Química Farmacéutica
Permanent URI for this collection
Browse
Browsing Química Farmacéutica by Author "Ciro Monsalve, Yhors Alexander (Director)"
Now showing 1 - 5 of 5
Results Per Page
Sort Options
Item Fabricación de una barra energética a base de Cannabidiol, Sacha Inchi y Quinua(Universidad Santiago de Cali, 2024) Pantoja Saenz, Luis Alberto; Cardona Velásquez, Héctor Fabio; Ciro Monsalve, Yhors Alexander (Director)Item Seguimiento farmacoterapéutico bajo la metodología CTCAE en la evaluación de las reacciones adversas de la doxorrubicina en pacientes con cáncer de mama polimedicadas(Universidad Santiago de Cali, 2024) Villanueva Gallego, Isabella; Ciro Monsalve, Yhors Alexander (Director)The study deals in depth with adverse drug reactions (ADR) in breast cancer patients treated with Doxorubicin and other drugs simultaneously. It is highlighted that polymedication increases the risk of ADR, presenting interactions in 24% of the drugs administered, especially in the gastrointestinal, hematological and neurological systems. According to Naranjo's algorithm, it was observed that 64% of the ADRs have a possible relationship, 44% a probable relationship and 7% a doubtful relationship. Likewise, using the Common Terminology Criteria for Adverse Events (CTCAE), 85% of the reactions were classified as mild, 9% as moderate and 6% as severe. A remarkably high incidence of 98% was observed in patients with breast cancer, who were also under treatment with Doxorubicin and polymedication, presenting adverse reactions. This finding suggests a significant likelihood that ADRs are related to Doxorubicin administration in this specific population. The study highlights the importance of comprehensive evaluation and monitoring to prevent interactions and ADRs, proposing strategies such as pharmacotherapeutic follow-up, pharmacovigilance and education for medical staff and patients, in order to optimize safety and improve patients' quality of lifeItem Validación de proceso de manufactura de una forma farmacéutica sólida en una planta farmacéutica(Universidad Santiago de Cali, 2023) Rodriguez Escobar, Sebastian; Lindo Sanclemente, Juliana Alejandra; Ciro Monsalve, Yhors Alexander (Director)This project consists of carrying out a concurrent validation of the manufacturing process of (calcium carbonate + vitamin D), produced by Fabrifarma S.A in the city of Cali. This validation is carried out in order to comply with the requirements set out in Resolution 1160 of 2016 of the Ministry of health and social protection, to make a diagnosis in the manufacturing process, in which a documentary review of the master formula, manufacturing instructions, analytical techniques and specifications of the finished product will be made. With this, the parameters to be improved will be detected and relevant corrective actions will be established, to start with the validation process based on the criteria established by Good Manufacturing Practices (GMP) and the validation master plan.Item Validación de un método analítico para la cuantificación de impurezas orgánicas de Lisinopril en el producto Lisinopril 10 mg tabletas, por cromatografía líquida de alta resolución (HPLC) y detector UV-PDA(Universidad Santiago de Cali, 2024) Zapata Salcedo, Gina Marcela; Diaz Peláez, Juan Sebastián; Ciro Monsalve, Yhors Alexander (Director)The purpose of the following work is to obtain a suitable and accessible chromatographic method for the quantification of known and unknown organic impurities in the Lisinopril 10mg Tablet product. For this, it was proposed to carry out the validation of an analytical method, by high performance liquid chromatography (HPLC) and UV-PDA detector. Evaluating 8 performance parameters in accordance with what is indicated by the ICH-Q2 and chapter 1225 of the United States Pharmacopeia – National Formulary (USP-NF): System suitability, specificity, selectivity, stability of the analyte in solution, linearity, accuracy, precision and range. Following the analytical parameters indicated in the USP-NF 2022 Edition Lisinopril monographItem Validación del método de análisis para la determinación de trazas de silimarina por cromatografia hplc-dad en el producto silimarina 150 mg cápsulas, fabricado en una planta farmaceutica, luego de la limpieza en áreas y equipos de fabricación y envase(Universidad Santiago de Cali, 2024) Dulce Herrera, Laura Camila; Flórez Sánchez, Brayan Steven; Ciro Monsalve, Yhors Alexander (Director)Trace determination is used in the pharmaceutical industry to ensure that cleaning processes remove the presence of active ingredients in the equipment used in the manufacturing process at adequate levels. In this way, an HPLC analysis method was validated for the determination of silymarin traces at a wavelength of 280 nm using a Zorbax SB – C18 5 µm 250 x 4.6 mm column (Agilent) maintained at a temperature of 25°. C, under binary gradient elution at a flow rate of 1.0 mL/min. The injection volume was 10µL and methanol was used as diluent. The method was satisfactorily validated in terms of specificity, showing the absence of signals that could interfere with the quantification of the signals of interest. The quantification limit was established at 1.0 ppm, complying with a signal-to-noise ratio greater than 10. The method proved to be linear with r>0.997, in terms of precision an RSD of less than 20.0% was obtained, in terms of accuracy, a recovery of 50% was obtained. The method proved to be robust against the changes made, complying with the evaluated adequacy parameters. F. It was demonstrated that the analytical methodology generates reliable, safe and applicable analytical results for the determination of traces of Silymarin.