Ciencia e Ingeniería en Alimentos y Biotecnología

URI permanente para esta comunidadhttp://repositorio.uta.edu.ec/handle/123456789/412

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Tema: search.filters.subject.LABORATORIO NEOFÁRMACO

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  • Miniatura
    Item type:Ítem,
    Desarrollo de un método para la extracción de cannabidiol (CBD) a partir de flores de Cannabis sativa L. en el Laboratorio Neofarmaco del Ecuador CIA. LTDA.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2023-09)
    Sánchez Guevara, Jazmine Estefania
    ;
    Tubón Usca, Irvin Ricardo
    The development of new pharmaceutical products in laboratories suggests the rigorous quality control of these, especially of plant matrices such as Cannabis sativa L. The present project developed a method for the extraction of cannabidiol (CBD) from two types of flowers (untrimmed and trimmed). For which the different types of flowers were evaluated based on their organoleptic and physicochemical characteristics, yield and amount of CBD considering parameters of the United States Pharmacopoeia (USP). Both types of flowers presented adequate morphological (color, aroma) and physicochemical (humidity, variety of trichomes) characteristics. However, the untrimmed flower presented a better extraction yield of 38.761 percent under decarboxylation and freezing conditions using 25 grams of plant material and 165 milliliters of ethanol for 24 days. In addition, the HPLC validation showed a correct linearity, precision (repeatability), limit of detection and quantification and suitability of the CBD standard. ANOVA also showed similar amount of CBD in the ethanol extract with values of 2.101 and 2.056 grams when the untrimmed flower was used under temperatures of -10 and 25 degrees Celsius respectively. The results support the suitability of the method using both types of flowers. However, to obtain higher yield and quantity of CBD it is ideal to use the untrimmed flower considering lower extraction temperatures, as well as longer decarboxylation times and temperatures. Finally, the method can be included in the quality control analysis in the Neofarmaco Laboratory.
  • Miniatura
    Item type:Ítem,
    Desarrollo e Implementación de un Sistema de Análisis de Riesgos y Puntos Críticos de Control (HACCP) en la elaboración de la tableta recubierta de nifuroxazida y atapulgita en el Laboratorio Neofármaco del Ecuador CIA.LTDA.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2023-09)
    Manobanda Mainato, Samantha Belén
    ;
    Tubón Usca, Irvin Ricardo
    Currently, the Analysis and Critical Control Points System (HACCP) in the pharmaceutical industry is of utmost importance, this is because it allows the identification of errors or hazards that may occur at each stage of the process, affecting the integrity or safety of the product. It should be noted that in 2018 ARCSA annexes HACCP to its system through the Methodology for the implementation of HACCP in Pharmaceutical Laboratories. In the present project, the objective was to develop and implement a HACCP System in the production line of a coated tablet of nifuroxazide and attapulgite in the laboratory Neofármaco del Ecuador, for that, the methodology proposed by the WHO based on 7 principles divided into 12 steps was used, through the use of severity matrices, probability and a tree, biological, chemical and physical hazards were identified. Applying the aforementioned methodology, four critical control points (CCPs) were identified: the count of microorganisms in the weighing process (CCP-B1), in the manufacturing process two CCPs were found, the formation of the frost point (CCP-F1) and the resting time of the granules before drying not to exceed eight hours (CCP-B2), and finally, in the packaging process, the control of the tightness of the blister (CCP-Q1). As the CCPs were established, critical control limits were defined for each of them, assigning qualitative and quantitative values. Finally, a PRO-AS-HACCP-026 protocol was implemented, in which a history log was attached to facilitate monitoring and verification for the CCPs.
  • Miniatura
    Item type:Ítem,
    Evaluación físico-química y microbiológica en el desempeño de las áreas de producción de productos naturales y cosméticos en el laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2022-09)
    Mosquera Sánchez, Marco Antonio
    ;
    Tubón Usca, Irvin Ricardo
    In this study, was evaluated the physicochemical and microbiological performance of the production areas of cosmetics and natural products at Laboratorio Neofármaco del Ecuador, located in the city of Ambato. Pharmaceutical laboratories require legal authorization to produce medicines in general, and they must comply with certain regulations such as good manufacturing practices (GMP) established by national and international health regulatory authorities, ensuring production processes and product quality. For performance evaluation, physicochemical tests were carried out to determine the temperature and humidity, the concentration of particles in the air with their respective process capability indexes (Cp), differential pressure, velocity air and exchange air rates. Then, a microbiological environmental monitoring of the air was carried out by means of different samplings such as active sampling in the area, active sampling of the diffuser, and passive sampling. On the other hand, for microbiological evaluation of surfaces, the swab sampling method was applied, where a microbiological count of total aerobes, molds-yeasts, and Salmonella spp was performed. To conclude, it was demonstrated that both areas comply with all the established specifications and maintain consistent results, which ensures the safety in manufacture of non-sterile pharmaceutical products.
