EP0235986A1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Slow release formulation
Assignee: Ethical Pharmaceuticals Ltd
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Filing: 1987-02-12
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Granted: —
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Expires: 2007-02-12
Abstract
Abstract A slow release formulation to be administered to humans or animals, comprising primary granules (1) which contain an active ingredient and are in a secondary matrix (2) of a water soluble/ dispersible slow release material, the granules (1) themselves comprising particles (3) containing the active ingredients and in a primary matrix (4) of a water soluble/dispersible slow release material. Optionally the formulation comprises a binder phase (5) of a water insoluble slow release material having embedded therein secondary granules (6) comprising the secondary matrix (2) containing the primary matrix granules (1). 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
EP
Data Source
google_patents
Last Synchronized
2026-11-04 00:00
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61K9/2077
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
88 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 of a water soluble/dispersible slow release material to form an agglomerate and granulating the agglomerate, drying the resultant primary granules and then mixing them with a solution or dispersion of a water soluble/dispersible slow release material to form an agglomerate and granulating the agglomerate to form secondary granules of a larger size than the primary granules, and drying the secondary granules.
Claim 2
Independent Claim
88 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 of a water soluble/dispersible slow release material to form an agglomerate and granulating the agglomerate, drying the resultant primary granules and then mixing them with a solution or dispersion of a water soluble/dispersible slow release material to form an agglomerate and granulating the agglomerate to form secondary granules of a larger size than the primary granules, and drying the secondary granules.
Claim 3
Dependent Claim
36 words
A method as claimed in claim 1 wherein the liquid vehicle of each solution or dispersion is water or a pharmaceutically acceptable organic liquid, preferably ethanol, methanol, aqueous ethanol, aqueous methanol, chloroform, isopropanol or methylene chloride.
Claim 4
Dependent Claim
26 words
A method as claimed in claim 1 or claim 2, wherein the water soluble/dispersible materials used in the first and second mixing steps are the same.
Claim 5
Dependent Claim
40 words
A method as claimed in claim 1 or claim 2 wherein the water soluble/dispersible material used in the first mixing step, the second mixing step or both the first and second mixing steps is a polysaccharide material, alginate or gelatine.
Claim 6
Dependent Claim
29 words
A method as claimed in claim 4 wherein the polysaccharide material is acacia, a mixture comprising at least 50 wt% acacia and another binder, or is low viscosity methylcellulose.
Claim 7
Independent Claim
60 words
A method as claimed in any one of claims 1 to 5, which has two granulating steps and wherein in the first granulating step the mixture is granulated to a size of 600 um to 250 um mesh aperture and in the second granulating step the mixture is granulated to a size of 2 mm to 1 mm mesh aperture.
Claim 8
Independent Claim
51 words
A method as claimed in any one of claims 1 to 6, wherein the particles containing active ingredient or the primary granules or both are dry blended with a slow release material (e.g. high viscosity methylcellulose) and subsequently admixed with a solution/dispersion of a slow release material (e.g. low viscosity methylcellulose).
Claim 9
Independent Claim
26 words
A method as claimed in any one of claims 1 to 7 which further comprises blending the secondary granules with a water insoluble slow release material.
Claim 10
Dependent Claim
100 words
A method as claimed in claim 8 wherein the water insoluble slow release material is formed of one or more of a mineral, vegetable or animal wax, a C 24 - C 62 ester of a C 12 C 31 fatty acid and a C 12 -C 31 fatty alcohol, a C 10 -C 22 fatty acid, a C 10 - C 22 fatty alcohol, or a mono-, di- or triglyceryl ester formed from a C 10 -C 22 fatty acid, and preferably of one or more of hydrogenated castor oil, glyceryl mono- or distearate, 12-hydroxystearyl alcohol or micro-crystalline wax.
Claim 11
Independent Claim
19 words
A method as claimed in any one of the preceding claims, wherein the formulation is formulated for oral administration.
References Cited (Backward Citations)
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