DITROPAN chloride Chemical name : benzeneacetic acid, ?-cyclohexyl-?-hydroxy-, 4-(diethylamino)-2-

DITROPANXL®OxybutyninchlorideExtended-releaseTablets, USP IntroductionOxybutyninis 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 2 – 4 times per day. The plasmahalf-life ranges from 2 – 3 hours. Therefore the more effective medication forthe treatment and convenient have been developed to reduce the frequency ofmedication and potential of side effect, including to improve thepharmacokinetics (constant concentration was maintained over 24 hours with oncedaily dosage regimen), minimizing the fluctuations between peak and troughconcentrations.  Ditropan XL® isan extended release tablets, based on the osmotic controlled-release oraldelivery system (OROS). To maintained over 24 hours of plasma concentration. Thecurrent Ditropan XL® extended-release tablets areavailable as 5(Pale yellow, round, tablet), 10(Pink, round, tablet) and 15 mg (Gray,round, tablet) tablets for oral use.      System Components and Performance DITROPAN XL® uses osmoticpressure to deliver oxybutynin chloride at a controlled rate over approximately24 hours.

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The system consists of an osmotically active bilayer core, which issurrounded by semi-transparent membranes. Bilayer cores consist of layers ofexcipients and push layers. There are osmotically active components withprecision laser drill holes.

 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 .HCl Molecularmass    : 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-ReleaseOxybutynin show comparison of mean plasma concentrations of R-oxybutyninfollowing administration of extended-release oxybutynin 10 mg once daily orimmediate-release oxybutynin 5mg every 8 hours for 1 day in 23 healthyvolunteers. A graph shows thatextended-release oxybutynin 10 mg once daily slowly release oxybutynin into thebloodstream and show target concentration over approximately 24hours. Concentration fluctuations in extended-release oxybutynin are smallerthan fluctuations in 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  Semipermeable membrane Composition Function Cellulose acetate Semi-permeable membrane Polyethylene glycol Plasticizer  Finish Coat Composition Function Titanium dioxide Opacifying agents Polyethylene glycol Plasticizer Ferric oxide Colorant  Printing ink Composition Function Iron oxide Colorant Polyethylene glycol Plasticizer  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 the treatment ofoveractive urinary bladder. Clinical Therapeutics.21(4):634-42.3.

Gleason DM,Susset J, White C, Munoz DR, Sand PK. Evaluation of a new once-dailyformulation of oxybutynin for the treatment of urinary urge incontinence11Thisstudy was funded by the Alza Corporation on behalf of Crescendo PharmaceuticalsCorporation, 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. US20050287185A1