Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.
Excipients are typically the major components of a solid dosage form. These non-active substances have well-defined roles in the development of tablets and capsules, and are included for a number of reasons such as to aid the manufacturing process or to add functionality to the formulation.
Excipients for processing
Excipients can be divided into several broad processing categories for functionality, notes Paul Skultety, vice-president, Pharmaceutical Development Services, Xcelience, a division of Capsugel. Bulking agents such as lactose, dibasic calcium phosphate, or microcrystalline cellulose are used to make the dosage form bigger in size, he says, firstly, so that it is easier to manufacture, and secondly, to achieve a practical tablet weight for patients to handle. The minimum tablet weight is typically approximately 50 mg.