CA2386339A1 - Dip coating compositions containing cellulose ethers - Google Patents

Dip coating compositions containing cellulose ethers

Info

Publication number
CA2386339A1
CA2386339A1 CA002386339A CA2386339A CA2386339A1 CA 2386339 A1 CA2386339 A1 CA 2386339A1 CA 002386339 A CA002386339 A CA 002386339A CA 2386339 A CA2386339 A CA 2386339A CA 2386339 A1 CA2386339 A1 CA 2386339A1
Authority
CA
Canada
Prior art keywords
percent
composition
coating
core
dosage form
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
CA002386339A
Other languages
French (fr)
Other versions
CA2386339C (en
Inventor
Cynthia Gulian
Walter G. Gowan, Jr.
Kishor B. Parekh
Joseph M. Morris
Thomas J. Markley
Dennis C. Wieand
Gerard P. Mcnally
Christopher Szymczak
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.
Cynthia Gulian
Walter G. Gowan, Jr.
Kishor B. Parekh
Joseph M. Morris
Thomas J. Markley
Dennis C. Wieand
Gerard P. Mcnally
Christopher Szymczak
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., Cynthia Gulian, Walter G. Gowan, Jr., Kishor B. Parekh, Joseph M. Morris, Thomas J. Markley, Dennis C. Wieand, Gerard P. Mcnally, Christopher Szymczak filed Critical Mcneil-Ppc, Inc.
Publication of CA2386339A1 publication Critical patent/CA2386339A1/en
Application granted granted Critical
Publication of CA2386339C publication Critical patent/CA2386339C/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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Abstract

ABSTRACT OF THE INVENTION

Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

Claims (40)

1. A water soluble composition for dip-coating a substrate comprised of:

a) hydroxypropylmethyl cellulose; and b) a thickener selected from the group consisting of xanthan gum, carrageenan, and mixtures thereof, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
2. The composition of claim 1, wherein the composition is comprised of, based upon the total dry weight of the composition, a) from about 95 percent to less than about 100 percent of hydroxypropylmethyl cellulose; and b) from about 0.5 percent to about 5 percent of a thickener selected from the group consisting of xanthan gum, carrageenan, and mixtures thereof,.
3. The composition of claim 1, wherein the composition is comprised of, based upon the total dry weight of the composition, a) from about 95 percent to about 99.5 percent of hydroxypropylmethyl cellulose; and b) from about 0.5 percent to about 5 percent of xanthan gum.
4. The composition of claim 2 further comprising, based upon the total dry weight of the composition, up to about 40% plasticizers,
5. The composition of claim 4 wherein the plasticizers are selected from the group consisting of polyethylene glycol, glycerin, sorbitol, methyl citrate, tribuyl citrate, dibutyl sebecate, vegetable oils, surfactants, propylene glycol, mono acetate of glycerol, diacetate of glycerol, triacetate of glycerol, natural gums, and mixtures thereof.
6. The composition of claim 4, wherein the plasticizers are selected from the group consisting of glycerin, polyethylene glycol, propylene glycol, castor oil, and mixtures thereof.
7. The composition of claim 2 further comprising, based upon the total dry weight of the composition, up to about 14% of a coloring agent.
8. The composition of claim 7 wherein the coloring agent is selected from the group consisting of azo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, natural dyes, and mixtures thereof.
9. A dosage form for delivering an active agent, the form comprising an outer coating, said outer coating comprising the composition of claim 2.
10. A pharmaceutical dosage form comprising an outer coating of the composition of claim 2.
11. A pharmaceutical dosage form comprising a core, a subcoating substantially covering said core, and an outer coating substantially covering said subcoating, wherein the outer coating is comprised of the composition of claim 2.
12. The coated dosage form of claim 11 wherein the subcoating comprises materials selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.
13. The coated dosage form of claim 11 wherein the subcoating comprises materials selected from the group consisting of hydroxypropylmethylcellulose, castor oil, polyethylene glycol, polysorbate 80, maltodextrin, and mixtures thereof.
14. The dosage form of claim 11 wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, a) from about 2 percent to about 8 percent of a water-soluble cellulose ether selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropytcellulose, hydroxyethylcellulose, and mixtures thereof.

