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Formulation of extended release cefpodoxime proxetil chitosan-alginate beads using quality by design approach.

Abstract：

:The purpose of this work was to develop and characterize chitosan-alginate beads for the extended delivery of cefpodoxime proxetil (CFP), to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design approach. For this, a study was performed with various formulation and process parameters to determine their impact on CQAs of beads, which were determined to be time for 80% of the drug released (T80%), particle size, and encapsulation efficiency. The beads of CFP were optimized using a three-factor, three-level Box-Behnken design. A formulation comprising of 4.38% (w/v) alginate, 1.39% (w/v) chitosan and 6.82% (w/v) calcium chloride was found to fulfill requisites of an optimum formulation. In vitro release studies showed that the drug is released from the optimized formulation over a period of 24h in a sustained release manner, primarily by non-Fickian diffusion. The optimized formulation was characterized by DSC, FTIR, XRD and SEM analysis. Antimicrobial studies revealed that the release of the drug over 24h periods was above the minimum concentration required for inhibition of microbial growth. This research highlights the level of understanding that can be accomplished through a well designed study based on the approach of QbD.

journal_name

Int J Biol Macromol

journal_title

International journal of biological macromolecules

authors

Mujtaba A,Ali M,Kohli K

doi

10.1016/j.ijbiomac.2014.05.066

subject

Has Abstract

pub_date

2014-08-01 00:00:00

pages

420-9

eissn

0141-8130

issn

1879-0003

pii

S0141-8130(14)00373-0

journal_volume

69

pub_type

杂志文章

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