All Categories (1-6 of 6)

1. Matrix-assisted cocrystallization (MAC) simultaneous production and formulation of pharmaceutical cocrystals by hot-melt extrusion

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   23 Jul 2024 | Contributor(s):: Boksa, Kevin, Otte, Andrew, Pinal, Rodolfo

   A novel method for the simultaneous production and formulation of pharmaceutical cocrystals, matrix-assisted cocrystallization (MAC), is presented. Hot-melt extrusion (HME) is used to create cocrystals by coprocessing the drug and coformer in the presence of a matrix material. Carbamazepine...

2. Nucleation kinetics of polymorphs: Induction period and interfacial energy measurements

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   09 Jun 2023 | Contributor(s):: Teychené, S., Biscans, B.

   Nucleation kinetics of eflucimibe polymorphs have been investigated in ethanol and n-heptane mixture. The two eflucimibe polymorphs, A and B, crystallize concomitantly for a wide range of operating conditions. The effects of supersaturation on the nucleation rates of the two existing polymorphs...

3. Continuous Heterogeneous Crystallization on Excipient Surfaces

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   09 Jun 2023 | Contributor(s):: Yazdanpanah, Nimaa, Testa, Christopher J., Perala, Siva R. K., Jensen, Keith D., Braatz, Richard D., Myerson, Allan S., Trout, Bernhardt L.

   A novel continuous heterogeneous crystallization process is, developed in which the active pharmaceutical ingredient (API) is crystallized directly on the surface of an excipient within the crystallizer. The produet is subsequently dried and formed into tablets without the need for complex...

4. Comparative investigation of supersaturation and automated direct nucleation control of crystal size distributions using ATR-UV/vis spectroscopy and FBRM

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   09 Jun 2023 | Contributor(s):: Saleemi, Ali N., Rielly, Chris D., Nagy, Zoltan K.

   The paper presents a thorough evaluation of different control strategies used in cooling crystallization, namely, unseeded linear cooling, seeded linear cooling, supersaturation control, and automated direct nucleation control. The sensitivity and robustness of supersaturation and automated...

5. API Continuous Cooling and Antisolvent Crystallization for Kinetic Impurity Rejection in cGMP Manufacturing

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   09 Jun 2023 | Contributor(s):: Johnson, MD, Burcham, CLMay, SA, Calvin, JR, Groh, JM, Myers, SS, Webster, LP, Roberts, JC, Reddy, VR, Luciani, CV, Corrigan, AP, Spencer, RD, Moylan, R, Boyse, R, Murphy, JD, Stout, JR

   Crystallization of 204 kg of final active pharmaceutical ingredient was accomplished continuously using a cascade of mixed suspension mixed product removal crystallizers in cGMP manufacturing. This article describes the journey taken to transform a set of technical to final batch crystallizations...

6. A Stochastic Population Balance Equation Model for Nucleation and Growth of Crystals with Multiple Polymorphs

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   09 Jun 2023 | Contributor(s):: Maggioni, Giovanni, Mazzotti, Marco

   Understanding polymorph crystallization is important due to the different properties, such as bioavailability or crystal shape, exhibited by the different crystal forms. In this work, we present a model, based on population balance equations, describing the unseeded crystallization by cooling of...