E-DRUG: Shelf life of liquid preparations after opening (5)
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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
chandrarobert@yahoo.com.au
E-DRUG: Shelf life of liquid preparations after opening and stability zones
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Dear e-druggers
There is very valuable guidance on Stability from WHO;
WHO stability testing requirements as exemplified in the WHO TRS 953 Annex 2, acccessed it through ICH website.
Section 2.2.10 outlines in-use stability testing requirements.
Country stability climatic Zones
http://www.who.int/medicines/areas/quality_safety/quality_assurance/StabilityTable2.pdf
With reference to stability in specific climatic Zones, National regulatory authorities can consider to make it a requirement for manufacturers that register products with them to only register those that meet the stability for the climatic Zone of the country, unless the API characteristics do not allow, in which case, special storage instructions will be provided. At UNICEF (and WHO prequalification), our requirement is for manufacturers to meet Zone IV B stability requirements unless the product characteristics do not allow.
http://www.unicef.org/supply/files/Final_Technical_Requirements_pharma_4th_edition_06.01.2012_AO.pdf
http://apps.who.int/prequal/info_general/documents/stability/Stability_Requirements.pdf
From the discussions, there seems to be need for stability studies beyond 30*C/75%RH and stress tests beyond 40* C/75%RH. Perhaps the academic fraternity can start to work on this to begin to generate the data.
Kind regards
Atieno Ojoo
Technical Specialist, pharmaceuticals
Unicef Supply Division
Unicef Plads, Freeport
2100 Copenhagen
Denmark
Tel; +45 35 27 31 03
Fax: +45 35 26 94 21
Email: atisojoo@yahoo.co.uk
http//www.unicef.org/supply