Bioequivalence and Bioavailability Forum

Dear Santosh!

❝ when we get investigational product from the sponser, we not get information about IP's is light sensitive or not?

Why don’t you ask him/her?

❝ for this i refere indian pharmacopoeia and British pharmacopoeia, in this many drugs labeled as "PROTECT FROM LIGHT" OR "STORE IN LIGHT RESISTANCE CONTAINER" it means this IP's should dispense in the monochromatic light e.g. Sodium vapour lamp?

Please use your judgement: storage is different from dispensing!

❝ So can I all this IP's dispense in the monochromatic light?

If you want to run into troubles…

❝ And what about film coated tablet in which key ingredient is light sensitive?

The API is well protected in a solid dosage form...

❝ or it is only necessery for drug in plasma/blood which is sensitive to the light?

BTW, sodium vapour lamps are not the resolution for everything. What if your drug shows an absorption maximum close to sodium’s 589 nm? In that case you will deliver a lot of energy just at the wrong wavelength…