US4468381A
Expired / Lapsed
US
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Concentrated magnesium hydroxide preparations
Assignee: Norcliff Thayer Inc
•
Filing: 1983-06-03
•
Granted: 1984-08-28
•
Expires: 2003-06-03
Abstract
Abstract Stable aqueous thixotropic compositions containing from about 16 to 24% by wt./vol. of magnesium hydroxide are obtained by using an anionic polymer, a stabilizing or thixotropy producing agent and a thinning or fluidizing agent in a specific order of addition.
Inventors
- 👤 Arun K. Mitra
- 👤 Robert G. Flynn
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 08:50
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0095; A61K33/00; A61K33/06; A61K33/08; A61K47/00; A61K47/02; A61K47/06; A61K47/08; A61K47/12
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
202 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 Spindle run at 30 RPM, and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gram measuring head comprising: ______________________________________
(a) magnesium hydroxide 16-24% w/v
(b) a water-soluble, pharmaceutically
0.05 to 0.8%
w/v
acceptable stabilizing or thixotropy
producing agent selected from the
group of polycarboxylic acids consist-
ing of citric, tartaric, succinic,
adipic, malic and fumaric acids
(c) a water-soluble, pharmaceutically
0.05 to 1.8
w/v
acceptable thinning or fluidizing agent
selected from the group consisting of
alkali and ammonium salts of
phosphoric acids and pharmaceutically
acceptable salts of polycarboxylic acids
selected from the group consisting
of citric, tartaric, succinic, adipic, malic,
and fumaric acids,
and mixtures of said salts
(d) a water-soluble, pharmaceutically
0.08 to 1.2
w/v
acceptable anionic polymer selected
from the group consisting of sodium
carboxymethylcellulose, alginic acid
derivatives and carrageenin
(e) sucrose 6 to 10 w/v
(f) water q.s 100 v.
______________________________________
Claim 2
Dependent Claim
202 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 Spindle run at 30 RPM, and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gram measuring head comprising: ______________________________________
(a) magnesium hydroxide 16-24% w/v
(b) a water-soluble, pharmaceutically
0.05 to 0.8%
w/v
acceptable stabilizing or thixotropy
producing agent selected from the
group of polycarboxylic acids consist-
ing of citric, tartaric, succinic,
adipic, malic and fumaric acids
(c) a water-soluble, pharmaceutically
0.05 to 1.8
w/v
acceptable thinning or fluidizing agent
selected from the group consisting of
alkali and ammonium salts of
phosphoric acids and pharmaceutically
acceptable salts of polycarboxylic acids
selected from the group consisting
of citric, tartaric, succinic, adipic, malic,
and fumaric acids,
and mixtures of said salts
(d) a water-soluble, pharmaceutically
0.08 to 1.2
w/v
acceptable anionic polymer selected
from the group consisting of sodium
carboxymethylcellulose, alginic acid
derivatives and carrageenin
(e) sucrose 6 to 10 w/v
(f) water q.s 100 v.
______________________________________
Claim 3
Dependent Claim
14 words
The composition of claim 1 wherein the thinning or fluidizing agent is sodium citrate.
Claim 4
Dependent Claim
14 words
The composition of claim 1 wherein said thinning or fluidizing agent is sodium hexametaphosphate.
Claim 5
Dependent Claim
14 words
The composition of claim 3 further comprising 20 to 25 v/v sorbitol liquid U.S.P.
Claim 6
Dependent Claim
12 words
The composition of claim 4 further comprising 2.5 to 3.5 v/v glycerin.
Claim 7
Dependent Claim
14 words
The composition of claim 5 further comprising 0.35 to 0.50 w/v flavorants and preservatives.
