Pre-formulation studies are the initial steps in the pharmaceutical formulation development process. These studies evaluate the chemical properties of the drug substance, such as solubility, stability, and compatibility with other excipients. The results of pre-formulation studies help in selecting the appropriate dosage form and excipients for the formulation.
Formulation Design and Evaluation:
Formulation design is the process of selecting the appropriate dosage form and excipients for the drug substance. The dosage form can be a solid, liquid, semisolid, or dispersion depending on the drug’s physical and chemical properties and the target patient population. The excipients are selected based on their compatibility with the drug substance, their function in the formulation, and their safety profile. Evaluation of the drug product with analytical, in vitro, and in vivo studies ensures that it meets FDA and ICH requirements and the desired target product profile.
CMC Pharma excels in the most common routes of administration (tablets, capsules, injectables) and also has specific expertise with innovative and complex drug delivery systems such as polymeric controlled release, in situ forming gels, suspensions, and more.
Manufacturing Scale-up and Process Development:
Process development is the optimization of the manufacturing process to ensure consistent quality, yield, and purity of the drug product. The manufacturing process is designed to ensure that the drug product meets the required specifications and is produced in compliance with regulatory requirements. The appropriate scale of the manufacturing process needs to be consistent with the needs of pre-clinical, clinical, and commercial requirements for the drug product.
Analytical Development and Characterization
Analytical methods must be developed to ensure that the drug product meets the identity, purity, and potency specifications and requirements. The workhorse of a pharmaceutical drug product development lab is Ultra and High Performance Liquid Chromatography (U/HPLC) instruments that are utilized to measure the purity and potency of a drug product. However, additional analytical methods are also employed to quantify residual water, critical excipient levels and other impurities, drug dissolution or release, pH, osmolarity, appearance, particle size, and other critical quality attributes.
Stability and Shelf-life Determination:
Stability testing is a critical aspect of the formulation development process. It ensures that the drug product maintains its quality and efficacy over time. Pharmaceutical stability testing involves storing the drug product to various environmental conditions, such as temperature, humidity, and light, and monitoring its physical and chemical properties over time. The stability data is then used to determine the appropriate storage condition and the shelf-life of the drug product. CMC Pharma executes both routine and custom-designed stability studies. Our formulation lab enables stability studies to be performed compliant with cGMPs, FDA regulations, and ICH guidance as needed for regulatory submissions.
Pharmaceutical formulations must comply with regulatory requirements to ensure patient safety and efficacy. Regulatory authorities, such as the US Food and Drug Administration (FDA), require that drug products meet certain quality, safety, and efficacy standards before they can be approved for marketing.
In conclusion, pharmaceutical formulation development is a complex process that requires a multidisciplinary approach. Pre-formulation studies, formulation design, process development, pharmaceutical stability testing, and regulatory requirements are all essential formulation development services that we offer.
CMC Pharmaceuticals routinely assists companies at these various stages and our labs equip us to be well-suited for partners looking to develop or optimize a drug product from the ground up, or to outsource associated analytical work to advance a program held back by capacity constraints. By ensuring that drug products meet the required quality, safety, and efficacy standards, pharmaceutical formulation development plays a critical role in improving patient outcomes and CMC Pharma is ready to partner with you.