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US4929446A Expired / Lapsed US ⏱️ 0.0 years remaining

Unit dosage form

Assignee: Wyeth Holdings LLC
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Filing: 1988-04-19
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Granted: 1990-05-29
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Expires: 2008-04-19
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Abstract

Abstract The present invention discloses edible unit dosage form for delivering a medicament comprising a relatively hard, unitary outer shell composed essentially of sugar which emcompasses a liquid or semi-solid center core containing the medicament dose accurate to within about ±5% of the prescribed dosage, and a method for production of said unit dosage form.

Inventors

  • 👤 Raymond A. Bartolucci

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 15:14
CPC Classifications
A; A61; A61J; A61J3/00; A61J3/07; A61K; A61K9/00; A61K9/0012; A61K9/0053; A61K9/0056; A61K9/20; A61K9/2072; A61K9/2086; A61K9/209; A61K9/28; A61K9/2806; A61K9/282; A61K9/2826

Claims Analysis

Total Claims: 22
Claim 1
Independent Claim 87 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar which crystallizes slowly from the melt, said sugar consisting of sucrose, glucose or a mixture thereof; and (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about ±5% by weight of the prescribed dosage.
Claim 2
Dependent Claim 87 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar which crystallizes slowly from the melt, said sugar consisting of sucrose, glucose or a mixture thereof; and (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about ±5% by weight of the prescribed dosage.
Claim 3
Dependent Claim 89 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzooane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar which crystallizes slowly from the melt, said sugar consisting of sucrose, glucose, or a mixture thereof; and a flavoring; and (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about + 5% of the prescribed dosage.
Claim 4
Dependent Claim 89 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzooane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar which crystallizes slowly from the melt, said sugar consisting of sucrose, glucose, or a mixture thereof; and a flavoring; and (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about + 5% of the prescribed dosage.
Claim 5
Dependent Claim 85 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar consisting of sucrose, glucose or a mixture thereof, a flavoring, and a therapeutic amount of a medicament (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about ±5% of the prescribed dosage.
Claim 6
Dependent Claim 85 words
An edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing comprising: (a) an outer relatively hard, unitary shell consisting essentially of a sugar consisting of sucrose, glucose or a mixture thereof, a flavoring, and a therapeutic amount of a medicament (b) a liquid or semi-solid center core contained within said shell comprising an accurate dose of a medicament, said dose being within about ±5% of the prescribed dosage.
Claim 7
Dependent Claim 22 words
An edible unit dosage form as in claim 1 wherein the liquid or semi-solid center core (b) further comprises a sugar syrup.
Claim 8
Dependent Claim 20 words
An edible unit dosage form as in claim 1 wherein the medicament liquid or semi-solid center (b) is water soluble.
Claim 9
Dependent Claim 49 words
An edible unit dosage form as in claim 3 comprising a cough or cold medicament within the hard outer shell (a) of the dosage form consists of sucrose, glucose, benzocaine, methanol-euclyptus and cherry flavoring; and the liquid or semi-solid center (b) comprises the medicament dextromethorphan and a sugar syrup.
Claim 10
Dependent Claim 99 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing said process comprising: (i) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof, simultaneously around a liquid or semi-solid center core composition comprising an acurate dose of a medicament, said dose being within about ±5% by weight of the prescribed dosage; and (ii) cooling to solidify and harden said shell composition.
Claim 11
Dependent Claim 99 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing said process comprising: (i) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof, simultaneously around a liquid or semi-solid center core composition comprising an acurate dose of a medicament, said dose being within about ±5% by weight of the prescribed dosage; and (ii) cooling to solidify and harden said shell composition.
Claim 12
Dependent Claim 36 words
The process for preparing the unit dosage form of claim 7 wherein the moisture content of the liquid or semi-solid center is less than or equal to the moisture content of the outer molten shell composition.
Claim 13
Dependent Claim 36 words
The process for preparing the unit dosage form of claim 8 wherein the moisture content of the liquid or semi-solid center core composition is less than 5% and is preferably equal to or less than 3%.
Claim 14
Dependent Claim 103 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing, said process comprising: (a) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof and a flavoring, simultaneously around a liquid or semi-solid center core composition comprising an accurate dose of a medicament, said dose being within about + 5% by weight of the prescribed dosage; and (iii) cooling to solidify and harden said shell composition.
Claim 15
Dependent Claim 103 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing, said process comprising: (a) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof and a flavoring, simultaneously around a liquid or semi-solid center core composition comprising an accurate dose of a medicament, said dose being within about + 5% by weight of the prescribed dosage; and (iii) cooling to solidify and harden said shell composition.
Claim 16
Dependent Claim 108 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing, said process comprising: (a) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof a flavoring and a therapeutic amount of medicament, simultaneously around a liquid or semi-solid center core composition comprising an accurate dose of a medicament, said dose being within about + 5% by weight of the prescribed dosage; and (iii) cooling to solidify and harden said shell composition.
Claim 17
Dependent Claim 108 words
A process for preparing an edible unit dosage form for delivering a medicament selected from the group consisting of menthol, eucalyptus, benzocane, dextramethorphan or a mixture of any of the foregoing, said process comprising: (a) forming a molten shell composition, consisting essentially of a sugar which crystallizes slowly from the melt said sugar consisting of sucrose, glucose or a mixture thereof a flavoring and a therapeutic amount of medicament, simultaneously around a liquid or semi-solid center core composition comprising an accurate dose of a medicament, said dose being within about + 5% by weight of the prescribed dosage; and (iii) cooling to solidify and harden said shell composition.
Claim 18
Dependent Claim 28 words
The process for preparing the unit dosage form of claim 11 wherein said medicament is selected from menthol, eucalyptus, benzocaine or a mixture of any of the foregoing.
Claim 19
Dependent Claim 19 words
The process for preparing the unit dosage form of claim 7 wherein the molten shell composition is water soluble.
Claim 20
Dependent Claim 24 words
The process for preparing the unit dosage form of claim 7 wherein the liquid or semi-solid center core com-position further comprises a sugar syrup.
Claim 21
Dependent Claim 22 words
The process for preparing the unit dosage form of claim 7 wherein the liquid or semi-solid center core com-position is water soluble.
Claim 22
Dependent Claim 46 words
The process for preparing the unit dosage of claim 8 wherein the moisture content of the liquid or semi-solid center core is lowered to that of, or less than that of the moisture content of the molten shell composition by the use of heat and vacuum.

References Cited (Backward Citations)

US2580683A Cited
US4260596A Cited
US4752485A Cited
US4753790A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1993-05-28 1993-11-27 1994-05-29 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1997-05-28 1997-11-27 1998-05-29 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2001-05-28 2001-11-27 2002-05-29 $7700.00 Window Closed / Lapsed

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