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[e-drug] Shelf life of liquid preparations after opening (5)

E-DRUG: Shelf life of liquid preparations after opening (5)

Most of liquid preparations, barring a few  are intended for children. Further, 
each( new) liquid preparation or formulation undergoes stability studies even 
for zone 4 temperatures. A drug is chosen to be made into liquid formulation in 
the best solvent or combination of solvents where the active ingredient is 
likely to be most stable. Otherwise it is not made into a liquid preparation. 
(In some formulation dry syrup route is chosen) -
The data on stability studies have to be submitted to the regulatory 
authorities viz..FDA and licence for manufacture is issued only after  data are 
studied & approved.
Further  overages are added to compensate for loss during storage & use.
It is assumed that the user or consumer follows the instructions on the label 
for use after the seal is broken. If the instructions are not followed by the 
consumer the company may not be accountable.

CK Aiyer
EX professor, Pharmaceutical Management, India

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