Buccal drug dosage form
First Claim
1. An injection molded, cast, or otherwise solidified buccal or transmucosal oral mucosa adherent dosage form having dimensions which fit into the buccal cavity or under the tongue of a user thereof comprising a pharmaceutical ingredient selected from a pharmaceutical compound, a pharmaceutically acceptable salt, and derivatives thereof adapted to be dispensed typically over a period of 10-30 minutes through transmucosal absorption directly into the bloodstream, said pharmaceutical ingredient being dispersed in a non-crystalline, solidified polymeric matrix which adheres to oral mucosa after being activated by water or saliva comprising,from about 20 to about 75 percent by weight of a polyethylene glycol component having a low molecular weight of from about 100-4000,from about 2 to about 54 percent by weight of a polyethylene glycol component having a medium to high molecular weight of from about 6000-20,000, andfrom about 1 to about 40 percent by weight of polyethylene oxide having a high molecular weight of from about 100,000 to 5,000,000.
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Accused Products
Abstract
Buccal dosage forms for transmucosal administration of drugs comprise a pharmaceutical compound dispersed in an erodible matrix comprising
from about 20 to about 75 percent by weight of a low molecular weight polyethylene glycol component,
from about 2 to about 65 percent by weight of a medium or high molecular weight polyethylene glycol component,
from about 1% to about 40% percent by weight of an auxiliary high molecular weight polymer.
Preferred auxiliary high molecular weight polymers are polyethylene oxide and polyvinylpyrrolidone which improve the molding properties of the matrix and provide water-activated adhesive properties to the compositions to provide a buccal dosage form.
459 Citations
45 Claims
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1. An injection molded, cast, or otherwise solidified buccal or transmucosal oral mucosa adherent dosage form having dimensions which fit into the buccal cavity or under the tongue of a user thereof comprising a pharmaceutical ingredient selected from a pharmaceutical compound, a pharmaceutically acceptable salt, and derivatives thereof adapted to be dispensed typically over a period of 10-30 minutes through transmucosal absorption directly into the bloodstream, said pharmaceutical ingredient being dispersed in a non-crystalline, solidified polymeric matrix which adheres to oral mucosa after being activated by water or saliva comprising,
from about 20 to about 75 percent by weight of a polyethylene glycol component having a low molecular weight of from about 100-4000, from about 2 to about 54 percent by weight of a polyethylene glycol component having a medium to high molecular weight of from about 6000-20,000, and from about 1 to about 40 percent by weight of polyethylene oxide having a high molecular weight of from about 100,000 to 5,000,000. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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39. The dosage form of claim 1 wherein said dosage form is a buccal dosage form.
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40. The dosage form of claim 1 wherein said dosage form is an oral dosage form.
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41. The dosage form of claim 1 wherein said dosage form is selected from the group consisting of a lozenge, a lamella, a disk, and a wafer.
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42. The dosage form of claim 1 wherein said dosage form is a buccal dosage form having a length of from about 5 mm to about 10 mm, a width of from about 2 mm to about 10 mm and a thickness of from about 0.2 mm to 3 mm.
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43. The dosage form of claim 42 wherein said thickness is from about 0.5 mm to about 1.5 mm.
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44. The dosage form of claim 1 wherein the total weight of said dosage is from about 10 mg to about 150 mg.
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45. The dosage form of claim 1 wherein the total weight of said dosage form is from about 50 mg to about 100 mg.
Specification
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- Resources
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Current AssigneeWatson Laboratories, Inc. (Connecticut) (Abbvie Incorporated)
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Original AssigneeZetachron Incorporated
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InventorsKeith, Alec D., Snipes, Wallace C.
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Primary Examiner(s)Rose, Shep K.
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Application NumberUS06/827,615Time in Patent Office918 DaysField of Search424/78, 424/80, 424/81, 424/435, 424/464, 424/486, 424/487US Class Current424/435CPC Class CodesA61K 9/006 Oral mucosa, e.g. mucoadhes...A61K 9/2013 Organic compounds, e.g. pho...A61K 9/2027 obtained by reactions only ...A61K 9/2031 obtained otherwise than by ...
