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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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A proton M that is coupled to a proton X results in doublet signals for M. However, NMR-active nuclei can be simultaneously coupled to more than one nonequivalent nucleus. When M is coupled to a second proton A, such as in styrene oxide, each peak in the doublet is split into another doublet.
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Aromatic compounds can be identified or analyzed using proton NMR and carbon‐13 NMR. Typically, aromatic hydrogens or hydrogens directly bonded to the aromatic rings are strongly deshielded by the aromatic ring current. Therefore, they absorb in the range of 6.5–8.0 ppm in proton NMR spectra. For instance, aromatic hydrogens directly bonded to the benzene ring absorb at 7.3 ppm. However, aromatic hydrogens of larger rings absorb farther upfield or downfield than the ideal range.
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FTIR, Raman spectroscopy and HT-XRD in compatibility study between naproxen and excipients.

Barbara Rojek1, Maria Gazda2, Alina Plenis1

  • 1Department of Analytical Chemistry, Faculty of Pharmacy, Medical University of Gdansk, Al. Gen. Hallera 107, 80-416 Gdansk, Poland.

Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
|June 24, 2023
PubMed
Summary

New spectroscopic methods reliably detect drug-excipient incompatibility in solid dosage forms. This rapid identification is crucial for selecting optimal excipients during pharmaceutical pre-formulation, ensuring drug stability and efficacy.

Keywords:
Compatibility/incompatibilityDSCFTIRHT-XRDNaproxenRaman spectroscopy

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Analytical Chemistry

Background:

  • Selecting appropriate excipients is critical for solid dosage form development.
  • Fast and reliable incompatibility detection methods are essential in pharmaceutical pre-formulation.
  • Understanding drug-excipient interactions impacts biopharmaceutical performance.

Purpose of the Study:

  • To introduce a novel approach for detecting active pharmaceutical ingredient (API) and excipient incompatibility.
  • To evaluate the efficacy of combined spectroscopic techniques (FTIR, Raman) and high-temperature X-ray diffraction (HT-XRD) for incompatibility assessment.
  • To compare the new methods with established techniques like differential scanning calorimetry (DSC).

Main Methods:

  • Fourier transform infrared (FTIR) and Raman spectroscopy combined with hierarchical cluster analysis (HCA) for data interpretation.
  • High-temperature X-ray diffraction (HT-XRD) to assess changes in drug crystallinity.
  • Differential scanning calorimetry (DSC) as a reference method for thermal analysis.
  • Intrinsic dissolution rate studies to evaluate the impact on drug release.

Main Results:

  • Spectroscopic analyses identified physical incompatibility between naproxen (NPX) and several polymer excipients (MC, HPMC, HEC, SSG, CMC).
  • HT-XRD revealed a decrease in naproxen crystallinity in incompatible mixtures upon heating and cooling.
  • Results from spectroscopic methods were corroborated by DSC and dissolution rate studies, confirming the findings.

Conclusions:

  • Combined FTIR, Raman, and HT-XRD offer a rapid and reliable method for detecting drug-excipient incompatibility.
  • This approach facilitates the selection of suitable excipients, improving the pre-formulation process for solid dosage forms.
  • The study highlights the importance of understanding physical incompatibilities for successful drug product development.