Pharmaceutical Composition Solubility Creatinine Solid Solution

The patent applies preliminary action by pre-forming a solid solution between compound (1) and creatinine before clinical use. This solid solution is prepared in advance and can be stored, eliminating the need for time-consuming heating and shaking operations at the point of use. The pre-prepared solid solution rapidly dissolves in aqueous carriers when needed, thus resolving the contradiction between solubility and preparation time.

The patent applies composite materials by creating a solid solution composite between compound (1) and creatinine. This composite structure allows the mixture to maintain high stability at low temperatures while simultaneously improving dissolution characteristics. The creatinine component acts as a solubility enhancer that remains effective even at refrigeration temperatures, thus resolving the contradiction between stability and solubility.

The patent applies parameter changes by intentionally changing the physical state from crystalline to amorphous through the formation of a solid solution with creatinine. This parameter change in the physical form of the compound is achieved by controlling the molecular arrangement in the solid state, where creatinine molecules intersperse with compound (1) molecules to prevent regular crystal lattice formation. The amorphous solid solution state provides superior dissolution characteristics compared to the crystalline form, thus resolving the contradiction between dissolution rate and crystal form.