PILLS WITH CONTROLED RELEASE OF DICLOFENAC NATRIUM

Invention herewith described protects a new pharmaceutical form, coated and double coated gastroresistent pills, with diclofenac natrium as an active substance. The peculiarity of formulation is in the film coating from which the initial dosage of active principle is released, while the core is a matrix system on the basis of cellulose derivates of different viscosity which, together with other auxiliary substances, provides for controlled release of diclofenac natrium within 12 to 24 hours, and therewith controls the level of active substance in plasma state. In the case of coated pills during the first hour the quantity of 25 mg is released, i.e. 50 mg of active substance, and the remaining 50 mg are released gradually during 12 to 24 hours. This type of release profile is achieved by application of the procedure of coating the pills with suspension that contains active principle, and carefully chosen high viscosity cellulose derivatives already existing in the core, and provide for lasting release. Peculiarity of gastroresistent pill formulations with controlled release is in the presence of additional coating, which contains co-polymers of metacryle acid which provide specific release of diclofenac natrium in certain part of gastroresistent trackt (proximal part of intestine). Its possible irritating effect to the mucous membrane of the stomach is prevented. Within 3 hours from taking the pill, 25 mg are released, i.e. 50 mg of active substance, and the remaining 50 mg is released gradully within the following 12 to 24 hours. Ovim pronalaskom se štiti novi farmaceutski oblik, obložene i dvostruko obložene gastrorezistentne tablete, sa diklofenak natrijumom kao aktivnom supstancom. Specifičnost formulacije je u film oblozi iz koje se oslobađa inicijalna doza aktivnog principa, dok jezgro čini matriks sistem na bazi derivata celuloze različitog viskoziteta koji, zajedno sa ostalim pomoćnim supstancama, obezbeđuje kontrolisano oslobađanje diklofenak natrijuma u toku 12 do 24 sata, uz održavanje određenog nivoa aktivne supstance u plazmi. U slučaju obloženih tableta u toku prvog sata oslobodi se 25 mg, odnosno 50 mg aktivne supstance, a ostatak, 50 mg, se oslobađa postepeno u toku 12 do 24 sata. Ovakav profil oslobađanja postignut je primenom postupka oblaganja tableta suspenzijom koja sadrži aktivni (- princip, a pažljivo odabrani derivati celuloze visokog viskoziteta, prisutni u jezgru, obezbeđuju produženo oslobađanje. Specifičnost gastrorezistentne tab