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Hot-melt coating for pharma applications

By Gerald Ondrey |

Polymer coatings are often used to mask the taste of pharmaceuticals, as well as to serve as moisture barriers to granules or tablets. However, the application of polymer solutions requires considerable time and energy for drying after the coating has been applied. Processing times can now be shortened by up to 85% using a hot-melt coating technology developed by Romaco Innojet GmbH (Steinen, Germany; www.romanco.com).

The company’s IHD series was specially designed for coating and granulating pharmaceutical products with hot greases and waxes, which simply harden when cooled, thereby eliminating the time and energy needed for drying. Speaking at a pre-Achema press event at Dechema (Frankfurt am Main, Germany) last month, technology director Kai Koch presented an example of the coating of 1 kg of granulate. Whereas the conventional process of coating with a polymer solution 500 g polymer in 2,833 g of water requires 278 minutes of processing time to form the coated granulate, the hot-melt coating of 500 g onto the same granulate required only 42 minutes.

Although the technology has been used in other sectors, the company has now launched a system that is compliant with Good Manufacturing Practice (GMP), specifically for pharmaceutical applications. That means the device is clean-in-place (CIP) capable, particularly regarding the validation of the cleaning processes.

In the IHD device, the hot-melt coating flows through straight tubes to prevent any buildup of product residues. All product-contacted surfaces inside the devices are positioned in such a way that they are fully visible and suitable for swab testing. The IHD series successfully avoids cross-contamination thanks to the hygienic design with no dead spaces.

To allow precise and uniform heat distribution, the Innojet IHD was designed as a heatable monobloc integrating all functional components. The melting container, dosing unit and valve block are all included in the same thermal cycle, which means they do not have to be heated and insulated separately.

A laboratory device designed to handle 5 L was introduced last year, and a 50–L pilot-scale machine is being launched in April.

hot-melt coating

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