title: 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.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India.
authors.forename: Ali
authors.initials: A
authors.lastname: Mujtaba
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India.
authors.forename: Mushir
authors.initials: M
authors.lastname: Ali
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India. Electronic address: kanchankohli50@gmail.com.
authors.forename: Kanchan
authors.initials: K
authors.lastname: Kohli
mesh_terms: D000464:Alginates / Q000737:chemistry*; D000890:Anti-Infective Agents / Q000737:chemistry / Q000494:pharmacology; D002122:Calcium Chloride / Q000737:chemistry; D015296:Ceftizoxime / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D048271:Chitosan / Q000737:chemistry*; D003692:Delayed-Action Preparations; D004926:Escherichia coli / Q000187:drug effects; D020723:Glucuronic Acid / Q000737:chemistry; D006603:Hexuronic Acids / Q000737:chemistry; D007700:Kinetics; D008863:Microspheres; D010316:Particle Size; D013211:Staphylococcus aureus / Q000187:drug effects; D013499:Surface Properties; D000097627:Cefpodoxime Proxetil
chemical_list: D000464:Alginates; D000890:Anti-Infective Agents; D002122:Calcium Chloride; D015296:Ceftizoxime; D048271:Chitosan; D003692:Delayed-Action Preparations; D020723:Glucuronic Acid; D006603:Hexuronic Acids; D000097627:Cefpodoxime Proxetil
keywords: Box–Behnken design; Cefpodoxime proxetil; Quality by design