Development of Sustained Release Alogliptin Tablets Using Multiparticulates System Made of Bentonite
Development of Sustained Release Alogliptin Tablets Using Bentonite
Objective: This study was designed to evaluate the using of bentonite for formulating sustained release tablets containing alogliptin benzoate after granulation.
Methods: Bentonite was used for preparing tablets after granulation. The prepared tablets were tested for their pharmacopeial requirements. Also, a high performance liquid chromatography (HPLC) method was developed to assess the release pattern of alogliptin from the tablets. Furthermore, Differential scanning calorimetery (DSC), Fourier transform infrared spectroscopy (FTIR) and powder X-ray diffraction (XRD) were used for evaluating the compatibility between the drug and bentonite. Finally the release from the tablets was tested using paddle apparatus.
Results: The results showed that the tablets comply with the compendial requirements. Furthermore, FTIR, DSC did not show any interaction between the drug and the excipient in contrast to powder-XRD pattern which showed a shift for montmorillonite crystal peak. However, the release profiles revealed a sustained release of alogliptin from the tablets prepared from bentonite matrix with aid of hydroxypropyl methyl cellulose (HPMC) as a binder. The fitting of release data showed that the release from these tablets followed Fickian diffusion.
Conclusion: Bentonite was used successfully for producing sustained release tablets of alogliptin. However, the maintaining crystal structure of montmorillonite was essential for building the gel structure of bentonite and releasing the drug in controlled manner.
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