![]() ![]() Figure 1 shows the changes that occur after storage for one week at varying humidity levels. Moisture content of gelatine and HPMC capsules will vary depending on the ambient conditions as the moisture content will gradually reach equilibrium with the surrounding relative humidity level. Regardless of the material used, this fluctuation can lead to some degree of compromised capsule strength and overall quality, so it needs to be considered from the very outset of production. ![]() These capsules can be dried down to less than 1% moisture without losing their mechanical strength and becoming brittle. Empty HPMC capsules have a moisture content of 3% to 6%. powders used in inhalers).Įmpty gelatine capsules have a moisture content between 13% and 16% - they will become brittle if the moisture content falls below this limit, and will soften if it increases above it. Its plant-based ingredients pose few dietary objections than animal-based gelatines, and it is well-suited to fillings that are sensitive to moisture or that may not work well with the residual moisture found in gelatine capsules (e.g. Since then, some form of air treatment has become the norm in production areas.Īfter gelatine, hypromellose (HPMC) is also used to produce capsules. As early as 1913, Eli Lilly first used air conditioning to allow production at times when the air temperature was above 30☌ - prior to this innovation production stopped, as the gelatine would not set. This presents challenges for production in climates where temperatures regularly exceed this. For example, the melting point of all types of gelatine is around 30☌ to 32☌. Regardless of the source and type of gelatine, the actual physical characteristics of different types of gelatine are similar from a drying and storage perspective. The most common material used for capsule production is gelatine. Not surprisingly, humidity control during the drying and storage processes plays a large role in achieving quality targets. One thing that has already changed and will also continue to develop, is the need to produce capsules with consistent quality characteristics, particularly when producing GMP-compliant products. New technologies have entered the production space, formulations and ingredients have changed to meet market demands, and even the climate itself has changed with seasonal temperature and humidity reaching new levels. While that assumption is mostly true, things have also changed since the first capsules were produced. It would be reasonable to assume that after some 180 years of experience there would be no secrets about how to achieve optimal capsule quality and consistency. The first recorded patent for gelatine capsule production was in 1834. As a dosage form, capsules have been around for a long time. ![]()
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