CA2086188A1 - Use of hyaluronic acid as ocular prosthesis lubricant - Google Patents
Use of hyaluronic acid as ocular prosthesis lubricantInfo
- Publication number
- CA2086188A1 CA2086188A1 CA 2086188 CA2086188A CA2086188A1 CA 2086188 A1 CA2086188 A1 CA 2086188A1 CA 2086188 CA2086188 CA 2086188 CA 2086188 A CA2086188 A CA 2086188A CA 2086188 A1 CA2086188 A1 CA 2086188A1
- Authority
- CA
- Canada
- Prior art keywords
- hyaluronic acid
- prosthesis
- lubricant
- ocular
- compositions according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Abstract
use of hyaluronic acid as ocular prosthesis lubricant Abstract The use of compositions comprising hyaluronic acid is described to lubricate a substitutive prosthesis of the ocular bulb to be fitted to sub-atrophic or microophtalmic bulbs of eyes.
Description
208~1~8 USE OF HYALURONIC ACID AS OCULAR PROSTHESIS LUBRICANT
The present invention relates to the use of hyaluronic acid as lubricant for ocular prosthesis.
More particularly, this invention relates to the use of compositions comprising hyaluronic acid as lubricant in fitting either an ocular bulb substituting prosthesis into an ocular cavity, or a prosthesis for sub-atrophic or micro-ophtalmic bulbs of eyes.
Hyaluronic acid is a polysaccharide, whlch is 1~ present to a large extent in a number of human tissues, such as the connective tissue, and in biological ~luids, such as the synovial fluid of the eye vitreous body (Balasz, B A., Armand, G.:"Glycosaminoglycans and ~roteoglycan8 in physiological and pathological processeR o~ Body Systems, Varmas, R.Ed. Karger Basel, 1982).
Generally, hyaluronic acid i8 used by means of intrarticular in~ections, as ad~uvant in the therapy of degenerative and/or in~lammatory diseases of the articular synovial sheats.
Hyaluronic acid is used largely in the oph~almic surgery, due to its elasto-viscous properties and rheologic properties ~Balasz, E.A., Fed.Proc., 17~
1086-1093, 1958). Particularly, hyaluronic acid is used in cataract operations, that are associated with intraocular lens implantation, as well as glaucoma and corneal tranaplant operations and more generally in any traumatopathy involving retinal detachement.
Moreover, diluted solutions of hyaluronic acid, less than 0.2 % w/v, could be used to relieve from S symptoms of lacrimal film diseases, as substitute of mucines, that are present in the physiological state (Stuart, A.C. and Linn, J.G., "Ann. of Ophtalmol.", 17 (3), 190-192, 1985).
Users of ocular prosthesis, to be fitted either into anophtalmic cavities or to sub-atrophic or micro-opthalmic bulbs of eyes, often suffer from an excess of ocular cavity dryness, particularly under special weather or environmental conditions, such as windy or cold conditions, or because of prolonged stay in too heated or dusty rooms. Thi8 is very troublesome, a~ it avoids the eyelids to correctly slide, thus causing conjunctive inflammatory process, due to the reaction against the eyelid friction. These problems occur frequently to patients with a prosthesis into the anophtalmic cavity, where the lacrimal gland function i5 very poor.
The collyrium compositions of the previous art are uneffective. Actually, the so-called nArtificial tears", though offering an immediate relief, evaporate very quickly and therefore need to be administered continuously.
~ 3 ~ 20 8 ~ 18 8 Vaseline-based ointments, though having higher stability and more lasting effect, are deposited on the front surface of the prosthesis, causing a lot of aesthaetic prejudice. Moreover, vaseline, though having acceptable lubrication properties, has `a poor elastoviscosity, thus causing the ointment, which is present between the prosthesis and the underlying tissues, to be gradually removed under shear conditions.
The authors of the present invention found that hyaluronic acid solutions are useful as elasto-viscous lubricants in ~itting ocular prosthesis, as they are-able to damp the pressure changements, frequently occuring between the ocular prosthesi~ and the underlying ti~sues.
