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Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.
Hermes Pharma, a company specializing in user-friendly oral solid dosage forms, announced in a Jan. 26, 2016 press release that it has commercially implemented hot-melt coating (HMC) technology at its production facility. The implementation came following the results of a research project focused on the development of stable, effective, and user-friendly formulations.
The project was initiated in 2012 by Hermes Pharma in conjunction with the Research Center Pharmaceutical Engineering GmbH (RCPE), INNOJET Herbert Hüttlin and the Karl Franzens University Graz, Department of Pharmaceutical Technology. The aim was to develop orally disintegrating granules (ODGs) for an unpleasant tasting API, acetylcysteine (NAC). ODGs are applied directly into the mouth and do not require water. This type of dosage form addresses the problem of difficulty in swallowing pills. It is important that ODGs are properly taste-masked because they spend more time in the mouth.
According to Hermes Pharma, the company successfully deployed HMC to mask the sour and metallic taste of NAC, as well as its sulfuric smell. The formulation also achieved a stable, immediate-release profile and unaltered polymorphic form of the coating during storage.
HMC is a solvent-free coating technology that offers short processing times (depending on the API, coating thickness, and scale) and lower costs. The process involves covering the API solid core with a molten coating material at a carefully controlled temperature, which then solidifies to create a homogenous coating. Near-infrared spectroscopy (NIR) was used to monitor and control the coating process inline, therefore, saving time and improving quality.
According to Hermes Pharma, the HMC technology has been scaled up from laboratory to production, meeting GMP standards. It can be transferred to other APIs as well as applied to other dosage forms such as orally disintegrating tablets (ODTs) and multiple unit pellet system (MUPS). Hermes Pharma recently won the Research and Innovation Award, a recognition that the Carinthian Economic Promotion Fund of Austria awards in this field for its research in HMC.
Source: Hermes Pharma