201209281326470A

							ROLE OF WATER ON IN VITRO PERFORMANCE OF A MODEL BCS CLASS II SOLID

          DISPERSION TABLET USING CELLULOSIC SUPERDISINTEGRANT




          Ushasi Das*, Indranil Mitra, Sutapa Biswas Majee, Gopa Roy Biswas, Subhasis Maity

             Corresponding author’s address: NSHM College of Pharmaceutical Technology,

                        NSHM Knowledge Campus, Kolkata Group of Institutions

                               124, B. L. Saha Road, Kolkata-700 053, India.

                   E-mail address: ushasidas88@gmail.com ; sutapa.majee@nshm.com




       Presence of water prior to compression of solid dispersion into tablet may compromise the
efficiency of the performance of superdisintegrants like sodium carboxymehyl cellulose (Ac-di-
sol). Granule formation from solid dispersion using suitable excipients necessitates incorporation of
water as granulating fluid. In order to overcome the poor performance of solid dispersion tablets
manufactured by wet granulation, the method of direct compression has been adopted as an
alternative strategy. The present investigation has been carried out to investigate the effect of
presence of water and hence, manufacturing process on the physical attributes of tablets like water
absorption ratio, disintegration time and cumulative percent dissolved using PEG 6000 based solid
dispersions of poorly water-soluble BCS Class II model drug, Danazol. Mechanical properties and
weight variation of tablets remained unaffected. Absence of water in the formulation along with the
ability of direct compression method to yield a porous tablet facilitates higher water uptake, faster
disintegration enabling greater percentage of drug dissolved when compared to control batch
without superdisintegrant and tablets by wet granulation. Thus, the potential of superdisintegrant in
improving the dissolution profile of a BCS Class II drug can be fully realized by optimum selection
of manufacturing conditions.