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Polyvinylpyrrolidone and Croscarmellose Sodium Interactions in Fluidized Bed Granulations and Their Corresponding Tablets

Apeenun Laohavichien, Bryan D. Olin, and Adel Sakr

Industrial Pharmacy Program, University of Cincinnati Medical Center, Cincinnati, Ohio (USA)

The interactions between polyvinylpyrro-lidone (PVP) as a binder and croscarmellose sodium as a disintegrant on characteristics of top-spray fluidized bed produced granules and their corresponding tablets were studied. A full factorial design was employed to investigate PVP at three concentrations incorporated by either wet or dry mode, and croscarmel-lose sodium at three concentrations incorporated intragranularly, extragranularly or equally in both phases. It was found that PVP and croscarmellose sodium concentrations and their incorporation modes significantly affected granule and tablet characteristics. An interaction between PVP concentration and croscar-mellose sodium concentration significantly affected tablet disintegration time and tablet dissolution (t₈₀). The effect of PVP concentration on geometric mean granule size, granule bulk density, tablet friability, tablet disintegration time, and tablet dissolution (t₈₀) depended on PVP incorporation mode used. At all conditions, wet incorporation mode of PVP produced tablets with higher hardness and lower friability than the dry incorporation mode. Geometric mean granule size was the best granule evaluation for predicting tablet hardness and tablet friability. This study provides the formu-lators with useful tools in selecting the proper binder concentration and incorporation mode, in conjunction with the proper disintegrant concentration and incorporation mode for the desired granule and tablet characteristics.

Key Words Croscarmellose sodium, interactions · Fluidized bed granulation · Polyvinylpyrrolidone, interactions · Tablets