Abstract
Objective: The current research objective is systematic development and characterization of binary and ternary inclusion complexes of cefuroxime axetil with β-cyclodextrin to improve its pharmaceutical characteristics by using the kneading method.
 Methods: Phase solubility study was carried out using Higuchi and Connors method. Based on its result, binary complexes of cefuroxime axetil with different ratio of β-cyclodextrin were developed and characterized using differential scanning calorimeter (DSC), fourier transform infrared spectroscopy (FT-IR) and X-ray powder diffractometry (XRD). Then, binary complexes were analyzed for in vitro dissolution testing. The ternary complexes were developed using different ratio of PVP K-30 as a ternary component and evaluated for in vitro dissolution testing and in vitro taste masking.
 Results: Binary complex of cefuroxime axetil with β-cyclodextrin (1:1) showed better drug release than pure drug. During the development of the ternary complex, β-cyclodextrin (1:1) and 1% w/v PVP K-30 as a ternary agent resulted in an optimized ternary complex. The DSC, FT-IR and XRD studies clearly revealed the formation of binary and ternary complexes. The ternary complex showed better drug release of>85% within 30 min. in comparison to binary complex. The in vitro taste-masking study revealed the taste masking efficiency of the ternary complex of cefuroxime with β-cyclodextrin.
 Conclusion: The developed binary and ternary complex of cefuroxime axetil based on β-cyclodextrin with PVP K-30 showed improved in vitro dissolution rate and taste masking in comparison to pure drug. The drug release was better in ternary complexes. The present research work successfully shows the utility of binary and ternary complexes for improving pharmaceutical characteristics of cefuroxime axetil.
Highlights
The main goal of oral drug delivery systems is to modulate the solubility of active pharmaceutical ingredients (APIs) that improve the absorption of the drug and its bioavailability
The binary and ternary complexes of cefuroxime axetil were prepared by the kneading method
It was concluded that PVP K-30 can act as a ternary component for improving the pharmaceutical characteristics of Cefuroxime axetil (CFA) with β-CD
Summary
The main goal of oral drug delivery systems is to modulate the solubility of active pharmaceutical ingredients (APIs) that improve the absorption of the drug and its bioavailability . The problem of low solubility is mainly related to the BCS (Biopharmaceutical Classification System) class-II and IV drugs. These drugs show low absorption that leads to inconsistent in vitro-in vivo correlation and poor bioavailability. Pharmaceutical researchers are constantly working on various approaches for improving the drug solubility and dissolution rate of BCS class II drugs, which improve the therapeutic responses and overcome the toxic effects owing to high dose [1,2,3,4]. Each technique has its own merits and demerits regarding solubility enhancement and the selection of suitable one mainly depends on the type of drug, polymers, therapeutic, and targeted delivery of drugs which to be obtained [7, 8]
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