AAPS PharmSciTech

, 9:1253 | Cite as

Design and Evaluation of a Novel Matrix Type Multiple Units as Biphasic Gastroretentive Drug Delivery Systems

  • Meka Lingam
  • Thadisetty Ashok
  • Vobalaboina Venkateswarlu
  • Yamsani Madhusudan Rao
Research Article

Abstract

A biphasic gastroretentive floating drug delivery system with multiple-unit mini-tablets based on gas formation technique was developed to maintain constant plasma level of a drug concentration within the therapeutic window. The system consists of loading dose as uncoated core units, and prolonged-release core units are prepared by direct compression process; the latter were coated with three successive layers, one of which is seal coat, an effervescent (sodium bicarbonate) layer, and an outer polymeric layer of polymethacrylates. The formulations were evaluated for quality control tests, and all the parameters evaluated were within the acceptable limits. The system using Eudragit RL30D and combination of them as polymeric layer could float within acceptable time. The drug release was linear with the square root of time. The rapid floating and the controlled release properties were achieved in this present study. When compared with the theoretical release profile, the similarity factor of formulation with coating of RS:RL (1:3)–7.5%, was observed to be 74, which is well fitted into zero-order kinetics confirming that the release from formulation is close to desired release profile. The stability samples showed no significant change in dissolution profiles (p > 0.05). In vivo gastric residence time was examined by radiograms, and it was observed that the units remained in the stomach for about 5 h.

Key words

biphasic release controlled release dissolution polymeric coating 

Notes

Acknowledgments

The authors would like to thank Dr Reddy’s Laboratories (Hyderabad, India) for providing the gift sample of ranitidine hydrochloride, and one of the authors (Meka Lingam) is thankful to the UGC India for providing Junior Research Fellowship.

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Copyright information

© American Association of Pharmaceutical Scientists 2008

Authors and Affiliations

  • Meka Lingam
    • 1
  • Thadisetty Ashok
    • 1
  • Vobalaboina Venkateswarlu
    • 1
  • Yamsani Madhusudan Rao
    • 1
  1. 1.Centre for Biopharmaceutics and PharmacokineticsUniversity College of Pharmaceutical Sciences, Kakatiya UniversityAndhra PradeshIndia

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