Browsing by Author "Castillo, Jorge Enrique (Director)"
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Item Evaluación de las alteraciones térmicas en el estado de mezcla sólido entre diferentes materiales poliméricos y Farmácos de clasificación biofarmacéutica I y II, por medio de la calorimetria de barrido diferencial (DSC) y FT-IR(Universidad Santiago de Cali, 2019) Cardona Gómez, Juan David; Aponza Narváez, Diana Marcela; Castillo, Jorge Enrique (Director)In the present study, the potential of using polymeric materials with drugs as useful raw materials in the development of delivery systems was evaluated, Thermal analysis and spectroscopy techniques were used to evaluate the compatibility of Metoprolol (MTP), a biopharmaceutical classification I drug, and Carbamazepine (CBZ), a biopharmaceutical classification II drug, with polymeric materials commonly used in the pharmaceutical industry such as Hydroxypropylmethylcellulose (HPMC) and Xanthan Gum; copolymeric materials derived from maleic anhydride corresponding to the sodium salt of poly (maleic acid-alt-ethylene) called PAM-ONa and the sodium salt of poly (maleic acid-alt-octadecene) called PAM-18Na were also used Mixtures were prepared in proportions of 10, 20, 30, and 40 percent, weight-to-weight (% w/w), in drug-to-polymer ratios. Each material, individually and under mixture, was subjected to thermal characterization by Scanning Calorimetry. Blends were prepared in proportions of 10, 20, 30, and 40 percent, weight-to-weight (% w/w), drug/polymer ratio. Each material, individually and under mixture, was subjected to thermal characterization by Differential Scanning Calorimetry (DSC) and FT-IR Infrared Spectroscopy (Smart ITR). The results of the FT-IR study showed that the blend systems of CBZ and MTP at 10 and 40% with the reference polymers did not exhibit any interactions, while for PAM-0Na and PAM-18Na, new signals were presented respectively at the C-H group stretching 2980-2800 cm'' of these polymers, mainly for the blend systems with PAM-18Na; however, in the thermal analysis by DSC, interactions were observed in the MTP blend systems mainly with PAM-18NaItem Implementación y validación de la técnica analítica para la cualificación–cuantificación de Dienogest/Etinilestradiol tableta recubierta, por espectroscopia de infrarrojo cercano(Universidad Santiago de Cali, 2018) Cardona Moreno, Gilma Liliana; Castillo, Jorge Enrique (Director)In this study, the implementation and validation of the analytical technique for the identification and quantification by NIR near infrared spectroscopy of Dienogest / Etinilestradiol in Coated Tablets was developed. This methodology was developed in order to provide a quick, simple and environmentally friendly analysis technique. To carry out this study, the spectra of 24 samples were collected, corresponding to 7 placebos loaded in a concentration range of 85 and 115%, 7 placebos loaded according to the DoE, 3 batches of finished product and 7 placebos loaded for validation. The NIR records were made in the diffuse reflectance mode and compared with the HPLC reference method. The PLS multivariate calibration method (partial regression by least squares) was used for the chemometric analysis of the data. The spectral correlation between the methods was established with correlation coefficients of (R2), in the range of 0.996 and 1.00. The validation process was developed based on the criteria of the EMA guide and demonstrated the compliance of the parameters of linearity, accuracy, specificity and precision, which guarantee and allow its application as a method of analysis for the control of the production process.