At Chalcogen Pharma, we specialize in the development and characterization of polymorphs, cocrystals, and salts to enhance the pharmaceutical properties of active pharmaceutical ingredients (APIs). Our expertise in solid-state chemistry enables us to optimize drug stability, solubility, and bioavailability, ensuring regulatory compliance and accelerating drug development timelines.
Understanding the solid-state properties of APIs is crucial for successful drug formulation and commercialization. Our team of experienced scientists provides comprehensive research and development (R&D) support in polymorphism, cocrystal engineering, and salt selection to help pharmaceutical companies improve drug performance.
Polymorphs are different crystalline forms of the same compound that exhibit distinct physicochemical properties. Our polymorphism studies help identify and control the most thermodynamically stable and bioavailable form of an API.
Polymorph Screening & Selection – Identifying optimal crystalline forms using solvent-based, cooling, sublimation, and other crystallization techniques.
Physicochemical Characterization – Utilizing XRD, DSC, TGA, FTIR, Raman Spectroscopy, and solid-state NMR to analyze polymorph stability.
Regulatory Support & Intellectual Property (IP) Strategy – Assisting in patent filings and regulatory documentation for polymorph exclusivity.
Cocrystals offer a novel approach to modifying drug solubility and stability without altering the API’s chemical structure. At Chalcogen Pharma, we employ advanced cocrystal screening and development strategies to enhance drug performance.
Cocrystal Screening & Selection – Evaluating potential cocrystallizing agents to form stable and bioavailable drug cocrystals.
Solubility & Stability Enhancement – Optimizing dissolution rates and improving API stability under various conditions.
Structural Characterization – Employing PXRD, DSC, Raman, and Single-Crystal XRD to confirm cocrystal formation and stability.
Patent & Regulatory Support – Providing IP protection strategies and regulatory documentation to support NDA and ANDA filings.
Salt formation is a widely used strategy in pharmaceutical development to enhance the aqueous solubility, stability, and processability of APIs. Our expertise in salt screening and characterization ensures the selection of the most suitable pharmaceutically acceptable salt forms.
Salt Screening & Selection – Identifying suitable counterions to improve drug solubility, stability, and manufacturability.
Solubility & Dissolution Testing – Conducting rigorous testing to ensure enhanced bioavailability.
Stability & Compatibility Studies – Evaluating solid-state stability under ICH-recommended conditions.
Process Development & Scale-Up – Optimizing salt crystallization processes for seamless transition to commercial manufacturing.
Partnering with Chalcogen Pharma for your solid-state development needs ensures the following advantages:
✔ Enhanced Drug Solubility & Bioavailability – Overcome poor water solubility challenges with optimized solid-state forms.
✔ Increased API Stability & Processability – Improve shelf-life and manufacturability with stable crystalline forms.
✔ Regulatory Compliance & IP Protection – Strengthen patent exclusivity and streamline regulatory approval processes.
✔ Cost-Effective & Scalable Solutions – Develop robust and scalable solid-state formulations from early R&D to commercial production.
✔ Advanced Analytical & Characterization Techniques – Utilize cutting-edge XRD, DSC, TGA, and solid-state NMR for precise characterization.
We provide polymorphism, cocrystal, and salt development services for various industries, including:
Pharmaceutical & Biotechnology Companies – Supporting drug formulation, regulatory submissions, and lifecycle management.
Contract Research Organizations (CROs) – Assisting in solid-state characterization and preformulation studies.
Academic & Research Institutions – Partnering for cutting-edge solid-state research and development
Enhance your drug formulation strategy with Chalcogen Pharma’s expertise in polymorphism, cocrystals, and salt selection. Contact us today to discuss your custom solid-state development requirements.
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