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• Polymorph Identification: Novel API polymorphs well characterized using XRPD, DSC/TGA, and IR to assess structure, stability, properties and phase-transformation.

• Multi-Component Systems: Co-crystals, salts, eutectics, and amorphous forms with enhanced solubility and dissolution, characterized via XRPD, DSC, and FTIR.

• Solubility Enhancement: Evaluate solubility and dissolution of solid forms using dissolution testing and intrinsic solubility measurements.

• Mechanochemical Synthesis: Use solvent-free methods (e.g., ball milling) for efficient, environmentally friendly solid form production.

• Structure-Property Correlations: Drawing correlations between the observed properties with respect to the underlying crystal structure and molecular arrangement.

• Regulatory Considerations: Ensure compliance with regulatory standards and conduct in vivo studies for efficacy.

Solid form screening and polymorphism are critical in the pharmaceutical industry as they significantly impact the physicochemical properties of active pharmaceutical ingredients (APIs), such as solubility, stability, and bioavailability. Polymorphs, different crystalline forms of an API, can exhibit distinct properties, with some polymorphs offering enhanced dissolution rates and better therapeutic outcomes. For example, the polymorphic forms of ritonavir were pivotal in the development of a more stable and bioavailable formulation, preventing manufacturing issues with the initial form. Solid form screening also plays a key role in regulatory compliance, as the FDA and other regulatory agencies require detailed characterization of solid forms to ensure product consistency and quality. Understanding polymorphism allows manufacturers to choose the optimal form for formulation and manufacturing, reducing the risk of regulatory delays. Additionally, polymorphs and other solid forms, such as salts or co-crystals, have substantial intellectual property (IPR) implications. By identifying novel forms, pharmaceutical companies can secure patents and gain competitive advantages. The case of imatinib mesylate, where the mesylate salt form was developed to enhance solubility and patent protection, demonstrates how solid form manipulation can be crucial for market exclusivity. Ultimately, solid form screening and polymorphism are integral to optimizing drug formulations, meeting regulatory requirements, and protecting intellectual property, ensuring both the commercial success and therapeutic efficacy of pharmaceutical products.
 

Novel crystal forms with thorough data on their structure, stability, solubility and other relevant physicochemical properties.
 

New solid forms with enhanced therapeutic efficacy