Moreover, the authors have de~ined the optimized hyaluronic acid concentrations, that differ ~rom the usual concentrations for other uses. Hyaluronic acid . . .
compositions according to this invQntion showed a good stability, a sufficient lasting lubrication effect and a transparent appearance. Furthermore, a decrease of the reaction conjunctive hyperaemia is experienced on treated pati~nts, due to the anti-inflammatory action of hyaluronic acid.
Therefore, it is an object of the present invention the use of compositions comprising hyaluronic acid having the formula.
o~ ~CO~, ~ ~ ; ~ ~coc-l>
where 400 < n < 8000, for the manufacture of a medicament acting as lubricant of ocular prosthesis.
Preferably, said medicament comprises hyaluronic acid at a concentration from 0.2% to 2.0% by weight, more preferably at a concentration from 0.7% to 1.25%
by weight.
According to a preferred embodiment of the inven-tion, said compositions of hyaluronic acids comprise hyaluronic acid at purity grade higher than 99%, pre~erably extracted ~rom non pathogenic bacteria of the Streptococcus genus.
Furthermore, according to the invention, said compositions comprise a NaCl solution in such amount to , give the solution with a cryoscopic lowering from 0.1C
to 0.7C, and a phosphate buffer at pH comprised between 6.5 and 7.5.
The present invention will be described with reference to an applicative but not limitating example.
~xample 1 2~ Commercially available hyaluron~c acid is purified either by cock creats or by Streptococcus non pathogenic bacterial ~tFains, grown into fermenters.
,... " . .
' '' ' ' : "' '' '.' '' ''' ' ' ' . ' . .- .
,~; ; . . :
- - , , - . - -~ 5 ~ 2086188 This last source produces a material of higher purity degree and with a more uniform molecular weigth.
The authors of the invention have used hyaluronic acid from bacteria fermentation, as described in US
Patent n.4,480,414; however it is to be understood that any other source and/or purification procedure could be used without being out of the scope of the invention.
The used hyaluronic acid has a purity degree higher than 99~ and a molecular weigth from 200,000 to 4,000,000 dalton. The purified hyaluronic acid is dissolved into a NaCl solution in such an amount to give the resulting solution with a cryoscopic lowering from 0.1C to 0.7C in the presence of a phosphate buffer with pH 7Ø The ~ore e~fective concentration results to be o~ 1.0%, as related to the parameters which will be discussed in the following.
The composition, which appears as a gel, has to be administered in two phases. When the prosthesis is .
introduced into the ocular cavity, a gel amount of appr. 1 cm is spread over the concave surface of the prosthesis. After the prosthesis has been inserted, an other gel amount of appr. 1 cm is also administered to the internal part of the superior eyelid; by allowing the eyelid to open and clo~e two or three times, the product is spread throughout the prosthesis surface and produces a transparent film, which lubricates the eye cavity as well as the eyelid by any winkling motion.
~' , The results of a comparison with other products, as related to the indicated parameters, are summarized in the table 1 herebelow.
Table l Lubricant Artificial Vaseline-based Hyaluronic TearsOintment Acid (1%) Prosthesis contact time + ~ ~ + + + + + +
Lubricatlon efficiency + ~ ~ + + ~ + + +
Transparency + + + ,+ ~ ~ + + +.
Anti-inflammatory effect ~ ~ ~ ~ ~ ~ +,+ +
The present invention has be~n described with 2~ reference to a preferred embodiment; however it is to '' ,' ' ' , -~ ' :
.
be understood that any change and/or modification could be made by any person skilled in the art without being out of the scope of the invention.
.~ ., ~ ....................... . .
""'' :' ~ : ~
: . . .: . .
,
The present invention relates to the use of hyaluronic acid as lubricant for ocular prosthesis.
More particularly, this invention relates to the use of compositions comprising hyaluronic acid as lubricant in fitting either an ocular bulb substituting prosthesis into an ocular cavity, or a prosthesis for sub-atrophic or micro-ophtalmic bulbs of eyes.
