Effect of starch 1500 as a binder and disintegrant in lamivudine tablets prepared by high shear wet granulation.

High shear wet granulation is a preferred manufacturing method of tablets. It allowed for rapid production of compressible granulations. The resultant granulation characteristics depend on a combination of formulation properties and processing parameters. Fully pregelatinized starches are currently being used as binders in wet granulated formulations. But due to the gelatinization, much of the disintegration properties are lost. Partially pregelatinized starches (starch 1,500) have a mixture of properties of both native and fully gelatinized starches; made them useful as both a binder and a disintegrant in wet granulated formulations. Starch 1,500 performed as an excellent binder producing a granulation that was compressible and produced lamivudine tablets of improved hardness and friability compared with those prepared with povidone. The formulation of lamivudine tablets with starch 1,500 exceeded the disintegration and dissolution performance of the povidone formulation that utilized a super disintegrant. High shear wet granulation is also well suited for the use of partially pregelatinized starches.