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.
Our scientists assess preformulation for almost any mode of drug delivery (liquid, suspension, solid oral, intravenous, subcutaneous, nasal, inhalation) using crystalline or non-crystalline materials. These insights empower you to make informed decisions when selecting the best approach for your compound and minimizing lost time if a strategy proves unsuccessful. At the stage-appropriate time, analytical methods are evaluated and developed to support your formulation development goals and support pre-GMP testing activities.
Once both the target formulation and processes are established, our team characterizes manufacturing processes with reliability, robustness, and scalability in mind.
We develop processes and documents for the materials to support release and testing. Then, our team puts these processes to the test for generating and releasing manufactured lots used during stability and in vivo testing.
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.
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.