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Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach
| Contributor(s):: Siva Ram Munnangi, Ahmed Adel Ali Youssef, Nagarjuna Narala, Preethi Lakkala, Sateesh Kumar Vemula, Rohit Alluri, Feng Zhang, Micheal A. Repka
Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot-melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of...
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Quantitative Solution Measurement for the Selection of Complexing Agents to Enable Purification by Impurity Complexation
| Contributor(s):: Weber, CC, Wood, GPFKunov-Kruse, AJ, Nmagu, DE, Trout, BL, Myerson, AS
The removal of carboxylic acid impurities from amide targets has been accomplished through crystallization featuring a complexing agent in solution. The interaction between the complexing agents and impurities was examined using isothermal titration calorimetry and the free energy of association...
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Complexation-Assisted Continuous Crystallization of Isomeric Systems with Nanofiltration Recycle
| Contributor(s):: Vartak, S, Myerson, AS
In API-impurity systems consisting of structural isomers, the impurity has a strong affinity to incorporate into the host crystal owing to their identical molecular weight and similar structure. Conventional successive recrystallization turns out to be an unattractive purification strategy in...