1. A coating composition for coating a polymeric cartridge of an intraocular lens delivery system; said composition comprising: (a) a base coat comprising a base polymer(s) dissolved in at least one first solvent and (b) a top coat comprising a hydrophilic polymer(s) dissolved in at least one second solvent(s).

2. A coating composition as claimed in claim 1, wherein the base polymer is at least one selected from the group consisting of Polypropylene- graft-maleic anhydride (chlorine free), chlorinated Polypropylene- graft-maleic anhydride and poly ethylene glycol.

3. A coating composition as claimed in claim 1, wherein the base polymer is polypropylene- graft-maleic anhydride (chlorine free).

4. A coating composition as claimed in claim 1, wherein the first solvent is at least one selected from the group consisting of hydrocarbons, esters, alcohols, anhydrides and ketones.

5. A coating composition as claimed in claim 1, wherein the first solvent is a mixture of methyl cyclohexane and butyl acetate.

6. A coating composition as claimed in claim 1, wherein the percentage of base polymer ranges between 6.0 % and 8.0 %; hydrocarbon solvent ranges between 45.0 % and 63.0 % and ester solvent ranges between 45.0 % and 63.0 % of the total composition of the base coat.

7. A coating composition as claimed in claim 1, wherein the polymer used for top coat is at least one selected from the group of hydrophilic polymers consisting of polyurethane and its co-polymer, poly (vinylpyridine), polyacrylamide and poly amines.

8. A coating composition as claimed in claim 1, wherein the hydrophilic polymer is a co-polymer of polyether and polyurethane.

9. A coating composition as claimed in claim 1, wherein the second solvent is at least one selected from the group of polar solvents consisting of alcohols, ethers, anhydrides and ketones.

10. A coating composition as claimed in claim 1, wherein the second solvent is a mixture of tetrahydrofuran and ethanol.

11. A coating composition as claimed in claim 1, wherein the percentage of hydrophilic polymer ranges between 1.0 % and 3.0 %, the percentage of ether solvent ranges between 48.0 % and 68.0 % and the percentage of alcohol solvent ranges between 31.0 % and 49.0 % of the total composition of the top coat.

12. A method for coating a polymeric cartridge of an intraocular lens delivery system; said method comprising the following steps: (a) cleaning the polymeric cartridge using water in the temperature range of 30 °C to 40 °C in ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying in hot air oven at a temperature ranging between 40 °C and 120 °C and cooling at room temperature; (b) Coating the cleaned polymeric cartridge by the process comprising the following steps: i) applying the base coat by mixing the base polymer in the first solvent for a time period ranging between 10 minutes to 120 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 30 minutes to 120 minutes in air circulated hot oven and cooling at room temperature; and ii) applying the top coat by mixing the hydrophilic polymer in second solvent(s) for a time period ranging between 10 minutes and 180 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 10 hours and 14 hours in air circulated hot oven and cooling at room temperature; and (c) cleaning the coated polymeric cartridge by water at a temperature ranging between 30 °C and 40 °C using ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying under hot air oven at a temperature ranging between 30 °C and 50 °C for a time period ranging between 30 minutes to 60 minutes.

13. A method as claimed in claim 12, wherein in step (b) the coating is applied by at least one coating method selected from the group consisting of micro spray coating, dipping and using pipette.

14. A coated polymeric cartridge as prepared by the method of claim 12.

15. An intraocular lens delivery system comprising the coated polymeric cartridge of claim 14.

16. A kit comprising a base polymer, a hydrophilic polymer, a first solvent, a second solvent and sprayers.

FIELD

The present disclosure relates to an intraocular lens delivery system.

BACKGROUND

An intraocular lens (IOL) is an implanted lens in the eye that replaces the existing crystalline lens. IOL implantation is done for the treatment of cataract or for altering the optical properties of or to provide vision correction to an eye in which the natural lens remains. IOLs include an optic and preferably at least one flexible fixation member or haptic which extends from the optic and becomes affixed in the eye to secure the lens in position within the capsular bag inside the eye. The optic normally includes an optically clear lens.

