US5330763A
Expired / Lapsed
US
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Delivery matrices prepared by solid-state dissolution
Assignee: Janssen Pharmaceuticals Inc
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Filing: 1991-07-23
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Granted: 1994-07-19
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Expires: 2011-07-23
Abstract
Abstract A method is disclosed for preparing pharmaceutical and other matrix systems that comprises solidifying a matrix composition dissolved or dispersed in a first solvent and subsequently contacting the solidified matrix with a second solvent that is substantially miscible with the first solvent at a temperature lower than the solidification point of the first solvent, the matrix components being substantially insoluble in the second solvent, whereby the first solvent is substantially removed resulting in a usable matrix.
Inventors
- 👤 Dilip J. Gole
- 👤 R. Saul Levinson
- 👤 James Carbone
- 👤 J. Desmond Davies
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 23:30
CPC Classifications
F; F26; F26B; F26B5/00; A; A61; A61K; A61K9/00; A61K9/14; A23; A23L; A23L27/00; A23L27/70; A61K8/00; A61K8/02; A61K8/0208; A61K8/18; A61K8/30; A61K8/33; A61K8/34; A61K8/40; A61K8/44; A61K8/64; A61K8/65; A61K8/72; A61K8/81; A61K8/817; A61K8/8176; A61K8/92; A61K8/922; A61K9/20; A61K9/2095; A61Q; A61Q19/00; B; B32; B32B; B32B29/00; B32B29/06; B65; B65D; B65D81/00; B65D81/38; B65D81/3813; B65D81/3823; A61K2800/00; A61K2800/40; A61K2800/56
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
150 words
A porous unit dosage form prepared according to a method comprising the steps of: (a) dispersing or dissolving a matrix forming agent in a first solvent; (b) solidifying a unit volume of the dispersion or solution; and (c) contacting the solidified unit volume with a second solvent, the first solvent in the solidified unit volume being substantially miscible with the second solvent, the solidification point of the first solvent being higher than the solidification point of the second solvent, the second solvent being at a temperature at or higher than the solidification point of the second solvent and at a temperature at or lower than the solidification point of the first solvent, the matrix forming agent being substantially insoluble in the second solvent, the contacting being sufficient to substantially remove the first solvent from the solidified unit volume yielding a unit dosage form; and (d) recovering the unit dosage form.
Claim 2
Dependent Claim
150 words
A porous unit dosage form prepared according to a method comprising the steps of: (a) dispersing or dissolving a matrix forming agent in a first solvent; (b) solidifying a unit volume of the dispersion or solution; and (c) contacting the solidified unit volume with a second solvent, the first solvent in the solidified unit volume being substantially miscible with the second solvent, the solidification point of the first solvent being higher than the solidification point of the second solvent, the second solvent being at a temperature at or higher than the solidification point of the second solvent and at a temperature at or lower than the solidification point of the first solvent, the matrix forming agent being substantially insoluble in the second solvent, the contacting being sufficient to substantially remove the first solvent from the solidified unit volume yielding a unit dosage form; and (d) recovering the unit dosage form.
Claim 3
Dependent Claim
22 words
The dosage form according to claim 1, wherein the first solvent is water and the second solvent is a water miscible alcohol.
Claim 4
Dependent Claim
79 words
The dosage form according to claim 1, wherein the matrix forming agent is selected from the group consisting of gelatins, dextrins, soy proteins, wheat proteins, psyllium seed proteins, gums, alginates, polysaccharides, carboxymethylcellulose, carrageenans, dextrans, pectins, polyvinylpyrrolidone, gelatin-acacia complexes, mannitol, dextrose, lactose, galactose, cyclodextrin, konjac fluor, cellulose, sodium starch glycolate, polydextrose, hydroxyethylcellulose, amino acids having 2 to 12 carbon atoms, corn syrup solids, chitosan, rice flour, wheat gluten, soy fiber proteins, potato proteins, papain, horse radish peroxidase and mixtures thereof.
Claim 5
Dependent Claim
29 words
The dosage form according to claim 1, wherein the matrix forming agent is present in a concentration of about 0.1% to 15% by weight of the dispersion or solution.
Claim 6
Dependent Claim
21 words
The dosage form according to claim 2, wherein the alcohol is at a temperature from about 0° to about -100° C.
Claim 7
Dependent Claim
28 words
The dosage form according to claim 1, wherein at least one of the matrix forming agents is selected from the group consisting of gelatin, pectin, mannitol and glycine.
Claim 8
Dependent Claim
27 words
The dosage form according to claim 1, prepared according to a method comprising the additional step of: (e) evaporating residual second solvent from the unit dosage form.
Claim 9
Dependent Claim
30 words
The dosage form according to claim 1 wherein the dispersion or solution also contains an active agent to be delivered, the active agent being substantially insoluble in the second solvent.
Claim 10
Dependent Claim
35 words
The dosage form according to claim 1, comprising the additionally step of: (e) contacting the unit dosage form with an active agent to be delivered such that the active agent is dispersed through the matrix.
Claim 11
Dependent Claim
15 words
The dosage form according to claim 9, wherein the active agent is a bioactive agent.
Claim 12
Dependent Claim
21 words
The dosage form according to claim 10, wherein the active agent is an effective unit dosage amount of a bioactive agent.
Claim 13
Dependent Claim
33 words
The dosage form according to claim 1, wherein the dispersion or solution to be solidified additionally comprises a gas dispersed therethrough such that the recovered unit dosage form is a foam dosage form.
Claim 14
Dependent Claim
16 words
The dosage form according to claim 1 wherein the dosage form additionally comprises an active agent.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-07-18 | 1998-01-17 | 1998-07-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-07-18 | 2002-01-17 | 2002-07-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-07-18 | 2006-01-17 | 2006-07-19 | $7700.00 | Window Closed / Lapsed |