Abstract
Carbamazepine (CBZ) is an active pharmaceutical ingredient used in the treatment of epilepsy that can form at least 5 polymorphic forms. Metastable form IV was originally discovered from crystallization with polymer additives; however, it has not been observed from subsequent solvent-only crystallization efforts. This work reports the reproducible formation of phase pure crystalline form IV by spray drying of methanolic CBZ solution. Characterization of the material was carried out using diffraction, scanning electron microscopy, and differential scanning calorimetry. In situ Raman spectroscopy was used to monitor the spray-dried product during the spray drying process. This work demonstrates that spray drying provides a robust method for the production of form IV CBZ, and the combination of high supersaturation and rapid solid isolation from solution overcomes the apparent limitation of more traditional solution crystallization approaches to produce metastable crystalline forms.
Highlights
Active pharmaceutical ingredients (APIs) and formulated dosage forms are largely produced using traditional batch manufacturing methods
The sample was identified as CBZ IV by comparison of the experimental X-ray powder diffraction (XRPD) data with calculated XRPD reference patterns for forms I-IV (Fig. 1)
There is no evidence of any diffraction peaks from the sample that are not accurately described by the structure of CBZ IV, confirming the phase purity, to the limit of detection for XRPD, of the spray-dried sample.[20,21]
Summary
Active pharmaceutical ingredients (APIs) and formulated dosage forms are largely produced using traditional batch manufacturing methods. There is increasing interest in exploiting the potential advantages of continuous processing that include improved consistency, process efficiency, and reduced cost of goods in the manufacture of pharmaceuticals.[1] Spray drying enables particle formation and isolation in a single continuous operation and so presents the opportunity to simplify multiple batch operations into a single step. The present study, investigates particle formation of the API carbamazepine (CBZ) in a spray dryer.
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