Any guideline is available for drug excipients compatibility of low and high dose API
Hi,
It is better to use 1:1 or 1:0.5 (Drug to Excipient) ratio to check the compatibity studies and then as per design exposed to different accelerated conditions. Actually, there is no strict rules, but several ANDA submission showed the above mentioned scenario.
The common sense will suggest the same ratio existing in the final formulation. However, the ratio 1:1 is to be tested in oreder tobe sure about the intense contact between drug nd excipient.
In general 1:1 ratio to avoid excess of excipients that can interfere the results.
If it is taken as final ratio sometimes the drug may be very less and u may misinterpret the results
Dear Pravin, It will be better if you choose the ratio used in your optimized batch. As we know we need our the stability of the product with desired drug release or activity..
1:1 and 1:0.5 of drug: excipient also can be used
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