CD Formulation's Contract Development and Manufacturing (CDMO) division is a leader in drug development and drug delivery pathway development, offering services such as bioresorbable particle system development. CD Formulation also offers integrated services from evaluation of drug formulation to drug product development, scale-up production, and commercial manufacturing, our pharmacy experts have experience and expertise to accelerate your particulate products to market.
Manufactured by API alone or in combination with protective and rate control materials, particulates can take the form of matrix-like microspheres or microcapsules with a unique core/shell structure. Depots typically consist of solid polymer microspheres physically produced from biodegradable polymers. Once formulated, these particles are typically lyophilized or freeze-dried to produce a stable dry powder, which remains in a dry state until they are bound to the diluent prior to administration. Because depots are parenteral or injectable, they must be provided in sterile form, requiring end-sterilization or aseptic manufacturing techniques. Once injected, depot formulations will degrade over time, usually spanning weeks to months.
Fig.1 Microparticle Depots mediate local nanoparticle release and subsequent intracellular delivery of nucleic acid to local cell populations. (Garland et al., 2019)
CD Formulation's team has extensive experience with a wide range of active pharmaceutical ingredients (APIs) and polymers to support drug identity assessment and drug development by understanding how to formulate and characterize these polymers. Our particle or microsphere formulation and drug manufacturing technologies can be applied to both small and large molecules.
CD Formulation is well versed in the formulation of particulate products and the design of particulate depots, and our team is motivated to advance your product to the desired endpoint.
Microparticle Formulation Development
CD Formulation can perform microparticle formulation development by adjusting polymer selection, particle size, and drug loading volume. When preparing depots from bioresorbable polymers, precise polymer chemistry and molecular weights need to be explored and optimized. Our formulators work closely with analysts to ensure polymer and API compatibility and to determine that there is no negative impact on the performance of either.
Design of Microparticle Depots
Particle size distribution (PSD) can have a significant impact on performance; if the particles in a long-acting injectable are polydispersed, meaning there is a wide range of particle sizes in the formulation, product performance will vary from dose to dose. Finding the right PSD is aided by formulation expertise and process optimization as well as design of experiments (DoE).
CD Formulation provides integrated innovation solutions from strategy to implementation to help you increase opportunities and address challenges. Through our in-depth experience in many different industries, including consumer and technology, we bring innovative solutions and cross-industry best practices to drug development. If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.