Beneo offers sweet success to the pharmaceutical sector

Beneo describes how its galenIQ can deliver multiple benefits in medicines formulation

The taste of a medicine is an important compliance factor for certain patient groups, including children, the elderly, those with chronic conditions and even in the growing field of veterinary medicine. Choosing the right filler-binder can enhance overall palatability significantly. With galenIQ the German company Beneo says it offers an excipient that can achieve this in a range of applications. 

Sugar-like sweetness

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 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.

A recent comparative study[1] 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 to 6% w/w led to a significantly higher reduction in bitterness.

A range of grades

galenIQ is primarily considered to be a soluble filler-binder for tablets and powdered products. However, the past 10 years have proven it to be a truly multi-functional 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 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.

The sachet trend

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.

Technological benefits

With well-defined particle size distribution, galenIQ 720 and 721 are designed to provide outstanding flow and mixing properties. galenIQ is the perfect excipient for easy tableting because of its 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 special 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.

Regulatory approvals

Isomalt (galenIQ) is monographed in leading pharmacopoeias (USP-NF, Ph. Eur, BP) and is approved in both Japan (JPE) and China (with an Import Drug License).

[1] Source: Luhn, Habara, Cepok, Black and Bernard, PharmaChem, 9-10, 2014