Advantages and Disadvantages

From an engineering and operational perspective, injection molding technology can be low cost, highly precise (ensuring accurate drug content), and provide a wide range of product geometries. Scale-up can be less of an issue because the "unit operation" remains unchanged. It can also facilitate a largely continuous rather than "batch" mode of manufacture. Disadvantages are high initial set-up costs, with

Fig. 12.7 MiniJet injection molder (left) and MiniLab-compounder. Courtesy Thermo Scientific HAAKE

application limited to drugs and excipients that are thermostable. Moreover, injection molding technology may be unsuitable for materials where interactions (e.g. drug-excipient) can occur at high temperatures, but not at conditions encountered with more conventional modes of unit dose manufacture. As with all technologies, suitability is likely to be drug and dosage form specific and there will undoubtedly be "niche" areas where the technology may help surmount some barrier to development. Cleaning and validation might be an issue as machines are not usually designed specifically for medicinal product manufacture. Hence, it is important to consider cleaning capability in machine design and acquisition.

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