Química Farmacéutica
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Item Caracterización de incidencias de reacciones adversas medicamentosas asociadas a anticoagulantes y diseño de guía de uso clínico para pacientes anticoagulados(Universidad Santiago de Cali, 2024) Vélez Hernández, Natalia; Rios Acevedo, Jhon Jairo; Echeverry Martínez, John JairoPathologies associated with poor blood coagulation such as DVT (deep vein thrombosis), stroke (cerebrovascular accident), venous thromboembolism, pulmonary embolism, among others; These require a drug that helps the clot that is produced inside a vein or artery not to occlude it, at this point is when anticoagulants play a very important role, being one of the most widely used groups of drugs in Colombia, for this reason a retrospective study was conducted by reviewing 150 clinical histories of anticoagulated patients in the health provider institution Hospital Universitario del Valle, in the period from 2018 to 2022, in order to identify what is the incidence of a patient to present or not an ADR (adverse drug reaction) or AE (adverse event). The age group between 40-90 years was identified, where the prevalence of presenting an undesired reaction during treatment varied according to the anticoagulant used: for Enoxaparin it was 74%, for Dalteparin it was 71%, for Apixaban it was 40% and for Heparin it was 89%. On the other hand, it was possible to identify that the most frequent adverse event was nausea with approximately 40%. Following this, the Chi-square test was performed, where correlation was observed between different variables such as the adverse event presented, the concentration of the anticoagulant and the duration of treatment; by means of these data, it was observed which of the hypotheses was fulfilled for each type of analysis, finding that there is no relationship of influence in terms of age vs. anticoagulant administered and age vs. frequency of presenting an undesired event, while there was a relationship between the other cases already mentioned.Item Desarrollo de un método alterno comprendido en la farmacopea estadounidense (USP) para la determinación cualitativa de impurezas de monoestearil maleato y alcohol estearílico presentes en el estearil fumarato sódico por cromatografía de capa fina (CCF)(Universidad Santiago de Cali, 2024) Rojas Daza, Andrés Felipe; Castro Bonilla, Duván Andrés; Flórez Flórez, Edwin (Director)In the pharmaceutical industry, analytical procedures play a crucial role in ensuring the quality, safety and efficacy of materials/products, where reproducible and reliable results are obtained. In the present study, an alternative methodology to that presented by the United States Pharmacopoeia (USP) was developed in the limit test of stearyl alcohol (AE) and monostearyl maleate (MM) of the raw material Sodium stearyl fumarate (SEF), through the thin layer chromatography technique with the in order to improve the separation and resolution (hue/intensity) of the spots of the compounds of interest because in the current methodology these parameters generate a confusing result for the analyst. Different tests were carried out, experimentally studying the stationary phase, modifying the proportions and solvents of the mobile phase and testing different revealing agents. Finally, an alternate procedure was proposed, where the separation of the spots of interest, their intensity and tonality were improved with RF values for sodium stearyl fumarate, stearyl alcohol and monostearyl maleate of 0,35; 0,65; 0,05; compared to what was obtained in the version of the pharmacopoeial methodology of 0,47; 0,48 and 0,40 respectively, which ensures the reliability of the resultsItem Desarrollo de un método alterno comprendido en la farmacopea estadounidense (USP) para la determinación cualitativa de impurezas de monoestearil maleato y alcohol estearílico presentes en el estearil fumarato sódico por cromatografía de capa fina (CCF)(Universidad Santiago de Cali, 2024) Rojas Daza, Andrés Felipe; Castro Bonilla, Duván Andrés; Flórez López, Edwin; Gutiérrez, HiulderIn the pharmaceutical industry, analytical procedures play a crucial role in ensuring the quality, safety and efficacy of materials/products, where reproducible and reliable results are obtained. In the present study, an alternative methodology to that presented by the United States Pharmacopoeia (USP) was developed in the limit test of stearyl alcohol (AE) and monostearyl maleate (MM) of the raw material Sodium stearyl fumarate (SEF), through the thin layer chromatography technique with the in order to improve the separation and resolution (hue/intensity) of the spots of the compounds of interest because in the current methodology these parameters generate a confusing result for the analyst. Different tests were carried out, experimentally studying the stationary phase, modifying the proportions and solvents of the mobile phase and testing different revealing agents. Finally, an alternate procedure was proposed, where