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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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Characterization of polymorphic ampicillin forms.

C Baraldi1, A Tinti2, S Ottani3

  • 1Department of Life Sciences, University of Modena and Reggio Emilia, via Campi n.183, 41125 Modena, Italy.

Journal of Pharmaceutical and Biomedical Analysis
|September 8, 2014
PubMed
Summary
This summary is machine-generated.

This study investigated ampicillin polymorphs using experimental and theoretical methods. Specific spectral features were identified for characterizing different ampicillin forms, which remained stable over two years.

Keywords:
AmpicillinDFT calculationsFTIR/ATR spectroscopyRaman microscopyThermal analysisX-ray powder diffraction

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Spectroscopy

Background:

  • Polymorphism significantly impacts drug properties like solubility and bioavailability.
  • Understanding ampicillin polymorphs is crucial for its pharmaceutical applications.
  • Previous studies have not fully characterized all ampicillin forms and their interconversions.

Purpose of the Study:

  • To prepare and characterize various polymorphs of ampicillin.
  • To identify unique spectral signatures for each polymorph using experimental and theoretical techniques.
  • To investigate the thermal behavior and interconversion pathways of ampicillin polymorphs.

Main Methods:

  • Preparation and characterization of amorphous monohydrate and crystalline forms (trihydrate, form I, form II) of ampicillin.
  • Spectroscopic analysis using FT-IR and micro-Raman spectroscopy.
  • Thermal analysis including Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA).
  • X-ray Powder Diffraction (XRPD) and hot-stage Raman spectroscopy.
  • Quantum mechanical calculations using Density Functional Theory (DFT) for spectral assignment.

Main Results:

  • Distinct spectral features (IR and Raman) were identified for each ampicillin polymorph, aiding characterization.
  • The zwitterionic form of ampicillin was studied theoretically for the first time.
  • DSC revealed the transformation of trihydrate crystals into anhydrous forms upon heating.
  • Hot-stage Raman spectroscopy and thermal analysis elucidated polymorph interconversion pathways.
  • Stability tests confirmed no transformation or degradation of polymorphs over a two-year period.

Conclusions:

  • Specific vibrational bands in IR and Raman spectra can reliably differentiate ampicillin polymorphs.
  • The study provides a comprehensive understanding of ampicillin solid-state forms and their behavior.
  • Ampicillin polymorphs exhibit good long-term stability under storage conditions.