Meloxicam (MLX) is an anti-inflammatory drug susceptible to variations and crystalline transitions. In compounding pharmacies, the complete crystallographic evaluation of the raw material is not a routine procedure. We performed a complete crystallographic characterization of aleatory raw MLX samples from compounding pharmacies. X-ray diffraction indicated the presence of two crystalline forms in one sample. DSC experiments suggested that crystallization, or a crystal transition, occurred differently between samples. The FTIR and 1H NMR spectra showed characteristic assignments. 13C solid-state NMR spectroscopy indicated the presence of more than one phase in a sample from pharmacy B. The Hirshfeld surface analysis, with electrostatic potential projection, allowed complete assignment of the UV spectra in ethanol solution. The polymorph I of meloxicam was more active than polymorph III in an experimental model of acute inflammation in mice. Our results highlighted the need for complete crystallographic characterization and the separation of freely used raw materials in compounding pharmacies, as a routine procedure, to ensure the desired dose/effect.
Azathioprine is an immunosuppressive drug for several inflammatory disorders. Due to its clinical relevance, to explore the solid-state properties for excipient compatibility in the product quality review process is essential. Fourier transform infrared spectroscopy, powder X-ray diffraction and thermal analysis (thermogravimetry/derivative thermogravimetry (TG/DTG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC)) were applied. The compatibility studies evidenced that starch pregelatinized, colloidal silicon dioxide, and talc are fully compatible with azathioprine. However, stearic acid, magnesium stearate, and mannitol are incompatible after heat supply at temperatures easily reached by industrial processing. The nonlinear Vyazovkin isoconversional treatment performed the kinetic study of the thermal degradation. The activation energies were determined to clarify the influence of each excipient on the thermal drug stability, an essential procedure in the pharmaceutical development, and all over the commercial live span, in Good Manufacturing Practices.
The presence of copper in distilled sugar cane spirits, especially cachaça produced in alembics, has impeded the marketing of this product. Red mud (RM) is a residue obtained from alumina production. It contains a high concentration of metal oxides and is very alkaline. The RM was dried at 100 oC and sifted through a 150-micron sieve. The sample was characterized by B.E.T. nitrogen adsorption, scanning electron microscopy-energy-dispersive X-ray (SEM-EDX) and Atomic Absorption Spectrometry (A.A.S.). The textural parameters indicate that the total surface area (S.T.) was 21.9 m2g-1, and the total volume pore (V.T.) was 0.09 cm3g-1. The RM (1 g) was stirred for two hours with a 1.0 L cachaça sample containing 9.39 mg of copper L-1 and filtered under atmospheric pressure. The concentration of copper ions detected in the filtrate was 0.00 mg L-1. No copper ions were retained when the cachaça was filtered through the RM under high pressure without stirring prior to filtration.
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