U.S. patent application number 13/924237 was filed with the patent office on 2014-12-25 for contact lens cleaning compositions.
The applicant listed for this patent is GNT, LLC. Invention is credited to Gerald Horn.
Application Number | 20140378361 13/924237 |
Document ID | / |
Family ID | 52105136 |
Filed Date | 2014-12-25 |
United States Patent
Application |
20140378361 |
Kind Code |
A1 |
Horn; Gerald |
December 25, 2014 |
CONTACT LENS CLEANING COMPOSITIONS
Abstract
The invention provides a contact lens cleaning composition
comprising at least two nonionic surfactants and optionally
including a non-Newtonian viscosity enhancing excipient.
Inventors: |
Horn; Gerald; (Deerfield,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GNT, LLC |
Dana Point |
CA |
US |
|
|
Family ID: |
52105136 |
Appl. No.: |
13/924237 |
Filed: |
June 21, 2013 |
Current U.S.
Class: |
510/112 |
Current CPC
Class: |
C11D 1/667 20130101;
C11D 3/0078 20130101; C11D 1/72 20130101; C11D 1/825 20130101; C11D
1/008 20130101; A61L 12/14 20130101 |
Class at
Publication: |
510/112 |
International
Class: |
A61L 12/14 20060101
A61L012/14 |
Claims
1. A contact lens cleaning composition comprising: 1) about 5% w/v
polyoxyl 40 stearate; 2) at least two other nonionic surfactants;
and 3) from 0.0% to 1.75% w/v of a non-Newtonian viscosity
enhancing excipient, wherein combined concentration of the polyoxyl
40 stearate and the at least two other nonionic surfactants is no
more than 7.0% w/v.
2. The composition of claim 1 wherein, the at least two other
nonionic surfactants are selected from poloxamers, polysorbates,
and polyoxyl alkyls.
3. The composition of claim 1 wherein, the viscosity enhancing
excipient is selected from carboxymethyl cellulose,
carboxypropylmethyl cellulose, hydroxypropyl cellulose,
hydroxyethyl cellulose, and hydroxypropylmethyl cellulose or a
combination thereof.
4. A contact lens cleaning composition comprising 0.10% w/v
poloxamer 188, 0.20% w/v poloxamer 407, 5.0% w/v polyoxyl 40
stearate and from 0.0% to 1.75% w/v of a non-Newtonian viscosity
enhancing excipient.
5. The composition of claim 4 wherein the viscosity enhancing
excipient is 0.20% w/v hydroxypropylmethyl cellulose.
6. The composition of claim 4 wherein the viscosity enhancing
excipient is 0.30% w/v hydroxypropylmethyl cellulose.
7. A contact lens cleaning composition comprising 0.10% w/v
poloxamer 188, 0.20% w/v poloxamer 407, 5.0% w/v polyoxyl 40
stearate, 0.25% to 1.50% w/v polyoxyl 35 castor oil, 0.30% w/v
hydroxypropylmethyl cellulose, 0.25% w/v sodium chloride and 0.01%
w/v benzalkonium chloride.
8. The contact lens cleaning composition of claim 7, wherein
polyoxyl 35 castor oil is at an amount of 0.25% w/v.
9. The contact lens cleaning composition of claim 7, wherein
polyoxyl 35 castor oil is at an amount of 1.00% w/v.
10. The contact lens cleaning composition of claim 7, wherein
polyoxyl 35 castor oil is at an amount of 1.50% w/v.
11. A method of cleaning a contact lens comprising, applying a
contact lens cleaning composition comprising polyoxyl 40 stearate
and at least one other nonionic surfactant to the contact lens
wherein, the contact lens remains in the eye.
12. A contact lens cleaning composition comprising: 1) about 5% w/v
polyoxyl 40 stearate; 2) at least one other nonionic surfactant;
and 3) from 1.0% to 1.75% w/v of a non-Newtonian viscosity
enhancing excipient wherein combined concentration of the polyoxyl
40 stearate and the at least one other surfactant is no more than
7.0% w/v.
