Solid Form Screening and Selection
Drug molecules may show different solid forms, including polymorph, hydrate, solvate, salt, cocrystal, and amorphous. Various solid forms of a drug substance may have different chemical and physical properties, including crystallinity, hygroscopicity, chemical reactivity, apparent solubility, dissolution rate, and stability. These properties can have a direct effect on the ability to manufacture the drug substance and the drug product, as well as on drug product stability, dissolution, and bioavailability. Thus, different solid forms can affect the quality, safety, and efficacy of the drug product. The appearance of a new solid form during late stages of development may delay filing and a new form appearing in drug product may cause product withdrawal. Therefore, it is critical to identify and select the optimal form during early drug development. A thorough solid form screening also provides rationale for form selection as required by regulatory filing.
At Porton J-STAR, we employ an integrated approach to screen and select the most suitable solid form. We conduct effective screening and rigorous assessments for polymorphs, salts, cocrystals, as well as amorphous solid dispersions, applying comprehensive expertise and experience including:
- Rational design of form screening using our rich experience based on development phase and simulation results.
- Intuitive and observative execution of solid form screening and characterization to identify the lead solid forms.
- Scale-up of the lead solid forms followed by in depth understanding of properties, including crystallinity, hygroscopicity, solubility and/or dissolution, stability, processability, & flowability.
- Skillful investigation of crystal form relationship, determination of relative stability, and expert recommendation of the best solid form for development.
- Expert elucidation of single crystal structure for regulatory filing and fundamental understanding of structure and property relationship.
- Synergy in pre-formulation evaluation, crystallization process development, particle engineering and drug product development facilitates the first time right solid form selection.
What we can offer:
- Polymorph screening and selection
- Salt screening and selection
- Cocrystal screening and selection
- Development of amorphous and amorphous solid dispersion (ASD)
- Solid form risk assessment
- Screening of chiral salt/cocrystal for chiral resolution
- Solid-state characterization
- Single crystal structure elucidation
- Solid form quantification method development
Featured Equipment
