US4880830A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Slow release formulation
Assignee: Ethical Pharmaceuticals Ltd
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Filing: 1987-02-09
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Granted: 1989-11-14
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Expires: 2007-02-09
Abstract
Abstract A slow release formulation to be administered to humans or animals, comprising primary granules which contain an active ingredient and are in a secondary matrix of a water soluble/dispersible slow release material, the granules themselves comprising particles containing the active ingredients and in a primary matrix of a water soluble/dispersible slow release material. Optionally the formulation comprises a binder phase of a water insoluble slow release material having embedded therein secondary granules comprising the secondary matrix containing the primary matrix granules. The water soluble/dispersible material may be a polysaccharide and acacia and low viscosity methylcellulose are exemplified, as well as alginate and gelatine.
Inventors
- 👤 Alan Rhodes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 14:52
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61K9/2077
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
59 words
A slow release formulation to be administered to humans or animals, comprising (1) granules which comprise particles comprising an active ingredient and a primary matrix of water soluble/dispersible slow release material in which are dispersed said particles comprising the active ingredient, and (2) a secondary matrix of a water soluble/dispersible slow release material in which said granules are dispersed.
Claim 2
Dependent Claim
59 words
A slow release formulation to be administered to humans or animals, comprising (1) granules which comprise particles comprising an active ingredient and a primary matrix of water soluble/dispersible slow release material in which are dispersed said particles comprising the active ingredient, and (2) a secondary matrix of a water soluble/dispersible slow release material in which said granules are dispersed.
Claim 3
Dependent Claim
20 words
A slow release formulation as claimed in claim 1 wherein both matrixes are formed of the same slow release material.
Claim 4
Dependent Claim
33 words
A slow release formulation as claimed in claim 1 wherein said slow release material of at least one of said matrixes is selected from the group consisting of polysaccharide material, alginate and gelatine.
Claim 5
Dependent Claim
37 words
A slow release formulation as claimed in claim 3 wherein said polysaccharide material is selected from the group consisting of acacia, a mixture comprising at least 50 wt % acacia and another binder, and low viscosity methylcellulose.
Claim 6
Dependent Claim
34 words
A slow release formulation as claimed in claim 1 wherein said secondary matrix/granule composition is itself in the form of granules and is in a binder phase of a water insoluble slow release material.
Claim 7
Dependent Claim
34 words
A slow release formulation as claimed in claim 3 wherein said secondary matrix/granule composition is itself in the form of granules and is in a binder phase of a water insoluble slow release material.
Claim 8
Dependent Claim
77 words
A slow release formulation as claimed in claim 6 wherein said water insoluble slow release material is selected from the group consisting of mineral, vegetable or animal wax, C 24 -C 62 esters of a C 12 -C 31 fatty acid and C 12 -C 31 fatty alcohol, C 10 -C 22 fatty acids, C 10 -C 22 fatty alcohols, mono-, di- and triglyceryl esters formed from a C 10 -C 22 fatty acid, and mixtures thereof.
Claim 9
Dependent Claim
37 words
A slow release formulation as claimed in claim 7 wherein said water insoluble slow release material is selected from the group consisting of hydrogenated castor oil, glyceryl mono- and distearate, 12-hydroxystearyl alcohol, micro-crystalline wax and mixtures thereof.
Claim 10
Dependent Claim
14 words
A slow release formulation as claimed in claim 3 and formulated for oral administration.
Claim 11
Independent Claim
99 words
A method of making a slow release formulation to be administered to humans or animals, comprising mixing particles comprising an active ingredient and a solution or dispersion in a liquid vehicle of a water soluble/dispersible slow release material to form an agglomerate and granulating said agglomerate to form primary granules, drying said primary granules and then mixing them with a solution or dispersion in a liquid vehicle of a water soluble/dispersible slow release material to form an agglomerate and granulating said agglomerate to form secondary granules of a larger size than said primary granules, and drying said secondary granules.
