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.
