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Pre Formulation

Pre Formulation

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Published by: ranjithreddy20004585 on Feb 04, 2010
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07/12/2013

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TRD -Your Partner for Technical R&D
Pharmaceutical Preformulation
Wei-Qin(Tony) Tong, Ph.D.
 Novartis Pharmaceuticals CorporationIntegrated Drug Product Development Process(3 day-course), University of UtahJuly 17-19, 2006
 
TRD -Your Partner for Technical R&D
IntroductionIntroduction
Preformulation
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a stage of development during which the physicochemical properties of drug substance are characterized
Some commonly evaluated parameters
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Solubility
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Dissolution behavior 
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Stability
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Partition coefficient
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Ionization constant (pKa)
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Solid state propertiessuch as crystal forms/polymorphs, water sorptionbehavior, surface properties, particle size and shape, and othermechanicalproperties, et. al.
 
TRD -Your Partner for Technical R&D
Why is Preformulation Important?Why is Preformulation Important?
It is a capital mistake to theorize before one has data
Scandal in Bohemia 
, Sir Arthur Conan Doyle
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Thorough preformulation work is the foundation odeveloping robust formulations.

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