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Design and development of co-processed excipients for fast dissolving tablets of Irbesartan by melt agglomeration technique

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Abstract

The co-processing is most widely explored method for development of directly compressible excipients. The present research was focused on development of co-processed excipients for fast dissolving tablets of Irbesartan by melt agglomeration technique. From the preliminary trials Lactose monohydrate and mannitol was selected as a diluent and Poly ethylene glycol 4000 as binder. To improve functionality of co-processed excipients 8 % crospovidone was incorporated. Diluent blend ratio and concentration of binder (%) were selected as independent variables in central composite design. The agglomerates were evaluated in terms of % fines, angle of repose, Carr’s index, Hausner ratio. The tablets were manufactured on a rotary press and their friability, tensile strength and disintegration time were evaluated. This optimized batch was characterized by means of the granular friability index, Heckel analysis, Kawakita, Kuno’s analysis, lubricant sensitivity ratio and a dilution potential study. Result of dilution potential showed that up to 40 % drug can be incorporated. In addition to these, bitter taste of drug was masked by forming drug—β-cyclodextrin inclusion complex and by adding aspartame as a Sweetener. Compared to conventional tablet it showed faster dissolution. Instrumental studies like Fourier transform-infrared spectroscopy, differential scanning calorimetry, X-ray diffraction showed that the compatibility of various excipients with drug. The present study underlines the fact that melt granulation technique may be adopted for the development of directly compressible adjuvant for use in pharmaceuticals.

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Acknowledgments

This article does contain Taste masking study with human subjects performed by the authors. All authors (Kothiya Madhvi, Kuldeep Mehta, K. R. Vadalia, Chavda Jay, Kapadiya Sandip) declare that they have no conflict of interest. We would like to thank the company CTX Lifescience Pvt. Ltd., Surat. for giving us the free gift samples of Irbesartan. We are also thankful to Gujarat microwax Pvt. Ltd. Ahmedabad, Chemdyes corporation Rajkot, Anil Limited Ahmedabad, Central Institute of Fisheries Technology Cochin, Maple Biotech Pvt. Ltd Pune, Apex Healthcare Limited Ankleshwar and Gangwal Chemicals Pvt. Ltd Mumbai for providing free gift sample of excipients. We would like to thanks also the following institutes Shree M. N. Virani Science College, Rajkot for FTIR study and Saurashtra University Department of Pharmacy, rajkot for DSC study.

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Author notes

  1. Kuldeep Mehta

    Present address: Department of Pharmaceutics, Atmiya Institute of Pharmacy, Yogidham Gurukul, Kalawad Road, Rajkot, 360005, Gujarat, India

Authors and Affiliations

  1. Department of Pharmaceutics, Atmiya Institute of Pharmacy, Yogidham Gurukul, Kalawad Road, Rajkot, 360005, Gujarat, India

    Kothiya Madhvi, K. R. Vadalia, Chavda Jay & Kapadiya Sandip

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  1. Kothiya Madhvi
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  2. Kuldeep Mehta
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  3. K. R. Vadalia
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  4. Chavda Jay
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Correspondence to Kothiya Madhvi or Kuldeep Mehta.

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Madhvi, K., Mehta, K., Vadalia, K.R. et al. Design and development of co-processed excipients for fast dissolving tablets of Irbesartan by melt agglomeration technique. Journal of Pharmaceutical Investigation 45, 163–186 (2015). https://doi.org/10.1007/s40005-014-0163-y

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  • DOI: https://doi.org/10.1007/s40005-014-0163-y

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