  • Miniatura
    Item type:Ítem,
    Validación del método de limpieza aplicado a la ruta de fabricación de tabletas de matico en el Laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2022-09)
    Guevara Freire, Karen Adriana
    ;
    Carrera Cevallos, Jeanette Verónica
    The Laboratory Neofármaco of Ecuador is a pharmaceutical company, which stands out for producing a wide variety of products, especially based on natural active ingredients, one of its natural products is the box of Matico tablets, made from Matico extract as API (Aristiguietia glutinosa), which, having flavonoids among its compounds, acts as an anti-inflammatory, antifungal and gastroprotective. However, Neofármaco, being a drug manufacturing company, must comply with good manufacturing practices (GMP) for its correct operation, standards established by the WHO, FDA and ARCSA. One of the many standards they must comply with is to validate their cleaning processes, mainly to avoid cross-contamination and microbiological contamination, especially if the same areas and equipment are used to manufacture different products. For the same reason, the cleaning validation of the Matico tablet manufacturing route has been carried out. It was demonstrated that the cleaning process does not leave soap residues, through the analysis of traces of detergent, and visual verification was also carried out. For sampling through the swabbing method, the characteristics of the swab were determined: absorption capacity (0.3401 mL), absence of swab interference, recovery test 96.54 percent, determination of the acceptance limit (75 ppm). On the other hand, in the analysis of samples, it was determined that the limit is not exceeded, in addition, no microbiological contamination was witnessed.
  • Miniatura
    Item type:Ítem,
    Verificación de la aptitud del método microbiológico para tres matrices farmacéuticas (sólida, semisólida y líquida) del laboratorio Neofarmaco del Ecuador Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2022-03)
    Rivadeneira Cueva, Brenda Patricia
    ;
    Calero Cáceres, William Ricardo
    This degree project describes the verification of the suitability of the microbiological method for non-sterile products, which includes tests for the presence and absence of the most common specific microorganisms such as: Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Candida albicans; and total aerobic (Bacillus subtilis) and mold-yeast (Aspergillus niger) count tests with certified ATCC strains. The results of the microbiological analyzes were evaluated according to the criteria established by USP and AEFI for each of the three pharmaceutical matrices: solid (chewable tablets), semi-solid (vaginal cream) and liquid (pediatric drops). For the verification of the method, it was evaluated under certain parameters, where it is highlighted that it is exact since it yielded percentages greater than 70 and that it was found within the range established by the USP, not less than 50 nor greater than 200 percent of microbial recovery; accurate because the data was less than 20 percent and robust. In addition, in the robustness test, factors such as temperature, incubation time and type of plate that can influence the growth of the counting microorganisms were compared. According to the results, it is shown that the verified microbiological method is reliable and appropriate for the determination of pathogenic microorganisms and the count of total aerobes and molds-yeasts in the three pharmaceutical matrices of the Neofarmaco Laboratory of Ecuador Cía. Ltd.
  • Miniatura
    Item type:Ítem,
    Calificación de diseño, instalación, operación y desempeño del sistema de generación, almacenamiento y distribución de aire comprimido en el laboratorio Neorfármaco del Ecuador Neorfármaco Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2021-03)
    Barros Villacrés, Leslie Melanie
    ;
    Arancibia Soria, Mirari Yosune
    In this study the compressed the qualification of the compressed air system was carried out from its generation, storage and distribution in the Neorfármaco Laboratory in Ambato city. Air system was qualified starting from its generation, storage and distribution in the Neofármaco Laboratory. Compressed air is widely used in various drug production processes. Impurities in compressed air may jeopardize products. Therefore, it is mandatory to satisfy the quality criteria that govern this type of critical support systems. For the qualification, the protocols and reports of design qualification (DQ), installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) were implemented. For DQ protocols, it was supports that the design satisfies the user requirements, in the same way the IQ was verified the physical conditions of the air, characteristics and components of the system. In the operation qualification, the correct operation of the system was verified and the results of the operational tests show that the compressed air system accomplish the quality attributes as established the ISPE and ISO 8573 standards, Thus, class 2 in particle content, class 4 for dew point and class 2 for oil content and without the presence of microbial growth. Finally, in the performance qualification, the same parameters were evaluated for 3 days, showing that the system is continuous, reproducible and distributes quality compressed air.