New pharmaceutical compositions for oral use containing diclofenac together with alkali metal carbonates and bicarbonates and particular flavouring substances.

Standardization of the gastric pH conditions at the best level for the absorption of the active ingredient

We have developed and patented the first pharmaceutical technology for bio-regulated immediate release formulations for oral use based on Diclofenac. This technology offer a wide spectrum of possible applications: a) the use of different Diclofenac salts considering the kind of product b) the customer wish to develop; c) the variety of feasible pharmaceutical forms; d) the variety of dosage in the pharmaceutical forms according to the strategic positioning the customer intends to claim. All the pharmaceutical forms developed according our technology, show the following therapeutic advantages, when compared to the existing formulations: a) very quick onset of action b) Cmax comparable or higher than the reference drug; c) Tmax considerably faster than the reference drug; d) AUC comparable to the reference drug e) regularity of absorption; Due to the presence of an excipient, which is the first to react in the site of absorption as a buffering of the pH increasing the same to the optimum level in which Diclofenac is absorbed, we obtained regular and standard absorption levels, strongly reducing the great variability of the existing formulations on the market. f) entirely palatable formulations free from any unpleasant aftertaste. Whatever will be the specific positioning in the market, our formulations may easily gather the following marketing claims: a) a higher analgesic activity than the traditional forms; b) a better gastric tolerability; the previous buffering activity of the pH and the fast absorption, greatly reduce the gastric acidity and on consequence the gastric side effects. c) smaller size, dosage being equal, than the traditional forms (tablets only); d) flexibility of dosage (drops only); e) easy to transfer Know-How; provided that it is a very simple manufacturing process using worldwide accepted ingredients and process, it is extremely simple to transfer the manufacturing know-how. f) cost competitive manufacturing process The pharmaceutical forms claimed by our patent are the following: - tablets - bilayer tablets (fast and slow release) - granular powder for drinkable solution (first granular form of Diclofenac for drinkable solution worldwide) - drops (first fast-acting, palatable oral drops at 5% available on the market) - gum tablets - mouthwash - tooth-paste

The patent has been granted in the following countries: Europe, South Africa, New Zealand, Australia and Poland. The Patent is still pending in the following countries: Argentina, Canada, Switzerland, Taiwan, USA.

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