13. The composition of claim 12 wherein, the at least one other
nonionic surfactant is selected from poloxamers, polysorbates, and
polyoxyl alkyls.
14. The composition of claim 12 wherein, the viscosity enhancing
excipient is selected from carboxymethyl cellulose,
carboxypropylmethyl cellulose, hydroxypropyl cellulose,
hydroxyethyl cellulose, and hydroxypropylmethyl cellulose or a
combination thereof.
Description
FIELD OF THE INVENTION
[0001] The invention is directed to contact lens cleaning
compositions comprising at least two nonionic surfactants and
optionally comprising one or more viscosity enhancing excipients.
The invention is further directed to a method of cleaning a contact
lens while the contact lens remains on the eye comprising applying
a contact lens cleaning compositions comprising at least two
nonionic surfactants and optionally comprising one or more
viscosity enhancing excipients.
BACKGROUND OF THE INVENTION
[0002] Contact lenses are worn for long periods of time each day,
including those that may be worn overnight. During this time debris
consisting of the macromolecular components of tears as well as
particulates from the environment builds up on the surface of the
lenses causing irritation to the wearer and reduced vision.
Traditional methods of cleaning the debris from the surface of the
contact lens includes separate steps of cleaning and rinsing, both
of which requires the removal of the contact lens from the eye.
[0003] There are also multipurpose solutions that can be used for
both cleaning and rinsing the contact lens. However, these
multipurpose solutions tend to do a poorer job at cleaning because
they must remain comfortable to the user when placed in the eye
after rinsing.
[0004] There are a few products such as Alcon Opti-tears Comfort
Contact Lens Drops which can be applied while the contact is on the
eye. These drops moisten the contact lens and help remove debris.
However, the cleaning ability of these drops does not match those
of either the multipurpose or two-step solutions.
[0005] There remains a need in the art for an effective contact
lens cleaning composition that can be applied while the contact
remains in the eye. This cleaning composition sufficiently cleans
the lens so that additional cleaning steps are not necessary and
debris can be removed by the natural drainage of the eye.
SUMMARY OF THE INVENTION
[0006] In certain embodiments, the present invention is directed to
a contact lens cleaning composition comprising: [0007] 1) from 0.2%
to 7.0% w/v of at least two different nonionic surfactants; and
[0008] 2) from 0.0% to 1.75% w/v of a non-Newtonian viscosity
enhancing excipient.
[0009] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0010]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0011] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein the nonionic
surfactants are selected from poloxamers, polysorbates and polyoxyl
alkyls.
[0012] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0013]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0014] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein the viscosity
enhancing excipient is selected from carboxymethyl cellulose,
carboxypropylmethyl cellulose, hydroxypropyl cellulose,
hydroxyethyl cellulose, and hydroxypropylmethyl cellulose or a
combination thereof.
[0015] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0016]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0017] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein the nonionic
surfactants are 0.10% w/v poloxamer 188, 0.20% w/v poloxamer 407
and 5.0% w/v polyoxyl 40 stearate.
[0018] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0019]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0020] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein: [0021] the
nonionic surfactants are 0.10% w/v poloxamer 188, 0.20% w/v
poloxamer 407 and [0022] 5.0% w/v polyoxyl 40 stearate; and [0023]
the viscosity enhancing agent is 0.10% w/v hydroxypropylmethyl
cellulose.
[0024] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0025]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0026] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein: [0027] the
nonionic surfactants are 0.10% w/v poloxamer 188, 0.20% w/v
poloxamer 407 and [0028] 5.0% w/v polyoxyl 40 stearate; and [0029]
the viscosity enhancing agent is 0.20% w/v hydroxypropylmethyl
cellulose.
[0030] In certain preferred embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0031]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0032] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient; wherein: [0033] the
nonionic surfactants are 0.10% w/v poloxamer 188, 0.20% w/v
poloxamer 407 and [0034] 5.0% w/v polyoxyl 40 stearate; and [0035]
the viscosity enhancing agent is 0.30% w/v hydroxypropylmethyl
cellulose.
