Examinando por Materia "Drug Stability"

Mostrando 1 - 7 de 7

Acceso abierto
Aplicación de pruebas de estabilidad acelerada para conocer la fecha de vencimiento de la Crema Facial Bioactiva en el laboratorio Brillant, Lima 2023
(Universidad Privada Norbert Wiener, 2024-10-02) Atencio Alvites, Violeta Maria; Flores Ojeda, Yoysi Romina; Pinedo Panduro, Lauro Sócrates
This research applied accelerated stability tests to the Bioactive Facial Cream. Objective: To determine the estimated expiration date for the Bioactive Facial Cream after subjecting it to accelerated stability tests at the Brillant laboratory, Lima 2023. Methodology: Deductive method, quantitative approach, applied research type, experimental design, and cross-sectional study; the research level is explanatory; the organoleptic, physicochemical, and microbiological parameters were evaluated after subjecting the Bioactive Facial Cream to the stress aging method using different temperatures such as refrigeration, ambient, and oven for 0, 1, 7, 15, 30, 60, and 90 days. Results: The application of the accelerated stability tests performed on the Bioactive Facial Cream demonstrates that over time the organoleptic parameters underwent a modification The physicochemical parameters showed slight but non-determining variation, and the microbiological parameters showed an absence of total aerobic mesophilic microorganisms, fungi, yeasts, and pathogens. Conclusion: The accelerated stability tests performed on the Bioactive Facial Cream allowed for the calculation of a shelf life of 14 months; this determined the expiration date, which should be confirmed with long-term stability testing.
Acceso abierto
Buenas prácticas de distribución y transporte, manteniendo la cadena de frío 2°C a 8°C en productos terminados de Paclitaxel Paclitex®, Toxina Botulínica Cunox® y Octreotide Azestan®
(Universidad Privada Norbert Wiener, 2015) Moreto Riofrio, Oscar Reinaldo; Carhuapoma Yance, Mario
In the preservation of the cold chain, the weakest and most critical stage is undoubtedly transportation during the distribution of finished products. It is essential to identify suitable materials to maintain the cold chain through a series of tests, which must be documented to demonstrate that a certain quantity of Gel Ice Packs combined with appropriately sized Cold Boxes ensures temperature control within a predefined period. This guarantees compliance with good distribution and transportation practices. In this study, a method was developed to ensure the proper distribution and conservation of finished pharmaceutical products requiring a specific temperature of 2°C to 8°C to maintain their stability. Cold Boxes from different suppliers were purchased, evaluated, and compared to assess their performance in preserving the cold chain. Gel Ice Packs, accompanied by certificates describing their chemical composition and freezing point, were analyzed and approved by an authorized health network laboratory. Storage equipment and facilities used for products such as Paclitaxel PACLITEX®, Botulinum Toxin CUNOX®, and Octreotide AZESTAN® were calibrated, certified, and maintained under a periodic maintenance program. Field tests were conducted in three provinces with extreme seasonal temperatures. Based on the results of the first and second phases, an instructional guide was prepared for proper product packaging. Finally, the fourth and fifth tests were carried out in Callao and Lima, respectively, using optimal quantities and sizes of materials, with satisfactory results confirmed by temperature controllers (Temptale4) graphs.
Acceso abierto
Estudio comparativo de la estabilidad acelerada del paracetamol jarabe y exploración de las formulaciones de laboratorios farmacéuticos en Lima metropolitana, 2024
(Universidad Privada Norbert Wiener, 2025-10-29) Chuquiyauri Carrasco, Anghela Ines; Tello Mestanza, Lila; Alvarado Chávez, Britt
Objective: To determine the accelerated stability comparisons of paracetamol syrup and explore formulations from pharmaceutical laboratories in Metropolitan Lima in 2024. Methodology: A quantitative approach was used, employing deductive reasoning, an experimental design, and a cross-sectional study. The population consisted of paracetamol syrups from national and generic laboratories, with one bottle sampled per formula. The technique used was observation, supported by a data collection form. Results: The organoleptic evaluation (color, odor, taste, and absence of particles) met the parameters established in the Peruvian Technical Standard for oral medications. The physicochemical properties remained within the specified ranges: delivery volume, moisture loss (no more than 5%), pH (3.8–6.1), and density (1.000 g/mL–1.120 g/mL). Microbiological controls revealed an absence of aerobic microorganisms and fungi in all samples. Compliance with Good Storage Practices (GSP) was verified in pharmacies and drugstores, which contributed to preserving the stability, efficacy, and safety of the product throughout its shelf life. Conclusions: After determining the accelerated stability comparisons of paracetamol syrup and exploring the formulations of pharmaceutical laboratories in Metropolitan Lima in 2024, it can be stated that they comply with Peruvian technical and regulatory standards, guaranteeing a safe, effective, and high-quality product. The importance of maintaining strict quality controls and appropriate storage conditions to ensure the stability and optimal therapeutic performance of medications is emphasized.
