Pharmaceutical Pre-formulation and Formulation
Our CMC based facility is in Cleveland, Ohio, but with a global reach. We can help you create solutions to many worldwide CMC challenges. Work with us to get access to our modern & cutting edge pharmaceutical preformulation, formulation, analytical, and stability laboratory services!
The scientists at CMC have been involved in a wide variety of consulting and lab based pre-formulation and formulation development studies. Our modern wet chemistry pharmaceutical development lab is equipped to execute both routine and unique studies. Here is a snapshot of projects that match our expertise and capabilities:
- Solubility Evaluation and Dissolution Behavior – A drug has to be in solution to be biologically absorbed following administration. Active pharmaceutical ingredients with low solubility can provide significant hurdles with respect to slow dissolution, low/variable bioavailability, inability to delivery high toxicological doses, and difficulty in developing liquid formulations. Our CMC lab professionals can experimentally evaluate a compound’s solubility in a number of pharmaceutically relevant solvents to overcome these challenges. We have studied a number of systems using solvents, co-solvents, surfactants, alternate salt or solid-state forms, pH adjustments/buffers, and drug-complexes to improve solubility.
- Stability Evaluation – We can evaluate the stability of a compound in long-term storage, accelerated, compatibility, and forced degradation studies. Evaluating the effect of pH, residual moisture, solid-state form, and understanding the degradation mechanism (e.g. hydrolysis, oxidation, impact of light, temperature, etc.) are critical when designing the appropriate formulation and analytical methods.
- Lead Optimization, Candidate Selection, and High Throughput Screening Support – We have experience in providing pre-formulation information to optimize compound selection. Our scientists understand the life cycle of a pharmaceutical product and can help identify the optimal compound to move forward into development.
- Dosage Form Selection – Our experience can determine if your drug candidate is an appropriate candidate for oral, injectable, pulmonary, controlled release, or other novel dosage forms. We evaluate the physicochemical data in collaboration cross-functional areas to identify the optimal dosage form for toxicology evaluation, clinical studies, and beyond.
- Excipient Compatibility Studies – During early formulation development, we execute an excipient compatibility study to determine compatible excipients. This information is then utilized to move forward into the design of a comprehensive formulation development program.
- Comprehensive Formulation and Analytical Development – We have extensive experience in designing and executing the appropriate formulation and analytical development studies to first move your product into the clinic with the ultimate goal of product approval. You also have access to our CMC consulting services that have developed products for worldwide use.
We would love to meet with you and help you achieve your development and manufacturing goals for your pharmaceutical product. Schedule a free meeting with us online or by giving us a call: 216-600-9430.