TY - THES 
TI - Estudio del comportamiento del producto reformulado amoxicilina 500 mg+ ácido clavulanico 125 mg tabletas recubiertas en 3 materiales de envase (2 blister)y 1 blister + sachet)
AU - Ardila Mantilla, Angie Xiomara
AB - Syntofarma S. A, is a pharmaceutical laboratory for oral solid beta-lactam antibiotic, that offer the making service, it has the formulation for the product Amoxicillin 500mg + Clavulanic Acid 125mg Tablets coated in primary container material glass bottle type III. However, it has not been able to fully meet the need of the Latin American market for this product, taking into account that currently the market requests that the primary packaging be a material other than the glass bottle. Therefore, it is necessary to evaluate the physicochemical and microbiological stability of the product Amoxicillin + Clavulanic Acid Tablets coated in 500mg-125mg concentration in primary blister packaging materials of: PVC / PCTFE / PVC-Aluminum, Aluminum 45 microns - Aluminum and PVC / PCTFE / PVC-Aluminum + Sachet under conditions of natural stability in climatic zone IV B (30 °C – 75% RH) and Accelerated (40 °C – 75% RH).
For this, three pilot batches of the Amoxicillin 500 mg + Clavulanic Acid 125 mg product were made. Then, tablets were coated and packed in Aclar®-Aluminum, Aclar®-Aluminum + Sachet and Alu-Alu packaging materials, which were subjected to conditions of natural stability in climatic zone IV B (30 °C – 75% RH) and Accelerated (40 °C – 75% RH) in a during 3 months; to identify the packaging material and the presentation of the most stable finished product, physicochemical and analytical tests were performed during the stability study, obtaining results within the specification. Finally, according to the results of the useful life time, when evaluating with the Galeno® Software, the valuation data for the two active principles, it is concluded that the type of packaging that provides greater stability to the product and would be the first choice to use in the commercial product is Aclar®-Aluminum + Sachet, regardless of cost
DA - 2019
KW - Amoxicilina
KW - Amoxicilina
KW - Amoxicilina
PB - Bogotá : Universidad de Ciencias Aplicadas y Ambientales, 2019
UR - https://repository.udca.edu.co/handle/11158/1925
ER -