Hyaluronic acid is a polysaccharide, whlch is 1~ present to a large extent in a number of human tissues, such as the connective tissue, and in biological ~luids, such as the synovial fluid of the eye vitreous body (Balasz, B A., Armand, G.:"Glycosaminoglycans and ~roteoglycan8 in physiological and pathological processeR o~ Body Systems, Varmas, R.Ed. Karger Basel, 1982).
Generally, hyaluronic acid i8 used by means of intrarticular in~ections, as ad~uvant in the therapy of degenerative and/or in~lammatory diseases of the articular synovial sheats.
Hyaluronic acid is used largely in the oph~almic surgery, due to its elasto-viscous properties and rheologic properties ~Balasz, E.A., Fed.Proc., 17~
1086-1093, 1958). Particularly, hyaluronic acid is used in cataract operations, that are associated with intraocular lens implantation, as well as glaucoma and corneal tranaplant operations and more generally in any traumatopathy involving retinal detachement.
Moreover, diluted solutions of hyaluronic acid, less than 0.2 % w/v, could be used to relieve from S symptoms of lacrimal film diseases, as substitute of mucines, that are present in the physiological state (Stuart, A.C. and Linn, J.G., "Ann. of Ophtalmol.", 17 (3), 190-192, 1985).
Users of ocular prosthesis, to be fitted either into anophtalmic cavities or to sub-atrophic or micro-opthalmic bulbs of eyes, often suffer from an excess of ocular cavity dryness, particularly under special weather or environmental conditions, such as windy or cold conditions, or because of prolonged stay in too heated or dusty rooms. Thi8 is very troublesome, a~ it avoids the eyelids to correctly slide, thus causing conjunctive inflammatory process, due to the reaction against the eyelid friction. These problems occur frequently to patients with a prosthesis into the anophtalmic cavity, where the lacrimal gland function i5 very poor.
The collyrium compositions of the previous art are uneffective. Actually, the so-called nArtificial tears", though offering an immediate relief, evaporate very quickly and therefore need to be administered continuously.
~ 3 ~ 20 8 ~ 18 8 Vaseline-based ointments, though having higher stability and more lasting effect, are deposited on the front surface of the prosthesis, causing a lot of aesthaetic prejudice. Moreover, vaseline, though having acceptable lubrication properties, has `a poor elastoviscosity, thus causing the ointment, which is present between the prosthesis and the underlying tissues, to be gradually removed under shear conditions.
The authors of the present invention found that hyaluronic acid solutions are useful as elasto-viscous lubricants in ~itting ocular prosthesis, as they are-able to damp the pressure changements, frequently occuring between the ocular prosthesi~ and the underlying ti~sues.
Moreover, the authors have de~ined the optimized hyaluronic acid concentrations, that differ ~rom the usual concentrations for other uses. Hyaluronic acid . . .
compositions according to this invQntion showed a good stability, a sufficient lasting lubrication effect and a transparent appearance. Furthermore, a decrease of the reaction conjunctive hyperaemia is experienced on treated pati~nts, due to the anti-inflammatory action of hyaluronic acid.
Therefore, it is an object of the present invention the use of compositions comprising hyaluronic acid having the formula.
o~ ~CO~, ~ ~ ; ~ ~coc-l>
where 400 < n < 8000, for the manufacture of a medicament acting as lubricant of ocular prosthesis.
Preferably, said medicament comprises hyaluronic acid at a concentration from 0.2% to 2.0% by weight, more preferably at a concentration from 0.7% to 1.25%
by weight.
According to a preferred embodiment of the inven-tion, said compositions of hyaluronic acids comprise hyaluronic acid at purity grade higher than 99%, pre~erably extracted ~rom non pathogenic bacteria of the Streptococcus genus.
Furthermore, according to the invention, said compositions comprise a NaCl solution in such amount to , give the solution with a cryoscopic lowering from 0.1C
to 0.7C, and a phosphate buffer at pH comprised between 6.5 and 7.5.
