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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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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Highly Soluble Dacarbazine Multicomponent Crystals Less Prone to Photodegradation.

Luan F Diniz1, Paulo S Carvalho2, Mateus A C Souza1

  • 1Laboratório de Controle de Qualidade de Medicamentos e Cosméticos, Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, 31270-901 Belo Horizonte, MG, Brazil.

Molecular Pharmaceutics
|June 10, 2024
PubMed
Summary

New Dacarbazine (DTIC) solid forms were developed to improve solubility and reduce photodegradation. These novel salts and cocrystals offer enhanced dissolution rates, potentially improving melanoma treatment efficacy.

Keywords:
cocrystalcocrystallizationdacarbazinesaltsolubilitystability

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Area of Science:

  • Pharmaceutical Science
  • Solid-State Chemistry
  • Oncology

Background:

  • Dacarbazine (DTIC) is crucial for advanced melanoma but suffers from poor solubility and photosensitivity.
  • Photodegradation yields inactive 2-azahypoxanthine (2-AZA), limiting therapeutic effectiveness.
  • Current formulations require strategies to enhance DTIC's biopharmaceutical profile.

Purpose of the Study:

  • To develop novel Dacarbazine (DTIC) salt and cocrystal forms.
  • To enhance DTIC's solubility and dissolution rate.
  • To minimize DTIC's photodegradation.

Main Methods:

  • Cocrystallization techniques using aliphatic carboxylic acids.
  • Structural characterization via Single Crystal X-ray Diffraction (SCXRD), Powder X-ray Diffraction (PXRD), FT-IR, 1H NMR, Thermogravimetric Analysis (TG), and Differential Scanning Calorimetry (DSC).

Main Results:

  • Successfully prepared two DTIC salts, two cocrystals, and one salt-cocrystal.
  • Achieved significant solubility enhancement (up to 19-fold) and increased intrinsic dissolution rates (1.3 to 22-fold).
  • These new forms demonstrated a positive impact on reducing DTIC photodegradation in solution.

Conclusions:

  • Novel DTIC salts and cocrystals significantly improve solubility and dissolution.
  • These enhanced solid forms hold promise for overcoming Dacarbazine's biopharmaceutical limitations.
  • The developed forms could lead to more effective melanoma treatments.