The manufacture of hard and soft capsules is a complex process that requires precise calculations such as empty HPMC capsules. Once the capsules are manufactured, their properties may also vary. Let’s take a look at some key technical considerations for hard and soft capsules.
Active Pharmaceutical Ingredient (API) / Dissolution
This is how quickly the capsule dissolves in the stomach, allowing the active ingredient to be absorbed by the body. For example, gelatin has one of the best (if not the best) dissolution rates for APIs, allowing the API to be absorbed quickly by the body. This is one of the most important considerations for drugmakers.
Normally the dissolution process proceeds smoothly in the body. However, exposure to unsuitable heat or humidity conditions, or the presence of certain aldehydes, can cause capsule shells to crosslink. Due to the low humidity, HPMC does not suffer from cross-linking issues. The gelatin used to be susceptible to this phenomenon, but newer generations of gelatin such as StabiCaps have been developed to significantly reduce and slow down possible cross-linking problems.
Cost-effectiveness
Gelatin was the most cost-effective compared to alternative excipients. The ingredients for first-generation HPMC hard capsules cost about four times as much as gelatin, and HPMC capsules cost about three times as much to manufacture. This, of course, affects what is charged to the healthcare system, consumers, and taxpayers.
Machinability
Gelatin has a high level of processability, which means it withstands mechanical processing well, so no additional ingredients or machines are required. The machinability of HPMC is lower: the first generation HPMC requires a secondary gelling agent, while the second generation HPMC does not require a gelling agent but requires machining.
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