The effect of some direct compression excipients and lubricants on the adhesion of hydroxypropyl methyl cellulose films has been examined using a specially designed tensile testing apparatus (Fisher & Rowe, 1976). The adhesion was found to be influenced by both the roughness, including microporosity, of the tablet surface and its polarity. Tablets prepared from microcrystalline cellulose showed very high adhesions despite having relatively smooth surfaces, owing to the surface being saturated with hydroxyl groups able to form hydrogen bonds with the corresponding groups on the polymer. The addition of magnesium or calcium stearate to the tablet was found to decrease the adhesion, but the addition of stearic acid caused a significant increase. The effect of lubricant concentration on the adhesion could be expressed by an equation similar to that proposed by Hofrichter & McLaren (1948) for the adhesion of vinyl chloride/vinyl acetate copolymers to regenerated cellulose.
A theoretical approach of film cracking is presented using equations which allow for the calculation of both the internal stress in a film coating due to shrinkage of the film on evaporation of the solvent and the thermal stress due to differences in the thermal expansion of the film coating and tablet substrate during changes in temperature arising out of the coating processes. The practical implications of this approach in film formulation are discussed with particular reference to the choice of tablet core formulation, the grade of polymer used, the type and concentration of both plasticizers and pigments and the solvent system used in the coating process.
Typical two dimensional solubility parameter maps for ethyl cellulose, hydroxypropyl methylcellulose and hydroxypropyl cellulose have been constructed using literature data. The maps of the polymers showed some degree of overlap indicating some mutual compatibility. Compatibility between ethyl cellulose and hydroxypropyl cellulose was greater than between ethyl cellulose and hydroxypropyl methylcellulose. The maps may also be used to predict the effect of added plasticizers.
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