galenIQ™ is a high quality Isomalt, designed by Beneo-Palatinit GmbH to meet the very specific
galenIQ™ is a high quality Isomalt, designed by Beneo-Palatinit GmbH to meet the very specific expectations of the pharmaceutical industry. BENEO is a member of the Südzucker Group, the world’s largest sugar producer, and of the International Pharmaceutical Excipients Council (IPEC).
galenIQ™ qualities are derived from beet sugar sucrose in a two-stage production process. It is a filler-binder that combines a multitude of outstanding characteristics, suitable for a wide range of pharmaceutical applications.
It can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti humectant agent, stabiliser or oral care and taste agent… to mention just a few additional functions.
galenIQ™ is ideal for the following oral solid-dosage forms:
- Capsule fillings
- Powder mixtures
- Pan coatings
- High-boiled lozenges
- Medical gums
The galenIQ™ product range comprises different grades of solid dosage forms: besides the 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, such as galenIQ™ 960 (starter pellets), galenIQ™ 981 (for pan coating and syrups) as well as galenIQ™ 990 (for medicated candy) complete the range.
galenIQ™ has a very low hygroscopicity. This characteristic enables galenIQ™ to provide optimal protection even for moisture-sensitive active pharmaceutical ingredients (APIs), which is a decisive advantage over other bulk excipients. Furthermore, the low hygroscopic nature - combined with an anti-caking property - eases production processes such as mixing, agglomeration or tableting.
galenIQ™ is soluble in water as well as in mixtures of water and ethanol. The solubility in water ranges, depending on the type, from about 24 g to 42 g in 100 g solution at 20 ºC and increases at higher temperatures. The release rate of active ingredients can be adjusted with the different solubility grades. This flexibility makes galenIQ™ a superior filler binder and facilitates its use for a wide range of pharmaceutical applications.
Based on its stable glycosidic bond, galenIQ™ demonstrates excellent stability. In addition, based on its chemical structure, it does not react with other components and is highly resistant to degradation by enzymes and acids. Unlike other carbohydrates, galenIQ™ does not contain reducing groups. Therefore it does not undergo reactions with other ingredients containing amino groups (“Maillard reaction”). No changes in the molecular structure occur even when the material is heated above the melting range or when aqueous solutions are heated above the boiling point, for example to create highboiled lozenges.
The direct-compressible types of galenIQ™ exhibit first rate tableting properties due to their excellent compactability and high dilution potential: at high concentrations of poorly compressible API in the formulation, the galenIQ™ enables the production of very hard tablets at extremely low compression forces.
galenIQ™ reduces the bitter taste of APIs, it masks the unpleasant taste (of e.g. plant extracts) and contributes to a pleasant, well-balanced taste profile and mouthfeel of the final product. Interestingly in comparison to Maltitol, Mannitol and Sucrose, the addition of Isomalt (galenIQ™ grade 721) produces a significantly higher bitterness reduction.
galenIQ™ has an intense but well-balanced sweet taste. It provides a good mouthfeel for chewable tablets, suckable tablets, stick packs and many more dosage forms. Isomalt does not have any significant off-taste and it is the only sugar alcohol that is derived from sucrose. It is mainly due to this reason that galenIQ™ has a sweetness and taste profile very close to sucrose.
galenIQ™ is suitable for pharmaceuticals, supplements and medical devices
galenIQ™ complies with the ISOMALT monograph of the current Pharmacopeias (Ph.Eur., BP, USP-NF, JPE) and also with the general standards food safety and quality, which makes it suitable for use in food and food supplements. Furthermore, galenIQ™ is listed under its generic name Isomalt in the FDA Inactive Ingredients Database.
Whether tablet or capsule, lozenge, chewing gum or syrup, galenIQ™ opens entirely new doors to the development of innovative pharmaceutical products.