Cyclobenzaprine-Mannitol Eutectic Composition for Stable Fast Absorption

The patent introduces an acidic excipient (such as citric acid, malic acid, or ascorbic acid) as an intermediary substance that forms a stable salt complex with the basic pharmaceutical ingredient. This intermediary complex protects the API from degradation by basifying agents while maintaining absorption characteristics, thus resolving the contradiction between fast absorption and stability.

The patent changes the chemical parameter (pH) of the formulation by incorporating acidic excipients that lower the overall pH of the composition. This parameter change creates a chemically stable environment that prevents degradation of the API when combined with basifying agents, while still allowing for rapid sublingual or oral absorption.

The acidic excipient acts as a mediator that forms a protective complex with the basic API, allowing the presence of basifying agents in the formulation without causing degradation. This intermediary complex maintains both the therapeutic effects and chemical stability simultaneously.

The patent converts the potentially harmful interaction between the basic API and basifying agent into a beneficial stable complex by introducing an acidic excipient. The acidic excipient first binds with the basic API to form a stable salt, which then can coexist with basifying agents without degradation, thus transforming a harmful interaction into a beneficial stable formulation.