CA2436386A1 - Polyacrylic film forming compositions - Google Patents
Polyacrylic film forming compositions Download PDFInfo
- Publication number
- CA2436386A1 CA2436386A1 CA002436386A CA2436386A CA2436386A1 CA 2436386 A1 CA2436386 A1 CA 2436386A1 CA 002436386 A CA002436386 A CA 002436386A CA 2436386 A CA2436386 A CA 2436386A CA 2436386 A1 CA2436386 A1 CA 2436386A1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering 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
- A61K9/2072—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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- A61K9/4816—Wall or shell material
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Paints Or Removers (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Cosmetics (AREA)
Abstract
Water soluble, gelatin-free dip coatings for substrates comprising an acrylic film former; a paraben plasticizer; and a secondary plasticizer such as polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400 or mixtures thereof.
Claims (34)
1. A film forming composition comprised of, based upon the total dry solids weight of the composition:
a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of acrylic acid or a derivative thereof;
b) from about 2 percent to about 20 percent of a primary plasticizer comprised of a paraben; and c) from about 1 percent to about 50 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof;
wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of acrylic acid or a derivative thereof;
b) from about 2 percent to about 20 percent of a primary plasticizer comprised of a paraben; and c) from about 1 percent to about 50 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof;
wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
2. The film forming composition of claim 1, wherein the film former is selected from the group consisting of a) a polymer or copolymer of methacrylic acid or derivative thereof; and b) mixtures of the polymer or copolymer of methacrylic acid or derivative thereof.
3. The film forming composition of claim 1, wherein the film former is ammoniomethacrylate copolymer.
4. The film forming composition of claim 1, wherein the film former is selected from the group consisting of:
a) poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) in a 1:2:0.1 weight ratio;
b) poly(methacrylic acid, methyl methacrylate) in a 1:2 weight ratio;
c) poly(methacrylic acid, methyl methacrylate) in a 1:1 weight ratio;
d) copolymers thereof; and e) mixtures thereof.
a) poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) in a 1:2:0.1 weight ratio;
b) poly(methacrylic acid, methyl methacrylate) in a 1:2 weight ratio;
c) poly(methacrylic acid, methyl methacrylate) in a 1:1 weight ratio;
d) copolymers thereof; and e) mixtures thereof.
5. The film forming composition of claim 1, wherein the film former is selected from the group consisting of:
a) poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride);
b) poly(methacrylic acid, ethyl acrylate);
c) poly(ethyl acrylate, methyl methacrylate);
d) poly(ethyl acrylate, methyl methacrylate)trimethylammonioethyl methacrylate chloride), e) copolymers thereof; and f) mixtures thereof.
a) poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride);
b) poly(methacrylic acid, ethyl acrylate);
c) poly(ethyl acrylate, methyl methacrylate);
d) poly(ethyl acrylate, methyl methacrylate)trimethylammonioethyl methacrylate chloride), e) copolymers thereof; and f) mixtures thereof.
6. The film forming composition of any one of claims 1 to 5 wherein the paraben is selected from the group consisting of methyl paraben, ethyl paraben, propyl paraben, butyl paraben, pharmaceutically available salts thereof, and mixtures thereof.
7. The film forming composition of any one of claims 1 to 6 wherein the secondary plasticizer is polyvinylpyrrolidone.
8. The film forming composition of any one of claims 1 to 7 wherein the composition is substantially free of gelatin.
9. The composition of any one of claims 1 to 8 further comprising, based upon the total dry weight of the composition, from about 0 percent to about 14 percent of a coloring agent.
10. The composition of claim 9 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.
11. A product comprising an exterior coating, said exterior coating comprising the composition of any one of claims 1 to 10.
12. A pharmaceutical dosage form comprising an exterior coating, said exterior coating comprising the composition of any one of claims 1 to 10.
13. The pharmaceutical dosage form of claim 12 further comprising a plurality of exterior coatings, wherein at least a first portion of the dosage form is comprised of a first exterior coating and at least a second portion of the dosage form is comprised of a second exterior coating.
14. The pharmaceutical dosage form of claim 13 wherein the second exterior coating is visually distinct from the first exterior coating.
15. A pharmaceutical dosage form comprising a core, a subcoating substantially covering said core, and an exterior coating substantially covering said subcoating, wherein the exterior coating is comprised of the composition of any one of claims 1 to 10.
