Pharma companies are under mounting pressure to produce high-quality, GMP-compliant excipients. In response, Palatinit has upgraded its polyol range with a new selection of isomalt-based products.
The pharmaceutical industry is faced with the task of reducing costs and switching to materials of non-animal origin that are nonetheless of high quality. Providing a new excipient for this highly competitive market is a real challenge; new entrants to the market have to deal with regulatory criteria, R&D expenditures and the need for excipient GMP-compliant production.
galenIQ, the newly developed multifunctional excipient range from Palatinit, offers the combined advantages of other well-known bulk excipients, and will facilitate pharmaceutical development and formulation. Chemically, galenIQ is based on hydrogenated isomaltulose (HI), a disaccharide alcohol that belongs to the polyols group. Exclusively derived from sucrose in a two-stage production process, galenIQ is a white, odourless, water-soluble, crystalline substance that complies with the isomalt monographs of the current Ph Eur, BP and USP29-NF24. Different galenIQ qualities are tailor-made for specific pharmaceutical applications.
galenIQ offers the benefits of excipients such as mannitol, sorbitol, lactose or microcrystalline cellulose. For example, galenIQ has a very low hygroscopicity. At 25°C, it hardly absorbs any additional water up to 65 per cent relative humidity. Significant water uptake starts only above 85 per cent RH.
With this characteristic, galenIQ provides optimal protection, even for moisture-sensitive APIs. The combination of low hygroscopicity and anti-caking properties will ease production processes such as mixing, agglomeration or tableting, and can reduce the need for costly protective packaging.
As galenIQ can be produced in a whole variety of solubility grades, the release rate of APIs can be directly influenced. This flexibility makes it a superior filler and binder.
Other advantages include excellent stability and compatibility with APIs. Based on its chemical structure, galenIQ does not react with other components and is highly resistant to degradation by enzymes and acids. No changes in the molecular structure occur, even when heated above melting point or - in aqueous solutions - above boiling point.
In addition to its non-animal origins, galenIQ exhibits only a very low glycaemic response, making it a highly suitable excipient in formulations for all patient target groups. Moreover, its outstanding organoleptic and non-cariogenic properties make it ideal for buccal applications.
The direct-compressible grades of galenIQ exhibit first-rate tableting properties due to their excellent compactability and high dilution potential. With a well-defined particle size distribution, they provide outstanding flow and mixing properties, ensuring high content uniformity, even in low-dosage formulations. Tablets show a smooth surface and can easily be film-coated or pan-coated with galenIQ to make them easier to swallow or to protect the active ingredients from moisture or light. Further particle engineering is helping create a product range tailor-made for specific solid-dosage forms.
Palatinit is a member of the International Pharmaceutical Excipients Council (IPEC) and produces galenIQ under GMP conditions for bulk pharmaceutical excipients.
Palatinit is a member of the Sudzucker Group, Europe's largest sugar producer and one of Germany's largest conglomerates.