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Question

Posted on: February 6 2019

Methylprednisolone capsules already or not with EC store in the refrigerator?

The FAMHP recommends storing capsules with methylprednisolone in the refrigerator and this by analogy with the indication for the raw material in the EUR PHARM. Does this also apply to capsules containing methylprednisolone, which are enterially encased? But what about the stability of the coating? Not sticky because of the low temperature and the high humidity level

Answer

after contact   The question box of the Eur Pharm sent me the following reply.  
 
the position of the Pharmacopoeia expert is that a distinction can be made between active ingredient (AB) and final prduct (EP)  
 
as far as AB is concerned, it takes the view not to tolerate AB's dissolution in AB and to adopt a more flexible stance for the EP.  
 
since various decomposition products in methylprednisolone powder were recovered, the Eur Pharm recommends
 
STORAGE
Protected from light, at a temperature of 2   °C to 8   °C.
 

For tablets or capsules does not give the Eur Pharm recommendations. But she takes   a more flexible stance for the EP, although   the dissolution can be faster in EP than AB but it is also being reconstituted.

 
in the case of EP, the rule is that the minimum level is 95%; for magistal preparations, FAMHP stands at 90%.  
 

is satisfied with this standard then   can be assumed that the capsules should not be kept in the refrigerator. The USP does not require the preservation of methylpredsnisolon in the refrigerator but   requires preserve in tight, light-resistant containers.      

The position of the FAMHP Is not unreasonable then the storage in the refrigerator requires the use of   a   well hermetically   closing packing,     which Is impenetrable for water vapour (i.e. glass)!.

This is certainly   for   the enteric coated capsules. After all, CAP is described as: "  Cellulose acetate phthalate occurs as hygroscopic" and the atmosphere in a refrigerator is rather moist.   Drying Stop capsules can be added.