Pellicious – Self-coating of lipid pellets by an extrusion/spheronisation process

The taste of a pharmaceutical product is a very important aspect in drug development as it possesses a major influence on the patient compliance, especially in the paediatric population. The present invention relates to a newly discovered method for preparing lipid pellets by solvent-free extrusion/spheronisation whereas the lipid coating on the entire pellet surface is formed during the spheronisation process. Said lipid coating is almost free of active ingredients and is responsible for a desirable delayed drug release depending on temperature. The

benefits of this new principle are taste-masking, stabilisation of active ingredients for a prolonged storage time and protection of the mucous membrane in the oral cavity against irritation. Commercial opportunities Different applications for this new method are possible. First of all, any pharmaceutical formulation with a pleasing taste would definitely be preferred over a competitor`s product and would translate into better compliance and therapeutic value for the patient. Second, stabilisation of active ingredients sensitive to moisture, oxygen or light is in the focus of drug development. Therefore, an ongoing need for coating of pellets exists. The aim of the present invention is to provide an economical process allowing the production of coated formulations while reducing costs and time of preparing the same. The invention comprises a simple process for generating solid pellets with an in-situ lipid coating, providing taste-masking or stabilising pharmaceutical formulations. With this self-coating procedure, a separate coating step of particulate formulations is thus no longer necessary.

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Dipl.-Ing. Alfred Schillert