23-Hydroxytormentic Acid Salt Forms for Bioavailability and Stability

The patent applies parameter changes by systematically varying the counterion parameters (sodium, potassium, ammonium, ethanolamine) to generate different salt forms of 23-hydroxytormentic acid. Each salt form represents a different parameter state that improves stability and bioavailability while maintaining the core active ingredient. This approach allows optimization of pharmacological properties through controlled chemical parameter modification.

The patent creates composite materials by combining 23-hydroxytormentic acid with various counterions to form distinct salt compounds. Each salt form (e.g., sodium salt, ethanolamine salt) is a composite material with unique crystalline structure and physicochemical properties. The composite approach enables tailoring of stability, solubility, and bioavailability characteristics for different therapeutic applications.

The patent segments the manufacturing process into distinct pathways for different salt forms and polymorphs. Each polymorph (Pattern 1 through Pattern 16) and salt form has its own optimized synthesis route, allowing independent manufacturing without requiring complex multi-step conversions. This segmentation enables flexible production where only the required form needs to be manufactured, simplifying the overall manufacturing process.

The patent uses parameter changes in the synthesis process (solvent selection, temperature, pH, counterion type) to directly produce the desired salt form or polymorph in a single step. By adjusting these parameters during manufacturing, the process can be tuned to produce specific stable forms without requiring complex purification or conversion steps, thereby maintaining ease of manufacture while ensuring optimal bioavailability.