the separation of the spots of interest, their intensity and tonality were improved with RF values for sodium stearyl fumarate, stearyl alcohol and monostearyl maleate of 0,35; 0,65; 0,05; compared to what was obtained in the version of the pharmacopoeial methodology of 0,47; 0,48 and 0,40 respectively, which ensures the reliability of the resultsItem Disminución de la resistencia a ampicilina en cepas de Staphylococcus aureus resistentes a meticilina a través de nanoliposomas funcionalizados con polímeros de Hidroxipropilmetilcelulosa y Carboximetilcelulosa(Universidad Santiago de Cali, 2023) Sáenz, María Valentina; Materon Luna, Daniela; Oñate Garzon, José Fernando; Liscano Martinez, YamilThe methicillin-resistant strain of Staphylococcus aureus (MRSA) causes infections that are resistant to most antibiotics, becoming a public health problem. The implementation of the delivery of ampicillin, a broad-spectrum antibiotic, was evaluated to avoid enzymatic degradation and achieve localized delivery that increases biological activity. For this, nanoliposomes coated with a non-ionic polymer such as hydroxypropylmethylcellulose (HPMC) and an anionic polymer such as carboxymethylcellulose (CMC) were used, which were prepared by the ethanol injection method and coated with the layer-by-layer method. Subsequently, the physicochemical characterization was carried out, using the Z-sizer equipment, to determine the size and find the surface charge (z potential). Then, by ultracentrifugation, the encapsulated ampicillin was separated and the encapsulation efficiency was extended. Then, the microbial susceptibility test was performed on two Staphylococcus aureus strains: sensitive ATCC25923 (MSSA) and resistant ATCC43300 (MRSA) to determine the minimum inhibitory concentration (MIC). Finally, variations in the size of the nanoliposomes functionalized with ampicillin-loaded polymers will be changed, which have various sizes (400-1000 nm), polydispersity from 0.4 to 0.7, zeta potential (-51 to -79 mV) and an encapsulation efficiency of about 92% in HPMC and 77% for CMC. However, the antibacterial effect was not as expected, since the nanosystems do not allow ampicillin to be fully released and can effectively reduce the bacterial resistance of the Staphylococcus aureus (MRSA) strain.Item Estandarización de medicamentos de pediatría en un Hospital Público Nivel 1 de la Ciudad de Cali(Universidad Santiago de Cali, 2023) Hidalgo Giraldo, Laura Marcela; Chamorro Rengifo, Andrés Felipe; García Quiñonez, Ángel DavidThis project standardizes the method of preparation, stability time and concentration of the drugs Amikacin 500 mg/2 mL, Betamethasone 4 mg/1 mL, Cephalexin 250 mg/5 mL, Cefradine 1 g, Furosemide 20 mg/2 mL, Penicillin g benzathine 2,400,000 U. I and Penicillin g sodium 5,000,000 U. I in a pediatric service in a public hospital of level one in the city of Cali, Colombia, from the development by non-sequential stages, and a quantitative methodology to collect information with closed questions, and open, with measurable answers to the nursing staff, about general knowledge of the administration of the seven medications. In this, the development of a table of dilution and stabilities of the drugs, and a guide for their safe use is achieved. Finally, it is important to strengthen patient safety, focused on the use of medications, because when considering the physiological conditions of pediatric patients, it is a requirement to have greater caution when administering medications; Likewise, the importance of implementing this type of documents in the institution is determined, in order to mitigate the occurrence of errors and adverse events associated with medications.Item Evaluación de los resultados negativos de medicación en mujeres embarazadas con preeclampsia que ingresan al área de alto riesgo obstétrico del Hospital Universitario del Valle.(Universidad Santiago de Cali, 2024) Navia Pérez, Ángela María; Ríos Acevedo, Jhon JairoPreeclampsia is a pathology that affects pregnant women, being considered the leading cause of maternal-fetal morbidity and mortality worldwide, being a population very susceptible to complications during hospital stay. Therefore, the negative results of medication were evaluated in pregnant women with preeclampsia who entered the high obstetric risk area of the Hospital Universitario del Valle in 2021 and 2022, carrying out pharmacotherapeutic monitoring using the SOAP method, which made it possible to identify problems related to medications (PRM) and negative medication results (RNM), obtaining that 60.53% of the pregnant women did not present NMR, 18.12% presented NMR of necessity and 21.05% presented safety, associated with untreated health problem, contraindication and therapeutic non-compliance, with nifedipine, enoxaparin, and ferrous sulfate being the medications involved. Likewise, the Chi square test was performed identifying that the factors that can influence NMR are associated with the level of education, socioeconomic stratum, number of prenatal checkups, pathological history and number of medications.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 ; Campo Misas, Rafael EnriqueItem Guía clínica para disminuir las reacciones negativas de la medicación (RNM) de Amikacina y Gentamicina a través de biomarcadores(Universidad Santiago de Cali, 2022) Bastidas Perdomo, Jorge Darío; Mondragón Claros, Stephany; Ríos Acevedo, John Jairo; Echeverry, Jhon JairoGentamicin and Amikacin are aminoglycoside antibiotics that target Gram-negative bacteria, but their clinical use is limited due to adverse reactions such as nephrotoxicity and ototoxicity. The objective of this work is to propose a clinical guide for pharmacotherapeutic follow-up that contains biochemical markers as a tool for treatment with Amikacin and Gentamicin. For this, a bibliographic search was carried out in specialized databases such as Taylor & Francis, ScienceDirect and Scopus, in which 1040 documents were found, of which 58 met the selection criteria to carry out the bibliographic review. From the selected documents, it was shown that the most common adverse reactions of aminoglycosides are nephrotoxicity, acute renal dysfunction, hepatotoxicity, ototoxicity, and oxidative stress, in addition, 48 possible biomarkers for these adverse effects were reported and the study of 43 compound organs - protectors to combat them. With the information found, a proposal was made for a clinical guide focused on the detection of adverse reactions induced by Gentamicin and Amikacin, as well as a proposal for their prevention.Item p.Obtención de péptidos con potencial farmacológico a partir de hidrólisis enzimática in silico de la proteína de quinua con pepsina(Universidad Santiago de Cali, 2024) García León, Nathaly; Moreno Vivas, Valentina; Oñate Garzón, José Fernando; Liscano, YamilPeptides are protein fragments, whose amino acid sequence determines their structure and function, they have various biological functions and have antimicrobial, anticancer, antioxidant, anti-inflammatory activities, among others. They are obtained through enzymatic or acid hydrolysis processes that catalyze the breaking of peptide bonds, thus obtaining bioactive peptides used in various industries due to their ability to selectively interact with other molecules, being of interest in medical research for the development of new therapies. and diagnoses. Quinoa is a rich source of peptides that contain bioactive compounds beneficial for health. Performing peptide synthesis with enzymatic hydrolysis in vitro can be complex and expensive, requiring precision in the union of amino acids and with low yields. Cheaper alternatives, such as in silico enzymatic hydrolysis, have been developed using bioinformatics tools to predict bioactive peptides. In some studies, the pharmacological potential of peptides obtained from quinoa by in silico enzymatic hydrolysis has been evaluated. This approach could significantly impact the pharmaceutical industry, facilitating the development of new drugs for chronic diseases and improving quality of life. This implies an advance in scientific and technological knowledge, especially in the pharmaceutical industryItem Potencial farmacológico in silico de péptidos obtenidos por hidrolisis enzimática de la proteína de quinua(Universidad Santiago de Cali, 2024) Ruiz Beltrán, Daniela; Uzuriaga Perlaza, Laura Mercedes; Oñate Garzón, José Fernando ; Liscano Martínez, YamilPeptides, organic compounds formed by the union of amino acids, are highly valued in the pharmaceutical field due to their high specificity and low toxicity. However, in vivo research with peptides can be costly and slow. In contrast, in silico research offers significant savings in time and costs, allowing a broader search and quick analysis of possible biological activities. The enzymatic hydrolysis of proteins, a process that breaks down proteins into amino acids to reach peptides, is fundamental in this field. Quinoa, a pseudocereal native to the Andes with a high protein content, has been the subject of research for the development of new drugs. Bioinformatics tools, which predict and analyze the breakdown of chemical bonds in biological molecules, are increasingly used to design and select peptides with biological activities. Using the NCBI biology tool, the sequence of the quinoa protein was obtained and bioactive predictions were made in 5119 peptidic sequences obtained by hydrolysis of the actinidin enzyme. The bioactive peptides found can be the basis for developing new drugs to prevent and treat microbial diseases and cancer, thus improving the quality of life of peopleItem 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; Echeverry Martínez, John JairoThe 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 AlexanderThis 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 ; Miller Peluffo, Jhon AlexanderThe 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 AlexanderTrace 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.