Solid Form Screening and Selection

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Solid Form Screening and Selection

It is widely accepted that majority of drug candidate compounds are solid in nature and can exist in a broad range of forms, which lead to diverse physicochemical properties, such as particle size, salt from, and others, and even the pharmacological activities. Therefore, screening and selection of the ideal API solid forms is critical to obtain the highest standard quality, performance and a good manufactured reproducibly. Since drug substances can be exhibited as various forms such as polymorphs, hydrates, solvates, cocrystals, salts, and the amorphous forms, thus the primary goal of solid-form screening and selection is to achieve the optimal solid forms through identification of as many forms as possible.

Below is a list of our Solid Form Screening and Selection Services (including but not limit following):

Salt Screening

The salt form of a given drug substances plays a significant role in determining many aspects of the properties for an API and even the finish products, such as solubility, stability, processability, and the bioavailability. Recognizing the fact that more than half of all approved drugs in the USA are pharmaceutical salts, it is, therefore, of great importance to conduct adequate screening of salt forming counter ions. Through a wide array of techniques such as XRPD, DSC, TGA, and DVS, our experts will offer you with hands on guidance and consultancy support. You can get high quality salt screening services from BOC Sciences such as:

    • Full range of analysis for the physicochemical properties of drug candidates
    • Comprehensive evaluation through a wide array of techniques such as DSC, TGA, spectroscopy (Raman, NMR and µATR-FTIR), and others.
    • Determination of the pKa values for those drugs with certain ionizable groups

When those non-ionizable organic molecules are not able to possess appropriate solid state properties or ionizable sites in the API, co-crystallization represents a highly serviceable alternative methodology. Co-crystal has been demonstrated to be an efficient method for improvement of the solubility of drug substances and the dissolution rates of an end product, which finally leads to an obvious increase of the bioavailability for most of hydrophobic drug molecules. Besides the custom made approaches, we also provide clients with:

    • A comprehensive co-crystal protocol will be theoretically and experimentally assessed.
    • A suit of tailored techniques such as dry- and solvent-drop grinding, cooling co-crystallization are available in our laboratory.
    • Manufacturing process and related parameters can be optimized by working with our experts.
    • Fully characterization of your solid samples can be achieved by methods such as X-ray powder diffraction.

When compare with the crystalline form of any drug substances, its amorphous phase displayed a greater solubility and pharmacokinetics behavior. Taking that reason, amorphous solid dispersions have a significant effect on the solid-state pharmaceuticals area. Our scientists have the relevant experience and competence to perform these studies and tailor-make a target profile for the desired properties of your products. Our scientists are dedicated to offering the following aspects:

    • Comprehensive solid dispersion assessment and manufacturing services
    • Preparation of amorphous phases are completed by our best trained and most experienced subject matter experts
    • Both solid and solution-based methods will be offered for characterization
    • Stabilization of amorphous phase
    • Provide consistency in the final product

Why Choose BOC Sciences?

BOC Sciences has great ability to offer complete suite of solid-form screening services to help you selecting the most appropriate solid forms and supporting your next drug development. BOC Sciences can employ a variety of latest and specialized screening approaches for meeting your requirements of polymorph, salt, cocrystal, amorphous, and amorphous dispersion screens. Additionally, many analytical techniques in our laboratory are amenable to laboratory equipment and able to be incorporated with minimal start-up time.

References

  1. Aaltonen, J., Allesø, M., Mirza, S., Koradia, V., Gordon, K. C., & Rantanen, J. (2009). Solid form screening–a review. European Journal of Pharmaceutics and Biopharmaceutics71(1), 23-37.
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