Examinando por Autor "Jáuregui Maldonado, José Fidel"

Mostrando 1 - 4 de 4

Acceso abierto
Control de proceso en la fabricación de comprimidos recubiertos de diclofenaco sódico 50 mg tableta con recubrimiento entérico
(Universidad Privada Norbert Wiener, 2017-12-07) Rodriguez Bardalez, Ireny; Jáuregui Maldonado, José Fidel
The present work validates the activities carried out during the manufacturing process control of 50 mg coated diclofenac sodium tablets, with the objective of demonstrating, through documented evidence, that the specific manufacturing process is under control and consistently and reproducibly provides a product that meets the previously established quality specifications. In the mixing phase, the following tests were performed: appearance, particle size distribution, bulk density, and moisture content. In the pre-lubrication granulate phase, the tests conducted were: appearance and moisture content. In the third phase, the lubricated granulate, the following parameters were evaluated: appearance, particle size distribution, bulk density, mixing of the active pharmaceutical ingredient with excipients and lubricants, moisture content, and angle of repose. During the compression phase, the following tests were carried out: appearance, weight uniformity, hardness, thickness, friability, active pharmaceutical ingredient content uniformity, dosage uniformity, dissolution, and moisture content. In the coating phase (coating 2), the tests performed were: appearance, weight uniformity, dissolution, and moisture content. For data analysis, statistical methods were employed, using control charts for means (X) and standard deviation (S) for each selected variable. The data for the appearance test of the tablets with coating 2 were analyzed using a proportion chart (p). Process capability was calculated for critical variables such as weight uniformity, hardness, and content uniformity, obtaining acceptable values.
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
Perfil del químico farmacéutico especializado en fórmulas magistrales
(Universidad Privada Norbert Wiener, 2017-11-22) Estrada Velasque, Carmelo; Quesada Peralta, José Luis; Jáuregui Maldonado, José Fidel
Observational study design, conducted in 2017 in the city of Lima, in which 100 Pharmaceutical Chemists working in authorized Specialized Pharmaceutical Establishments, both public and/or private, were surveyed as the sample. The functions and activities they perform, those in which they could potentially be involved, and the ideal professional profile of the Pharmaceutical Chemist specialized in the preparation of magistral formulas were evaluated. A research instrument was designed with criteria validated by experts in a questionnaire of questions regarding performance, competencies, and skills of the Pharmaceutical Chemist engaged in the preparation of magistral formulas. After the analysis, evaluation, and processing of the sample, the following results were obtained: Of the 100 Pharmaceutical Chemists consulted (100%), it was found that 65% (65) responded that the activity they considered most important is “Interviewing and selecting personnel for hiring in the field of magistral formulas.” Likewise, 58% (58) of all respondents considered very important the “Resolution of questions and concerns raised by medical personnel, nursing staff, and users of magistral formulas.” In third place, with 56% (56), was “Affinity and vocation for the preparation of magistral compounds,” which may be considered highly significant since 99% of respondents indicated that they considered it at least important (resulting from the combination of those who considered it important and very important). Therefore, it is concluded: the functions and activities performed by the Pharmaceutical Chemist specialized in the preparation of magistral formulas are planning, organization, supervision, preparation, and research of magistral formulas; there are deficiencies in the teaching of courses on processes and preparation of magistral formulas.
Acceso abierto
Validación de la prescripción en recetas médicas dispensadas en una botica en el distrito de San Juan de Lurigancho, en los meses de enero a abril 2017
(Universidad Privada Norbert Wiener, 2017-12-05) Muyón Cashpa, Gloria Serafina; Jáuregui Maldonado, José Fidel
In the present study, the validation of prescriptions in medical prescriptions dispensed at a pharmacy in the district of San Juan de Lurigancho during the months of January to April 2017 was analyzed. It was a descriptive, cross-sectional, prospective study. A total of 45 medical prescriptions were photographed, analyzed, and then dispensed in order to detect deficiencies according to the Good Prescribing Practices Manual of the Ministry of Health of Peru. Of the prescriptions received, it was found that 44 contained at least one deficiency. The types of deficiencies in good prescribing practices found at a high percentage were those related to patient information (surname and name, gender, age, and diagnosis) at 44.44%; deficiencies in good prescribing practices related to medication information (International Nonproprietary Name) at 53.33% (only trade names were included); and deficiencies related to the legibility of handwriting at 53.37%. Conclusion: There is a high percentage of deficiencies in good prescribing practices.