What are some knowledge introductions about Empty Gelatin Capsule Shell?

Update:26 Apr 2023

Empty gelatin capsule shell (also called hard or solid capsule) is a solid dosage form used to enclose one or more drug substances in a small shell. Capsules are among the most popular drugs delivery dosage forms used in pharmaceutical and nutraceutical industry.

Gelatin, a protein that is derived from the connective tissues of animals and vegetables, is widely regarded as Generally Recognised as Safe by major regulatory bodies. It offers a tasteless, non-allergenic, GMO free and gluten-free solution for producers to create a comfortable, palatable oral dosage form that can be customized in color, shape or size to meet varying fill and target market requirements.

Aside from its use as a capsule filler, it can also be used to cover powdered ingredients or premade tablets. Some gelatin types, including bovine bone gelatin, offer firmness while porcine options deliver plasticity characteristics.

The encapsulation process involves a number of different steps which ensures the quality of the end product. It includes preparing the raw materials, dipping, molding and encapsulation. The capsule is then sealed in a cap and is placed into the container or packaging to be shipped.

Problems during the encapsulation process can include: Excessive closure length setting, excessive closing pressure, over-filling of capsules, incorrect pin size or configuration, incorrect storage conditions that favor the transfer of moisture from the capsule shell to the encapsulated components and improper alignment of the upper and lower capsule segments.

In addition, the quality of a capsule may be affected by foreign materials in the gelatin solution during dipping or printing. The presence of bacterial growth in the capsule may also affect its quality. This requires careful inspection and analysis of the finished capsules to make sure that it meets all the required specifications.


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