X7 Hydrochloride Crystal Forms for Stable Drug Solid State
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Solution Overview
Problem
The crystal structure of compound X7 hydrochloride, which has vasodilator and hypotensive effects, is prone to changes due to different crystallization and storage conditions, affecting its chemical and physical stability, necessitating the identification of forms with better properties.
Innovation Solution
The development of six distinct crystal forms (A, B, C, D, E, F) of compound X7 hydrochloride, characterized by specific X-ray diffraction peaks and thermal analysis, along with various preparation methods using solvents and anti-solvents, to stabilize the crystal structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If different crystallization and storage conditions are used, then various crystal forms can be obtained, but the physical and chemical stability of the drug is affected
Solution Approach 1:
The patent applies parameter changes by systematically varying crystallization conditions (solvent type, temperature, pH, concentration) to obtain different crystal forms of compound X7 hydrochloride. Each crystal form (A-F) has distinct X-ray diffraction patterns and stability characteristics, allowing selection of optimal forms for specific pharmaceutical applications
Solution Approach 2:
The patent utilizes phase transitions between different crystal forms of compound X7 hydrochloride. By controlling crystallization conditions, the patent transforms the compound into specific stable phases (crystal forms A-F) with defined physical and chemical properties, including anhydrous and hydrate forms with different stability profiles
2Stability of the object's composition
If crystal structure is optimized for stability, then physical and chemical properties improve, but the complexity of characterization and selection increases
Solution Approach 1:
The patent applies local quality by providing specific, localized characterization data for each crystal form (A-F) including distinct X-ray diffraction peak patterns, DSC thermal profiles, and solubility characteristics. This allows researchers to identify and select the appropriate crystal form based on specific quality requirements without needing to analyze all possible forms
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The identified crystal forms, particularly anhydrous form A, exhibit enhanced physical and chemical stability, maintaining stability under varying conditions and solubility, suitable for pharmaceutical applications.
Implementation Method 1
the 2θ diffraction angle of the X-ray powder diffraction diagram of the crystal has characteristic diffraction peaks in the range of 5° ̃35°
Implementation Method 2
the thermogravimetric analysis diagram of crystal form A exhibits a weight loss of 0.8±0.5% in the range of 30.0 ̃155.0° C.
Implementation Method 3
the differential scanning calorimetry of crystal form A exhibits endothermic peaks in the range of 210.0 ̃220.0° C.
Data Source
AI summary
1. The present invention relates to the crystal of compound X7 hydrochloride and its preparation method and application. The 2θ diffraction angle of the X-ray powder diffraction diagram of the crystal of compound X7 hydrochloride exhibits characteristic diffraction peaks in the range of 5°˜35°. The crystal of the compound X7 hydrochloride has better physical and chemical properties.