Implantation of IOLs in the eye involves making an incision in the eye. Insertion of an intraocular lens for the treatment of cataracts is the most commonly performed eye surgical procedure. The procedure can be done under local anesthesia with the patient awake throughout the operation. The use of a flexible IOL enables the lens to be rolled for insertion into the capsule through a very small incision, thus avoiding the need for many stitches.

A small incision in the eye for implantation of IOL is advantageous as it helps to reduce trauma and speeds healing after surgery. IOLs are known which are foldable (deformable) so that the IOL can be inserted through a smaller incision into the eye. A substantial number of instruments have been proposed to aid in inserting such a foldable lens in the eye.

Many of the prior art IOL insertion systems load and/or fold the lens at the distal end, that is at the end closest to the eye or the end inserted into the eye. Such "distal loading" systems often disadvantageous^ include a space consuming loading component at or near the distal end of the system which causes the distal end to be relatively large. This relatively large distal end makes inserting the IOL through a small incision more difficult. Systems which fold and load the IOL proximally provide certain advantages compared to "distal loading" systems, such as reduced stress on the IOL and/or inserter.

However, whether using a distal loading or proximal loading system, one factor which limits the size of the inserter tube is the inserter tube itself; e.g. material from which the inserter tube is made like polypropylene and the like polymeric materials. These materials are not compatible to cause optics made from polymeric materials like silicone, to pass through relatively small hollow spaces. The injector tubes are made of materials, in particular polymeric materials, which have insufficient lubricity to facilitate the passage of a folded IOL through the tube. As a result of this lack of lubricity, the hollow space of the injector tube must be made relatively larger to accommodate the folded intraocular lens. This is detriment since it is advantageous to have the smallest possible incision for insertion of the IOL. In addition, if one were to use a small diameter tube to pass the IOL, excessive force might be needed to pass the IOL through the small hollow space thereby increasing the risks of damaging the IOL and, in extreme cases, even damaging the eye into which the IOL is placed.

One approach that is considered for facilitating the passage of folded intraocular lens is to use a lubricity agent such as conventional visco-elastic agents, in the hollow space of the tube to facilitate passing the IOL through the insertion apparatus. However, such lubricity agents themselves occupy valuable space, thereby at least partially defeating the purpose of using such agents. Also, such lubricity agents often end up in the eye, thereby creating the risk of causing trauma and/or irritation and/or damage to the eye.

Existing Knowledge:

United States Patent No. 4240163 discloses an intraocular lens coated with a compatible medicament, such as an anticoagulant, an anti-inflammatory agent or an anti-complement agent.

United States Patent No. 5272012 discloses a method for providing a medical apparatus with a protective, lubricious coating is described. The method comprises providing a coating solution which contains a protective compound such as urethane, a slip additive such as siloxane, and optionally, a cross linking agent for the protective compound such as polyfunctional aziridine, coating the solution onto a surface of a medical apparatus and allowing the coating to set. The resulting surface coating is lubricious, tough and flexible.
The coating is well suited for use with materials used as components of balloon catheters.

United States Patent No. 5803925 discloses an apparatus for inserting intraocular lenses (IOLs) into the eyes. In one embodiment, such apparatus includes a hollow tube including an interior wall defining a hollow space through which an IOL is passed and an outlet through which the IOL is passed from the hollow space into an eye, and a lubricity enhancing component covalently bonded to the hollow tube at the interior wall in an amount effective to at least assist in facilitating the passage of the IOL through the hollow space.

United States Patent No. 6177523 disclose functionalizable and crosslinkable polyurethanes formed of a polyurethane intermediate including one or more ester groups which react with an amine equivalent to form an amide unit. The polyurethane intermediate comprises the reaction product of alkyl ester of dihydroxypolyacid or dimethylolalkanoic acid, a polyoxyalkylene diol and an organic diisocyanate.

The polyurethane is reacted with a solution of an amine equivalent and a solvent or an amine. An article of manufacture can be formed from the polyurethane.

United States Patent No. 6280449 discloses inserter devices that employ a flexible, deformable sleeve to house an implant. In one embodiment, a device is described that employs squeezing blades to advance an implant through the flexible sleeve into a passageway, tissue or cavity of the body. The invention further relates to holders for the sleeve to facilitate loading of an implant into the sleeve.

