Polymorph, Salt & Cocrystal Screening and Selection
CD Formulation has extensive experience in screening and selecting polymorph, salt, and co-crystal. With in-depth understanding of crystallization theory and technical reserves formed from numerous crystal screening experiments, we have developed a comprehensive screening process that can help you select advantageous drug solid forms that are easy to produce, highly bioavailable, and conducive to formulation.
Why Do Polymorph, Salt & Cocrystal Screening and Selection
Different solid forms (polymorph, cocrystals and salts) of APIs have significant differences in thermodynamics, kinetics, and physical properties, which may affect the stability, production process, dissolution, and bioavailability of APIs and formulations, and thus may affect the safety, efficacy, and quality controllability of drugs. Therefore, screening and selecting the ideal solid form (polymorph, cocrystals and salts) of APIs is crucial for reducing R&D risks, improving success rates, reducing production costs, and improving product quality.
Our Overall Strategy for Polymorph, Salt & Cocrystal Screening and Selection
If the physical and chemical properties of drug molecules can meet the development needs, priority will be given to using the free form for polymorph screening and selecting the dominant crystal form with excellent physical and chemical properties and scalable process.
When the stability and solubility of drug molecules are poor, we recommend screening salts or co-crystals to obtain the ideal drug solid form. The physical and chemical properties of drug molecules such as solubility, stability and bioavailability can be improved through salts/co-crystals.
Our Process of Polymorph Screening and Selection
When drug molecules crystallize in different crystal forms, their bioavailability, solubility, dissolution rate, chemical and physical stability, melting point and other properties may be different. Excellent polymorph screening and selection is an efficient means to reduce R&D risks, reduce production costs, and improve product quality. Our services include:
- Obtain basic information about drug molecules
- Approximate solubility test
- Choose appropriate solvent system and crystallization method
- Preliminary crystal form screening
- Scale-up preparation of dominant crystal forms
- Crystal form evaluation
- Mutual transformation relationship, stability, hygroscopicity, solubility, pressure and abrasion resistance...
Our Process of Salt Screening and Selection
Many APIs are in the form of acids or bases, but in many cases, their physicochemical properties are difficult to meet the requirements for pharmaceutical properties. By selecting the appropriate salt form, many problems in drug development can be solved, and the most reliable method for discovering suitable salt forms is salt screening and selection. Our services include:
- Obtain basic information about drug molecules
- Analyze structural formula and pKa information
- Basic characterization of free forms
- Free form solubility test
- Choose appropriate counterions and solvents
- Preliminary salt form screening
- Scale-up preparation of advantageous salt forms
- Salt form assessment
- Stability, hygroscopicity, solubility, crystal morphology...
Our Process of Co-crystal Screening and Selection
Co-crystals can significantly improve the physical and chemical properties of APIs without destroying covalent bonds, such as solubility, stability, bioavailability and mechanical properties. In addition, co-crystals also have good applications in masking the taste of drugs, improving drug tableting performance, and expanding production. Co-crystal screening and selection can help us find superior eutectic. Our services include:
- Obtain basic information about drug molecules
- Approximate solubility test
- Select the appropriate FCC and solvent
- Preliminary cocrystal screening
- Scale-up preparation of advantageous cocrystal
- Cocrystal assessment
- Stability, hygroscopicity, solubility...
Advantages of Our Polymorph, Salt & Cocrystal Screening and Selection Services
- Senior team with rich experience: our researchers have been deeply engaged in the field of solid-state drug research for several years, with extensive experience in salt & cocrystal screening and selection. They are able to develop optimal screening strategies based on material properties.
- Personalized solutions: provide customized solutions according to customer needs, and closely cooperate with the project.
- Rapid delivery: efficient experimental processes and operational experience, delivering results in a timely manner to meet time requirements.
- Price concessions, perfect after-sales service: reasonable and competitive prices, providing customers with comprehensive and professional after-sales services.
CD Formulation focuses on providing high-quality polymorph, salt & cocrystal screening and selection services. We are committed to providing our customers with efficient and reliable solutions that meet their specific needs and create maximum value for them. For more information or interest in our services, please contact us!
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