Drug Product Formulation Services
CMC Pharma excels in the formulation development of a variety of active pharmaceutical ingredients (API), including drug products that are challenging to stabilize or solubilize.
We specialize in the most common routes of administration with traditional formulations (tablets, capsules, injectable solutions) and more innovative and complex drug delivery systems (polymeric controlled release, in situ forming gels, suspensions, etc.) to overcome your development challenges and maximize the safety and efficacy of your drug product. Our capabilities include the identification and preparation of drug product prototypes in our pilot plant for in vitro and in vivo studies.
We also provide expert laboratory services to remediate existing drug products to meet current FDA regulations. We focus on understanding the characteristics and the requirements of your pharmaceutical product, FDA and worldwide regulations, and applying scientific rigor and innovation to bring your product to market.
The formulation and analytical development services at CMC Pharma help product developers, manufacturers, and entrepreneurs turn innovative ideas into approved products.
Our Formulation Expertise Includes:
- Pharmaceutical Formulation Development of traditional (tablets, capsules, injectables) and complex (long-acting, controlled release, suspensions) dosage forms
- Reformulated drug products to increase shelf life
- Formulations with combinations of drugs (two or more pharmaceutical ingredients)
- Use of non-aqueous vehicles for hard-to-solubilize drugs
- Development of long-acting injectable formulations utilizing accepted controlled release technology
- New chemical entities and repurposed drugs with high potency, low solubility, poor stability, or that may require segregation from other manufacturing operations such as beta-lactams, cytotoxics, and hormones
Contact Us Today and find out how CMC Pharma can help you!
Our expert team of scientists provide exceptional pharmaceutical formulation services for a variety of dosage forms.
Send us a message or give us a call at 440-485-1734
Pharmaceutical Pre-Formulation & Formulation Services Include:
Compatibility Evaluation
Our capabilities include evaluating 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.
Poorly Soluble Drugs
Active pharmaceutical ingredients with low solubility can provide significant development hurdles with respect to slow dissolution, low and variable bioavailability & absorption, inability to deliver high toxicological doses, and difficulty in developing liquid formulations. The CMC Pharma team can experimentally evaluate a compound’s solubility in a number of pharmaceutically acceptable solvents to overcome these challenges. Our proven track record of overcoming solubility and dissolution challenges includes evaluation of a number of systems using solvents, co-solvents, surfactants, alternate salt or solid-state forms, pH adjustments & buffers, and drug complexes to improve solubility.
Lead Optimization & Candidate Selection
We are specialists in providing pre-formulation guidance and evaluation 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 help determine if your drug candidate is appropriate for oral, injectable, inhaled, controlled release, or other novel dosage forms. We evaluate the physicochemical data in collaboration with pharmacologists and biologists to identify the optimal dosage form for toxicology evaluation, clinical studies, and beyond.
Excipient Compatibility Studies
During early formulation development, we execute excipient compatibility studies for selection of the components in an acceptable formulation (e.g. stabilizers, binders/disintegrants/lubricants, solubilizers, preservatives, buffers, tonicifiers, etc.) Appropriate and compatible excipients allowing optimal design of a comprehensive formulation development program to meet all FDA and ICH requirements.
Comprehensive Formulation & Analytical Development
Our extensive experience in designing and executing appropriate formulation and analytical development studies for early phase products creates a strategic path to move your product into the clinic with the ultimate goal of product approval.
Pharmaceutical Pre-Formulation & Formulation Services Include:
