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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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,...
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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A Guided Materials Screening Approach for Developing Quantitative Sol-gel Derived Protein Microarrays
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Published on: August 26, 2013

Polymorph screening of an active material.

P Láng1, V Kiss, R Ambrus

  • 1University of Szeged, Department of Pharmaceutical Technology, Eötvös u. 6, H-6720 Szeged, Hungary.

Journal of Pharmaceutical and Biomedical Analysis
|July 13, 2013
PubMed
Summary
This summary is machine-generated.

This study identified eight polymorphs of a drug candidate, revealing significant differences in their dissolution rates and stabilities. Form II and IVb demonstrated superior thermodynamic stability compared to other crystal forms.

Keywords:
Dissolution testDrug candidatePolymorphRelative stability

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Solid-State Chemistry

Background:

  • Polymorph screening is crucial for pharmaceutical innovators and generic companies, impacting drug properties and intellectual property.
  • Different polymorphic forms exhibit varying physicochemical properties, notably solubility, which directly affects bioavailability.
  • Understanding polymorphism is essential for drug development and formulation.

Purpose of the Study:

  • To explore the polymorphism of a former drug candidate from Sanofi.
  • To characterize distinct morphologies and assess their relative stabilities.
  • To investigate the dissolution behavior of different polymorphs.

Main Methods:

  • Utilized an Avantium Crystal 16 reactor system for polymorph screening and dissolution studies.
  • Employed crystallization and transformation techniques to obtain eight polymorphs.
  • Characterized polymorphs using X-ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), Raman spectroscopy, scanning electron microscopy (SEM), and light microscopy.

Main Results:

  • Successfully obtained and characterized eight distinct polymorphs.
  • All identified morphologies remained stable for up to two years.
  • Forms II and IVb exhibited the highest thermodynamic stability, while other forms (I, III, IVa, V, VI, VII) were metastable.
  • Developed a specialized dissolution medium revealing significant differences in dissolution rates among the eight polymorphs.

Conclusions:

  • The study successfully characterized eight polymorphs of a drug candidate, detailing their stability and dissolution profiles.
  • Forms II and IVb represent the most thermodynamically stable polymorphs, crucial for formulation development.
  • The distinct dissolution rates observed highlight the importance of polymorph selection for optimizing drug bioavailability.