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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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X-ray diffraction or XRD is an analytical tool that utilizes X-rays to study ordered structures such as crystalline organic and inorganic samples, polycrystalline materials, proteins, carbohydrates, and drugs.
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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Dynamic Crystallization Pathways of Polymorphic Pharmaceuticals Revealed in Segmented Flow with Inline Powder X-ray

Mark A Levenstein1,2, Lois Wayment3,4,5, C Daniel Scott3,6

  • 1School of Mechanical Engineering, University of Leeds, Woodhouse Lane, Leeds LS2 9JT, U.K.

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Studying pharmaceutical crystallization with in situ X-ray diffraction reveals critical polymorph transition pathways. Controlled flow crystallization enhances understanding of urea: barbituric acid and carbamazepine crystallization dynamics.

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Area of Science:

  • Materials Science
  • Chemical Engineering
  • Crystallization Science

Background:

  • Pharmaceutical polymorph transitions are crucial for drug manufacturing and efficacy.
  • Crystallization is sensitive to environmental factors, making precise control challenging.
  • In situ monitoring is vital for understanding complex crystallization mechanisms.

Purpose of the Study:

  • To investigate pharmaceutical crystallization mechanisms using a segmented flow crystallizer.
  • To elucidate polymorph transition pathways for urea: barbituric acid (UBA) and carbamazepine (CBZ).
  • To demonstrate the utility of in situ synchrotron powder X-ray diffraction (PXRD) in controlled environments.

Main Methods:

  • Utilized a segmented flow crystallizer for reproducible reaction conditions.
  • Employed in situ synchrotron powder X-ray diffraction (PXRD) to monitor crystallization in real-time.
  • Conducted seeded and unseeded crystallization runs for UBA and CBZ.

Main Results:

  • Observed a polymorph progression from UBA III to UBA I, influenced by seeding.
  • Demonstrated that UBA I seeds promote the formation of UBA I, while UBA III seeds still allow transformation.
  • Uncovered mixing-dependent kinetics for the CBZ form II to III transformation.

Conclusions:

  • Coupling controlled reaction environments with in situ XRD is essential for studying polymorphic materials.
  • In situ measurements provide critical insights into crystallization pathways and polymorph control.
  • Flow crystallization offers a reproducible platform for investigating pharmaceutical solid-state transformations.