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Effect of processing on Celecoxib and its solvates
Garima Chawla1, Arvind K Bansal
1Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India.
Pharmaceutical Development and Technology
|December 8, 2004
Summary
Pharmaceutical processing can alter drug crystal forms (polymorphism), affecting drug properties. This study investigated how processes like compression impact Celecoxib
Area of Science:
- Solid-state chemistry and pharmaceutical sciences.
- Materials science and drug formulation.
Background:
- Polymorphism, the existence of different crystal forms, is inherent to many pharmaceuticals.
- Pharmaceutical manufacturing processes, particularly those involving mechanical stress, can induce polymorphic transformations.
- These transformations can undesirably alter drug physicochemical and material properties, impacting efficacy and stability.
Purpose of the Study:
- To investigate the impact of key energy-intensive pharmaceutical unit processes on the solid-state transformation of Celecoxib and its solvated forms.
- To evaluate the influence of size reduction, wet granulation, consolidation, and compression on polymorphic changes.
- To develop a quantitative method for assessing solid-state transformations during compression.
Main Methods:
- Differential Scanning Calorimetry (DSC) for thermal analysis.
- Microscopy for visual assessment of crystal morphology.
- Fourier Transform Infrared (FTIR) spectroscopy for chemical structure analysis and quantification.
- X-ray Powder Diffraction (XRPD) for crystalline phase identification.
Main Results:
- Energy-imparting processes like compression were shown to induce significant solid-state transformations in Celecoxib and its solvated forms.
- FTIR spectroscopy proved effective for qualitative assessment and quantitative determination of polymorphic changes, particularly in the N,N-dimethyl acetamide solvated form during compression.
- The study confirmed that pharmaceutical unit processes can lead to undesirable changes in drug solid-state forms.
Conclusions:
- Pharmaceutical unit processes significantly influence the solid-state characteristics of Celecoxib, necessitating careful control.
- Understanding and monitoring polymorphic transformations during manufacturing is crucial for ensuring drug product quality and performance.
- FTIR spectroscopy offers a viable method for quantifying solid-state transformations in pharmaceutical formulations.