Pre-formulation Studies

Pre Formulation Service

Comprehensive Physicochemical Property Evaluation

A comprehensive physicochemical property evaluation is an important premise for the development of pre formulation and process. It provides an important basis for the druggability evaluation of the compound, route of administration and dosage form selection, formulation and process design, and the quality control of the drug product. It is a solid foundation for the development of safe, effective, and quality-controllable medicines.

crystal pharmatech

Relying on the top-notch instruments and technical capabilities, Crystal Pharmatech can provide customers with a comprehensive physicochemical property evaluation.

Excipient Selection and Compatibility Studies

Excipients play an important role in drug release, drug stability and manufacture of drug product. We help customers select the appropriate excipients in early formulation development through screening and technical know-how to investigate the interactions between API and excipients. The excipient selection will be tailored to the individual API depending on physicochemical properties of API, indication, route of administration, species and so on. By optimizing formulation, bioavailability and exposure levels can be improved.

Formulations for PK/Efficacy/Tox Studies

Contrary to popular belief, early formulation development is not simply dumping API in a vehicle and gavage feeding an animal. If you do this, you will most likely lose time and money with unnecessary and confusing PK studies. This led to the development of our SMART biopharmaceutical solutions that offer input from our scientific advisory board: A one-stop shop from candidate selection through GMP FIH.

Animal Dosing Vehicle Selection

Choosing an optimal vehicle for animal PK and Tox studies requires multidisciplinary skillsets and a sound understanding of the physicochemical properties of your compound. Controlling solid and solution variability of your vehicle is critical to yielding consistent and coherent PK data.

Amorphous Solid Dispersions

Amorphous solid dispersions have been shown to alter the properties of an API, including solubility, dissolution, and bioavailability. A variety of polymers or additives are available, and screening is needed to find possible miscible dispersions that will have the properties needed for development. Our service including:

The amorphous solid dispersion will then be used in simple formulations for early development (such as suspensions, drug in capsules, or preliminary formulations) or formulated into a drug product (such as tablets or capsules) for late-stage development and marketed products.

We perform comprehensive amorphous solid dispersion screening to identify ASD formulation that can provide sufficient solubility and drug release rate. Our capabilities include making mg quantity material for early development up to kilogram scale for late-stage studies to support different needs.

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