BENEO-Palatinit GmbH is extending its galenIQ range of bulk excipients, tailor-made for oral solid dosage forms such as tablets, capsules, coatings, and high-boiled lozenges, with a new grade for granulation. galenIQ 801 is a high-solubility refined powder grade that extends the capability of the 800 Series to include formulation of tablets, sachets or dry powder syrups through granulation processes.
Easy to granulate, agglomerate or compact, it joins agglomerated grades galenIQ 720 and 721. These variants present excellent alternatives for direct compression, capsule filling or powder-mixture applications, whereas galenIQ 800 and 810 are special refined powder grades for wet granulation, compaction and other agglomeration processes.
The new galenIQ 801 can be processed in standard aqueous or ethanolic granulation processes with no difficulty. In wet granulation, it is granulated with approximately 5-15% of an aqueous solution containing povidone, hydrocolloids or other binders. When galenIQ 801 is used in fluidised-bed agglomeration processes, water is the only binder required.
Final granulates and agglomerates made with galenIQ 801 exhibit high mechanical stability and very good flow properties.
As part of the galenIQ range, the 801 is GMO-free and of non-animal origin - derived from sucrose in a two-stage production process - and combines the advantages of other well known bulk excipients. Besides being very low hygroscopic as well as highly resistant to degradation, such as by enzymes and acids, galenIQ 801, like all galenIQ variants, is extremely stable chemically and thus shows no reaction, such as to amino groups. It also provides excellent compressibility and good dissolution/disintegration profiles (solubility 42g/100g at 20°C), has high dilution potential, and adds good taste to formulations. In addition, all galenIQ variants are generally regarded as non-toxic, cariostatic, non-allergenic, and low-glycemic.
Based on their physicochemical, physiological and technological properties, galenIQ bulk pharmaceutical excipients fulfil all criteria for an ideal filler/binder in a wide range of oral solid dosage forms.
BENEO-Palatinit is a member of the International Pharmaceutical Excipients Council, and produces galenIQ under GMP conditions for pharmaceutical excipients. In addition, it is listed in the US Food and Drug Administration's inactive ingredient database under its generic name, Isomalt.
For more information and product samples please visit BENEO-Palatinit at CPhI, hall 5.1 stand 51C50 or email galeniq@beneo-palatinit.com.