Produção Nacional
Revisado por pares
Near infrared spectroscopy to monitor drug release in-situ during dissolution tests
2016; Elsevier BV; Volume: 513; Issue: 1-2 Linguagem: Inglês
10.1016/j.ijpharm.2016.09.010
ISSN1873-3476
AutoresMafalda C. Sarraguça, Rita Matias, Raquel Figueiredo, Paulo Roberto da Silva Ribeiro, Ana Teixeira Martins, João A. Lopes,
Tópico(s)Crystallization and Solubility Studies
ResumoDissolution tests can be used to demonstrate suitable in vivo drug release through in vivo/in vitro correlations. This work explores the possibility of using near infrared spectroscopy (NIRS) to monitor in-situ dissolution tests. It aims at expanding surrogate methods in quality control of drug products. Laboratory designed tablets of an immediate-release formulation containing folic acid and four excipients were used as case study. The dissolution tests were performed on a 1 L vessel filled with 500 ml of Milli-Q water with a rotating paddle apparatus (apparatus 2, Ph. Eur.) at 50 rpm and 37 ± 0.5 °C. Near infrared (NIR) spectra were acquired in-situ with a transflectance probe connected to a Fourier-transform near infrared spectrometer. NIR spectra were regressed against folic acid concentration by partial least squares (PLS) regression. Folic acid concentrations during dissolution tests were obtained by periodically sampling the dissolution vessel and resourcing to an UV method. The proposed real-time NIR method was tested on a validation run yielding a root mean squared error of 0.25 μg ml−1 (0.16 μg ml−1 for the calibration runs) and a R2 of 0.93 (0.95 for the calibration runs). The results suggest that NIRS is a suitable analytical technique for monitoring in-situ dissolution tests.
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