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WHOCI: Oxybutynin Extended-Release Provides Steady Delivery In Varying pH Levels PARIS, FRANCE -- July 3, 2001 -- Study results evaluating the effect of pH on Ditropan XL® (oxybutynin) and Detrol LA (tolterodine), two leading medications for the treatment of overactive bladder, were presented at the World Health Organization (WHO) Second International Consultation on Incontinence in Paris, France by Roger R. Dmochowski, M.D., Medical Director of the North Texas Center for Urinary Control. Study findings demonstrated that drug delivery for extended-release (ER) oxybutynin was constant in all pH solutions while the drug delivery rate of extended-release tolterodine was less than expected when exposed to varying pH levels. Under certain conditions, 70 percent of ER tolterodine was released within the first four hours after ingestion, rather than slowly over a 24-hour period. "This study is important to all overactive bladder sufferers who also rely on other prescription or over-the-counter medications for treatment of stomach acidity conditions. Something as common as Maalox or Mylanta may interfere with some overactive bladder medications in terms of releasing the medicine over an extended period of time," said Dr. Dmochowski. "Drug delivery with Ditropan XL remained steady in different pH solutions which allows patients to experience the benefit of an extended release treatment over a full 24-hour period for their overactive bladder symptoms, regardless of their use of medications which may change the pH of their gastrointestinal tract." Potential hydrogen (pH) is a method of measuring degrees of acidity or alkalinity on a measurable scale. The scale runs from zero, which is very strongly acid, to 14, which is very strongly alkaline. This study monitored each medication in different pH environments that mimicked stomach pH, pH-1.2, intestinal pH, pH-7.5, and water, pH-6.1. Over a 24-hour period, the percentage of drug release was measured through samples taken every two hours. It was found that the delivery of drug for extended-release oxybutynin was consistent regardless of pH levels. However, ER tolterodine, while steady in pH-1.2, released drug at a much faster rate in higher pH media, with 70 percent of the drug being released within four hours. "These results support the fact that the delivery technology in Ditropan XL is effective and constant in varying pH levels," said Dr. Dmochowski. "We hope this information will help physicians make more informed decisions about the best medication to prescribe when treating patients who rely on other medications that can cause variations in stomach pH." Overactive bladder, affecting approximately 17 million Americans, is more widespread than many commonly discussed conditions, such as diabetes (seven million) and Alzheimer's disease (four million). Overactive bladder is one of the most under-diagnosed and under-treated conditions in the United States, and includes symptoms of urinary urge incontinence, involuntary loss of bladder control; urinary urgency; and urinary frequency, urinating more than eight times a day. Ditropan XL (extended-release oxybutynin) was developed utilizing Oros® technology, a unique oral drug delivery technology developed by Alza Technologies. The Oros technology improves oral drug dosing by providing rate-controlled delivery of drug and reducing the number of times per day the medication is taken. A Ditropan XL Oros tablet works by allowing water to enter the tablet and suspend the drug in the tablet's core. The drug is then pushed through a laser-drilled hole at a steady, controlled rate. SOURCE: ALZA Pharmaceuticals Related Link: ALZA Pharmaceuticals. E-mail this page to a friend or colleague! To print, use this version