IP Library Patent Application 11052570
Patent Application
App. No. 11/052,570

Rapidly dissolving metoclopramide solid oral dosage and method thereof

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Patent No.
US None
App. No.
11/052,570
Abstract

A solid metoclopramide oral dosage formulation, such as a lyophilized oral dosage, dissolves within the mouth within about 60 seconds or less. This formulation is used for abating manifestations of gastroparesis in a patient, and may be taken with or without water.

Claims (24)

1 . A metoclopramide oral dosage formulation comprising a solid oral dosage containing metoclopramide, or a pharmaceutically acceptable salt thereof, wherein the solid oral dosage dissolves within the mouth within a time period of from about 60 seconds or less.

2 . The metoclopramide oral dosage formulation of claim 1 , wherein the time period is from about 30 seconds or less.

3 . The metoclopramide oral dosage formulation of claim 2 , wherein the time period is from about 1 second to about 15 seconds.

4 . The metoclopramide oral dosage formulation of claim 3 , wherein the time period is from about 3 seconds to 15 seconds.

5 . The metoclopramide oral dosage formulation of claim 4 , wherein the time period is from about 3 seconds to 10 seconds.

6 . The metoclopramide oral dosage formulation of claim 5 , wherein the time period is from about 3 seconds to about 5 seconds.

7 . The metoclopramide oral dosage formulation of claim 1 , wherein the metoclopramide oral dosage comprises from about 40 mg of metoclopramide or less.

8 . The metoclopramide oral dosage formulation of claim 7 , wherein the metoclopramide oral dosage comprises about 20 mg of metoclopramide.

9 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a lyophilized dosage form.

10 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a dosage form selected from the group consisting of tablet, pill, capsule and melt.

11 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a dosage form selected from the group consisting of a tablet.

12 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a dosage form selected from the group consisting of a pill.

13 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a dosage form selected from the group consisting of a capsule.

14 . The metoclopramide oral dosage formulation of claim 1 , wherein the solid oral dosage formulation comprises a dosage form selected from the group consisting of a melt.

15 . A process for formulating a lyophilized metoclopramide tablet, comprising the steps of:

forming a solution of metoclopramide; and,

drying by freezing in a high vacuum to form a lyophilized metoclopramide formulation.

16 . A metoclopramide lyophilized tablet product produced by the process of claim 15 .

17 . The metoclopramide lyophilized tablet product of claim 16 , where the metoclopramide comprises a dosage of 10 mg.

18 . A method for abating manifestations of gastroparesis in a patient comprising the steps of:

providing a metoclopramide oral dosage formulation of claim 1; and,

administering the oral dosage formulation effective to dissolve within the mouth within a time period of from about 60 seconds or less.

19 . The method of claim 18 , wherein the step of administering metoclopramide occurs without administration fluids.

20 . The method of claim 19 , wherein the step of administering metoclopramide occurs without administration of water.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
SECURITY AGREEMENT Recorded Apr 2, 2015
From: GLYCYX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 035364/0396 →
RELEASE OF SECURITY INTEREST Recorded Apr 1, 2015
From: JEFFERIES FINANCE LLC
To: SALIX PHARMACEUTICALS, LTD.
Reel/Frame 035353/0661 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2014
From: HALEY, EUGENE T.
To: WILMINGTON PHARMACEUTICALS, LLC
Reel/Frame 032155/0822 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2014
From: WILMINGTON PHARMACEUTICALS, LLC
To: SALIX PHARMACEUTICALS, INC.
Reel/Frame 032155/0880 →
SECURITY AGREEMENT Recorded Jan 2, 2014
From: SALIX PHARMACEUTICALS, LTD.
To: JEFFERIES FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 031896/0752 →