During development of pharmaceutical products, excipients are evaluated for their impact on the formulation process and product performance. This is part of quality by design (QbD) principles. The aim is to increase overall product quality.
The development of a capsule product requires accurate dimensional and weight specifications. Variations in these specifications can lead to dimensional errors that may cause machine stops or damaged capsules. These dimensional errors can also lead to moisture transfer from the capsule shell to encapsulated components.
Hard gelatin empty capsules are an established dosage form for pharmaceutical products. They are available in various sizes, shapes, and colors. They are used for a wide range of applications, including research, drug delivery, and pharmacy.
Hard gelatin empty capsules can be filled manually with a hand-operated capsule machine or by pressing open end of the capsule downward. Filling of these capsules is a well-established technology.
Capsules are solid dosage forms that are used for oral administration. They are filled with active pharmaceutical ingredients. The capsules are filled with liquid formulations to improve the bioavailability of the drug. They may be liquid filled, dry filled, or semisolid formulations.
In addition to liquid formulations, hard gelatin empty capsules are also filled with semisolid formulations. They can be filled with liquid-based formulations, such as lipids, solvents, and hydroxy propyl methyl cellulose (HPMC). The gelling agents used in these capsules include hydroxy propyl methyl cellulose, carrageenans, cellulose, and plant polysaccharides.
The use of gelatin as an excipient has been common for nearly a century. It is derived from the bones of animals. However, gelatin can be contaminated during the manufacturing process. This contamination can lead to microbiological contamination of the empty capsule.