[0036] In certain other embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0037]
1) from 0.20% to 7.0% w/v of at least two different nonionic
surfactants; and [0038] 2) from 0.0% to 1.75% w/v hydroxypropyl
cellulose.
[0039] In certain other embodiments, the present invention is
directed to a contact lens cleaning composition comprising: [0040]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; [0041] 2) from 0.0% to 1.75% w/v of a non-Newtonian
viscosity enhancing excipient; and [0042] 3) from 0.1% to 1.0% w/v
of glycerin.
[0043] In certain other embodiments, the present invention is
directed to a method of a contact lens comprising, applying a
composition comprising: [0044] 1) from 0.2% to 7.0% w/v of at least
two different nonionic surfactants; and [0045] 2) from 0.0% to
1.75% w/v of a non-Newtonian viscosity enhancing excipient to the
contact lens wherein, the contact lens remains in the eye.
DETAILED DESCRIPTION OF THE INVENTION
[0046] The present invention is directed to a contact lens cleaning
composition comprising: [0047] 1) from 0.2% to 7.0% w/v of at least
two different nonionic surfactants; and [0048] 2) from 0.0% to
1.75% w/v of a non-Newtonian viscosity enhancing excipient.
[0049] As used herein, the term "composition" is intended to
encompass a product comprising the specified ingredients in the
specified amounts, as well as any product which results, directly
or indirectly, from a combination of the specified ingredients in
the specified amounts.
[0050] As used herein, all numerical values relating to amounts,
weights, and the like, that are defined as "about" each particular
value is plus or minus 10%. For example, the phrase "about 5% w/v"
is to be understood as "4.5% to 5.5% w/v." Therefore, amounts
within 10% of the claimed value are encompassed by the scope of the
claims.
[0051] As used herein "% w/v" refers to the percent weight of the
total composition.
[0052] As used herein the term "contact lens" refers, but is not
limited to, soft contact lens for daily wear, extended wear, or
unit daily disposable wear and rigid gas permeable lenses.
[0053] Nonionic surfactants that can be used in accordance with the
present invention include but are not limited to poloxamers,
polysorbates, cyclodextrins, and polyoxyl alkyls; where preferred
embodiments include but are not limited to Poloxamer 188, Poloxamer
407, Polysorbate 20, Polysorbate 80, Polyoxyl 40 stearate, Polyoxyl
35 castor oil, and Polyoxyl 40 hydrogenated castor oil or
combinations thereof.
[0054] In certain embodiments the nonionic surfactants are
polysorbate 80 and polyoxyl 40 stearate.
[0055] In certain other embodiments the nonionic surfactants are
poloxamer 407 and polyoxyl 40 stearate.
[0056] In certain other embodiments the nonionic surfactants are
poloxamer 188, poloaxmer 407, polysorbate 80, and polyoxyl 40
stearate.
[0057] In preferred embodiments the nonionic surfactants are
poloxamer 188, poloxamer 407 and polyoxyl 40 stearate.
[0058] In more preferred embodiments the amount of nonionic
surfactants is 0.10% w/v poloxamer 188, 0.20% w/v poloxamer 407,
and 5.0% w/v polyoxyl 40 stearate.
[0059] In other preferred embodiments the nonionic surfactants are
poloxamer 188, poloxamer 407, polyoxyl 40 stearate and polyoxyl 35
castor oil.
[0060] In other embodiments the amount of polyoxyl 35 castor oil is
from 0.10% to 2.5% w/v, preferably from 0.25% to 1.50% w/v
including 1.00% w/v, and more preferably from 0.50% to 0.75%
w/v.
[0061] In more preferred embodiments the nonionic surfactants are
0.10% w/v poloxamer 188, 0.20% w/v poloxamer 407, 5.0% w/v polyoxyl
40 stearate and 0.25% to 1.50% w/v polyoxyl 35 castor oil.
