When it comes to producing medicated hard-boiled lozenges, then galenIQ 900, the pharmaceutical excipient grade of Beneo’s isomalt, is, according to the company a preferred choice. galenIQ 900 claims to offer 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. Therefore lozenges dissolve more slowly in the mouth than sucrose or corn starch equivalents and provide a more sustained release of the API to the consumer.
According to the press release, Beneo’s galenIQ 900 is suitable for making deposited, stamped, and filled lozenges. Each production process is similar to that of hard-boiled lozenges based on sucrose or 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.
Maj-Britt Cepok, head of Business Development Pharma, Beneo, explains, “Isomalt is known to form an amorphous glass extremely stable against degradation by heat, humidity or acids. 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 can offer the perfect excipient for high-boiled medicated lozenges.”