Could anyone answer me that why the softening of hard gelatin capsules happen & how to overcome it.
With that please provide whether there is any specifications in buying of Hard gelatin capsules.
Empty hard gelatine capsules should comply specification as per IP or other pharmacopoeia. There is a limit for water / moisture content or loss on drying.
Additionally, empty hard gelatin (EHG) capsules must be dtored at specified temperature and relative humidity as recommended by the manufacturerer or printed on the box-lables. The EGG capsules will become soft if thise are stored at high humidity conditions. Please ensure that the storage facility is provided with adequate Air Handling System (AHU) for storage of EHG capsules. Temp. & humidity mapping of storage area must be carried out as a part of qualification. Only upon satisfactory qualification of storage area the EHG should be stored.
After sampling of EHG capsules, the polybag / box containing EHG capsules must be properly sealed & closed.
In case of capsules finished product the moisture content of blend mixure to be filled in capsules must be controlled. There should be specification of water / LOD for capsules-blend.
Additionally, capsules finished product must be stored in cool & dry place to avoid softening of capsules. Generally finisihed product capsules should be packed in blisters or Aluminum strips rather than HDPE bottles to have better moisture barrier. The finished product capsules when packed in bulk in HDPE or glass bottles there should be silica gel bags kept in it as a desicant to abosorb moisture from atmosphere during storage.
Thank you for your informative reply sir.
Thank you so much sir.