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(12) PATENT APPLICATION PUBLICATION (21) Application No.6703/DELNP/2008 A<br />

(19) INDIA<br />

(22) Date <strong>of</strong> filing <strong>of</strong> Application :01/08/2008 (43) Publication Date : 24/10/2008<br />

(54) Title <strong>of</strong> the invention : "DRUG DELIVERY SYSTEMS COMPRISING WEAKLY BASIC SELECTIVE SEROTONIN 5-HT3<br />

BLOCKING AGENT AND ORGANIC ACIDS"<br />

(51) International classification :A61K 9/22 (71)Name <strong>of</strong> Applicant :<br />

(31) Priority Document No :60/762,750<br />

1)EURAND,INC.<br />

(32) Priority Date :27/01/2006<br />

Address <strong>of</strong> Applicant :845 CENTER DRIVE,VANDALIA,<br />

(33) Name <strong>of</strong> priority country :U.S.A.<br />

OH 45377 USA. U.S.A.<br />

(86) International Application No :PCT/US2007/061217 (72)Name <strong>of</strong> Inventor :<br />

Filing Date<br />

:29/01/2007<br />

1)VENKATESH GOPI M.<br />

(87) International Publication No :WO 2007/090082 A2 2)LAI JIN-WANG<br />

(61) Patent <strong>of</strong> Addition to Application<br />

Number<br />

Filing Date<br />

:NA<br />

:NA<br />

3)VYAS NEHAL H.<br />

(62) Divisional to Application Number :NA<br />

Filing Date<br />

:NA<br />

(57) Abstract :<br />

A pharmaceutical dosage form such as a capsule, a conventional or orally disintegrating tablet capable <strong>of</strong> delivering a weakly basic,<br />

nitrogen (N)-containing selective serotonin 5- HT3 blocking agent having a pKa in the range <strong>of</strong> <strong>from</strong> about 5 to 14 <strong>and</strong> a solubility <strong>of</strong><br />

not more than about 200 µg/mL at pH 6.8 into the body in a sustained-released fashion, suitable for a once-daily dosing regimen,<br />

comprises at least one organic acid, which solubilizes said weakly basic selective serotonin 5-HT3 blocking agent prior to releasing it<br />

into the hostile intestinal environment wherein the blocking agent is practically insoluble. The unit dosage form may be composed <strong>of</strong> a<br />

multitude <strong>of</strong> multicoated <strong>part</strong>iculates (i.e., immediate-release beads, sustained-release beads <strong>and</strong>/or one or more timed, pulsatile-<br />

.release bead populations) <strong>and</strong> is designed in such a way that the weakly basic blocking agent <strong>and</strong> the organic acid do not come into<br />

close contact during processing <strong>and</strong>/or storage thereby avoiding in-situ formation <strong>of</strong> acid addition compounds while ensuring that the<br />

acid is not depleted prior to completion <strong>of</strong> the drug release.<br />

No. <strong>of</strong> Pages : 55 No. <strong>of</strong> Claims : 37<br />

The Patent Office Journal 24/10/2008 26199

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