Application of Dynamic Mechanical Analysis (DMA) to the determination of the mechanical properties of coated pellets

Pellets containing a model drug, paracetamol, and microcrystalline cellulose (MCC) were designed to vary their mechanical properties by the incorporation of lactose, glyceryl monostearate (GMS), ethanol, or glycerol, and were produced by the process of extrusion and spheronization. The pellets were coated with an aqueous dispersion of ethyl cellulose (Surelease(R)) to different levels of weight gain (5, 10, and 20%). The tensile strength, deformability, linear strain, elastic modulus, and shear strength of the coated and uncoated pellets were determined by conventional techniques, which are obtained from diametral compression test of individual pellets and compaction of a bed of pellets. Dynamic Mechanical Analysis (DMA) was performed on single pellets to determine the storage modulus and phase angle of the coated pellets. This work demonstrated that the coating film affected the mechanical properties of the pellets differently depending on the properties of the core pellets. Analysis of variance established a significant increase in the strength of the soft GMS- or glycerol-containing pellets with coating, while the effect of the coating material was not significant with respect to the elastic modulus, storage modulus, and phase angle of such pellets. The effects of the coating material on the elastic modulus, deformability, storage modulus, and phase angle of the rigid lactose-containing pellets were significant. The sinusoidal stress-relaxation cycle of the DMA illustrated the increase in the viscoelasticity of all the pellets after coating. Finally, the work demonstrate the advantages of DMA in determining the reversible or dissipated energy by means of storage modulus or phase angle when compared with the irreversible structural destruction of the pellets by conventional techniques. (C) 2004 Elsevier B.V. All rights reserved.