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Crystallization

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Design Of Active Pharmaceutical Ingredients Solid States In Crystallization Processes, Weizhong Gong Jan 2024

Design Of Active Pharmaceutical Ingredients Solid States In Crystallization Processes, Weizhong Gong

Electronic Thesis and Dissertation Repository

Crystallization is an important technique to obtain solid-state drugs from solutions. Physicochemical properties of the active pharmaceutical ingredients (APIs) are determined by crystallization. More than half of the active pharmaceutical ingredients exhibit polymorphism, the phenomenon of chemical species showing more than one unit-cell structure in the solid state. Controlling polymorphism is one of the most important goals during pharmaceutical manufacturing. Nevertheless, the control of polymorphism is sometimes not enough to realize the targeted physicochemical properties. Suitable additives (coformers/salt formers) are explored to generate new multi-component solid phases of poorly soluble/bioavailable active pharmaceutical ingredients (APIs). The design of pharmaceutical cocrystals and …


Crystal Engineering Of Active Pharmaceutical Ingredients With Low Aqueous Solubility And Bioavailability, Jenna M. Skieneh Aug 2017

Crystal Engineering Of Active Pharmaceutical Ingredients With Low Aqueous Solubility And Bioavailability, Jenna M. Skieneh

Electronic Thesis and Dissertation Repository

Approximately 75% of new molecular entities approved by the Food and Drug Administration (FDA) for use in the pharmaceutical industry are found to have poor aqueous solubility. This undesirable attribute leads to consequences such as higher doses required to reach therapeutic levels, greater vulnerability to food effects, lesser fraction absorbed in the small intestine and damage to the environment due to increased quantity of excretion. The addition of an excipient (i.e. a FDA approved inactive ingredient) to the molecular structure of an active pharmaceutical ingredient (API) through intermolecular bonding is of growing interest because the properties of the API can …