Composed of a group of pharmaceutical experts, including chemists, biochemists and engineers, CD Formulation has gained a depth of experience in the pharmaceutical industry as a trustworthy contract service provider. Earlier this month, the company announced a decision to further optimize its custom excipient development services. Through such an attempt, CD Formulation will be devoted to unlocking the tremendous possibilities in excipient development and be fully dedicated to solving every unique challenge that may arise from the drug development process.
With the continuous expansion of the pharmaceutical industry, traditional excipients can hardly meet the market demand. To achieve the desired key quality attributes of the final formulation, the pharmaceutical industry starts to seek the option of new excipients or simply uses multi-functional excipients or co-processing excipients.
CD Formulation mainly provides the following two customized services of new pharmaceutical excipients to meet customer demands.
Modification of a known excipient as a derivative or successor
Compared with creating a completely new excipient, this type of development is relatively less risky. By developing its derivative or successor, the already existing excipients can be modified. Chemical modification in the structure of excipient is done by changing or introducing new functional groups to existing excipient. The development of different cellulose derivatives and cyclodextrins is conducted with this guiding principle.
Creating a new chemical entity without a base structure
Such an attempt is more challenging and needs more investment of time, money and effort. The whole process starts from specifying a base moiety for the excipient. After the target is identified, researchers will screen different chemical structure classes in order to select the most optimal structure, which is subject to further optimization to gain particular characteristics. No matter in which step, quality control testing is a necessary step. Along with this, toxicological testing in animals is carried out which generally takes three years to complete. In most cases, it takes 6-8 years to complete a novel excipient development project.
At CD Formulation, the most cost-effective and time-saving solutions will be opted and implemented to tackle the most pressing issues encountered by clients in their efforts to develop excipients or drugs. After the project is finished, a full study report will be provided together with the tailor-made pharmaceutical excipients, including the data of composition analysis, impurity analysis, complete compendia testing (USP, EP, BP, JP, FCC, ACS testing), USP <467> residual solvent testing, metals analyses (AA, GFAA, ICP), etc. More information about CD Formulation’s custom excipient development service can be found here: https://www.formulationbio.com/custom-pharmaceutical-excipients.html.
About the role of excipients in drug formulation
An excipient usually acts as a carrier or component of the carrier of an active substance. It can promote product properties such as stability, biopharmaceutical properties, appearance and patient acceptability, and ease of manufacture of the product.
About CD Formulation
As a science-driven company, CD Formulation has accumulated rich experience in drug formulation and is qualified to serve the pharmaceutical industry by providing CRO services to develop, design and produce pharmaceutical excipients for solid, semi-solid and liquid dosage forms. With an innovative spirit and a down-to-earth attitude, the company is missioned to address the long-standing issue of new API development. It has completed several development projects and proudly extends its capability, which covers generic to innovative formulation with an ambition to enhance the solubility and bioavailability of difficult-to-formulate compounds. Equipped with advanced facilities that comply with GMP regulations, the company continues to provide personalized solutions for clients, taking into consideration the unique requirements and circumstances of each new project, whether it is initial pre-formulation trials or commercial manufacturing.