Claim 8
Dependent Claim
125 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 spindle run at 30 RPM, and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gram measuring head comprising: ______________________________________
(a) magnesium hydroxide 16 to 24 w/v
(b) citric acid 0.05 to 0.8 w/v
(c) sodium citrate 0.05 to 0.8 w/v
(d) sodium hexametaphosphate
0.1 to 1.0 w/v
(e) sodium carboxymethylcellulose
0.08 to 1.2 w/v
(f) sucrose 7 to 8.5 w/v
(g) water q.s. to 100 v
______________________________________
Claim 9
Dependent Claim
125 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 spindle run at 30 RPM, and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gram measuring head comprising: ______________________________________
(a) magnesium hydroxide 16 to 24 w/v
(b) citric acid 0.05 to 0.8 w/v
(c) sodium citrate 0.05 to 0.8 w/v
(d) sodium hexametaphosphate
0.1 to 1.0 w/v
(e) sodium carboxymethylcellulose
0.08 to 1.2 w/v
(f) sucrose 7 to 8.5 w/v
(g) water q.s. to 100 v
______________________________________
Claim 10
Dependent Claim
118 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 spindle run at 30 RPM and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gm measuring head comprising: ______________________________________
magnesium hydroxide 24% w/v
sorbitol liquid USP 22% v/v
glycerine 2.5% v/v
sodium carboxymethylcellulose
0.3% w/v
citric acid 0.3% w/v
sodium citrate 0.15% w/v
sodium hexametaphosphate
0.15% w/v
sucrose 8.0% w/v
flavorant and preservatives
0.4% w/v
water q.s. 100 v.
______________________________________
Claim 11
Dependent Claim
118 words
A stable aqueous thixotropic composition for the oral administration of magnesium hydroxide, said composition having a viscosity immediately after manufacture of about 25 to 150 CPS as measured by a Brookfield-LVT viscometer with a No. 2 spindle run at 30 RPM and a yield value 24 hours after manufacture of about 5 to 14 as measured by a Haake Rotovisco R VIII viscometer at room temperature at 4 RPM with a 50 gm measuring head comprising: ______________________________________
magnesium hydroxide 24% w/v
sorbitol liquid USP 22% v/v
glycerine 2.5% v/v
sodium carboxymethylcellulose
0.3% w/v
citric acid 0.3% w/v
sodium citrate 0.15% w/v
sodium hexametaphosphate
0.15% w/v
sucrose 8.0% w/v
flavorant and preservatives
0.4% w/v
water q.s. 100 v.
______________________________________
Claim 12
Dependent Claim
226 words
A process for the preparation of a stable, thixotropic composition for the oral administration of magnesium hydroxide which comprises in the order specified the steps of: (a) preparing an aqueous solution of 0.08 to 1.2% w/v of an anionic polymer selected from the group consisting of sodium carboxymethylcellulose, alginic acid derivatives and carrageenin and 0.05 to 0.8% w/v of a thinning or fluidizing agent selected from the group consisting of alkali and ammonium salts of phosphoric acids and pharmaceutically acceptable polycarboxylic acid salts selected from the group consisting of citric, tartaric, succinic, adipic, malic, and fumaric acids, and mixtures of said salts; (b) adding with stirring to said aqueous solution a magnesium hydroxide paste to obtain 16 to 24% w/v of magnesium hydroxide to produce a suspension; (c) adding with stirring to said suspension an aqueous solution of 0.05 to 0.8% w/v of a stabilizing or thixotropy producing agent selected from the group of polycarboxylic acids consisting of citric, tartaric, succinic, adipic, malic and fumaric acids; (d) adding with stirring to said suspension 6 to 10% of a sucrose at any one of steps (a), (b) or (c); (e) adding to said suspension 0.1 to 1.0% w/v of a thinning or fluidizing agent to prevent gelling; (f) adding to said suspension with stirring water to bring volume to 100; and (g) stirring to obtain uniform suspension.
Claim 13
Dependent Claim
226 words
A process for the preparation of a stable, thixotropic composition for the oral administration of magnesium hydroxide which comprises in the order specified the steps of: (a) preparing an aqueous solution of 0.08 to 1.2% w/v of an anionic polymer selected from the group consisting of sodium carboxymethylcellulose, alginic acid derivatives and carrageenin and 0.05 to 0.8% w/v of a thinning or fluidizing agent selected from the group consisting of alkali and ammonium salts of phosphoric acids and pharmaceutically acceptable polycarboxylic acid salts selected from the group consisting of citric, tartaric, succinic, adipic, malic, and fumaric acids, and mixtures of said salts; (b) adding with stirring to said aqueous solution a magnesium hydroxide paste to obtain 16 to 24% w/v of magnesium hydroxide to produce a suspension; (c) adding with stirring to said suspension an aqueous solution of 0.05 to 0.8% w/v of a stabilizing or thixotropy producing agent selected from the group of polycarboxylic acids consisting of citric, tartaric, succinic, adipic, malic and fumaric acids; (d) adding with stirring to said suspension 6 to 10% of a sucrose at any one of steps (a), (b) or (c); (e) adding to said suspension 0.1 to 1.0% w/v of a thinning or fluidizing agent to prevent gelling; (f) adding to said suspension with stirring water to bring volume to 100; and (g) stirring to obtain uniform suspension.
