Pharmaceutical Science

We provide analyses, test results, and interpretation to help progress your candidate into the preferred dosage form.  

Characterization of API properties that inform drug product formulation selection is the next set of critical information needed to guide a new chemical entity (NCE) into dosage form selection. These tests help pave the way to a robust dosage form by understanding sensitivities of an NCE. We provide analyses, test results, and interpretation to help progress your candidate into the preferred dosage form. 

Preformulation Characterization

Physicochemical Profiling

  • pKa

  • Log P/D

  • Hygroscopicity

  • Particle properties

  • Thermal properties (Tm, Tg)

  • Crystallinity

 

Solubility Characterization

  • pH-solubility profile

  • Solubility in biorelevant media (e.g. FaSSIG, FeSSIG, FaSSIF, FeSSIF)

  • Intrinsic dissolution rate

 

Polymorph Screening

Solid Form Characterization

Salt Formation / Screening

Crystallization Potential

Impurity Identification

preformulation-characterization.jpg

Isolation by precipitation or crystallization requires fundamental knowledge of a systems kinetic and thermodynamic properties such as solubility, supersaturation, desaturation rate,
dissociation constant (pKa), and Vapor Liquid Equilibria (VLE) in order to map the solid form
landscape.

Nalas conducts salt screening, cocrystal screening, and polymorph screening to identify the
thermodynamically stable solid form to meet the requirement of the dosage form and route of
administration. Enabling Drug Development through selection of a fit-for-purpose solid form for Early Development while developing the knowledge to underwrite the selection of the
appropriate solid forms for each route of administration provides the opportunity to optimize the physical and chemical properties of the API to facilitate drug-to-target medicinal therapies.

Design and selection of energetic materials is dependent on an understanding of each solid
state forms properties, e.g. density and decomposition energy. Nalas has experience in
conducting solid form screening activities for polymorphs, salts, and cocrystals of highly
energetic materials.

Talazoparib tosylate NAL-065-07959-print

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