CA2461893A1 - Immediate release tablet comprising a powered wax - Google Patents

Immediate release tablet comprising a powered wax Download PDF

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Publication number
CA2461893A1
CA2461893A1 CA002461893A CA2461893A CA2461893A1 CA 2461893 A1 CA2461893 A1 CA 2461893A1 CA 002461893 A CA002461893 A CA 002461893A CA 2461893 A CA2461893 A CA 2461893A CA 2461893 A1 CA2461893 A1 CA 2461893A1
Authority
CA
Canada
Prior art keywords
tablet
active ingredient
wax
group
immediate release
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002461893A
Other languages
French (fr)
Other versions
CA2461893C (en
Inventor
Joseph Luber
Frank J. Bunick
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson Consumer Inc
Original Assignee
Mcneil-Ppc, Inc.
Joseph Luber
Frank J. Bunick
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mcneil-Ppc, Inc., Joseph Luber, Frank J. Bunick filed Critical Mcneil-Ppc, Inc.
Publication of CA2461893A1 publication Critical patent/CA2461893A1/en
Application granted granted Critical
Publication of CA2461893C publication Critical patent/CA2461893C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats

Abstract

An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90 ~C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.

Claims (20)

1. An immediate release tablet comprising at least 60 weight % of an active ingredient and a powdered wax having an melting point greater than about 90° C, said tablet meeting the USP dissolution specifications for immediate release tablets containing said active ingredient.
2. The tablet of claim 1, wherein the active ingredient is selected from the group consisting of acetaminophen, ibuprofen, calcium carbonate, magnesium hydroxide, magnesium carbonate, magnesium oxide, aluminum hydroxide, mixtures thereof, and pharmaceutically acceptable salts thereof.
3. The tablet of claim 1, wherein the wax is selected from the group consisting of linear hydrocarbons, microcrystalline wax, and mixtures thereof.
4. The tablet of claim 1 prepared by direct compression.
5. The tablet of claim 1 which is substantially free of water-soluble, non-saccharide polymeric binders.
6. The tablet of claim 1, which is substantially free of hydrated polymers.
7. The tablet of claim 1 further comprising at least one outer coating.
8. The tablet of claim 7, wherein the outer coating comprises a material selected from the group consisting of gelatin, isomalt, monosaccharides, disaccharides, polysaccharides such as starch, cellulose derivatives, shellacs, polyhedric alcohols such as xylitol, mannitol, sorbitol, maltitol, erythritol, and polyalkylene glycols.
9. The tablet of claim 1 comprising up to about 20 weight percent wax.
10. The tablet of claim 1 further comprising an excipient selected from the group consisting of disintegrants, flow aids, and optionally lubricants.
11. The tablet of claim 1 further comprising an insert disposed within tablet.
12. The tablet of claim 11, wherein the insert comprises additional active ingredient.
13. The tablet of claim 12, wherein the additional active ingredient has a different release profile from the active ingredient in the tablet.
14. The tablet of claim 12, wherein the amount of additional active ingredient is from about 0.1 to about 30 mg.
15. The tablet of claim 12, wherein the additional active ingredient is selected from the group consisting of loratadine, fexofenadine, cetirizine, chlorpheniramine, brompheniramine, diphenhydramine, pseudoephedrine, cyproheptadine, montelukast, loperamide, famotidine, dexamethasone, hydrocortisone, cyclobenzaprine, alendronate, hydrochlorthiazide, rofecoxib, indomethacin, ketoprofen, meloxicam, piroxicam, lovastatin, atorvastatin, pravastatin, simvastatin, finasteride, and pharmaceutically acceptable salts, esters, and mixtures thereof.
16. The tablet of claim 1, wherein the particle size of the wax is in the range of about 5 to about 100 microns.
17. An immediate release tablet comprising at least 60 weight percent of an active ingredient and a powdered wax selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof; wherein said tablet is prepared by direct compression.
18. An immediate release tablet comprising at least 60 weight percent of an active ingredient and a powdered wax selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof; wherein said tablet is substantially free of water-soluble, non-saccharide polymeric binders.
19. An immediate release tablet comprising at least 60 weight percent of an active ingredient and a powdered wax selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof; wherein said tablet is substantially free of hydrated polymers.
20. The tablet of claim 17, wherein said active ingredient is in its native crystalline form.
CA2461893A 2001-09-28 2002-09-26 Immediate release tablet comprising a powered wax Expired - Fee Related CA2461893C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/966,493 US7323192B2 (en) 2001-09-28 2001-09-28 Immediate release tablet
US09/966,493 2001-09-28
PCT/US2002/030613 WO2003028703A2 (en) 2001-09-28 2002-09-26 Immediate release tablet

Publications (2)

Publication Number Publication Date
CA2461893A1 true CA2461893A1 (en) 2003-04-10
CA2461893C CA2461893C (en) 2010-07-06

Family

ID=25511492

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2461893A Expired - Fee Related CA2461893C (en) 2001-09-28 2002-09-26 Immediate release tablet comprising a powered wax

Country Status (6)

Country Link
US (2) US7323192B2 (en)
EP (1) EP1429809A2 (en)
AU (1) AU2002327068A1 (en)
CA (1) CA2461893C (en)
MX (1) MXPA04002890A (en)
WO (1) WO2003028703A2 (en)

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DE19963569B4 (en) 1999-12-29 2006-11-16 Reckitt Benckiser N.V. Composition for use in a dishwasher
US20020028240A1 (en) 2000-04-17 2002-03-07 Toyohiro Sawada Timed-release compression-coated solid composition for oral administration
US7323192B2 (en) * 2001-09-28 2008-01-29 Mcneil-Ppc, Inc. Immediate release tablet
CN1688291A (en) * 2002-02-01 2005-10-26 辉瑞产品公司 Immediate release dosage forms containing solid drug dispersions

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WO2003028703A3 (en) 2003-07-10
MXPA04002890A (en) 2005-06-20
US20030068373A1 (en) 2003-04-10
CA2461893C (en) 2010-07-06
WO2003028703A2 (en) 2003-04-10
US7323192B2 (en) 2008-01-29
AU2002327068A1 (en) 2003-04-14
US20080095845A1 (en) 2008-04-24
EP1429809A2 (en) 2004-06-23

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