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

        Kothiya Madhvi,Kuldeep Mehta,K. R. Vadalia,Chavda Jay,Kapadiya Sandip 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.2

        The co-processing is most widely exploredmethod for development of directly compressible excipients. The present research was focused on development ofco-processed excipients for fast dissolving tablets of Irbesartanby melt agglomeration technique. From the preliminarytrials Lactose monohydrate and mannitol wasselected as a diluent and Poly ethylene glycol 4000 asbinder. To improve functionality of co-processed excipients8 % crospovidone was incorporated. Diluent blendratio and concentration of binder (%) were selected asindependent variables in central composite design. Theagglomerates were evaluated in terms of % fines, angle ofrepose, Carr’s index, Hausner ratio. The tablets weremanufactured on a rotary press and their friability, tensilestrength and disintegration time were evaluated. Thisoptimized batch was characterized by means of the granularfriability index, Heckel analysis, Kawakita, Kuno’sanalysis, lubricant sensitivity ratio and a dilution potentialstudy. Result of dilution potential showed that up to 40 %drug can be incorporated. In addition to these, bitter taste ofdrug was masked by forming drug—β-cyclodextrin inclusioncomplex and by adding aspartame as a Sweetener. Compared to conventional tablet it showed faster dissolution. Instrumental studies like Fourier transform-infraredspectroscopy, differential scanning calorimetry, X-raydiffraction showed that the compatibility of various excipientswith drug. The present study underlines the factthat melt granulation technique may be adopted for thedevelopment of directly compressible adjuvant for use inpharmaceuticals.

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