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Dear Forum,
For animal GLP toxicity studies how one can verify the desired amount
of the drug in capsules. Is there a specific FDA guidance or any
reference for the applicable method(s).
Any suggestion greatly appreciated.
Regards
Venkatesh
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To my information, the drug amount in a capsule will depend upon the
sp. gr. of drug and the volume of capsules of various sizes (the same
information can be downloaded from capsules suppliers). Either a neat
filled capsule or a blend of drug with excipient can be used to fill
such capsules and such product then have to follow the same
requirements to qulaify as a drug product as per GLP.
It would be highly difficult to titrate the doses which can easily be
managed with test item formulations like suspensions. Such
flexibilities will not be accessible with unit dosage forms like
tablets or capsules.
regards,
Vaibhav
Vaibhav Sihorkar, Ph.D
Principal Scientist
Formulations R&D, Discovery Research
Dr. Reddy's Laboratories Ltd.
Miyapur, Hyderabad 500 049, India
sihorkarv.at.drreddys.com
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