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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).
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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Monitoring the Dissolution Mechanisms of Amorphous Bicalutamide Solid Dispersions via Real-Time Raman Mapping.

Francesco Tres1, Jamie D Patient1, Philip M Williams1

  • 1†School of Pharmacy, University of Nottingham, Boots Science Building, Nottingham NG7 2RD, United Kingdom.

Molecular Pharmaceutics
|April 16, 2015
PubMed
Summary

Real-time Raman mapping revealed amorphous bicalutamide in a copovidone VA64 matrix transforms into polymorphic forms during dissolution. Higher drug loading impacts crystallization mechanisms, with direct amorphous crystallization being dominant.

Keywords:
Raman mappingamorphous solid dispersionsbicalutamidedissolutionkinetic modelingmultivariate curve resolutionpolymorphic changespoorly soluble drugssolid-state transformationsspatial correlations

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Solid-State Chemistry

Background:

  • Amorphous solid dispersions enhance drug solubility and bioavailability.
  • Understanding crystallization transitions during dissolution is crucial for drug product performance.
  • Bicalutamide is an anti-androgen medication used to treat prostate cancer.

Purpose of the Study:

  • To investigate the in situ crystallization transitions of amorphous bicalutamide in a copovidone VA64 matrix during dissolution.
  • To explore the effect of increasing bicalutamide loading on dissolution performance and crystallization behavior.
  • To elucidate the mechanisms of recrystallization during the dissolution of amorphous bicalutamide.

Main Methods:

  • Real-time in situ Raman mapping to monitor crystallization.
  • Rotating disc dissolution rate methodology for simultaneous active ingredient and polymer dissolution determination.
  • Multivariate curve resolution (MCR) for analyzing spatially time-resolved Raman maps.
  • Kinetic modeling to understand recrystallization mechanisms.

Main Results:

  • Amorphous bicalutamide in a 50% drug-loaded dispersion transformed into metastable polymorphic form II and low-energy polymorphic form I during dissolution.
  • Higher bicalutamide loading influenced the crystallization pathways.
  • Polymorphic form I primarily crystallized directly from the amorphous solid dispersion, with minor crystallization from form II.

Conclusions:

  • Real-time Raman mapping provides insights into drug crystallization during dissolution.
  • The crystallization mechanism of bicalutamide is dependent on drug loading within the copovidone VA64 matrix.
  • Direct crystallization from the amorphous state is the predominant pathway for the formation of the stable polymorphic form.