Acceso abierto
Estudio de estabilidad de las formulaciones crema y gel elaborados con la fracción polar del extracto alcohólico de las hojas de Oenothera rosea L´Her. ex Aiton "chupasangre"
(Universidad Privada Norbert Wiener, 2018-06-09) Bellodas Castillo, Ronald Martín; Cano Salvador, Fanny Chris; Nué Martinez, Jorge Jonathan
This study conducted an accelerated stability study of two semi-solid pharmaceutical formulations—cream and gel—prepared with the polar fraction of the alcoholic extract from the leaves of Oenothera rosea L'Her. ex Aiton, "Chupasangre." The Peruvian regulations in force, according to Ministerial Resolution (R.M.) 805-2009-MINSA, were used for this study, evaluating the organoleptic characteristics (appearance, color, odor), viscosity, pH, the quantification of flavonoids as an indicator of extract concentration, and the microbial limit, based on climatic zone IVa. The results of the accelerated stability study for both pharmaceutical forms demonstrate that both products maintained the microbiological quality parameters. However, for the physicochemical parameters, only the cream showed conservation within the product specifications, while the gel suffered degradation at the end of the study.
Acceso abierto
Estudio de la estabilidad acelerada de una formulación de solución oral de ivermectina 6 mg/ml, Lima 2021–2022
(Universidad Privada Norbert Wiener, 2023-09-05) Gutiérrez Shimabukuro, Astrid Carolina; Pertuza Izquierdo, Cristian; Cano Pérez, Carlos Alfredo
The accelerated stability study of a formulation is important to determine the physical, chemical, and microbiological stability of the medication before commercialization. Therefore, the objective of this research was to conduct an accelerated stability study of a 6 mg/mL Ivermectin Oral Solution formulation. Method: The study was deductive, basic, and experimental, conducted on three pilot batches subjected to chemical, physical, and microbiological analyses. Results: The 6 mg/mL Ivermectin Oral Solution formulation maintained its organoleptic characteristics throughout the study period. Its delivery volume was no less than 95% of the declared amount, its pH ranged between 6.22 - 6.73, and its specific weight ranged between 1.0372 - 1.0909. In the identification test, it tested positive, and its concentration ranged from 5.40 to 6.60 mg/mL. Additionally, the total aerobic microorganism count (TAMC) was ≤102 cfu/mL, the total combined count of filamentous fungi and yeasts was ≤101 cfu/mL, and in the specific microorganism test, Escherichia coli was absent per mL. Conclusion: The 6 mg/mL Ivermectin Oral Solution formulation meets the physical, chemical, and microbiological specifications.
Acceso abierto
Nivel de conocimiento sobre el manejo de productos farmacéuticos que requieren cadena de frío según el R.M. N.° 132-2015-MINSA en egresados, Facultad de Farmacia y Bioquímica, Universidad Norbert Wiener, 2020-II y 2021-I
(Universidad Privada Norbert Wiener, 2022-07-09) Cusi Pasion, Katy Gabriela; Luyo Antonio, Maria Joaquina; Ramos Jaco, Antonio Guillermo
The objective of this research was to determine the level of knowledge about the handling of pharmaceutical products that require a cold chain, according to Ministerial Resolution (R.M.) 132-2015-MINSA, among graduates of the Faculty of Pharmacy and Biochemistry at Norbert Wiener University from the 2020-II and 2021-I semesters. Method: This was a deductive study with a quantitative approach, a basic research type, a non-experimental design, and a descriptive level. A non-intentional sample of 169 graduates was used. The technique employed was a 25-question survey, and SPSS version 25 was used for statistical analysis. Results: For the general objective, 124 out of the 169 respondents obtained a high level of knowledge. A high percentage of high knowledge was observed in each dimension: knowledge in the manufacturing plant (71.6% or 121), knowledge in storage (60.9% or 103), distribution (77.5% or 131), transport (62.7% or 106), and user knowledge (74.6% or 126). Conclusion: The graduates obtained a high level of knowledge regarding the general objective and the dimensions of the topic, and a low, non-significant level was also evident in each result.
Acceso abierto
Revisión del cumplimiento de las buenas prácticas de almacenamiento y conservación de productos dietéticos en la droguería Italfarmaco Perú, Distrito de Miraflores. Lima 2023
(Universidad Privada Norbert Wiener, 2024-09-25) Lara Moran, Andres Eusebio; Ortega Canchari, Kevynn Alejandro; Aquino Comun, Mery
In this present investigation, the objective was: "to determine the relationship that exists between the review of compliance with good storage practices and the conservation of dietary products in the Italfarmaco Perú drugstore, Miraflores district, Lima 2023". Methodology: A hypothetical-deductive approach was used with a basic quantitative design. The research did not follow an experimental design and was carried out with a cross-section, using a correlational level. The population was composed of the warehouse areas and the dietary products, which are in the Italfarmaco drugstore warehouse. Results: the asymptotic significance was 0.199 > 0.05, therefore, the null hypothesis was accepted and the alternative hypothesis was rejected. Conclusion: it was determined that there is no relationship between both variables.