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Pharmaceutical Manufacturing and Packing Sourcer

Innovation in Excipients

Bodo Fritzsching, Maj-Britt Babbel and Oliver Luhn from Palatinit GmbH discuss new directcompressible filler/binders for oral solid-dosage forms, which offer innovative qualities

Newly developed pharmaceutical excipients of isomalt, a polyol that has been widely used for more than 20 years as a bulk sweetener in sugar-free confectionery and nutraceutical products have been launched the brand name GalenIQ. Based on its physical, chemical and physiological properties, the new range of pharmaceutical excipients, brings together the advantages of well-known bulk excipients, facilitating drug development and formulation whilst meeting the high standards required by the pharmaceutical industry. Moreover, with physical and chemical modifications, the new isomalt excipients are tailor-made for pharmaceutical applications in the field of solid-dosage forms for oral delivery (1). The following article discusses the most important properties of isomalt excipients, and the tabletting characteristics of direct-compressible (DC) grades.

MANUFACTURE – NON-ANIMAL ORIGIN

The qualities of isomalt excipients are derived from sucrose in a two-stage production process (2). First, sucrose is converted in an enzymatic transglucosidation to the disaccharide 6-O-α-Dglucopyranosyl fructose (isomaltulose) – a significantly more stable reducing compound. Secondly, the hydrogenation of isomaltulose leads to the stereoisomer disaccharide alcohol 1- O-α-D-glucopyranosyl-D-mannitol dihydrate (1,1-GPM dihydrate) and 6-O-α-D-glucopyranosyl-D-sorbitol (1,6-GPS) in an approximate equimolecular mixture (see Figure 1).

Through an additional process, the ratio between the two molecular components can be varied. As a result, specific qualities are obtained – enriched in 6-O-α-D-glucopyranosyl- D-sorbitol (1,6-GPS), providing higher solubility (3). Depending on the composition, the qualities of the excipient contain approximately three to five per cent crystal water, which is strongly bound to the GPM crystal. In its final state, it is a white, odourless, water soluble, crystalline substance that complies with the isomalt monographs of the current Ph Eur, BP and USP29-NF24.

Through particle engineering, a wide product range can be developed that includes specific solid-dosage forms like tablets, pellets, capsules, granules, sugar-free coatings (3) and highboiled lozenges (7,8). Grades for applications such as wetgranulation, agglomeration (9), powder mixtures or melt extrusion processes, complete the range (10). As direct compression is the most frequently administered application form, two special grades have been developed to support formulators in the design of all kinds of tablets.

GENERAL PROPERTIES


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Bodo Fritzsching graduated as a Nutrition and Equipment Technology Engineer from the University of Applied Sciences, Trier, in 1992. He subsequently joined Palatinit GmbH, a subsidiary of Suedzucker AG Mannheim/Ochsenfurt, Germany, as a representative of the Technical Services Department to advise the food and pharmaceutical industry of the properties and applications of isomalt – a sucrose derived polyol. Between 1992 and 1995 he was in charge of technical application services within Europe. He has also been responsible for the technical application services of NAFTA/North America, supporting Palatinit of America, Inc as Area Manager Technical Services. Bodo then became Area Manager Sales and Technical Services, developing the company’s business in the Middle East and Africa. Since 2005, Bodo has lead the Pharma Sales Unit of Palatinit GmbH as Sales Manager Pharma.

Maj-Britt Babbel graduated as a Food Chemist from the Technical University of Berlin in 2001. For her PhD thesis she joined the analytical department of the Central Department of Research, Development and Services of the Suedzucker AG in Offstein, Germany. In 2005, she moved to the Technical Services team of Palatinit GmbH, and was in charge of technical application services concerning food and confectionery for customers in Latin American and European countries. At present, Maj-Britt is working as Sales and Technical Services Manager in the Pharma Unit of Palatinit GmbH, focusing on Central Europe.

Oliver Luhn graduated as a Process Engineer from the University of Applied Sciences, Mannheim, in 1995. After working with BASF AG as part of his course, he held positions as Technical Manager Pharma, Head of Research and Development Pharma at Meggle GmbH and Project Manager, Innovations, at Reckitt Benckiser. In 2003 he joined the Technical Services Department of Palatinit GmbH as Technical Manager Pharma, and was transferred to the Central Department of Research, Development and Service at Suedzucker AG in 2005. Working in the department of product development, he heads the group of pharmaceutical technology and currently focuses on the research and development of pharmaceutical excipients.

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Bodo Fritzsching
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Maj-Britt Babbel
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Oliver Luhn
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