Examinando por Materia "Diclofenac"

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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.