URINARY ALKALIZING MEDICINAL AND/OR PHARMACEUTICAL COMPOSITION FOR THE ORAL TREATMENT OF INTERSTITIAL CYSTITIS / BLADDER PAIN SYNDROME (IC/BPS) AND FORMULATION THEREOF

The present invention relates to novel medicinal and/or pharmaceutical urinary, extended-release alkalizing composition advantageously a tablet for the oral treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) and/or for general alkalization of the human body for long term where according to the subject matter of the invention the composition is potassium free, the composition has a sustained and/or controlled release dosage form and comprises following components advantageously with certain consistence: Citric acid, Sodium citrate, Magnesium citrate, and comprises following components advantageously with a certain consistence as excipients: Aerosil, Avicel DG, Benecel hypromellose microcrystalline cellulose (HPMC) as grade, advantageously Benecel K100M PH DC HPMC and Magnesium stearate. The subject matter of the present invention relates furthermore to novel medicinal and/or pharmaceutical urinary, extended-release alkalizing composition wherein a single administered dose of the composition achieves a therapeutic alkalizing concentration for providing a neutral pH value of the urine between values of 6.9 to 7.5 advantageously 7.38 in an individual for 12 hours. According to the release kinetics of the active ingredient of the composition the final conclusion is that the sustained and/or controlled release tablet according to the invention provides in vivo constant and continuous therapeutic concentration in case of 2×1 daily dosage. The subject matter of the present invention furthermore relates to the process for the formulation of the composition according to the invention because during the homogenization of the above described active ingredients a special formulation process is needed for avoiding liquefaction and the formation of eutectic.