Formulation and examination of a new urine alkalizing tablet for the symptomatic treatment of bladder pain syndrome

Abstract

The bladder pain syndrome is a condition with frequent urinary complaints and significant bladder pain. The problem is caused by the loss of the barrier function of the GAG-layer against the irritant substance in the urine, resulting a chronic inflammation of non-bacterial origin.Our aim was to create a potassium-free, prolonged-release tablet that provides a pH of about 7 by alkalizing the urine, reducing pain and provides proper patient adherence.Powder blends were formulated, their powder flow was tested and tablets were prepared by direct compression of the powder mixtures with the best flow properties. Dissolution characteristics of the hydrophilic matrix tablets were evaluated, appropriate candidate was selected for a clinical study involving 20 adult patients, previously diagnosed with bladder pain syndrome.Summarizing the results, an effective alkalizing tablet, causing fewer side effects has been developed for interstitial cystitis/bladder pain syndrome patients. We can conclude that our objectives have been achieved, because the prolonged-release and potassium-free tablet, effectively increases urinary pH, does not irritate the wall of the stomach, and the bladder, which is especially sensitive to potassium.