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I am working on development of new NCE molecule given through
Inhalation route; but we are confused with initial pre-clinical
studies to be done animal for toxicity design and dose determination
for inhalation route.
First some suggest, first try with pMDI >DPI> nebulizing solution
while other group strongly suggest DPI>>pMDI>Nebulizing solutions.
If we are developing new NCE products for inhalation, how to conduct
initial pre-clinical testing in animal model using appropriate dosage
Research Scientist, Pharma Research
Ranbaxy Labs Ltd
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The following message was posted to: PharmPK
You mention two issues: toxicity and formulation. You want to defer to
your internal pharmaceutics people on the "best" formulation approach,
the long-term decision depends on a plethora of issues such as aqueous
stability, moisture sorption, crystal formation, particle specs and
deaggregation characteristics. You won't know definitively MDI vs. PDI
without integrating specific physicochemical information on your NCE.
comment on the tox screen.
Best of luck to you
SHAWN SPENCER, PhD.
Assistant Professor of Biopharmaceutics
Dyson Bldg., Rm 227
College of Pharmacy and Pharmaceutical Sciences Florida A&M University
Tallahassee, FL 32307 shawn.spencer.-at-.famu.edu
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