Accelerate Preformulation Development
Gain a better understanding of your molecule’s unique attributes through strategic prediction, experimentation, and measurements. Our preformulation studies characterize and analyze critical properties of your molecule to inform preclinical development.
By assessing how your drug behaves under various conditions and environments you’ll be able to narrow down which candidates have greater odds of success, saving you time and money in the long run. Our process takes multiple factors into account, including physicochemical characteristics, solid state screening, polymorphism, delivery dependent bioavailability, chemical and physical stability, and compatibility with other materials.
Understanding Polymorphism to De-Risk Drug Development
Polymorphism in drug development is used to characterize the different crystalline phases of a molecule, which then informs selection of a solid form for further development. Each polymorph may vary in drug dissolution and solubilization resulting in assorted rates of bioavailability in the body. Tune into the on-demand webinar to explore the concept of polymorphism, the techniques used to discover polymorphs, and how to apply them to your drug development strategy.
Preformulation Studies
Measuring your molecule’s fundamental characteristics help predict the effects on formulation and delivery. These include solid profiles using:
- X-ray diffraction to determine crystallinity
- Thermal techniques to determine phase transitions, melting points, presence of moisture/residual solvent, onset temperature of decomposition, and hygroscopicity
- Microscopy to determine the size and shape of particles
- Aqueous solubility
Solid state screening is imperative for achieving successful formulation manufacturability, stability, and solubility. We conduct extensive screening to identify possible solid forms and determine the best opportunities to achieve your program goals.
Distinguishing the various polymorphs and their properties in the early phases of development helps predict potential impacts during downstream activities. Our team has proven expertise in determining your drug’s various crystalline forms. We survey these possibilities and make favorable recommendations for formulation and intellectual property so you can confidently move forward.
Pharmaceutical salts are a desirable solid dosage form with various options to consider. We screen acceptable salts for your API and determine the best candidate to select for formulation development.
Ensuring stability is a core aspect of pharmaceutical development, but the combination of possible components is seemingly limitless. Narrowing the scope of materials usee is essential to maintaining progress. Our team helps you understand the compatibility of your molecule with excipients and other components, such as devices.
Developing a Hydrogel Microneedle Array Patch
Microneedles, or micro array patches (MAPs), are an evolving technology that is set to change the way we think about transdermal drug delivery systems. MAPs provide a method to bypass the stratum corneum barrier, creating new opportunities for a large variety of compounds to be delivered through the skin.
Hydrogels are a subcategory of MAPs that can be custom tailored to fit the needs of various delivery strategies, particularly those that require extended or controlled release. Careful planning needs to go into designing a hydrogel MAP, and seemingly trivial aspects should not be underestimated. Learn more about these innovative dosage forms and delivery technologies in our whitepaper.
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.