Hard Gelatin Empty Capsule Quality Knowledge Introduction!

Despite advancement in capsule manufacturing technologies, the pharmaceutical industry is faced with significant challenges. With the rising need for treatment medicines, the global burden of chronic diseases has increased. As a result, health-minded consumers are looking for easy-to-swallow dosage formats.

Hard gelatin empty capsules play an important role in the final product quality. They can be filled manually or on a machine.
The disintegration time of hard gelatin capsules is one of the key quality attributes. This is used as a quality assurance parameter and as a measure of performance of the product. For product development, this can also be an input parameter.

Among the factors influencing the disintegration process, some gelatin types dissolve faster than others in acidic fluids. Additionally, some hygroscopic components can absorb water from the capsule shell. This could lead to microbiological contamination of the empty capsule.
Other factors affecting the disintegration process include the use of gelling agents and lubricants. These can be animal protein (mainly gelatin) or plant polysaccharides.

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