Pre-preparation studies were initiated prior to the commencement of pharmaceutical preparation activities. In the pre-preparation stage, the physical and chemical properties of the active drug component (API) were determined. For chemical API, the knowledge gained will help you choose the correct salt or polymorphism form and will support the design and development of your dosage form, both preclinical and clinical use. For bioactive drugs, pre-prescription studies ensure that the best candidates for CMC characteristics are selected, which will prove useful in further drug product development. In addition, during the pre-prescription study, the relevant analytical methods can be optimized for use at a later stage of drug product development.
Physicochemical characterizations of active pharmaceutical ingredients are mainly including molecular structure analysis, solubility profile, stability investigation, pKa determination, solvent/oil solubility, stability, polymorph screening, partition coefficient, hygroscopicity, permeability measurement, salt form selection, mechanical properties, and micromeritics. An understanding of the active ingredients’ physical and chemical characteristics plays a central role in the early stage of drug development. The solubility, for example, determines whether an injection or liquors can be successfully prepared.
Formulation design and screening determine the final drug-delivery way and optimal composition of a tablet or capsule. The aim of formulation screening is to make the drug formulation more safe, effective, reasonable, stable, convenience and economic. Selection of appropriate excipients, the best preparation process, and the best form of preparation can be used to facilitate the development and clinical study of the late preparations. Such as, appropriate type and dosage of excipients result in satisfactory release behavior from tablets or capsules, which is the most prerequisite for achieving an excellent treatment efficacy.
The chemistry, manufacturing and controls (CMC) is a critical section of controlling the quality and safety of pharmaceutical products. CMC has gained a lot of importance to clinical trial or marketing application due to its essential role in ensuring the properties of product and manufacturing process to meet or excess the sufficiently high standards required by local or national regulators.
The scientists and experts of BOC Sciences, who are experienced and specialized in the field of R&D of new drug products and generic drugs, can provide you with an excellent report of pre-formulation screening. In addition, the advanced instrumentation, equipment and the principle of “Clients are First” are also the preponderances of BOC Sciences. More importantly, a complete appraisal report or certificate of analysis is also provided to ensure the service quality.