Antianginal film and method of treating ischemic heart disease

Claim 1

In the method of treating ischemic heart disease in patients subject to anginal pectoris by placing anti-anginal coronary vasodilating nitrates buccally for rapid arresting of anginal pectoris attacks, the improvement whereby said buccally placed coronary vasodilating nitrates are highly adhered and remain fixed and glued to a chosen site of the mouth mucosa to insure uniform delivery of said anti-anginal nitrate directly into the blood circulation system through the mouth mucosa, with the great advantage that it is possible to control and easily discontinue the nitrate uptake by removing the unresolved film in cases where it becomes necessary or, on the contrary, to renew the therapy, which comprises placing at a selected site of the mouth mucosa of said patient, an anti-anginal effective amount of said anti-angle nitrate admixed and dissolved in film form with a selected mouth mucosa-soluble, swellable and resolvable polymeric film-forming carrier, in which solutions of the biologically resolvable soluble polymer carrier and the active substance were mixed, and a film cast and dried until the residual amount of the solvent does not exceed about 10 percent by weight; said resolvable, polymeric film forming carrier having been evaluated to determine its ability to provide immediate, uniform and substained release of a safe but adequate dose of said anti-anginal nitrate, for a particular patient, by: (i) first applying a film of said soluble and resolvable carrier polymer containing no active anti-anginal ingredient, to a chosen site of the mouth mucosa of the patient in the region of the upper gum above the canine or premolars. (ii) determining the time of full resolution of the film, and (iii) preparing a film containing that dose of the active principle which should be given to the patient during the time required for full resolution of the film, thereby insuring continuous and optimal therapeutic effect during the entire period of dissolution of the film once the film containing the required amount of the anti-anginal preparation is applied to the chosen site of the mouth mucosa of the patient; said film-forming carrier having the ability to: (a) form labile complex bonds with said anti-anginal coronary vasodilating nitrate; (b) remain highly adhered to the mouth mucosa, but can be removed to interrupt or discontinue treatment; and (c) release the active principle of said coronary vasodilator nitrate immediately, and thereafter at such a sustained rate and for a period of time that the pharmacodynamic effects as expressed by the mean data of the repeated individual selected standard physical loads with treadmill in combination with ECG-monitoring (i) are detectable practically instantaneously after affixing to the mouth mucosa, (ii) confirm tha presence of a continous therapeutic concentration of said active principle in the patient's blood during resolution of said carrier, and (iii) confirm a bioavailability of said active principle in an amount substantially greater than that obtained with a sublingual nitroglycerin tablet as the standard.