methods: The in vitro diffusion of chloramphenicol in situ gel study was carried out using franz diffusion cells to know the effect of the Critical Process Parameters (CPPs) as independent variables (poloxamer 407 and hydroxypropyl methylcellulose (HPMC)) on the Critical Quality Attribute (CQA) as dependent variable (cumulative amount of drug release) with 2² factorial design.

Results: 2² factorial design of chloramphenicol in situ gel yielded 4 variations of poloxamer 407 and HPMC bases component in %w/v as follows, F1 (5:0.45), F2 (10:0.45) F3 (5:1) and F4 (10:1). The amount of drug release results from in vitro dissolution assay were 30.60% (F1), 45.64% (F2), 58.30% (F3), and 22.50%) (F4).

Conclusion: Formula 3 (F3) was considered as the best formula component in terms of in vitro assay of chloramphenicol in situ gel with a desirability value of 0.58.

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