The US Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's Lamictal Orally Disintegrating Tablets (ODT).
Co-developed by Eurand NV and GSK, Lamictal (lamotrigine) ODT uses Eurand's AdvaTab orally disintegrating tablet and Microcaps taste-masking technologies to provide Lamictal in a pleasant-tasting tablet that disintegrates on the tongue and that may be taken with or without liquid.
Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older, that have been treated for mood episodes with other medicine.
Lamictal ODT uses a combination of two of Eurand's novel drug delivery technologies.
AdvaTab orally disintegrating tablet technology uses Eurand's proprietary granulation and tabletting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid.
Key features of AdvaTab include: excellent mouth-feel; tablets that can be packaged in bottles or blisters; rapid disintegration in the oral cavity; ability to incorporate microencapsulated drug particles; and the capacity to incorporate larger drug doses than conventional ODT technologies.
AdvaTab is distinct from conventional ODT technologies because it can be combined with Microcaps taste-masking technology. Microcaps taste-masking technology provides a coating that encapsulates drug particles, forming a barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.
Eurand's microencapsulation technology, known as Microcaps, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste and odour masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps is incorporated in more than 12 marketed products.