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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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Phase II biotransformation reactions are essential for detoxifying and eliminating xenobiotics, including many pharmaceutical compounds. These reactions typically involve conjugation, the covalent attachment of polar endogenous groups such as glucuronic acid, sulfate, methyl, or acetyl moieties to functional groups introduced during Phase I metabolism. The resulting conjugates are more water-soluble, enabling efficient renal or biliary excretion.The major classes of Phase II enzymes include...
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Genetic polymorphisms in drug targets have emerged as critical determinants of interindividual variability in drug response and toxicity. Pharmacogenomic investigations increasingly focus on identifying these variations to personalize and optimize therapeutic interventions. A drug target may be a receptor, enzyme, or signaling protein involved in pharmacologic responses or disease-related pathways. While early pharmacogenetic studies focused primarily on drug metabolism, current research...
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Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...

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A Method for Screening and Validation of Resistant Mutations Against Kinase Inhibitors
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Conformational polymorphism on imatinib mesylate: grinding effects.

Damián Grillo1, Griselda Polla, Daniel Vega

  • 1Departamento Física de la Materia Condensada, Gerencia de Investigación y Aplicaciones, Comisión Nacional de Energía Atómica, San Martín, Buenos Aires, Argentina.

Journal of Pharmaceutical Sciences
|October 7, 2011
PubMed
Summary
This summary is machine-generated.

Polymorphs α and β of imatinib mesylate show distinct crystal structures and conformational differences. Form β is more stable at room temperature, and both forms can become amorphous when ground, with form β forming upon aging.

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Area of Science:

  • Solid-state chemistry
  • Pharmaceutical sciences
  • Crystallography

Background:

  • Imatinib mesylate is a crucial pharmaceutical agent.
  • Understanding its solid-state forms (polymorphs) is vital for drug formulation and stability.
  • Polymorphism can significantly impact drug bioavailability and efficacy.

Purpose of the Study:

  • To elucidate the crystal structures of imatinib mesylate polymorphs α and β.
  • To investigate the thermal behavior and grinding effects on these polymorphs.
  • To compare the stability and crystallization pathways of different imatinib mesylate forms.

Main Methods:

  • X-ray powder diffraction (XRPD) for crystal structure analysis.
  • Differential scanning calorimetry (DSC) for thermal behavior assessment.
  • Kinetic studies of amorphous-to-crystalline phase transitions.

Main Results:

  • Distinct crystal structures and conformational differences were observed between polymorphs α and β.
  • Both polymorphs form dimer-chain arrangements stabilized by hydrogen and π-π interactions.
  • Form β is more thermodynamically stable at room temperature; grinding induces amorphous phases, with form β crystallizing upon aging.

Conclusions:

  • Imatinib mesylate exhibits significant polymorphism with distinct structural and stability characteristics.
  • Grinding induces amorphous states, highlighting the mechanical sensitivity of the drug.
  • Crystallization pathways are dependent on conditions, emphasizing the role of seeding in controlling polymorph formation.