Controlled release formulation of ranitidine-containing montmorillonite and Eudragit® E-100

Abstract

Aim: The objective of this work was to illustrate the suitability of montmorillonite (MMT) as a drug delivery carrier, by developing a new clay–drug composite of ranitidine hydrochloride (RT) intercalated in MMT. Methods: The MMT–RT composite was prepared by ion-exchange process. X-ray diffraction and Fourier transform infrared spectra were employed to confirm the intercalation of RT in the MMT interlayers. The prepared MMT–RT hybrid was coated with cationic polymer Eudragit® E-100 by oil-in-water solvent evaporation method. The release processes of RT from MMT–RT and MMT–RT/Eudragit® E-100 were monitored under in vitro condition in the gastric fluid. Results: X-ray diffraction and Fourier transform infrared spectra analysis indicated the intercalation of RT molecules within the clay lattice. The in vitro release studies showed that MMT–RT released RT in a controlled manner. In the case of MMT–RT/Eudragit® E-100, both the release rate and the release percentages noticeably increased in the presence of Eudragit® E-100, because of its effective exchange with intercalated RT molecules. The release kinetics followed parabolic diffusion mechanism. Conclusion: MMT has great potential as a drug delivery carrier with various scenarios. The dosage of the MMT–RT/Eudragit® E-100 can be in the tablet form. The hybrid material and polymer-coated hybrids are microparticles.

Keywords:

• Controlled release
• Eudragit®E-100
• intercalation
• kinetics
• montmorillonite
• ranitidine

Acknowledgments

We are thankful to the Council of Scientific and Industrial Research (CSIR) for funding under Network Project: NWP 0010; to Dr. P. Bhatt (XRD) and Mr. V. Agarwal (FT-IR) of the analytical section of the institute. We are also thankful to Mr. G.P. Dangi for helping us in determining the molecular structure and size of RT molecules. The authors are especially thankful to Mr. Amit Shah, Vikram Thermo Ltd., India, for providing Eudragit® E-100.