In 2005 BENEO-Palatinit launched its multifunctional bulk excipient range under the brand name galenIQ™. Now, the pharmaceutical grade of isomalt has found its way into direct compressed tablets and sachets for direct oral application at first. The highly functional filler-binder is available in various particle modifications and different solubilities.
Highly functional filler-binder
The unique morphology of agglomerated galenIQ™ grades eases (especially in powder blends) the formulation with different API particle sizes at the same time. The large specific surface area enables the incorporation of high concentrations of active ingredients on the one hand without compromising the flow properties of the final mixture. On the other hand, the surface structure prevents segregation even in very low dose blends during the whole process, thus ensuring the homogeneity of the mixture and subsequently the required content uniformity.
Moreover, these grades exhibit high agglomerate stability during the mixing process and are very low hygroscopic. Thus the excipient protects even moisture-sensitive APIs. In addition, their excellent compactability makes the grades suitable for tablets, showing a smooth surface that can easily be film-coated or pan-coated.
Multifunctional excipient with sweet taste
Derived from pure beet sugar, galenIQ™ gives a pleasant sugar-like taste. This sweet, well-balanced taste is a decisive advantage for sachet products for direct oral application as well as for chewable or lozenge tablets. However, in contrast to sucrose, it has very low glycemic response and does not promote tooth decay, which makes galenIQ™ superior for use in these kind of dosage forms.
All these properties make galenIQ™ an ideal base for the formulation of any kind of powder blend – be it blends that are further processed (i.e. to compressed tablets) or blends that are used directly (e.g. in capsule fillings or sachets).
Tailor-made grades for solid dosage forms
In addition to agglomerated grades that are suitable for powder blends, a product range of tailor-made grades for specific solid-dosage forms, such as pellets, pan coatings and lozenges, is also available.
galenIQ™ is a white, odourless, water-soluble, crystalline substance of non-animal origin, derived from sucrose. Chemically, galenIQ™ is isomalt, a disaccharide alcohol, widely used as a bulk sweetener in sugar-free confectionery and nutraceutical products for over 20 years. galenIQ™ complies with the isomalt monographs of the current Ph Eur, BP and USP-NF and is approved for use in Japan and China.
BENEO-Palatinit, part of the Südzucker Group, is a member of the International Pharmaceutical Excipients Council (IPEC) and produces galenIQ™ under GMP conditions for pharmaceutical excipients.