United States Patent No. 6679891 discloses an apparatus for inserting intraocular lenses (IOLs) into eyes which includes a hollow tube including a material and having an interior wall defining a hollow space through which an IOL is passed and an outlet through which the IOL is passed from the hollow space into an eye, and a lubricity enhancing component physically secured to said hollow tube and concentrated at or near the interior wall in an amount effective to facilitate the passage of the IOL through the hollow space.

United States Patent Application No. 2001000351 discloses a method of selecting an intraocular lens material for reducing the risk of posterior capsule opacification.

United States Patent Application No. 2009155595 discloses a polymeric composite including (1) a substrate formed of a moldable polymer; (2) a first polymeric layer containing a base polymer, the first layer adhering to a surface of the substrate by physical entrapment of at least some molecules of the base polymer in the substrate; and (3) a second polymeric layer containing a hydrophilic polymer, the second layer adhering to a surface of the first layer by physical entrapment of at least some molecules of the hydrophilic polymer in the first layer. The aforementioned patent application also discloses a device including such a composite for delivering an intraocular lens.

WO2010059655 discloses intraocular lens (IOL) delivery device. The device includes an intraocular lens cartridge having an internal coating wherein the coating includes a polymeric material that is compatible with a polymeric material of a material that forms the cartridge. Preferably, the polymeric material of the coating, the cartridge or both is polyurethane.

WO2010118080 discloses an IOL injector that includes a hydrophilic coating component that is effective to facilitate the passage of the IOL through the injector, particularly an injector tip. The IOL injector is prepared by a process that includes irradiating at least a portion of a polymeric, IOL injector with UV light in an environment comprising oxygen to provide a positive percent change in the atomic oxygen content of the polymer material at the surface as determined by X-ray Photoelectron Spectroscopy (XPS). The irradiated portion is then contacted with a solution comprising a hydrophilic coating component is selected from a hydrophilic polymer, a hydrophilic copolymer or any one mixture thereof to provide a solution coated portion. The solution coated portion is then heated at a temperature to provide portions of the IOL injector with a shelf-stable, lubricious hydrophilic coating to facilitate delivery of an IOL from the injector.

However the intraocular lens delivery apparatus known in the prior art documents makes use of lubricity agents for smooth delivery of lens in to the eyes; thus increasing the risk of causing trauma and/or irritation and/or damage to the eye due to the contact of these lubricants with the eyes. Also, the methods described for preparing coating composition for smooth delivery of lens are tedious and time consuming and thereby costly. Therefore there is felt a need for simple, safe and cost effective method for preparing a coating composition for smooth delivery of lens that can overcome the drawbacks of the prior art documents and provide an efficient and smooth delivery of lens in controlled manner without using excessive force.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

An object of the present disclosure is to provide an intraocular lens delivery system for smooth delivery of lens without using excessive force.

Another object of the present disclosure is to provide a coating composition for smooth delivery of lens.

Yet another object of the present disclosure is to provide an intraocular lens delivery system that helps in making a small incision in the eye and reduces the trauma and speeds healing in patients.

An additional object of the present disclosure is to provide a simple, safe and cost effective intraocular lens delivery system for smooth delivery of lens.

Other objects and advantages of the present disclosure will be more apparent from the following description when read in conjunction with the accompanying figures, which are not intended to limit the scope of the present disclosure.

SUMMARY

In accordance with the present disclosure, there is provided a coating composition for coating a polymeric cartridge of an intraocular lens delivery system; said composition comprising:

(a) a base coat comprising a base polymer(s) dissolved in at least one first solvent and

(b) a top coat comprising a hydrophilic polymer(s) dissolved in at least one second solvent(s).

Typically, the base polymer is at least one selected from the group consisting of Polypropylene- graft-maleic anhydride (chlorine free), chlorinated Polypropylene-graft-maleic anhydride and poly ethylene glycol.

Preferably, the base polymer is polypropylene- graft-maleic anhydride (chlorine free).

