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Drug Product Development

CMC provides Formulation and Drug Product Development Laboratory Services to our clients. Our decades of experience in pharmaceutical development and our modern R&D laboratory are ideally suited to meet all of your drug product development needs. Our focus is on pharmaceutical APIs that require pre-formulation evaluation, formulation development, or require later-stage Drug Product characterization and compatibility studies. These include compounds in discovery or early development through commercialization, sterile drug products, novel dosage forms, low solubility, unstable & potent compounds, and controlled release formulations.

Our new and modern 700 square foot wet chemistry development lab is equipped to execute both routine and unique drug product development studies. We customize our drug product development studies for each client. Our current focus is:

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Pre-formulation evaluation

These studies can be customized to include excipient compatibility, solid form evaluation, solubility measurements in pharmaceutically acceptable solvents, pKa determination, forced degradation studies, pH degradation rate profile, evaluation of adverse conditions (water/humidity, temperature excursions, oxygen, light, freeze/thaw, etc.) and other studies as needed to evaluate an active pharmaceutical ingredient (API) for pre-clinical or clinical studies.

Formulation development studies

CMC can execute studies and evaluate the physicochemical properties of an API and recommend an appropriate dosage form for preclinical and clinical studies. Prototype formulations are prepared and evaluated under stressed, ICH, and custom conditions. CMC has a variety of stability conditions and chambers that provide ICH conditions (frozen (-20°C), refrigerated (5°C), room temperature (25°C/60%RH), intermediate (30°C/65%RH), and accelerated (40°C/75%RH) temperatures) in addition to custom temperatures, humidity, and other conditions, as appropriate. We have extensive expertise in evaluating the stability and compatibility of drug products at various storage and in-use conditions to support stability during clinical trials and commercialization and in support of IND and NDA filings.

Analysis of drug product

CMC’s is well equipped to analyze drug products by a number of advanced techniques that include HPLC, UPLC, UV/V is spectrophotometer, visual analysis, and other analytical techniques. Our Cleveland Health-Tech Corridor location provides financial incentives to purchase equipment and access to a wealth of advanced lab services at the area’s universities and hospitals.

Formulation Preparation

CMC can prepare a number of traditional and complex dosage forms for in vitro and in vivo exploratory, proof-of-concept, and tox studies. We can provide the appropriate analysis and documentation to support each stage of development.