Multilayered controlled release oral solid pharmaceutical composition in tablet form suitable for oral administration comprising at least two layers containing active material in association with excipients and additives.

First impulse = disintegrants. Extended release = polymeric materials. Modular system.

This patented technology is based on multilayered controlled release solid pharmaceutical composition in tablet form suitable for oral administration and comprising at least two layers containing active materials in association with excipients and additives. Modifying the quantity of the active materials, excipients and additives in each layer, but mainly studying properly the manufacturing process and the way of working and mixing such active materials and excipients, we may easily modulate and modify the pharmacokinetic profile of each delivered drug. Manufacturing costs are always comparable to normal tablets except for not important differences due to the double compression on each tablet and preparation of two different granulates for the same product. Up to the present and on all the products we tested we never faced industrial reproducibility or stability problems; industrial scale up has been always performed without any problems.

Phase II

Italy: Issued - No. 01264696 of 04.10.96 Europe: Pending - No. PCT/EP94/1050 of 02.04.94 USA: Issued - No. 5,681,583 of 28.10.97 Canada: Pending - No. 2,144,167 of 19.01.95 Korea: Pending - No. 700926 of 09.03.95 Israel: Pending - No. 109512 of 02.05.94 India: Issued - No. 177580 of 08.07.94

Licensing agreement on the already developed products in the still available countries and/or contract development agreements on other products using our technology