Introduction 

Manufacturing processes have not kept pace with inventions in the pharmaceutical industry.  However, the Quality by design approach which integrates quality into every aspect of the design and the manufacturing process of drugs, promises more powerful and yet cost effective production of drugs. The use of factorial design principles in the QbD approach enables researchers to alter the various critical parameters to establish the quality target product profile. However, in order to create the optimal tablet formulation, a thorough study of the mechanical properties of the active ingredient as well as the excipients is a prerequisite.  Variation of excipient properties are known to impact the tablet performance. Studies have indicated that excipients are very sensitive to environmental conditions and they affect dissolution rate of the active pharmaceutical ingredient. Also, environmental variables such as moisture, temperature affect the bonding properties of powders. For instance, ‘air entrapment’ is a big problem during the compaction process as it leads to development of cracks and disintegration of the tablet. Furthermore, decompression effects and the capping mechanisms of tablets also pose problems for the compaction process. The usefulness of the QbD principles in the powder compaction process offers immense scope for pharmaceutical researchers to achieve optimal formulations while at the same time adheres to the strict drug safety standards.

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