Hot Melt Extrusion Technology for Nucleic Acid Formulations

CD Formulation has a team of formulation scientists and analytical scientists dedicated to the HME technology platform. We develop nucleic acid formulations at scales ranging from exploratory research and development at the gram level to process optimization at the kilogram scale. Our technical team has the theoretical foundation and hands-on experience to ensure the success of every project.

Advantages of Hot Melt Extrusion (HME) Technology

Hot Melt Extrusion (HME) is an innovative technology used for preparing amorphous solid dispersions (ASDs) to improve the bioavailability of challenging-to-dissolve compounds. Known for its flexibility, scalability, high quality, and process development efficiencies, HME technology finds applications in various areas such as the creation of ASDs, sustained release formulations, targeted delivery systems, and oral films.

Fig.1 Advantages of HME technology. (CD Formulation)

Workflow of Nucleic Acid Formulation by Hot Melt Extrusion Technology

CD Formulation utilizes state-of-the-art hot-melt extrusion equipment and rigorous process development procedures to deliver high-quality nucleic acid formulations and to support the full range of services from R&D to scale-up. The following outlines the basic process for preparing nucleic acid formulations using hot melt extrusion technology.

Fig.2 Workflow of nucleic acid formulation by HME technology. (CD Formulation)

Selection of Appropriate Carriers - Select appropriate polymer carriers for blending with nucleic acid drugs. Ensure that the chosen materials are thermally stable at extrusion temperatures and do not react adversely with the nucleic acid drug.

Raw Material Pretreatment and Weighing - Nucleic acid drugs and polymer carriers are accurately weighed according to the formulation proportions. All raw materials are handled in a clean and dry environment to ensure purity and quality.

Co-mixing and Homogenization - The weighed raw materials are homogenized and mixed, typically using a high-shear mixer or dry mixer. It is essential to ensure that the nucleic acid drug is uniformly dispersed in the mixture to prevent localized concentration differences.

Hot-melt Extrusion - The mixture material is fed into the inlet of the hot-melt extruder, and the material is melted inside the extruder by the rotation of the screw and an applied heat source. The molten material is then extruded into strips or other desired forms through a die under the action of screw shear.

Cooling and Curing - The extruded molten material is rapidly cooled in a cooling unit to solidify it into a stable solid dispersion. The cooled extrudate may be further pulverized or cut to obtain the desired granule or tablet form.

Post-processing and Quality Control - The cooled solid dispersion product undergoes necessary post-processing steps such as pulverization, sieving, and encapsulation. The final product is subjected to stringent quality control tests to ensure that its solubility, stability, and potency meet the requirements.

Highlights of Nucleic Acid Formulation Preparation

• HME integrates heating, mixing, and molding, which reduces the multi-step operations such as dissolving, drying, and pulverizing in traditional preparation methods.
• For those compounds that are difficult to dissolve in the gastrointestinal tract, HME can mix the drug with polymer carriers to form an amorphous solid dispersion, which greatly improves its solubility and bioavailability.
• In addition to traditional oral tablets, HME is also widely used in the preparation of sustained-release formulations, topical drugs, transdermal systems, oral membranes, and other applications.
• HME improves the safety and environmental protection of the production process, while significantly reducing the impact of solvent residues on drug quality.

Our Hot Melt Extrusion Solutions for Nucleic Acid Formulations

CD Formulation is a prominent nucleic acid formulation development company committed to offering customers efficient, scientific, and personalized drug formulation solutions. We employ state-of-the-art hot melt extrusion technology to create a range of nucleic acid formulations, such as oral, injectable, ophthalmic, nasal, and transdermal nucleic acid formulations.

Publication Data

Through rational application and optimization, CD Formulation's HME technology not only enhances the bioavailability and stability of drugs but also substantially reduces production costs and environmental impact. This technology offers robust technical support for the advancement of modern pharmaceuticals. Contact us for a customized solution for your project.

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.