Typically, the first solvent is at least one selected from the group consisting of hydrocarbons, esters, alcohols, anhydrides and ketones.

Preferably, the first solvent is a mixture of methyl cyclohexane and butyl acetate.

Typically, the percentage of base polymer ranges between 6.0 % and 8.0 %; hydrocarbon solvent ranges between 45.0 % and 63.0 % and ester solvent ranges between 45.0 % and 63.0 % of the total composition of the base coat.

Typically, the polymer used for top coat is at least one selected from the group of hydrophilic polymers consisting of polyurethane and its co-polymer, poly (vinylpyridine), polyacrylamide and polyamines.

Preferably, the hydrophilic polymer is a co-polymer of polyether and polyurethane.

In accordance with the present disclosure, the second solvent used for mixing the hydrophilic polymer is at least one selected from the group of polar solvents consisting of alcohols, ethers, anhydrides and ketones.

Preferably, the second solvent is a mixture of tetrahydrofuran and ethanol.

Typically, the percentage of hydrophilic polymer ranges between 1.0 % and 3.0 %, the percentage of ether solvent ranges between 48.0 % and 68.0 % and the percentage of alcohol solvent ranges between 31.0 % and 49.0 % of the total composition of the top coat.

In accordance with the present disclosure, there is provided a method for coating a polymeric cartridge of an intraocular lens delivery system; said method comprising the following steps:

(a) cleaning the polymeric cartridge using water in the temperature range of 30 °C to 40 °C in ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying in hot air oven at a temperature ranging between 40 °C and 120 °C and cooling at room temperature;

(b) Coating the cleaned polymeric cartridge by the process comprising the following steps:

i) applying the base coat by mixing the base polymer in the first solvent for a time period ranging between 10 minutes to 120 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 30 minutes to 120 minutes in air circulated hot oven and cooling at room temperature; and

ii) applying the top coat by mixing the hydrophilic polymer in second solvent(s) for a time period ranging between 10 minutes and 180 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 10 hours and 14 hours in air circulated hot oven and cooling at room temperature; and

(c) cleaning the coated polymeric cartridge by water at a temperature ranging between 30 °C and 40 °C using ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying under hot air oven at a temperature ranging between 30 °C and 50 °C for a time period ranging between 30 minutes to 60 minutes.

In accordance with the present disclosure, in step (b) the coating is applied by at least one coating method selected from the group consisting of micro spray coating, dipping and using pipette.

In accordance with the present disclosure, there is provided a coated polymeric cartridge.

In accordance with the present disclosure, there is provided an intraocular lens delivery system comprising the coated polymeric cartridge of the present disclosure.

In accordance with the present disclosure, there is provided a kit comprising a base polymer, a hydrophilic polymer, a first solvent, a second solvent and sprayers.

BRIEF DESCRIPTION OF DRAWINGS

The present disclosure will now be described with reference to the accompanying drawings, in which;

Figure 1 illustrates a coated cartridge prepared in accordance with the present disclosure.

Figure 2 illustrates both coated and uncoated cartridge.

Figure 3 A illustrates coating thickness of the coated cartridge in accordance with the present disclosure.

Figure 3 B illustrates a graph of height against width of the thickness of the coated cartridge prepared in accordance with the present disclosure. The height (A-B) is 26.83 urn and the width (C-D) is 167.9 urn.

DETAILED DESCRIPTION

The description herein after the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

The present disclosure provides an intraocular lens delivery system for smooth and efficient delivery of lens into the eyes. The system includes an intraocular lens polymeric cartridge having coatings; base and top coat, wherein the coating includes a polymeric material that is compatible with the polymeric material that forms the cartridge. The top coat is applied of a hydrophilic polymer in order to increase the lubricity of the polymeric cartridge of the intraocular lens delivery system to facilitate the passage of the folded lens through a small incision in the eye.

The polymeric material of the cartridges includes but is not limited to polypropylene, polycarbonate, polyethylene, polyamide, polytetrafluoroethylene, polystyrene, polyvinylchloride and polyether ketones.

Preferably, the polymeric material of the cartridge is polypropylene.

