Application of the SeDeM system for the preparation of antiparasitic tablets from mesquite flour for use in sheep.

The use of herbal medicine to treat various diseases is becoming increasingly important as an alternative therapy. Numerous plants have been traditionally used for different purposes, including antiparasitic in humans and animals. Diseases caused by gastrointestinal parasites in ruminants, especially by the nematode Haemonchus contortus, cause large economic losses to the producers, whether by complications of the diseases or the cost of treatment. The main way of handling nematodiasis is by administering anthelmintic drugs, but their excessive use has the disadvantage of causing drug resistance; therefore, an alternative is the use of herbal medicine for this purpose. Mesquite (Prosopis spp.) has been used in Mexico to treat gastrointestinal diseases attributed to helminths. The present study aimed to characterize the rheological properties of mesquite flour using the SeDeM Expert System to determine its suitability for tablet production by direct compression. Direct compression technology facilitates the tableting process by reducing manufacturing costs. The results of the present study indicate that mesquite flour can be processed by direct compression. The latter could allow the manufacturing of economic tablets to treat infections by H. contortus in ruminants.

Diseño de estudios Gauge R&R cruzado y anidado para la validación de los modelos matemáticos de Heckel y Ryshkewitch-Duckworth / Design of crossed and nested Gauge R&R studies for the validation of the Heckel and Ryshkewitch-Duckworth mathematical models

INTRODUCCIÓN: Los estudios gauge permiten ganar información sobre el desempeño de procesos y son de utilidad para control de calidad, así como identificación de fuentes de variación. El objetivo del presente estudio, fue diseñar y analizar sistemas de medición para los modelos de Heckel y Ryshkewitch-Duckworth para caracterizar materiales, a través de estudios Gauge R&R. MÉTODO: Estudio Gauge R&R cruzado para evaluar el sistema de medición del peso y estudio Gauge R&R anidado para el sistema de la resistencia a la fractura. RESULTADOS: Ambos estudios cumplieron con los supuestos de normalidad, varianza constante e independencia de los datos, por lo que fue posible determinar la significación de las fuentes de variación (factores) mediante un ANOVA así como su porcentaje de contribución. Para el estudio Gauge R&R cruzado los punzones evaluados contribuyen a la variación de la medición de manera significativa y en un 97,38% de la variación total; los operadores contribuyen en menos del 1% y de manera no significativa y no existió interacción parte-operador. Respecto al estudio Gauge R&R anidado, se identificó que el operador no influyó de manera significativa en la variabilidad de la medición y que ésta es atribuible en un 95% a las diferencias existentes entre las tabletas evaluadas. CONCLUSIONES: Se realizó el diseño, ejecución y análisis de los sistemas de medición, destacando que en ambos estudios la principal fuente de variación fueron las partes evaluadas y que los operadores no contribuyen en la variabilidad de las mediciones, por lo que los estudios pueden usarse para evaluar los modelos matemáticos y durante el control estadístico de un proceso

INTRODUCTION: Gauge studies allow gaining information about the performance of processes and are very useful tools for quality control and identification of variability sources. The objective of the present study was design and analyzes measurement systems for the Heckel and Ryshkewitch-Duckworth models for characterizing materials, through Gauge R&R studies. METHOD: Crossed Gauge R&R study for the evaluation of weight measurement system and nested Gauge R&R study for the system of tablet hardness. RESULTS: Both studies fulfilled with the assumptions of normality, constant variance and data independence, therefore it was possible to estimate the significance of variation sources (factors) through ANOVA and their contribution percentage. The crossed Gauge R&R study showed that the flat punches contributed to variability of the measurement in a significant manner in 97.38% of the total variation of the study; operators did it in less than 1% and they were not statistically significant and there was no Part-Operator interaction. With respect to the nested Gauge R&R study, it was found that the operator did not influence in a statistically significant way in the variability of the measurement and it was attributable in 95% to the existing differences between the tablets evaluated. CONCLUSIONS: Design, run and analysis of the measurement systems was performed, we remark that in both of the studies the main source of variability were the parts evaluated and that operators did not contribute to variability in the measurements; therefore, both studies could be used to evaluate the Heckel and Ryshkewitch-Duckworth mathematical models and also for statistical process control

Comparison of the performance of two grades of metformin hydrochloride elaboration by means of the SeDeM system, compressibility, compactability, and process capability indices.

Quality by design, applied to the development of a pharmaceutical drug, demands scientific methodologies, representing a source of information that will allow for a complete understanding the production process and the materials used for its manufacturing. Although the SeDeM system is a tool that enables a rational development of a product, result does not assure that an assessed material or mixture will be successful in terms of compression, hence, further research will be necessary on these features. The objective of this study was to assess and compare two grades of metformin hydrochloride elaboration: crystalline and direct compression using PXRD, the SeDeM expert system, the Heckel and Ryshkewitch-Duckworth models, as well as process control tools such as control charts and process capability indices to characterize and predict the performance of the materials in a direct compression process. The assessment identified that in spite of dealing with two different technical grades of a material with specific critical quality attributes for each one, PXRD analysis showed we dealt with the same crystalline structure, while the SeDeM system profiles obtained have very close values, and the main differences in materials were observed when subjecting them to conditions that simulate a compaction process with the Ryshkewitch-Duckworth model, in which a 46-times higher mechanical resistance was observed in the direct compression material compared with the crystalline one. The statistical control analysis revealed that only the direct compression material could be used to elaborate tablets whose weight variation was always maintained within the specification and control limits.