Scientific papers
Lactose serves as a widely used excipient for bulking, diluting, and shaping active pharmaceutical ingredients in tablet manufacturing. Specifically, granulated lactose (GL) designed for direct powder compression possesses unique characteristics resulting from variances in manufacturing methods. Its role is crucial in handling blended powders for tablet production and influencing tablet quality. This study aimed to compare the functionalities of different forms of GL, incorporated as excipients during direct powder compression, on tablet properties. Additionally, we explored the impact of magnesium stearate (Mg-S), used as a lubricant, on each GL type.
Various GL types, obtained through distinct manufacturing methods (agitated granulation, GL-AG; spray-dried granulation, GL-SD; fluidized bed granulation, GL-FB), were blended with maize starch, low-substituted hydroxypropyl cellulose, and paracetamol in a V-type blender for 10 minutes. Mg-S was introduced at different amounts (0.1%, 1.0%, and 2.0%) and blending times (5, 10, and 30 minutes) for the nine formulations of blended powders for tableting. The resulting powders underwent tableting, and the tablets were assessed for variations in weight and drug loading, tensile strength, friability, and disintegration time.
Upon comparing tablets with identical blending conditions, the order of tensile strength and disintegration time was found to be GL-FB > GL-SD > GL-AG. For each GL type, we analyzed the effects of varying Mg-S amounts and blending times using contour plots. This approach enabled the evaluation of blending conditions on tablet properties and the determination of target tablet properties. The study delved into optimizing lubricant blending conditions to achieve tablets with desirable characteristics.
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