New perspective to develop memantine orally disintegrating tablet formulations: SeDeM expert system

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Formulation Science

Background:

• Pharmaceutical industries increasingly adopt Quality by Design (QbD) principles for efficient formulation development.
• The SeDeM Expert System is a predictive tool for preformulation, assessing Active Pharmaceutical Ingredient (API) suitability for direct compression.
• Evaluating 12 key parameters, the SeDeM system aids in API characterization and excipient selection to enhance compressibility.

Purpose of the Study:

• To develop direct compressed memantine orally disintegrating tablets (ODTs).
• To utilize the SeDeM Expert System for guiding formulation development and excipient selection.
• To overcome memantine's inherent poor flow and compressibility properties.

Main Methods:

• Application of the SeDeM Expert System to evaluate memantine's preformulation properties.
• Screening and selection of direct compressibility and super disintegrating agents (Ludiflash®, Ludipress®, Parteck®).
• Formulation of memantine ODTs using the selected excipient (Parteck®) based on SeDeM diagram analysis.

Main Results:

• Memantine exhibited poor flow and compressibility characteristics.
• Parteck® was identified as the optimal excipient for improving memantine's compressibility via SeDeM analysis.
• The developed memantine ODTs demonstrated acceptable tablet properties (friability, hardness, thickness) and rapid disintegration (<15 seconds).

Conclusions:

• The SeDeM Expert System is an effective and user-friendly tool for developing direct compressed ODT formulations.
• Successful development of memantine ODTs was achieved by optimizing excipient selection using the SeDeM approach.
• This study highlights the utility of predictive systems in streamlining pharmaceutical formulation and improving product quality.