BENEO's excipient galenIQ™ is a range of water-soluble filler-binders. Derived from beet sugar it has a sweet taste and promotes a pleasant, well-balanced gustatory profile in pharmaceutical formulations. Due to these unique sensorial properties it is an optimal choice for solid and liquid oral applications, and especially those in combination with active ingredients or plant extracts that have a bitter and/or unpleasant flavour.
galenIQ is the pharmaceutical grade of BENEO's ISOMALT, a disaccharide alcohol derived from beet sugar. Its source material is the main reason why galenIQ has a sweetness and taste profile that is very close to sucrose. With its well-balanced sweetness, the filler-binder has no significant off-tastes or aftertaste. galenIQ reduces the bitter taste of active pharmaceutical ingredients (APIs), masks the unpleasant taste of ingredients such as plant extracts, and contributes to a palatable pleasant taste profile and mouthfeel in the final pharmaceutical or nutraceutical product. galenIQ is the optimal choice for the formulation of solid as well as liquid oral applications and is particularly useful in paediatric formulations.
A recent comparative study has shown that galenIQ is able to considerably suppress the bitterness of a quinine hydrochloride solution. In comparison to maltitol, mannitol and sucrose, the addition of galenIQ (grade 721) in concentrations as low as 3-6% w/w led to a significantly higher reduction in bitterness. It is therefore not surprising that galenIQ is the excipient of choice where taste matters.
galenIQ is primarily considered to be a soluble filler-binder for tablets and powdered products. However, the past ten years have proven it to be a truly multifunctional excipient: It has been used to coat solid dosage forms, as a component in hot melt extrusion processes and, most importantly, it has improved the taste of many medicines, even in liquid applications.
The galenIQ product range comprises different grades that serve a broad variety of dosage forms. Besides the agglomerated grades 720 and 721 for direct compression and dry blend applications, the 800 series offers special powder grades of different solubilities and particle size distributions for wet granulation, roller compaction and other agglomeration processes. Sieved grades for starter pellets (galenIQ 960), for pan coating and syrups (galenIQ 981) as well as for medicated confectionery (galenIQ 990) complete the range.
Due to its cost effectiveness and time saving benefits, dry blending of all ingredients without further processing is the most favoured method of drug preparation. Dry blends can be used in compression and compaction processes or simply filled into capsules, bottles or sachets. The 'sachet trend' is already becoming evident, with line extensions of well-established brands increasingly moving into sachets and stick pack packaging. Dry blends facilitate a convenient and fashionable form of drug delivery. When developing these powder mixtures for oral application, it is important that bulk excipients fulfil the necessary requirements, such as excellent flowability, low hygroscopicity, high physical stability during mixing, and high dilution potential and content uniformity, to name just a few.
With well-defined particle size distribution, galenIQ 720 and 721 provide outstanding flow and mixing properties. galenIQ is the perfect excipient for easy tableting because of its excellent compactability and high dilution potential. At the same time only low compaction forces are required to achieve a high tablet hardness. Agglomerated galenIQ is a white, odourless and water-soluble material with a unique morphology. The porous and large surface areas enable high concentrations of active ingredients to be incorporated without compromising the flow properties of the final mixture. These surface structures also prevent segregation, even in very low dose blends, throughout the whole process, thus ensuring the homogeneity of the mixture and, subsequently, the required content uniformity.
galenIQ complies with the isomalt monographs of the current Ph Eur, BP and USP-NF and is approved in both Japan (JP) and China (with an Import Drug License).
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