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Rufinamide: Crystal structure elucidation and solid state characterization.

Nita Salunke1, Rajesh Thipparaboina1, Rahul B Chavan1

  • 1Solid State Pharmaceutical Research Group (SSPRG), National Institute of Pharmaceutical Education and Research, Hyderabad, India.

Journal of Pharmaceutical and Biomedical Analysis
|November 10, 2017
PubMed
Summary
This summary is machine-generated.

This study characterized Rufinamide (R) solid-state properties, revealing its triclinic crystal structure and purity. Formulation challenges include poor solubility and excipient incompatibility, necessitating careful development strategies.

Keywords:
CompressibilityDSCDissolution mediaHPLC methodSolubility

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Rufinamide (R) is an antiepileptic drug used for partial seizures and Lennox-Gastaut Syndrome.
  • Understanding solid-state properties is crucial for effective drug formulation and development.

Purpose of the Study:

  • To elucidate the crystal structure of Rufinamide (R) using single crystal X-ray diffraction.
  • To characterize the solid-state properties of R, including thermal, spectroscopic, and crystallographic aspects.
  • To assess drug-excipient compatibility, solubility, dissolution, and flow behavior for formulation development.

Main Methods:

  • Single crystal X-ray diffraction for crystal structure determination.
  • Differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and powder X-ray diffraction (PXRD) for solid-state characterization.
  • RP-HPLC for drug quantification, solubility, and dissolution studies; Carr's index and Hausner's ratio for flow evaluation.

Main Results:

  • Rufinamide crystallized in the triclinic system (P-1 space group) with intermolecular hydrogen bonding.
  • Solid-state analyses confirmed the drug's purity, free from polymorphic impurities.
  • Poor aqueous solubility was improved 4.6-fold with 2% sodium lauryl sulphate (SLS); pH had minimal impact.
  • Incompatibility was observed between Rufinamide-DMF and several common excipients (PEG 8000, SLS, lactose, starch, HPMC E15).

Conclusions:

  • The crystal structure and solid-state characterization provide essential data for Rufinamide formulation.
  • Strategies to overcome poor solubility and excipient incompatibilities are necessary for successful drug product development.