b) from about 0.1 percent to about 1 percent castor oil.
15. The dosage form of claim 11 wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, a) from about 4 percent to about 6 percent hydroxypropylmethylcellulose; and b) from about 0.1 percent to about 1 percent castor oil.
16. The dosage form of claim 15 wherein the hydroxypropylmethylcellulose has a viscosity of about 5000 cps in an aqueous solution containing 2 weight percent hydroxypropylmethylcellulose.
17. The dosage form of claim 11 wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, a) from about 20 percent to about 50 percent hydroxypropylmethylcellulose;

b) from about 45 percent to about 75 percent maltodextrin;

c) from about 1 percent to about 10 percent PEG 400.
18. The coated dosage form of claim 11, wherein the coating is comprised of, based upon the total dry weight of the subcoating, a) from about 25 percent to about 40 percent hydroxyethylcellulose;

b) from about 50 percent to about 70 percent maltodextrin;

c) from about 5 percent to about 10 percent PEG 400.
19. A tablet coated with the film forming composition according to claim 2.
20. The coated dosage forth of claim 11, further comprising an effective amount of a pharmaceutical active ingredient, wherein said dosage form meets USP
dissolution requirements for immediate release forms of said pharmaceutical active ingredient.
21. An aqueous dispersion of the composition of claim 2 for the manufacture of dip-coated tablets.
22. The aqueous dispersion of claim 21 comprised of, based upon the total weight of the aqueous dispersion, a) from about 10 percent to about 14 percent of hydroxypropylmethylcellulose;
and b) from about 0.1 percent to about 0.14 percent of xanthan gum.
23. The composition of claim 1 which is substantially free of gelatin.
24. Use of the aqueous dispersion of claim 21 for the manufacture of dip coated tablets.
25. A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core and having a surface gloss of at least 150; wherein said coating comprises the composition of claim 1.
26. The composition of claim 2 further comprising a weight enhancer selected from the group consisting of simethicone, polysorbate 80, and mixtures thereof.
27. A simulated capsule-like medicament comprising:

a. a core having a first end and a second end, b. a first coating layer having a first color provided on said first end of said core;

c. a second coating layer having a second color on said second end of said core, said first color is different from said second color;

wherein at least one of said first coating layer and second coating layer comprises the composition of claim 1.
28. The medicament of claim 27 wherein at least one of said first coating layer and said second coating layer is comprised of a coating composition, said coating composition comprised of, based upon the total dry weight of the coating composition, a) from about 95 percent to less than about 100 percent of hydroxypropylmethyl cellulose; and b) from about 0.5 percent to about 5 percent of xanthan gum.
29. The medicament of claim 28 further comprising a subcoating layer substantially covering said core, said subcoating layer provided between said core and said first coating layer and said second coating layer.
30. The medicament of claim 29 wherein the subcoating comprises materials selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.
31. A water soluble composition for dip-coating a substrate comprised of:

a) hydroxypropylmethyl cellulose; and b) castor oil, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
32. A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core; wherein said coating comprises the composition of claim 31.
33. Use of the composition of claim 31 for the manufacture of dip coated tablets.
34. A water soluble composition for dip-coating a substrate comprised of:

a) hydroxypropylmethyl cellulose; and b) maltodextrin, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
35. The composition of claim 34 further comprising polyethylene glycol.
36. A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core; wherein said coating comprises the composition of claim 34.
37. Use of the composition of claim 34 for the manufacture of dip coated tablets.
38. The water soluble composition of claim 1, wherein the composition is comprised of, based upon the total dry weight of the composition:

a) greater than about 95 percent and less than about 99.5 percent of hydroxypropylmethyl cellulose; and b) greater than about 0.5 percent and less than about 5 percent of carrageenan, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
39. A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core; wherein said coating comprises the composition of claim 38.
40. Use of the composition of claim 38 for the manufacture of dip coated tablets.
CA2386339A 2001-05-15 2002-05-14 Dip coating compositions containing cellulose ethers Expired - Fee Related CA2386339C (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US29112701P 2001-05-15 2001-05-15
US60/291,127 2001-05-15
US32572601P 2001-09-28 2001-09-28
US60/325,726 2001-09-28
US10/122,999 US20030070584A1 (en) 2001-05-15 2002-04-12 Dip coating compositions containing cellulose ethers
US10/122,999 2002-04-12

Publications (2)

Publication Number Publication Date
CA2386339A1 true CA2386339A1 (en) 2002-11-15
CA2386339C CA2386339C (en) 2010-12-07

Family

ID=27382893

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2386339A Expired - Fee Related CA2386339C (en) 2001-05-15 2002-05-14 Dip coating compositions containing cellulose ethers

Country Status (15)

Country Link
US (2) US20030070584A1 (en)
EP (1) EP1260219B1 (en)
JP (1) JP2003012561A (en)
KR (1) KR20020087370A (en)
CN (1) CN1388189A (en)
AR (1) AR034335A1 (en)
AT (1) ATE427741T1 (en)
AU (1) AU4061802A (en)
BR (1) BR0201904A (en)
CA (1) CA2386339C (en)
CO (1) CO5400143A1 (en)
DE (1) DE60231850D1 (en)
ES (1) ES2323526T3 (en)
MX (1) MXPA02004823A (en)
NZ (1) NZ518950A (en)

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US20070259098A1 (en) 2007-11-08
CA2386339C (en) 2010-12-07

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