Compound Solubility, Dissolution, and Stability Services

Pharmaceutical scientists at Charles River can measure the solubility, dissolution, and stability of compounds under a variety of conditions. We leverage our expertise and experience to de-risk candidate molecules with respect to their pharmaceutical developability. Charles River clients successfully gain insight into major liabilities at a stage when they can be easily addressed.

Design composed of conceptual atoms, molecules, and fractal elements as a metaphor on the subject of toxicology

Off-target Toxicities and Links with Physicochemical Properties of Medicinal Products
This article discusses the risks of off-target and/or non-specific toxicities that may be associated with the physicochemical properties of compounds, especially those carrying dominant positive or negative charges.
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Stability Studies of Pharmaceuticals

Stability in the solid form is intrinsically related to the polymorphism and salt form of a compound. Photostability, thermal stability, and stability to humidity are all governed by solid form, and early profiling allows liabilities to be identified. Likewise, a thorough understanding of a compound's solubility and solution rate enables you to select the formulation approach that will achieve the required pre-clinical exposure and lead you to the clinic.

Take this quiz to quickly learn more about whether your compound’s best route to formulation. Charles River offers services such as inhaled formulation – lactose stability/blending, excipient compatibility studies – with a range of excipients, capsule dissolution studies (non-ICH).

Formulation Studies – Where Should I Begin?
Answer a few quick questions to map out next steps, see how much material you will need, process workflow and timing, and plan for other considerations to achieve success.
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Conducting stability studies of pharmaceuticals under the conditions they would encounter during administration is also a key consideration during development. Biological mimetics such as simulated gastric, intestinal, or lung fluid provide a quick way to evaluate stability issues associated with the anticipated route of administration, while assessment of stability to pH and common vehicles can help inform the formulation strategy.

Charles River uses analytical techniques to evaluate solid forms for physical characterization and pharmaceutical sciences. In this webinar, learn about a case study of a typical polymorphic system, demonstrating the impact of solid form issues on drug discovery programs.

Solid State Considerations During Lead Optimization: Aim to De-risk Early
Learn how early investigation of solid-state form of novel APIs can help identify and mitigate issues.
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With decades of stability studies of pharmaceuticals experience across a wide range of compound types, therapeutic areas, and administration routes, Charles River’s pharmaceutical science experts are perfectly placed to support your program.

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Frequently Asked Questions (FAQs) About Solubility, Dissolution, and Stability Studies of Pharmaceuticals

  • What can I do if my compound has poor solubility?

    Enabling formulation techniques can often be used to significantly improve a compound's solubility. Depending on the characteristics of your compound, the use of amorphous solid dispersions, nanosuspensions, lipid formulations, or complexing agents can overcome solubility challenges.

  • What can I do if my compound has poor stability?

    Understanding the causes of the instability and the appropriate stability studies of pharmaceuticals is important. Stability issues in the solid state can often be overcome by identifying a more stable polymorph or salt form. Solution phase instability can be more challenging to address.

  • What is the difference between solubility and dissolution rate?

    Solubility refers to the maximum amount of compound that can dissolve in a given volume, whilst dissolution rate refers to how quickly that maximum level is reached. If you are formulating as a solution, dissolution rate may be irrelevant; if you are dosing solids that will dissolve after administration, a slow dissolution rate can limit bioavailability.

  • What is the difference between chemical and physical stability?

    Chemical instability refers to the breakdown of your molecule into other chemical species, whilst physical instability refers to changes in characteristics such as solid-form and particle size; both are important to understand and mitigate during pre-clinical development. Charles River scientists perform stability studies of pharmaceuticals and have a range of experience across compound types, therapeutic areas, and administration routes.