The excipient, introduced at this year’s CPhI in Madrid, is a pharma grade of sugar-alcohol isomalt specifically designed for the coating of solid dosage forms for both traditional small molecule active pharmaceutical ingredients (API) and biologics.
It is intended to replace coating agents like sucrose, which, while effective, have some production drawbacks according to company head of pharma technical services Bodo Fritzsching.
Fritzsching told in-PharmaTechnologist that: “Classical sugar coating takes a long time and is an art, which is why the drug industry began seeking alternatives.”
He explained Beneo-Palatinit, part of Europe’s largest sugar maker Sudzucker, developed galenIQ 981 in response to drug industry requests for an excipient that was easy to process.
“In the early 1990s the pharmaceutical industry became aware of isomalt, which had been primarily used in sugar-free confectionary and registered pharmaceutical cough drops.”
He added that, having been attracted by isomalt’s chemical stability, low hygroscopicity and ease of handling, drugmakers asked the firm to develop a similar product that can be used in other dosage forms, such as tablets and sachets.
GalenIQ’s qualities are derived from sucrose in a two-stage conversion protocol. First, sucrose is converted to the stable disaccharide 6-0-D-glucopyranosyl fructose, orisomaltulose, in an enzymatic process called transglucosidation.
In the second step, isomaltulose is hydrogenated to produce the stereoisomer disaccharide alcohol 1-0-D glucopyranosyl-D-mannitol dihydrate and 6-0D-glucopyranosyl-D-sorbitol in an approximate equimolecular mixture.
This mixture, and hence galenIQ’s specific properties can be varied through a number of crystallization processes, which enables the production of a number of excipient grades.
Fritzsching added that galenIQ 981, like all the excipients in Beneo-Palatinit’s range, is listed in the US Food and Drug Administration’s (FDA) inactive ingredient database.
The galenIQ technology also complies with isomalt monographs issued by the Ph Eur, BP and USP-NF.