Water-Solid Interactions. III. Effect of Glass Transition Temperature, T_g, and Processing on Tensile Strength of Compacts of Lactose and Lactose/Polyvinyl Pyrrolidone

ABSTRACT

The effect of moisture sorption at different relative humidities on the tensile strength and the physical stability of compacts of crystalline and partly amorphous lactose, alone and in binary mixtures with PVP, has been studied. Furthermore, the role of moisture as a plasticizer and its effect on the glass transition temperature, T_g, are related to the compactibiltiy. Samples were conditioned for 2 hr using a climate test chamber at different relative humidites. Moisture sorption was determined, the radial crushing strength for compacts was measured immediately and after storage, and the tensile strength was calculated. The glass transition temperature, T_g, was determined using DSC. The tensile strength of the compacts was found to depend on both the conditioning humidity and the humidity during storage. An increase in humidity to a level at which the glass transition temperature, T_g, fell below the operating temperature, T, resulted in transition from a rigid glassy state to a mobile rubbery state. For compacts of partly amorphous lactose, an increase in the tensile strength was observed during storage of tablets, due to recrystallization of the amorphous regions above T_g. Tablets of mixtures of lactose and PVP exhibit a sharp decrease in tensile strength at humidities above 70% RH, due to the glass-to-rubber transition of PVP.

Key Words: :

• Compatibility
• Glass transition
• Lactose
• Moisture
• Polyvinyl pyrrolidone
• Processing.