[0062] Non-Newtonian viscosity enhancing excipients that can be
used in accordance with the present invention include, but are not
limited to, carboxymethyl cellulose high molecular weight blend
("CMC"), methylcellulose, methyl cellulose 4000, hydroxymethyl
cellulose, hydroxypropyl cellulose ("HPC"), hydroxypropylmethyl
cellulose high molecular weight blend ("HPMC"), hydroxyl propyl
methyl cellulose 2906, carboxypropylmethyl cellulose high molecular
weight blend, hydroxyethyl cellulose, or hydroxyethyl cellulose and
hyaluronic acid, such that the concentrations cumulatively do not
create a phase transition to an in situ gel.
[0063] In certain embodiments CMC is present at an amount from
0.50% to 0.75% w/v including 0.50% w/v, 0.62% w/v and 0.75%
w/v.
[0064] In certain embodiments HPC is present at an amount from
1.00% to 1.75% w/v including 1.00% w/v, 1.50% w/v and 1.75%
w/v.
[0065] In preferred embodiments the viscosity enhancing excipient
is HPMC at an amount from 0.10% to 0.50% w/v including 0.10% w/v,
0.20% w/v, 0.30% w/v, 0.40% w/v and 0.50% w/v.
[0066] In other embodiments the contact lens cleaning composition
further comprises a preservative.
[0067] Preservatives that can be used in accordance with the
present invention include, but are not limited to, benzalkonium
chloride ("BAK"), methylparaben, polypropylparaben, chlorobutanol,
thimerosal, phenylmercuric acetate, perborate, or phenylmercuric
nitrate. BAK, in particular, has been found to be effective with
preferred embodiments.
[0068] In more preferred embodiments the amount of BAK is 0.01%
w/v.
[0069] Buffers and pH adjustors include, but are not limited to,
acetate buffers, carbonate buffers, citrate buffers, phosphate
buffers and borate buffers, wherein carbonate buffer is preferred.
It is understood that various acids or bases can be used to adjust
the pH of the composition as needed. pH adjusting agents include,
but are not limited to, sodium hydroxide and hydrochloric acid.
Surprisingly, pH has not been found to alter comfort in the contact
lens cleaning compositions. pH of the compositions can be from 4.0
to 8.0.
[0070] In other embodiments the contact lens cleaning composition
further comprises glycerin from 0.1% to 1.0% w/v, wherein 0.3% and
0.4% are preferred.
[0071] The present invention is further directed to a method of a
contact lens comprising, applying a composition comprising: [0072]
1) from 0.2% to 7.0% w/v of at least two different nonionic
surfactants; and [0073] 2) from 0.0% to 1.75% w/v of a
non-Newtonian viscosity enhancing excipient to the contact lens
wherein, the contact lens remains in the eye.
[0074] The contact lens cleaning compositions of the present
invention are suitable for administration two, three or four times
per day to a subject in need thereof.
Representative Embodiments
[0075] In a more preferred embodiment the contact lens cleaning
composition comprises 0.10% w/v poloxamer 188, 0.20% w/v poloxamer
407, 5.0% w/v polyoxyl 40 stearate, 0.30% w/v hydroxypropylmethyl
cellulose, 0.25% w/v sodium chloride and 0.01% BAK.
[0076] In a more preferred embodiment the contact lens cleaning
composition comprises 0.10% w/v poloxamer 188, 0.20% w/v poloxamer
407, 5.0% w/v polyoxyl 40 stearate, 0.20% w/v hydroxypropylmethyl
cellulose, 0.25% w/v sodium chloride and 0.01% BAK.
[0077] In a more preferred embodiment the contact lens cleaning
composition comprises 0.10% w/v poloxamer 188, 0.20% w/v poloxamer
407, 5.0% w/v polyoxyl 40 stearate, 0.25% w/v polyoxyl 35 castor
oil, 0.30% w/v hydroxypropylmethyl cellulose, 0.25% w/v sodium
chloride and 0.01% BAK.
[0078] In a more preferred embodiment the contact lens cleaning
composition comprises 0.10% w/v poloxamer 188, 0.20% w/v poloxamer
407, 5.0% w/v polyoxyl 40 stearate, 1.0% w/v polyoxyl 35 castor
oil, 0.30% w/v hydroxypropylmethyl cellulose, 0.25% w/v sodium
chloride and 0.01% BAK.
