Gelatin capsule shell made of gelatin is one of the most important dosage forms in the pharmaceutical and nutraceutical industry. Capsules enclose the drug or active pharmaceutical ingredient (API) in an odorless, tasteless, elegant, and easy-to-fill shell.
Gelatin is a naturally occurring protein obtained from the partial hydrolysis of collagen that is found in skin, connective tissue and bones of animals. It is a very good source of protein and is used in many applications, including food supplements, pharmaceuticals, animal feed and cosmetics.
There are two basic types of gelatin capsules: hard and soft.
In a hard gelatin capsule, the upper part of the shell, called the cap, has a slightly larger diameter than the lower part, called the body. Together, these parts fit perfectly to form a hermetically sealed unit.
The hard gelatin capsule is ideal for encasing solid powdered drug formulations or nutraceuticals. However, they are not suitable for aqueous liquids as water can soften the gelatin and distort the capsule.
The production of hard gelatin capsules is a highly controlled and automated process, requiring strict quality control to ensure product integrity and compliance with Good Manufacturing Practices. The quality of the capsule is monitored through physical tests such as humidity, diameter and size, ash test and collapse time.