From September 4 to 5, 2026, the 8th CMC-CHINA China Pharmaceutical Industry Expo had been held at the Suzhou International Expo Center. At booth E-B13, Hartek Technology used its HTGD series pharmaceutical-grade twin-screw hot-melt extruders to successfully complete the hot-melt extrusion process validation of copovidone VA64 + API (simulated process), producing samples that were crystal-clear and exhibited excellent uniformity and dissolution test results, attracting numerous R&D professionals from the pharmaceutical industry to stop by for discussions.

The core value of HME technology in the pharmaceutical field

Hot-melt extrusion is a formulation technology that has rapidly gained popularity in the pharmaceutical field in recent years. By mixing the API with a polymeric carrier in the molten state to form a solid dispersion, it can significantly enhance the dissolution rate and bioavailability of poorly soluble drugs. This technology was first applied in the plastics, rubber, and food industries; approximately 20 years ago, the pharmaceutical industry began adopting it for drug formulation development. Compared with traditional methods, HME avoids the use of organic solvents and water, simplifies the manufacturing process, improves drug stability, and markedly enhances the solubility and bioavailability of poorly soluble drugs.

Application of Copovidone VA64 in Hot-Melt Extrusion

Kollidon VA64 is a copolymer of vinylpyrrolidone and vinyl acetate (60:40), exhibiting excellent plasticity and suitable for preparing pharmaceutical solid dispersions via hot-melt extrusion. An ideal polymer should possess good thermoplasticity, a moderate glass transition temperature (between 50°C and 180°C), low hygroscopicity, and non-toxicity. Kollidon’s widespread use in the HME field stems precisely from its outstanding performance in these respects, making it particularly well-suited for formulation with poorly soluble drugs.

In this validation, the HTGD series hot-melt extruder thoroughly blended VA64 with an API‑simulated excipient, yielding a sample that was uniformly transparent, with no phase separation or precipitation, thereby demonstrating the equipment’s process stability in solid dispersion preparation. These results also confirm the suitability of VA64 for hot‑melt extrusion—when used as a binder, it is applicable to wet and dry granulation as well as direct powder compression; it can also serve as a solubilizing agent in solid dispersion processes.

Pharmaceutical Application Capabilities of the HTGD Series Hot-Melt Extruders

The HTGD series features a parallel co-rotating twin-screw configuration, with intermeshing screws that deliver highly efficient mixing, resulting in excellent drug dispersion and short residence times. The split-type barrel can be quickly opened for cleaning, eliminating dead zones where material might remain; the modular screw design allows flexible adjustment of screw element assemblies to suit different APIs and excipient systems. The equipment is equipped with a Siemens PLC control system, enabling recipe storage and one‑click recall, while process parameters are traceable and reproducible. Designed in accordance with GMP principles, all components that come into contact with the product are made from food‑grade stainless steel, ensuring ease of cleaning and maintenance.

On-site validation at this year’s CMC exhibition fully demonstrated the HTGD series hot-melt extruders from Hartek Technology in preparing pharmaceutical solid dispersions, while also confirming the equipment’s performance in process stability, temperature-control accuracy, and ease of operation.

Hartek Technology is a national high-tech enterprise, holding over 30 national patents and certified to ISO9001 and the EU CE standards. Its business spans packaging, agriculture, industry, food, tobacco, healthcare, specialty materials, and new energy electronics, covering eight major sectors.