Pharmaceutical companies often begin drug development with capsules due to their cost-effectiveness and ease of formulation during early-stage clinical trials. However, while capsules provide initial savings, they can lead to higher production costs upon commercialization. As a result, many companies transition to tablet formulations benefiting from improved efficiency, cost reduction, and enhanced patient compliance.
Transitioning from a capsule to a tablet presents several challenges that need to be addressed to maintain product quality and performance:
To streamline the switch from capsules to tablets, it is beneficial to start with a capsule formulation that can be readily adapted for tableting later on. A blend of Starch 1500 and Microcrystalline Cellulose (MCC) facilitates this process, enabling a seamless shift with minimal adjustments.
A study demonstrated that using a Starch 1500®: MCC blend in both capsule and tablet formulations resulted in unchanged dissolution profiles, indicating that reformulation did not compromise drug release characteristics. This consistency is crucial for regulatory approval and patient efficacy.
A structured approach to formulation development ensures a successful transition.
This strategy provides process flexibility while reducing the risk of reformulation challenges. Additionally, it supports granulation techniques like high shear and fluid bed granulation without the need for additional excipients, thereby avoiding extensive stability studies and regulatory hurdles.
A Starch 1500 and MCC blend provides a well-balanced approach to tablet formulation, offering advantages in compressibility, disintegration, flow properties, and scalability. This formulation strategy minimizes the complexity of transitioning from capsules to tablets, allowing pharmaceutical companies to achieve cost savings, regulatory compliance, and manufacturing efficiency with ease.