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US5098715A Expired / Lapsed US ⏱️ 0.0 years remaining

Flavored film-coated tablet

Assignee: Boehringer Ingelheim Pharmaceuticals Inc
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Filing: 1990-12-20
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Granted: 1992-03-24
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Expires: 2010-12-20
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Abstract

Abstract The invention comprises a flavored thin film coating on solid oral dosage pharmaceutical tablets containing unpleasant tasting ingredients such as triprolidine hydrochloride and pseudoephedrine hydrochloride. The flavored coating of the invention is comprised of a film-forming substance such as a hydroxypropyl methylcellulose and a polyethylene glycol, a sweetening agent and a flavoring agent. The method of the invention comprises aqueous spray-coating of the flavored sweetened coating onto the pharmaceutical tablets.

Inventors

  • 👤 Terrance T. McCabe
  • 👤 Robert A. Stagner
  • 👤 Joel E. Sutton, Jr.

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 05:43
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/28; A61K9/2806

Claims Analysis

Total Claims: 26
Claim 1
Independent Claim 98 words
A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a water-soluble, film-forming polymer, a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
Claim 2
Dependent Claim 98 words
A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a water-soluble, film-forming polymer, a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
Claim 3
Dependent Claim 15 words
The pharmaceutical tablet of claim 1, wherein the core comprises triprolidine hydrochloride and pseudoephedrine hydrochloride.
Claim 4
Dependent Claim 32 words
The pharmaceutical tablet of claim 2, wherein the pharmaceutically acceptable, polymeric coating comprises hydroxypropyl methylcellulose and a plasticizing agent, the flavoring agent comprises peppermint flavoring and the sweetening agent comprises confectioners sugar.
Claim 5
Dependent Claim 16 words
The pharmaceutical tablet of claim 3, wherein the pharmaceutically acceptable, polymeric coating further contains titanium dioxide.
Claim 6
Dependent Claim 32 words
The pharmaceutical tablet of claim 2, wherein the pharmaceutically acceptable, polymeric coating comprises hydroxypropyl methylcellulose and a plasticizing agent, the flavoring agent comprises fruit flavoring and the sweetening agent comprises confectioners sugar.
Claim 7
Dependent Claim 16 words
The pharmaceutical tablet of claim 5, wherein the pharmaceutically acceptable, polymeric coating further contains titanium dioxide.
Claim 8
Dependent Claim 12 words
The pharmaceutical tablet of claim 1, wherein the core comprises triprolidine hydrochloride.
Claim 9
Dependent Claim 12 words
The pharmaceutical tablet of claim 1, wherein the core comprises pseudoephedrine hydrochloride.
Claim 10
Dependent Claim 14 words
A pharmaceutical tablet according to claim 1, wherein the film coating comprises hydroxypropyl methylcellulose.
Claim 11
Dependent Claim 13 words
A pharmaceutical tablet according to claim 9, wherein the sweetening agent comprises sucrose.
Claim 12
Dependent Claim 14 words
A pharmaceutical tablet according to claim 10, wherein the sweetening agent comprises confectioners sugar.
Claim 13
Dependent Claim 24 words
A pharmaceutical tablet according to claim 11, wherein the sweetening agent comprises about 2.5 per cent based on the weight of the film coating.
Claim 14
Dependent Claim 24 words
A pharmaceutical tablet according to claim 1, wherein the sweetening agent comprises about 2.5 per cent based on the weight of the film coating.
Claim 15
Independent Claim 160 words
A method for preparing flavor-coated pharmaceutical tablets, comprising the steps of: (a) preparing an aqueous dispersion comprising a pharmaceutically acceptable, film-forming substance, a volatile flavoring agent and sweetening agent, said film-forming substance comprising a water-soluble polymer; (b) placing unpleasant tasting uncoated core tablets in a coating pan; and (c) spray-coating the aqueous dispersion onto the exterior surface of the core tablets at a pan rotation speed and under air flow and temperature conditions sufficient to enable evaporation of water and even-coating of the core tablets, said conditions sufficient to provide a flavored coating that increases the weight of the tablet by an average of about 5%, said flavored coating being capable of masking the unpleasant taste of the core, and said flavored coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
Claim 16
Independent Claim 160 words
A method for preparing flavor-coated pharmaceutical tablets, comprising the steps of: (a) preparing an aqueous dispersion comprising a pharmaceutically acceptable, film-forming substance, a volatile flavoring agent and sweetening agent, said film-forming substance comprising a water-soluble polymer; (b) placing unpleasant tasting uncoated core tablets in a coating pan; and (c) spray-coating the aqueous dispersion onto the exterior surface of the core tablets at a pan rotation speed and under air flow and temperature conditions sufficient to enable evaporation of water and even-coating of the core tablets, said conditions sufficient to provide a flavored coating that increases the weight of the tablet by an average of about 5%, said flavored coating being capable of masking the unpleasant taste of the core, and said flavored coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
Claim 17
Dependent Claim 45 words
The method of claim 14, wherein the pan is perorated and is rotated at about 8 rpm, the inlet airflow rate is about 1300 cubic feet per minute, the air temperature is about 90 degrees C., and the bed temperature is about 45 degrees C.
Claim 18
Dependent Claim 45 words
The method of claim 14, wherein: (a) the pharmaceutically acceptable, polymeric, film-forming substance comprises hydroxypropyl methylcellulose, titanium dioxide and polyethylene glycol; and (b) the aqueous dispersion is comprised of about 7.5% pharmaceutically acceptable, polymeric, film-forming substance, about 0.5% flavoring agent, and about 2.5% sweetening agent.
Claim 19
Dependent Claim 12 words
The method of claim 16, wherein the flavoring agent is peppermint flavoring.
Claim 20
Dependent Claim 12 words
The method of claim 16, wherein the flavoring agent is fruit flavoring.
Claim 21
Dependent Claim 15 words
The method of claim 14, wherein said core tablets comprise triprolidine hydrochloride and pseudoephedrine hydrochloride.
Claim 22
Dependent Claim 11 words
A method of claim 14, wherein the sweetening agent comprises sucrose.
Claim 23
Dependent Claim 13 words
A method according to claim 20, wherein the sweetening agent comprises confectioners sugar.
Claim 24
Dependent Claim 13 words
A method according to claim 14, wherein the film-forming substance comprises hydroxypropyl methylcellulose.
Claim 25
Dependent Claim 112 words
A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, wherein said coating has been formed by application of an aqueous dispersion of a water-soluble, polymeric film-forming substance, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
Claim 26
Dependent Claim 112 words
A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, wherein said coating has been formed by application of an aqueous dispersion of a water-soluble, polymeric film-forming substance, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-03-24 1995-09-23 1996-03-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-03-24 1999-09-23 2000-03-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-03-24 2003-09-23 2004-03-24 $7700.00 Window Closed / Lapsed

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