KLEPTOSE® Linecaps maltodextrin allows the delivery of an efficient taste masking solution.

Situation

Patient wellbeing and quality of life greatly depend on medicine acceptance. Excipients may taste bitter or irritate mouth and throat. Inherited defensive reaction of the body is to reject unpalatable taste. For this reason, various strategies to enhance patient compliance taking such oral medication have been developed, for example coating/encapsulation, complexing with camouflaging agents, taste neutralizing by intricate drug modifications, and so on. Though, for children, elderly and even some adults, swallowing solids (tablets/capsules/powders) possess a challenge. Thus, these consumers often take medicine in a liquid or suspension form. Sugars and sugar-free sweeteners reduce bitterness but show to be ineffective for strongly bitter agents. Long chained compounds (polymers) could be used in this regard by “wrapping around” the drug, creating a barrier between bitter remedy and taste buds while keeping a drug in suspended state. On another hand, traditional solvent-based pharmaceutical production is complex and labor-consuming. Thus, a more robust, cost-effective, safe and easy to scale-up taste masking technology is in great need.

Challenges

#1: Taste masking of bitter/irritable drugs is a must for pediatric oral medications.
#2: Need for easy to scale-up, environment-friendly manufacturing process of oral suspensions aiming towards high pediatric populations.
#3: Need for excipients in pediatrics that are as safe as possible.

Solution

KLEPTOSE® Linecaps (KL) is a polymer (maltodextrin) obtained from pea starch and readily available in bulk. It has great potential for taste masking owing to origin, structure, and Hot Melt Extrusion (HME) processability. HME is a continuous solvent-free technique that originated from the plastic industry. A mixture of polymer matrix and other agents (such as, drugs) is melted, pushed, and blended together (extruded). The uniformed product can be milled/granulated/shaped in line with desired dosage form.

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