16. The coated dosage form of claim 15 wherein the subcoating is selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.
17. A tablet dip coated with the film forming composition according to any one of claims 1 to 10.
18. The pharmaceutical dosage form of claim 12 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.
dissolution requirements for immediate release forms of said pharmaceutical active ingredient.
19. A dispersion comprised of the composition of any one of claims 1 to 10 and a solvent.
20. The dispersion of claim 19 comprised of, based upon the total weight of the dispersion, a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or derivatives thereof, or mixtures of a polymer or copolymer of acrylic acid or derivatives thereof;
b) from about 1 percent to about 40 percent of a primary plasticizer comprised of a paraben; and c) from about 5 percent to about 20 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof; and d) from about 5 percent to about 30 percent of water, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
b) from about 1 percent to about 40 percent of a primary plasticizer comprised of a paraben; and c) from about 5 percent to about 20 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof; and d) from about 5 percent to about 30 percent of water, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
21. A method of making coated tablets comprising dip coating tablets with the aqueous dispersion of claim 19 or 20 under conditions sufficient.
22. A pharmaceutical dosage form comprising a core and a coating, said coating covering at least a portion of said core and having a surface gloss of at least 150 gloss units, wherein the coating comprises a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of acrylic acid or a derivative thereof;
b) from about 2 percent to about 20 percent of a primary plasticizer comprised of a paraben; and c) from about 1 percent to about 50 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof.
b) from about 2 percent to about 20 percent of a primary plasticizer comprised of a paraben; and c) from about 1 percent to about 50 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof.
23. 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 visual distinction provided on said first end of said tablet core; and c.) a second coating layer having a second visual distinction on said second end of said tablet core;
wherein at least one of said first coating layer and second coating layer is comprised of the composition of any one of claims 1 to 10.
a.) a core having a first end and a second end, b.) a first coating layer having a first visual distinction provided on said first end of said tablet core; and c.) a second coating layer having a second visual distinction on said second end of said tablet core;
wherein at least one of said first coating layer and second coating layer is comprised of the composition of any one of claims 1 to 10.
24. The medicament of claim 23 wherein the second visual distinction is visually different from said first visual distinction.
25. The medicament of claim 24 wherein the first visual distinction is a first color, and the second visual distinction is a second color.
26. The medicament of claim 23 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.
27. The medicament of claim 26 wherein the subcoating is selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.
28. The film forming composition of any one of claims 1 to 10 further comprising, based upon the total weight of the composition, from about 0.01 percent to about 0.25 percent of a weight gain enhancer.
29. The film forming composition of claim 28 wherein the weight gain enhancer is simethicone, polysorbate 80, or mixtures thereof.
30. A method for increasing the weight gain of a dried coating layer on a dip molded substrate comprised of adding an effective amount of weight gain enhancer selected from simethicone, polysorbate 80 and mixtures thereof to the coating wherein the coating is comprised of the composition of any one of claims 1 to 10 and 28.
31. A method for improving the color uniformity of a dried coating composition layer on a dip molded substrate comprised of:
adding an effective amount of simethicone, polysorbate 80, or a mixture thereof to an aqueous dispersion of the coating composition, wherein the coating composition is comprised of the composition of any one of claims 1 to 10 and 28.
adding an effective amount of simethicone, polysorbate 80, or a mixture thereof to an aqueous dispersion of the coating composition, wherein the coating composition is comprised of the composition of any one of claims 1 to 10 and 28.
32. The composition of claim 1 wherein the film former is a mixture comprising a polymer or copolymer of acrylic acid or derivative thereof.
33. The composition of claim 1 wherein the film former is a copolymer comprising a polymer or copolymer of acrylic acid or derivative thereof.
