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Re: Tartiaboy post# 394

Monday, 06/05/2023 6:32:26 PM

Monday, June 05, 2023 6:32:26 PM

Post# of 569
A couple of quotes. "Precipitation of orally administered drugs in the gastrointestinal (GI) tract is an undesirable process which often can be observed upon the entry of solutes containing poorly soluble weak bases into the small intestine. Precipitation can be a result of a sharp pH change, the dilution of the formulation with GI fluids, or the digestion of solubilizing agents in the formulations."
"In the pharmaceutical industry, various high-throughput methods are applied to determine the kinetic or thermodynamic (equilibrium) solubility of drug candidates. Kinetic solubility is often determined by first dissolving the drug in a polar aprotic organic solvent such as dimethyl sulfoxide and then adding this
drug solution to a buffer in a 96-well plate. The solution is then allowed to equilibrate for a predetermined time in which the drug may precipitate. After filtration, the drug remaining in solution is measured using an UV plate reader".
My question is, why it had not be done before initiation of dose escalation study?
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