in hard gelatin capsules, usually there are three main components, namely water, sugar and gelatin. Water contents are in the range of 13-16%,how much gelatin and sugar must be added for a suitable hard gelatin capsule??
The manufacturer has to provide you with a Cerificate of Analysis. Based on this you should assess if your drug product is suitable for the water content in the capsules on long term stability.
I think it's not written in the COA. I didn't see it before in any COA. But in general, I used to prepare gelatin shell for softgels using water, sorbitol (optional), glycerin, titanium dioxide, coloring agent, preservatives, gelatin. In case of hard gelatin capsules, the same, but the concentration of water is in between 12-16% and sulphur dioxide is added to prevent decomposition during storage.
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