When it comes to producing medicated hard-boiled lozenges, then galenIQ™ 900, the pharmaceutical excipient grade of BENEO’s isomalt, is the number one choice.
BENEO’S new galenIQ™ 900 provides a broad range of benefits, such as low hygroscopicity, which promotes long shelf-life stability; as well as prolonged oral dissolution due to its sustained solubility. Furthermore, the sweet-tasting excipient remains inert in the presence of other components such as active pharmaceutical ingredients (APIs) and flavorings.
Providing only half the calories compared to sucrose, galenIQ™ 900 is also consumer-friendly by being kind to teeth and having almost no effect on blood sugar or insulin levels, due to its low glycaemic index.
High-boiled lozenges, as oral solid dosage forms have the distinct advantage in that the APIs are released continuously as the lozenge dissolves in the mouth. Therefore, they are ideal for APIs such as antitussives, decongestants, antihistamines and expectorants that have a targeted sustained delivery in the oral cavity. galenIQ™ 900 has a lower solubility than sucrose, and therefore lozenges dissolve more slowly in the mouth, as compared to sucrose/corn starch equivalents and provide a more sustained release of the API to the consumer.
Thanks also to their smooth surface and the ability to incorporate a wide range of flavors, hard-boiled lozenges with galenIQ™ 900 are popular with consumers.
BENEO’s galenIQ™ 900 is suitable for making deposited, stamped as well as filled lozenges. Each production process is similar to that of hard-boiled lozenges based on sucrose/corn syrup, with only minor changes in processing parameters being required. The finished lozenge is resistant against acidic or enzymatic hydrolysis, humidity and temperature, and has a long shelf-life.
“Isomalt is known to form an amorphous glass that is extremely stable against degradation by heat, humidity or acids,” says Dr Maj-Britt Cepok, BENEO Head of Business Development Pharma. “Worldwide, it’s the most frequently used sugar replacer in hard candies — and galenIQ™ offers the same benefits in pharmaceutical quality. Compared with sugars and other polyalcohols, it ensures that the lozenge does not become sticky or difficult to handle, even under high temperature and humidity storage conditions. With galenIQ™ 900, we are able to offer the perfect excipient for high-boiled medicated lozenges.”
BENEO is part of the Südzucker Group and a member of the International Pharmaceutical Excipients Council (IPEC). The company produces galenIQ™ (Isomalt Ph. Eur., BP, USP-NF, JP), a multifunctional range of water-soluble filler-binders according to cGMP conditions for pharmaceutical excipients. galenIQ™ is available in a wide variety of median particle sizes, morphologies and solubilities and therefore is readily used in solid and liquid dosage forms such as tablets, sachets, effervescents, lozenges and syrups. It is physically and chemically stable, non-hygroscopic and enhances the palatability of the final form.