Abstract
Objective: The aim of present work was to develop of pediatric cefuroxime axetil 125 mg dispersible tablets by using ion exchange resin as a taste masking agent and quality target product profile was defined based on the properties of the cefuroxime axetil.
 Methods: Initially, cefuroxime axetil and various resin complexes (DRC) were prepared with different conditions and evaluated for taste masking and drug loading. Optimized DRC was used to formulate the dispersible tablet. A 32 full factorial design was employed to study the effect of mannitol (X1) and microcrystalline cellulose PH-101 (X2) on drug release at 10 min and time taken to 80% drug release. In the present study, the following constraints were arbitrarily used for the selection of an optimized batch: Q10>65% and T80%<30 min. Multiple linear regression analysis, ANOVA and graphical representation of the influence factor by 3D plots were performed by using Sigmaplot 11.0. Checkpoint batch was prepared to validate the evolved model.
 Results: Among the various drug resins complex DRC-9 was found with less bitter taste which was containing kyron T-114 and among the all factorial batch F7 showed highest drug release at 10 min (Q10) and lowest time taken to 80% drug release (T80) hence batch F7 was selected as an optimized batch and it’s found to be stable in the stability evaluation.
 Conclusion: The results of full factorial design indicate mannitol and MCC PH-101 have a significant effect on drug release.
Highlights
Oral route of drug administration is the most appealing route for drug delivery
On the basis of preliminary results, the amount of mannitol (X1) and the amount of MCC PH-101 (X2) were chosen as independent variables in 32 full factorial design, while % drug release at 10 min (Q10%) and time required for 80% drug release (t80). were taken as dependent variables
The differential scanning calorimetric (DSC) analysis of the drug alone elicited a peak at 255.22 °C and complex of cefuroxime axetil with kyron T-114 shows peak of drug at 256.78 °C
Summary
Oral route of drug administration is the most appealing route for drug delivery. Among the various dosage forms tablet is one of the most preferred dosage forms because of its ease of manufacturing, convenience in administration, accurate dosing, and stability compared with other forms etc. A number of orally administered drugs exhibit natural bitter taste that creates an unpleasant feeling in the mouth [1, 2]. It is necessary to reduce or mask the bitterness for enhancing patient acceptability and improving oral palatability of bitter drugs. Cefuroxime axetil has a broad spectrum antibacterial agent with a bitter taste, so it is necessary to mask the bitter taste for pediatric patients [3, 4]. Different methods have been suggested for masking of the bitter taste, which includes coating, inclusion complexes, molecular complexes, solid dispersion, microencapsulation, multiple emulsions, liposome's, Prodrugs and mass extrusion method from that ion exchange resin is one of most extensively method to overcome this problem [5, 6]
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