Claim 12
Independent Claim
99 words
A method of making a slow release formulation to be administered to humans or animals, comprising mixing particles comprising an active ingredient and a solution or dispersion in a liquid vehicle of a water soluble/dispersible slow release material to form an agglomerate and granulating said agglomerate to form primary granules, drying said primary granules and then mixing them with a solution or dispersion in a liquid vehicle of a water soluble/dispersible slow release material to form an agglomerate and granulating said agglomerate to form secondary granules of a larger size than said primary granules, and drying said secondary granules.
Claim 13
Dependent Claim
32 words
A method as claimed in claim 10 wherein each said liquid vehicle is independently selected from the group consisting of water, ethanol, methanol, aqueous ethanol, aqueous methanol, chloroform, isopropanol and methylene chloride.
Claim 14
Dependent Claim
27 words
A method as claimed in claim 10 in which the or each water soluble/dispersible material is selected from the group consisting of polysaccharide material, alginate and gelatine.
Claim 15
Dependent Claim
55 words
A method as claimed in claim 10 wherein there are two granulating steps and in the first granulating step said agglomerate is granulated to a size of 600 um to 250 um mesh aperture and in the second granulating step said agglomerate is granulated to a size of 2 mm to 1 mm mesh aperture.
Claim 16
Dependent Claim
36 words
A method as claimed in claim 10 wherein said particles containing active ingredient or said primary granules or both are dry blended with high viscosity methylcellulose and subsequently admixed with a solution/dispersion of low viscosity methylcellulose.
Claim 17
Dependent Claim
21 words
A method as claimed in claim 10 which further comprises blending said secondary granules with a water insoluble slow release material.
Claim 18
Dependent Claim
56 words
A slow release formulation to be administered to humans or animals, comprising particles comprising an active ingredient and water soluble/dispersible matrix material, said particles being arranged as clusters or relatively densely packed particles dispersed in said water soluble/dispersible matrix material, said matrix material at said clusters optionally being different to said matrix material between said clusters.
Claim 19
Dependent Claim
56 words
A slow release formulation to be administered to humans or animals, comprising particles comprising an active ingredient and water soluble/dispersible matrix material, said particles being arranged as clusters or relatively densely packed particles dispersed in said water soluble/dispersible matrix material, said matrix material at said clusters optionally being different to said matrix material between said clusters.
Claim 20
Dependent Claim
42 words
A slow release formulation as claimed in claim 16 wherein said matrix material at said clusters is the same as said matrix material between said clusters and said matrix material is selected from the group consisting of polysaccharide material, gelatine and alginate.
Claim 21
Dependent Claim
39 words
A slow release formulation as claimed in claim 16 wherein said matrix material with said particles dispersed therein is in the form of granules and said granules are in a binder phase of a water insoluble slow release material.
Claim 22
Dependent Claim
14 words
A slow release formulation as claimed in claim 16 and formulated for oral administration.
Claim 23
Independent Claim
91 words
A method of treating a human or animal for a disease, comprising orally administering to said human or animal an oral dosage form comprising an active ingrdient for treating said disease, said active ingredient being arranged in particles dispersed in a primary matrix of water soluble/dispersible slow release material, said primary matrix with said particles dispersed therein being formed as granules and said granules being dispersed in a secondary matrix of water soluble/dispersible material, said secondary matrix and said primary matrix being formed of the same or different slow release material.
Claim 24
Independent Claim
91 words
A method of treating a human or animal for a disease, comprising orally administering to said human or animal an oral dosage form comprising an active ingrdient for treating said disease, said active ingredient being arranged in particles dispersed in a primary matrix of water soluble/dispersible slow release material, said primary matrix with said particles dispersed therein being formed as granules and said granules being dispersed in a secondary matrix of water soluble/dispersible material, said secondary matrix and said primary matrix being formed of the same or different slow release material.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-11-13 | 1993-05-15 | 1993-11-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-11-13 | 1997-05-15 | 1997-11-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-11-13 | 2001-05-15 | 2001-11-14 | $7700.00 | Window Closed / Lapsed |