DITROPAN To maintained for up to 24 hours, the

DITROPANXL®OxybutyninchlorideExtended-releaseTablets, USPIntroductionOxybutyninis used to treat symptoms of overactive bladder, such as frequent urination andinability to control urination. This is due to oxybutynin is an anticholinergicmedication can reduce muscle spasms of the bladder and urinary tract.Mechanismof action of oxybutynin, it inhibits the action of acetylcholineneurotransmitters on smooth muscle particularly the M1 and M2 receptors of thebladder, detrusor activity.Thedosage regimen of oxybutynin is one tablet (5mg) 2 – 3 times per day.

Theplasma half-life ranges from 2 – 3 hours. So the more effective medication forthe treatment and convenient have been developed to reduce the amount ofmedication and potential of side effect, including to improve thepharmacokinetics (constant concentration was maintained for up to 24 hours(once daily dosage regimen), minimizing the fluctuations between peak andtrough concentrations.  Ditropan XL® isan extended release tablets, based on the osmotic controlled-release oraldelivery system (OROS). To maintained for up to 24 hours, the current DitropanXL® extended-release tablets are available as 5(Paleyellow, round, tablet), 10(Pink, round, tablet) and 15 mg (Gray, round, tablet)tablets for oral use.      System Components and PerformanceDITROPAN XL® uses osmotic pressure to deliveroxybutynin chloride at a controlled rate over approximately 24 hours. Thesystem consists of an osmotically active bilayer core, which is surrounded bysemi-transparent membranes.

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Bilayer cores consist of layers of excipients and pushlayers. There are osmotically active components with precision laser drillholes.Pharmaceutical informationDrug SubstanceProper name                  : oxybutynin chlorideChemicalname     : benzeneacetic acid,?-cyclohexyl-?-hydroxy-, 4-(diethylamino)-2- butynyl ester hydrochloride, (±)-.

4-(Diethylamino)-2-butynyl (±)-?-phenylcyclohexaneglycolate hydrochloride.Molecular formula         : C22H31NO3 .HClMolecular mass    : 393.

9Structural formula         :   Solubility             : readily soluble in water andacids, but relatively insoluble inalkalis.Pharmacokinetic ProfileAlison M. Comerand Karen L. Goa Adis International Limited, Auckland, New Zealand,Extended-Release Oxybutynin show comparison of mean plasma concentrations ofR-oxybutynin following administration of extended-release oxybutynin 10mg oncedaily or immediate-release oxybutynin 5mg every 8 hours for 1 day in 23 healthyvolunteers. A graph shows thatthe dose of extended-release oxybutynin 10mg once daily is characterized by theincreased amount of drug in the blood stream.

There is a small fluctuation ofthe concentration than immediate-release oxybutynin 5 mg every 8 hours. Composition Drug layer Composition Function Oxybutynin HCL Active pharmaceutical ingredient Polyethylene oxide (MW. 200,000) Osmopolymer HPMC (MW. 9,200) Binder Sodium chloride Osmogen Magnesium stearate Lubricant  Push layer Composition Function Polyethylene oxide (MW. 7,500,000) Osmopolymer Sodium chloride Osmogen Ferric oxide Colorant HPMC (MW. 11,200) Binder Butylated hydroxytoluene Antioxidant/Lubricant Magnesium stearate Lubricant Polysorbate 80 absorption enhancer  Semipermeablemembrane Composition Function Cellulose acetate Semi-permeable membrane Polyethylene glycol Solvent 1.

      Manufacturingprocess The main processes can be dividedinto following flow chart.  Reference 1.Comer AM, Goa KL.

Extended-ReleaseOxybutynin. Drugs & Aging. 2000;16(2):149-55.2.Goldenberg MM.

An extended-release formulation of oxybutynin chloride for thetreatment of overactive urinary bladder. Clinical Therapeutics.21(4):634-42.

3.Gleason DM, Susset J, White C, Munoz DR, Sand PK. Evaluation of a newonce-daily formulation of oxybutynin for the treatment of urinary urgeincontinence11This study was funded by the Alza Corporation on behalf ofCrescendo Pharmaceuticals Corporation, Palo Alto, California.

Urology.1999;54(3):420-3.4. https://www.webmd.com/drugs/2/drug-16864/ditropan-xl-oral/details5.US005674895A 6.US005912268A7.US 20050287185A1