Comparison between polymeric excipients using SeDeM expert system in combination with mathematical modeling and quality control tools

Based on the quality by design approach, we used the SeDeM expert system to assess seven polymers of different chemical nature and molecular weight for their use in direct compression. Because the SeDeM system fails by not evaluating the mechanical properties of materials, we used the Heckel and the Ryshkewitch-Duckworth mathematical models to study compressibility and compactibility of the materials, respectively. The deformation mechanism and the bonding capacity of the polymers were identified, evidencing that polyethylene oxide 301 and 303 and the carbomer homopolymer had an outstanding performance. In addition, tools such as control charts of the statistical process control and indices of the potential and actual capability in a polymer compaction process were implemented, using the weight and tablet breaking force as critical attributes of quality. In these studies, polyethylene oxide 301 and 303, hydroxypropylmethyl cellulose, and hydroxypropyl cellulose HF had the best performance and less breaking force variation. On the other hand, carbomer homopolymer exhibited the best outcomes in terms of weight variation. The use of the mentioned tools contributed to achieve a better knowledge of the properties and behavior of materials to make a rational selection of the components of a formulation.