34. A film forming composition comprised of, based upon the total dry solids weight of the composition:
a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of acrylic acid or a derivative thereof; and b) from about 3 percent to about 70 percent of a plasticizer selected from the group consisting of triacetin, acetylated monoglyceride, rape oil, olive oil, sesame oil, acetyltributyl citrate, glycerin sorbitol, diethyloxalate, diethylmalate, diethyl fumarate, dibutyl succinate, diethylmalonate, dioctylphthalate, dibutylsuccinate, triethylcitrate, tributylcitrate, glyceroltributyrate, propylene glycol, polyethylene glycols, hydrogenated castor oil, fatty acids, substituted triglycerides and glycerides, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, and pharmaceutically acceptable salts thereof and mixtures thereof, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of acrylic acid or a derivative thereof; and b) from about 3 percent to about 70 percent of a plasticizer selected from the group consisting of triacetin, acetylated monoglyceride, rape oil, olive oil, sesame oil, acetyltributyl citrate, glycerin sorbitol, diethyloxalate, diethylmalate, diethyl fumarate, dibutyl succinate, diethylmalonate, dioctylphthalate, dibutylsuccinate, triethylcitrate, tributylcitrate, glyceroltributyrate, propylene glycol, polyethylene glycols, hydrogenated castor oil, fatty acids, substituted triglycerides and glycerides, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, and pharmaceutically acceptable salts thereof and mixtures thereof, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/211,139 | 2002-08-02 | ||
| US10/211,139 US7429619B2 (en) | 2002-08-02 | 2002-08-02 | Polyacrylic film forming compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2436386A1 true CA2436386A1 (en) | 2004-02-02 |
| CA2436386C CA2436386C (en) | 2011-09-20 |
Family
ID=31187512
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2436386A Expired - Fee Related CA2436386C (en) | 2002-08-02 | 2003-08-01 | Polyacrylic film forming compositions |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US7429619B2 (en) |
| EP (1) | EP1421932B1 (en) |
| JP (1) | JP2004131474A (en) |
| KR (1) | KR20040012596A (en) |
| CN (1) | CN1480496A (en) |
| AR (1) | AR040761A1 (en) |
| AT (1) | ATE481966T1 (en) |
| AU (1) | AU2003231606A1 (en) |
| BR (1) | BR0302541A (en) |
| CA (1) | CA2436386C (en) |
| CO (1) | CO5390064A1 (en) |
| DE (1) | DE60334274D1 (en) |
| MX (1) | MXPA03006929A (en) |
| NZ (1) | NZ527342A (en) |
| ZA (1) | ZA200305942B (en) |
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-
2002
- 2002-08-02 US US10/211,139 patent/US7429619B2/en not_active Expired - Fee Related
-
2003
- 2003-07-31 AT AT03254789T patent/ATE481966T1/en not_active IP Right Cessation
- 2003-07-31 EP EP03254789A patent/EP1421932B1/en not_active Expired - Lifetime
- 2003-07-31 ZA ZA2003/05942A patent/ZA200305942B/en unknown
- 2003-07-31 DE DE60334274T patent/DE60334274D1/en not_active Expired - Lifetime
- 2003-08-01 AR AR20030102772A patent/AR040761A1/en not_active Application Discontinuation
- 2003-08-01 CO CO03065794A patent/CO5390064A1/en not_active Application Discontinuation
- 2003-08-01 CA CA2436386A patent/CA2436386C/en not_active Expired - Fee Related
- 2003-08-01 KR KR1020030053411A patent/KR20040012596A/en not_active Application Discontinuation
- 2003-08-01 NZ NZ527342A patent/NZ527342A/en unknown
- 2003-08-01 MX MXPA03006929A patent/MXPA03006929A/en unknown
- 2003-08-01 AU AU2003231606A patent/AU2003231606A1/en not_active Abandoned
- 2003-08-01 JP JP2003285182A patent/JP2004131474A/en active Pending
- 2003-08-04 CN CNA031530060A patent/CN1480496A/en active Pending
- 2003-08-04 BR BR0302541-1A patent/BR0302541A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| NZ527342A (en) | 2005-07-29 |
| CO5390064A1 (en) | 2004-04-30 |
| AU2003231606A1 (en) | 2004-02-19 |
| AR040761A1 (en) | 2005-04-20 |
| CN1480496A (en) | 2004-03-10 |
| ZA200305942B (en) | 2005-06-29 |
| BR0302541A (en) | 2004-08-24 |
| KR20040012596A (en) | 2004-02-11 |
| EP1421932A1 (en) | 2004-05-26 |
| MXPA03006929A (en) | 2004-10-14 |
| JP2004131474A (en) | 2004-04-30 |
| ATE481966T1 (en) | 2010-10-15 |
| CA2436386C (en) | 2011-09-20 |
| US20040022755A1 (en) | 2004-02-05 |
| DE60334274D1 (en) | 2010-11-04 |
| US7429619B2 (en) | 2008-09-30 |
| EP1421932B1 (en) | 2010-09-22 |
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| EEER | Examination request | ||
| MKLA | Lapsed |
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