Investigation of the physical–mechanical properties of Eudragit^® RS PO/RL PO and their mixtures with common pharmaceutical excipients

Abstract

Ammonio methacrylate copolymers Eudragit^® RS PO and Eudragit® RL PO have found widespread use as key components in various types of extended release solid dosage forms. The deformation behavior of neat polymers and binary mixes was evaluated using Heckel Analysis, strain rate sensitivity, work of compaction and elastic recovery index. Additionally, the compact forming ability of neat materials and binary mixes were evaluated by analyzing their tabletability, compressibility and compactibility profiles. The Heckel analysis of both polymers exhibited a speed-sensitive deformation behavior typical to plastic materials. The yield values of the binary mixes of the polymers with microcrystalline cellulose revealed a linear relationship with the weight fractions of individual components. The yield values of binary mixes of both the polymers with dibasic calcium phosphate exhibited slight negative deviations from linearity. Both polymers exhibited axial relaxation after ejection typical of viscoelastic materials, as measured by the elastic recovery index values. The work of compaction and the elastic recovery index values of the binary mixtures were found to be linearly related to the weight fractions of the individual components thus, confirming ideal mixing behavior based on the composition. Addition of microcrystalline cellulose to both polymers significantly improved their tabletability and compactibility. The tensile strengths of the compacts prepared with neat materials and binary mixes with microcrystalline cellulose, dibasic calcium phosphate and lactose were the function of their solid fraction and independent of the tableting speeds tested; thus, validating compactibility as a reliable parameter in predicting acceptable tablet properties.

Keywords::

• Heckel analysis
• strain rate sensitivity
• tabletability
• compressibility
• compactibility
• work of compaction
• elastic recovery index

Acknowledgments

The authors are grateful to Sean T. Murphy, vice-president, Metropolitan Computing Corporation, E. Hanover, NJ, for providing the equipment (Presster^™) and guidance for the compaction studies. The authors are also thankful to CIPET (Consortium for Industrial Pharmaceutics Education and Training) and FDA for funding the study.

Declaration of interest

The authors declare that none of the authors have any relationship with any organization or person or financial interest in the subject matter or materials discussed in this manuscript that may affect the conduct or reporting of the work submitted.