Generic Nanoformulation Development

CD Formulation is committed to exploring and researching the generic nanoformulation process, pharmaceutical quality, and therapeutic equivalence of generic nanoformulations and reference preparations, which has important reference significance for the research and development, large-scale production, and quality control of generic nanoformulations.

What is Generic Nanoformulation?

Generic nanoformulations are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD). And Generic nanoformulation and RLD hold the same active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics, and are equivalent in safety and therapy.

Why Develop Generic Nanoformulation?

Currently, nanomedicines that have been approved and can be commercialized include lipid nanomedicines, polymer nanomedicines, nanocrystals, inorganic nanoparticles, and protein nanoparticles. Due the production process of nanoformulation is relatively complex, and it is difficult to break through the technical barriers of patent imitation, resulting in low reproducibility of related products and difficulty in ensuring quality. Therefore, to ensure the safety, effectiveness, and quality control of generic nanoformulation, it is necessary for us to quickly develop generic nanoformulations to reduce the cost of consumption for patients.

Our Generic Nanoformulation Development Services

Nanoformulations use new excipients and their compositions are relatively complex. The composition and dosage of the excipients must not only be the same as the RLD, but the microstructure should also be consistent with RLD. The production process of nanoformulations is more complex and often requires the use of proprietary processes and equipment, and expansion of production scale can easily affect product quality. In addition, after nanoformulations enter the human body, they usually need to release drugs to exert their efficacy. So the rate and location of drug release in the body may affect clinical efficacy and safety.
We are committed to generic nanoformulation development based on our advanced design concept and reverse engineering research platform for RLD many years. Our solutions for generic nanformulation development are mainly include formulation and process studies, quality analysis and evaluation, in vitro PBE studies.

Fig.1 Our workflow of generic nanoformulation development. (CD Formulation)

Formulation and Process Studies for Generic Nanoformulations

Based on our reverse engineering technology platform and uses appropriate characterization techniques to reverse analyze RLD. quality target product profile (QTPPs), and critical quality attributes (CQAs) are designed according to the QbD design concept to ensure that the types and amounts of excipients are consistent with the RLD, and the physical and chemical properties of the excipients that are critical to the performance of the nanoparticles are consistent. At the same time, we conduct in-depth research on key production processes such as emulsification, homogenization, filtration, and sterilization preparation methods to ensure that manufacturing equipment and process parameters are consistent with RLD.

Quality Analysis and Evaluation for Generic Nanoformulations

Different nanoformulations have different structures and compositions, and their physical, chemical, and biological properties are also different. In the quality study of generic nanoformulations, we use appropriate methods to conduct a comprehensive analysis of COAs including but are not limited to, nanoparticle shape, surface characteristics such as surface charge and functionalization, drug loading and encapsulation efficiency, drug release, particle size and distribution, etc.

In Vitro Population Bioequivalence (PBE) Studies for Generic Nanoformulations

According to FDA regulatory guidance requirements, we use the mixed scale method to compare the in vitro population bioequivalence (PBE) of generic nanoformulations and reference products (RP). We are committed to the formulation development, quality analysis and in vitro PBE services for generic nanoformulations including lipid nanomedicines, polymer nanomedicines, nanocrystals, inorganic nanoparticles, protein nanoparticles, etc.

Why Choose Us to Develop Generic Nanoformulation?

• We have a professional technical team with a background in nanoformulation expertise and drug development experience.
• We can not only provide researchers and global pharmaceutical companies with the development of innovative nanoformulations, but also the development of nanoformulations.
• With cutting-edge technology and a skilled team, we can quickly fulfill your requirements for creating universal nanoformulations. We have established a very complete development process in the development of nanoformulations, including formulation process design and development, quality analysis and evaluation, and in vitro PBE studies.

Published Data

Compared with RLD, generic nanoformulations not only have the same quality and efficacy, but also have significant price advantages, providing convenience to patients. Therefore, the development of generic nanoformulations has attracted great attention from researchers. CD Formulation has consistently been a leader in the advancement of creating generic nanoformulation. If you have any inquiries regarding our services, please kindly contact us for detailed communication.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.