[0079] In a more preferred embodiment the contact lens cleaning
composition comprises 0.10% w/v poloxamer 188, 0.20% w/v poloxamer
407, 5.0% w/v polyoxyl 40 stearate, 1.5% w/v polyoxyl 35 castor
oil, 0.30% w/v hydroxypropylmethyl cellulose, 0.25% w/v sodium
chloride and 0.01% BAK.
EXAMPLE
[0080] Contact lenses were worn continuously for 16 hours at which
point the users complained of dry, uncomfortable lenses.
Surprisingly, instillation of contact lens cleaning drops of
compositions described in Table 1 provided long-lasting relief with
minimal to no blurred vision upon instillation, no prolonged effect
on vision and improved comfort over pre-instillation. These drops
also, unexpectedly, proved durable with wetting effect lasting from
30 to 240 minutes.
TABLE-US-00001 TABLE 1 Efficacy of Contact Lens Cleaning
Compositions (% w/v) 1 2 3 4 5 6 7 8 9 Polyoxyl 40 5.00% 5.00%
5.00% 5.00% 1.00% 5.00% 5.00% 5.00% 5.00% stearate Poloxamer 407
0.20% 0.20% 0.20% 0.20% 0.20% 0.20% 0.20% 0.20% Poloxamer 188 0.10%
0.10% 0.10% 0.10% 0.10% 0.10% Polysorbate 80 5.00% 1.00% Polyoxyl
35 castor oil CMC 0.75% 0.75% 0.50% 0.62% HPC 1.00% 1.50% 1.75%
HPMC 0.30% 0.30% Glycerin 0.30% NaC10.25% BAK 0.01% Visual Blur 90
5 5 20 20 40 45 45 5 (sec) Wetting Effect 30 30 60 60 60 60 90 30
60 (min) Comfort 1.5 3.7 4.0 3.5 3.5 3.5 3.5 3.5 3.5 (4 is best)
Visual Quality 3.0 3.5 3.5 3.5 3.5 3.5 3.5 3.5 3.5 (4 is best)
Overall 2.5 3.0 3.0 3.2 3.2 3.2 3.5 3.5 3.5 Performance (% w/v) 10
11 12 13 14 15 16 17 18 Polyoxyl 40 5.00% 5.00% 5.00% 5.00% 5.00%
5.00% 5.00% 5.00% 5.00% stearate Poloxamer 407 0.20% 0.20% 0.20%
0.20% 0.20% 0.20% 0.20% 0.20% 0.20% Poloxamer 188 0.10% 0.10% 0.10%
0.10% 0.10% 0.10% 0.10% 0.10% 0.10% Polysorbate 80 Polyoxyl 35
0.25% 1.00% 1.50% castor oil CMC HPC HPMC 0.40% 0.50% 0.10% 0.20%
0.30% 0.30% 0.30% 0.30% Glycerin NaC10.25% BAK 0.01% Visual Blur 10
15 2 4 5 7 0 1 1 (sec) Wetting Effect 60 60 30 45 60 60 120 240 240
(min) Comfort 3.7 3.2 4.0 4.0 4.0 4.0 4.0 4.0 4.0 (4 is best)
Visual Quality 3.7 3.7 3.7 3.8 3.9 3.9 3.9 4.0 4.0 (4 is best)
Overall 3.6 3.6 3.7 3.8 3.8 3.9 3.9 4.0 4.0 Performance
[0081] Contact lens cleaning compositions with three nonionic
surfactants or more are preferred over those with one, or two
surfactants. Polyoxyl 40 stearate>Polyoxyl 35 castor
oil>Poloxamer 407>Poloxamer 188>Polysorbate 80. A
cumulative concentration of nonionic surfactant of at least 5% is
most preferred. Of the four surfactant compositions those with HPMC
as the non-Newtonian viscosity enhancing agent are preferred over
those with CMC, HPC or combinations thereof. Of the three
surfactant compositions with HPMC those that additionally include
polyoxyl 35 castor oil are preferred. Compositions 12-18 are most
preferred.
* * * * *