How Are Transparent Empty Capsules Manufactured?

High quality empty capsule

The emergence of gelatin capsules as the preferred dosage form for dietary supplements and pharmaceutical products has driven growth in the global market. Capsules are easier to swallow than tablets and provide an airtight seal after filling with the required drug formulation. This makes them a convenient option for a broad range of products, including dietary supplements, pain relievers, and anti-biotics. The growing emphasis on preventive healthcare has also fueled demand for capsules, as they are a safe and convenient way to deliver medications.

In the manufacture of both hard and soft capsules, gelling agents are typically derived from animal proteins such as gelatin or plant polysaccharides such as starch and cellulose, as well as other ingredients such as plasticizers to reduce the brittleness of the finished product, preservatives to control contamination, disintegrants, and lubricants to facilitate the release of the product from the capsule. These ingredients are combined in aqueous solutions that can be molded into the desired size and shape of the final capsule using machinery with either an iron mold or a set of dies with pockets.

The results show that the CQAs considered in this study (disintegration and visual endpoint detection) remained within their specified ranges for both hard and transparent capsules. The physical data indicate that most variation occurs on a within lot basis due to noise in the manufacturing process, while the statistical distributions reveal that both the mean and mean-to-median of the individual batches of the empty capsules fell within the specification limits. These data will support risk assessments and QbD product development by describing the operating space for these material attributes.