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Solid State Screening

Life Sciences / CDMO/CRO Services / Small Molecules / Preformulation / Solid State, Polymorph & Salt Screening

Inform Preformulation with Solid State Form Discovery, Characterization, & Dosage Insights

Identify your drug substance’s important compound characteristics with our preformulation support. As part of preclinical development, solid form screening facilitates prototype deliverability and defines the optimal formulation composition. With a combination of characterization techniques, we analyze your molecule’s solid state, solubility, stability, and other physicochemical properties to select the best solid form.

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Solid Form Development & Engineering

Determine the structural forms and qualities of your molecule with our proven workflows. Understanding your compound’s bioavailability, stability, and manufacturability empowers you to make more informed decisions while also safeguarding your intellectual property.

Polymorph Screening
Thorough screening for possible polymorphs is necessary to ensure effectiveness, comply with regulatory expectations, and protect intellectual property. Polymorph screens identify and characterize the different structural forms of your molecule to optimize downstream development. Different polymorphs vary in their performance, solubility, dissolution rates, and resulting bioavailability. After initial screening, our team characterizes the properties of any additional forms, including the propensity for interconversion, and determines the most thermodynamically stable form. If the properties are sufficiently different, we determine if the product performance will be affected. Conducting this screening mitigates risks, such as variable product performance, regulatory issues, and manufacturing.
Salt Screening

If your compound contains ionized groups, processing it into a salt form could dramatically improve its solubility, stability, and physicochemical properties. Our screening approach gives you a better understanding of your molecule’s propensity for forming pharmaceutically acceptable salts. All salts are characterized for physical and chemical stability necessary for downstream development. As with polymorphs, discovering salt forms provides regulatory and intellectual property protection.

Co-crystal Screening
If your API is intrinsically not ionized, it could form strong interactions with other molecules that lead to stable crystalline complexes. We employ comprehensive co-crystallization screening using developable co-formers and industry experienced personnel. Co-crystals are made in a similar manner to polymorphs and salts, with some added techniques specific to co-crystallization.
Amorphous Solid Dispersion (ASD)

Amorphous materials offer advantageous formulation opportunities to help your compound achieve enhanced solubility and optimal bioavailability. Our team is experienced in a variety of techniques to prepare amorphous solid dispersions, including spray dying. Because amorphous materials are metastable, it is paramount to evaluate the physical and chemical stability of amorphous materials during manufacturing, storage, and administration. To that end, we have scientifically directed workflows to evaluate the benefits and risks of your drug materials for your drug substance and drug product.

Solid State Characterization

Solid state characterization profiles the solid drug materials you have made with respect to fundamental attributes that affect efficacy. This profile includes factors such as dissolution rate, solubility, and bioavailability. Our solid state characterization workflow predicts the physical stability of your material over time, thus derisking the chance that your material changes to a less desirable form later in development.

Solution State Characterization

It is essential that you understand how your compound behaves in different environments, especially since solubility endpoints vary between solid forms. Our team evaluates this phenomenon at different pH profiles to determine the fundamental charge structure and chemical stability of your drug, as well as the physical stability of its solid form. We also evaluate how the solid forms perform in biorelevant fluids that simulate gastrointestinal environments. Solution state stability informs formulation and process development and the associated complexity, timing, and costs of product development.

Solid Form Selection

Solid state screening generates real possibilities for doseable pharmaceutical materials. Our team follows up by evaluating solid state stability and aqueous solubility, empowering you to make informed decisions on lead selection.

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.