The present invention will be described with reference to an applicative but not limitating example.
~xample 1 2~ Commercially available hyaluron~c acid is purified either by cock creats or by Streptococcus non pathogenic bacterial ~tFains, grown into fermenters.
,... " . .
' '' ' ' : "' '' '.' '' ''' ' ' ' . ' . .- .
,~; ; . . :
- - , , - . - -~ 5 ~ 2086188 This last source produces a material of higher purity degree and with a more uniform molecular weigth.
The authors of the invention have used hyaluronic acid from bacteria fermentation, as described in US
Patent n.4,480,414; however it is to be understood that any other source and/or purification procedure could be used without being out of the scope of the invention.
The used hyaluronic acid has a purity degree higher than 99~ and a molecular weigth from 200,000 to 4,000,000 dalton. The purified hyaluronic acid is dissolved into a NaCl solution in such an amount to give the resulting solution with a cryoscopic lowering from 0.1C to 0.7C in the presence of a phosphate buffer with pH 7Ø The ~ore e~fective concentration results to be o~ 1.0%, as related to the parameters which will be discussed in the following.
The composition, which appears as a gel, has to be administered in two phases. When the prosthesis is .
introduced into the ocular cavity, a gel amount of appr. 1 cm is spread over the concave surface of the prosthesis. After the prosthesis has been inserted, an other gel amount of appr. 1 cm is also administered to the internal part of the superior eyelid; by allowing the eyelid to open and clo~e two or three times, the product is spread throughout the prosthesis surface and produces a transparent film, which lubricates the eye cavity as well as the eyelid by any winkling motion.
~' , The results of a comparison with other products, as related to the indicated parameters, are summarized in the table 1 herebelow.
Table l Lubricant Artificial Vaseline-based Hyaluronic TearsOintment Acid (1%) Prosthesis contact time + ~ ~ + + + + + +
Lubricatlon efficiency + ~ ~ + + ~ + + +
Transparency + + + ,+ ~ ~ + + +.
Anti-inflammatory effect ~ ~ ~ ~ ~ ~ +,+ +
The present invention has be~n described with 2~ reference to a preferred embodiment; however it is to '' ,' ' ' , -~ ' :
.
be understood that any change and/or modification could be made by any person skilled in the art without being out of the scope of the invention.
.~ ., ~ ....................... . .
""'' :' ~ : ~
: . . .: . .
,
Claims (6)
1. Compositions for the use as lubricant of ocular prosthesis comprising hyaluronic acid with the formula:
where 400 < n < 8000, in a pharmaceutically acceptable carrier.
where 400 < n < 8000, in a pharmaceutically acceptable carrier.
2. Compositions according to claim 1, comprising hyaluronic acid at a concentration from 0.2% to 2.0% by weight.
3. Compositions according to claim 2, comprising hyaluronic acid at a concentration from 0.7% to 1.25%
by weight.
by weight.
4. Compositions according to any of the previous claims, comprising hyaluronic acid at purity grade higher than 99%.
5. Compositions according to claim 4, comprising hyaluronic acid extracted from non pathogenic bacteria of the Streptococcus genus.
6. Compositions according to any of the previous claims, comprising a NaCl soultion in such an amount to give the solution with a cryoscopic lowering from 0.1°C
to 0.7°C in presence of a phosphate buffer with pH from 6.5 to 7.5.
to 0.7°C in presence of a phosphate buffer with pH from 6.5 to 7.5.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITCT920039 | 1992-01-20 | ||
| IT92-A/000039 | 1992-01-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2086188A1 true CA2086188A1 (en) | 1993-07-21 |
Family
ID=11348459
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2086188 Abandoned CA2086188A1 (en) | 1992-01-20 | 1992-12-23 | Use of hyaluronic acid as ocular prosthesis lubricant |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2086188A1 (en) |
-
1992
- 1992-12-23 CA CA 2086188 patent/CA2086188A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |