Examinando por Materia "Technology, Pharmaceutical"

Mostrando 1 - 4 de 4

Acceso abierto
Equivalencia farmacéutica preliminar in vitro de forma farmacéutica sólida de Nimodipino Innovador v/s Multifuentes
(Universidad Privada Norbert Wiener, 2026-02-04) Flores Guizado, Frecia Darlyne Rosita; Reyes Mendoza, Katherine Elizabeth; Pineda Pérez, Neuman Mario
El objetivo fue conocer las diferencias y similitudes que se observan en los perfiles de equivalencia farmacéutica in vitro de la forma farmacéutica sólida de Nimodipino al comparar el medicamento innovador con sus versiones multifuentes. La metodología utilizada en el estudio fue de tipo comparativo, con un enfoque cuantitativo y un diseño experimental exploratorio. La población de estudio estuvo constituida por las marcas comerciales y genéricas de comprimidos de Nimodipino 30 mg disponibles en la ciudad de Lima. Se emplearon técnicas de observación y experimentación, utilizando una ficha de recopilación de datos como instrumento principal. Los resultados mostraron que, en los perfiles de equivalencia farmacéutica in vitro de las formas sólidas de Nimodipino, la muestra M1 cumplió con los parámetros de friabilidad, dureza y desintegración; la M2 cumplió con friabilidad y desintegración, pero no con dureza; la M3 presentó friabilidad adecuada, pero dureza y tiempo de desintegración fuera de los parámetros aceptables; la M4 cumplió con friabilidad, pero no con dureza ni desintegración; la M5 cumplió con todos los parámetros evaluados, mostrando un perfil similar al medicamento innovador; y la M6, aunque presentó friabilidad adecuada, mostró dureza y desintegración fuera de los límites establecidos. En conclusión, las muestras M1, M2 y M5 son las que más se aproximan a ser declaradas, de manera preliminar, como equivalentes farmacéuticos al medicamento innovador.
Acceso abierto
Implementación del método de filtración por membrana empleando el sistema de filtración EZ-FIT™ en análisis microbiológico de agua purificada en laboratorio de caramelos farmacéuticos en el periodo de mayo–octubre del 2019
(Universidad Privada Norbert Wiener, 2020-11-27) Minaya Laureano, Maribel Florencia; Guevara Vicaña, Rita Aurora
The objective of this thesis was to compare the implementation of the membrane filtration method using the EZ-FITTM filtration system in a pharmaceutical candy laboratory for the analysis of purified water. The research design was observational, analytical, and descriptive. The study confirmed that the percentage of recovery for the inoculated microorganisms was greater than 70%. It was also evident that the data had a normal distribution, which allowed for the use of the Student's t-test to compare the results of both methods, with a 95% confidence level for the intervals of microbial counts. The comparison was made between the TSA agar medium method and the EZ-FITTM membrane filtration method. This work determined that the mean differences in CFU recovery for E. coli, P. aeruginosa, and S. aureus cultures were not statistically significant, meaning that either technique would provide satisfactory results. Ultimately, according to its established procedures, the laboratory decides which method to apply, prioritizing the benefits of its management.
Acceso abierto
Implementación del sistema de calidad por diseño para procesos de manufactura de formas farmacéuticas sólidas en laboratorios peruanos
(Universidad Privada Norbert Wiener, 2018-04-10) Castro Torres, Carlos Alberto; Jáuregui Maldonado, José Fidel
The importance of Quality by Design (QbD) implies supplementing activities and tools with a scientific approach that allows for the adequate manufacture of pharmaceutical products with a high degree of safety and harmlessness. The contribution of the QbD system for solid pharmaceutical dosage form manufacturing processes allows for the application of a new way to improve manufacturing processes, starting from new specialized concepts linked to the product life cycle. These concepts are outlined in articles, journals, regulations, and international guidelines such as those from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH). These new specialized concepts provide Peruvian pharmaceutical laboratories with greater process knowledge to identify critical points through risk analysis and to control them from the product development stage, through industrial manufacture, and continuous process verification, maintaining traceability that ultimately allows for greater control, always focused on continuous improvement to ensure quality throughout the product life cycle. The purpose of this research was to implement process validation in Peruvian laboratories, migrating from the traditional manufacturing process to the Quality by Design system approach. This approach covers product design, process design, process transfer, process performance before and during industrial manufacture, and continuous process verification. Furthermore, it aimed to identify critical quality attributes and process parameters that may have a critical impact on the product. These were identified through risk analysis to be controlled by establishing design spaces, thereby ensuring compliance with acceptance criteria, which allows for a safer pharmaceutical product for the patient.
Acceso abierto
Medicamentos falsificados reportados en las alertas de DIGEMID en el Perú 2019 - 2023
(Universidad Privada Norbert Wiener, 2025-10-13) De la Cruz Arango, Gladys; Cano Pérez, Carlos Alfredo
Objective: To analyze the characteristics of counterfeit medications reported in sanitary alerts issued by General Directorate of Medicines, Supplies, and Drugs in Peru (DIGEMID) between 2019 and 2023, based on ATC codes, pharmaceutical forms, and product name classification. Methodology: This is a basic research study with a deductive approach and a non-experimental, descriptive design. The population was finite, and the sample consisted of 100 DIGEMID alerts. Results: It was observed that in 2022, 36% of the alerts were registered, while in 2019 and 2020 only 9.0% were recorded; 16% of the falsified medicines belonged to group "L", compared to 2.0% for groups "B" and "C". The most frequently falsified pharmaceutical form was tablets at 24.4%, followed distantly by aerosols at 6.9%. Regarding the correlation analyses, Spearman's Rho showed very high and positive relationships (Rho between 0.785 and 0.898) that were significant (p ≤ 0.004) between variables such as falsified medicines and ATC codes, pharmaceutical forms, brand names, and the increasing trend of alerts. The null hypothesis (H₀) was rejected in all cases. Conclusion: Counterfeit medicines reported in health alerts issued by DIGEMID between 2019 and 2023 do occur more frequently in certain ATC codes and pharmaceutical forms.