Claim 14
Dependent Claim
16 words
A process according to claim 9 wherein the stabilizing or thixotropy producing agent is citric acid.
Claim 15
Dependent Claim
15 words
A process according to claim 9 wherein the thinning or fluidizing agent is sodium citrate.
Claim 16
Dependent Claim
15 words
A process according to claim 9 wherein the thinning or fluidizing agent is sodium hexametaphosphate.
Claim 17
Dependent Claim
13 words
A process according to claim 9 wherein the anionic polymer is sodium carboxymethylcellulose.
Claim 18
Dependent Claim
14 words
A process according to claim 9 wherein the sucrose is added in step (a).
Claim 19
Dependent Claim
24 words
A process according to claim 9 wherein 2 to 4% v/v of glycerin and 10 to 25% v/v sorbitol are added with the sucrose.
Claim 20
Dependent Claim
19 words
A process according to claim 9 wherein, desired amounts of preservative and flavorant are added prior to step (e).
Claim 21
Dependent Claim
19 words
The stable, thixotropic composition for the oral administration of magnesium hydroxide made according to the process of claim 9.
Claim 22
Dependent Claim
141 words
A process for the preparation of a stable, thixotropic composition for the oral administration of magnesium hydroxide, which comprises in the order specified the steps of: (a) preparing an aqueous solution of 0.08 to 1.2% w/v of sodium carboxymethylcellulose and 0.05 to 0.8% w/v of sodium citrate; (b) adding with stirring to said aqueous solution a magnesium hydroxide paste to obtain 16 to 24% w/v magnesium hydroxide to produce a suspension; (c) adding with stirring to said suspension an aqueous solution of 0.05 to 0.8% w/v citric acid; (d) adding with stirring to said suspension 6 to 10% w/v of a sucrose at any steps (a.), (b.) or (c.); (e) adding to said suspension 0.1 to 1.0% w/v of sodium hexametaphosphate; (f) adding to said suspension with stirring water to bring volume to 100; and (g) stirring to obtain uniform suspension.
Claim 23
Dependent Claim
141 words
A process for the preparation of a stable, thixotropic composition for the oral administration of magnesium hydroxide, which comprises in the order specified the steps of: (a) preparing an aqueous solution of 0.08 to 1.2% w/v of sodium carboxymethylcellulose and 0.05 to 0.8% w/v of sodium citrate; (b) adding with stirring to said aqueous solution a magnesium hydroxide paste to obtain 16 to 24% w/v magnesium hydroxide to produce a suspension; (c) adding with stirring to said suspension an aqueous solution of 0.05 to 0.8% w/v citric acid; (d) adding with stirring to said suspension 6 to 10% w/v of a sucrose at any steps (a.), (b.) or (c.); (e) adding to said suspension 0.1 to 1.0% w/v of sodium hexametaphosphate; (f) adding to said suspension with stirring water to bring volume to 100; and (g) stirring to obtain uniform suspension.
Claim 24
Dependent Claim
13 words
The process of claim 18 wherein the sucrose is added at step (a).
Claim 25
Dependent Claim
23 words
The process of claim 18 wherein 2 to 4% w/v of glycerin and 10 to 25% v/v sorbitol are added with the sucrose.
Claim 26
Dependent Claim
18 words
The process of claim 18 wherein desired amounts of preservatives and flavorant are added prior to step (e).
Claim 27
Dependent Claim
19 words
The stable, thixotropic composition for the oral administration of magnesium hydroxide made according to the process of claim 18.
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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) | 1987-08-28 | 1988-02-27 | 1988-08-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-08-28 | 1992-02-27 | 1992-08-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-08-28 | 1996-02-27 | 1996-08-28 | $7700.00 | Window Closed / Lapsed |