Professional Documents
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Haslwanter et al.
[45]
[54]
[75]
Date of Patent:
[52]
US.
[58]
Cl.
[56]
[87]
. . . . . . . . . . ..
514/385
References Cited
Us PATENT DOCUMENTS
5,114,979
[22]
[86]
[51]
5,854,269
640,767
_
PCT Flled'
PCT No.:
NOV 17 1994
PCT/US94/12945
371 Date:
Aug. 5, 1996
[57]
ABSTRACT
. .
. .
preserva Wes
t'
8 Claims, N0 Drawings
5,854,269
1
ingredients.
10
It is knoWn that one of the most common complaints of 15 salt thereof suf?cient to effect nasal decongestion and an
aqueous carrier comprising:
patients and consumers that use nasal spray products is the
25
35
40
45
55
60
and OS Water.
The present invention further provides a method of treat
to
to
to
to
to
to
microbial preservative
0
0
0
0
0
0
most preferable.
65
5,854,269
3
EXAMPLE 2
10
15
80.0000
0.5525
0.0975
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
1.0000
0.1177
3.5000
1.2500
L-Menthol USP
0.1750
0.0300
0.0300
0.0500
QS
20
Method of Preparation
% Wt/Vol
Ingredients
25
0.025% by Weight/volume.
C.
35
40
of step 1.
6. While mixing, add the benZalkonium chloride 17%
solution to the aqueous mixture of step 5 and mix for at least
5 minutes.
7. Adjust the ?nal batch volume With Water, mix until
uniform and then ?lter.
45
EXAMPLE 3
50
% Wt/Vol
80.0000
5.7100
0.3747
0.1169
2.2000
L-Menthol USP
0.2000
0.0400
0.0400
Phenylmercuric Acetate
0.0024
0.0500
Ingredients
QS
60
% Wt/Vol
80.0000
0.5525
0.0975
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
Propylene glycol USP
0.2500
0.1177
1.5000
0.1500
L-Menthol USP
0.0900
0.0300
0.0300
Oxymetazoline hydrochloride
0.0500
QS
65
5,854,269
6
EXAMPLE 4
antimicrobial preservative;
% Wt/Vol
80.0000
0.5525
0.0975
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
Propylene glycol USP
0.2500
0.1177
1.5000
0.1500
L-Menthol USP
0.0400
0.0100
0.0100
Oxymetazoline hydrochloride
0.0500
10
15
QS
QS Water.
20
Ingredients
biliZing agent.
30
% Wt/Vol
80.0000
0.5525
0.0975
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
Propylene glycol USP
Eucalyptol
0.2500
0.1177
1.5000
0.0300
Oxymetazoline hydrochloride
0.0500
QS
EXAMPLE 5
Ingredients
% Wt/Vol
80.0000
0.5525
0.0975
Disodium EDTA
35
0.0200
Benzyl alcohol
1.0000
0.1177
3.5000
Polysorbate 80
1.2500
L-Menthol USP
0.1750
Camphor USP
0.0300
Eucalyptol
Oxymetazoline hydrochloride USP
0.0300
0.0500
QS.
40
Ingredients
Water USP puri?ed
Sodium phosphate monobasic
Sodium phosphate dibasic
50
microbial preservative;
0 to 10% by Weight/volume of a moisturiZing agent;
0 to 0.10% by Weight/volume of an antioxidant;
0 to 2.00% by Weight/volume of a surfactant;
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
0.2500
0.1177
Propylene glycol
1.5000
Polysorbate 80
1.1500
L-Menthol USP
0.0900
Camphor USP
0.0300
Eucalyptol
Oxymetazoline hydrochloride USP
0.0300
0.0500
QS.
Ingredients
Water USP puri?ed
Sodium phosphate monobasic
Sodium phosphate dibasic
servatives.
80.0000
0.5525
0.0975
QS Water,
said composition being free of mercurial antimicrobial pre
% Wt/Vol
45
65
% Wt/Vol
80.0000
0.5525
0.0975
Disodium EDTA
0.0200
Benzyl alcohol
Benzalkonium chloride (17% solution)
0.2500
0.1177
5,854,269
-continued
Ingredients
-continued
% Wt/Vol
Propylene glycol
Polysorbate 80 (TWeen 80)
1.5000
1.1500
Ingredients
5
% Wt/Vol
0.0975
0.0200
L-Menthol USP
0.0400
BenZyl alcohol
0.2500
0.0100
0.0100
0.0500
QS.
0.1177
1.5000
0.0300
0.0500
10
QS.
_
Ingredients
Water USP puri?ed
Sodium phosphate monobasic
% Wt/VOI
80.0000
0.5525
CERTIFICATE OF CORRECTION
PATENT NO.
: 5,854269
DATED
No. PCT/US 94/12945, ?led November 17, 1994 and designating the United States, which PCT application is in
turn a continuation of US. Application Serial No. 08/155,052, ?led November 19, 1993, the benefit of which
applications are claimed pursuant to the provisions of 35 U.S.C. 120, 363 and 365(C). -
Q. TODD DICKINSON
Arresting O?icer
US005854269C1
(73)
(58)
References Cited
U. S. PATENT DOCUMENTS
Patent No.:
Issued:
5,854,269
Dec. 29, 1998
Appl. No.:
Filed:
08/640,767
Aug. 5, 1996
(2006.01)
(2006,01)
(52)
Int. Cl.
A61K 9/00
A61K 31/415
3,975,536 A
5,562,908 A
* 8/1976
* 10/1996
OTHER PUBLICATIONS
(22)
PCT Filed:
(86)
PCT No.:
PCT/US94/12945
371 (0X1)
(2), (4) Date:
Aug. 5, 1996
* cited by examiner
(87)
ABSTRACT
preservatives.
US 5,854,269 Cl
1
EX PARTE
REEXAMINATION CERTIFICATE
DETERMINED THATI
Claims 1% are cancelled.