In accordance with one aspect of the present disclosure there is provided a coating composition for coating a polymeric cartridge, preferably polypropylene cartridge, of the intraocular lens delivery system.

There are two coatings done on the surface of the polymeric cartridge, preferably on the interior surface:

1) Base coat and

2) Topcoat.

1) Base coat:

The polymer used for base coat is termed as base polymer and the solvent used for mixing it is referred as the first solvent for detailed understanding of the present disclosure.

The base polymer of the present disclosure used for base coat is at least one selected from the group consisting of Polypropylene- graft-maleic anhydride (chlorine free), chlorinated Polypropylene- graft-maleic anhydride and poly ethylene glycol.
Preferably, the base polymer is polypropylene- graft-maleic anhydride (chlorine free).

The first solvent of the present disclosure used for mixing the base polymer is at least one selected from the group of hydrocarbons, esters, alcohols, anhydrides and ketones.

Preferably, the first solvent used is a mixture of methyl cyclohexane and butyl acetate.

In accordance with the present disclosure, the percentage of base polymer present in the composition of the base coat ranges between 6.0 % and 8.0 %.

The percentage of hydrocarbon solvent ranges between 45.0 % and 63.0 %.

The percentage of ester solvent ranges between 29.0 % and 49.0 %.

In accordance with one of the embodiment of the present disclosure, the amount of base polymer present in the composition of base coat ranges between 5 grams and 50 grams.
In accordance with another embodiment of the present disclosure, the amount of non polar solvent present in the composition of the base coat ranges between 50 grams and 300 grams.

In accordance with still another embodiment of the present disclosure, the amount of polar solvent present in the composition of the base coat ranges between 25 grams and 300 grams.

2) Top coat;

The polymer used for top coat is a hydrophilic polymer and the solvent used for mixing it is referred as the second solvent for detailed understanding of the present disclosure.
In accordance with the present disclosure, the polymer used for the top coat is at least one selected from the group of hydrophilic polymers consisting of polyurethane and its co-polymer, poly (vinylpyridine), polyacrylamide and polyamines.
Preferably, the hydrophilic polymer is co polymer of polyurethane and polyether;
(hydrophilic polyether polyurethane).

The second solvent used in the present disclosure is at least one selected from the group of polar solvents.

The polar solvent used for mixing the hydrophilic polymer in accordance with the present disclosure is at least one selected from the group of alcohols, ethers, anhydrides and ketones.

Typically, the second solvent used is a mixture of ether and alcohol.

Preferably, the second solvent used is a mixture of tetrahydrofuran and ethanol.

The percentage of hydrophilic polymer present in the composition of the top coat of polymeric cartridge in accordance with the present disclosure ranges between 1.0 % and 3.0 %.

The percentage of ether solvent present in the composition of the top coat of polymeric cartridge in accordance with the present disclosure ranges between 48.0 % and 68.0 %.

The percentage of alcohol solvent present in the composition of the top coat of polymeric cartridge in accordance with the present disclosure ranges between 31.0% and 49.0%.

In accordance with one of the embodiment of the present disclosure, the amount of polymer present in the composition of the top coat ranges between 1.0 gram and 8.0 grams.

In accordance with another embodiment of the present disclosure, the amount of ether present in the composition of the top coat ranges between 45 grams and 350 grams.

In accordance with still another embodiment of the present disclosure, the amount of alcohol present in the composition for the top coat ranges between 20 grams and 350 grams.

In accordance with another aspect of the present disclosure there is provided a method for coating the polymeric cartridge of the intraocular lens delivery system; said method comprising the following steps:

(a) cleaning the polymeric cartridge before coating;

(b) coating the cleaned polymeric cartridge using coating composition provided by the present disclosure; and

(c) cleaning the coated polymeric cartridge.

(a) cleaning the polymeric cartridge before coating; -

Polymeric cartridges are cleaned using water in the temperature range of 30 C to 40 °C using ultrasonic cleaning machine.

Preferably, polypropylene cartridges are used in the process provided by the present disclosure.

Preferably, distilled water is used for cleaning the polymeric cartridges.

The time period required for cleaning ranges between 1 minute and 30 minutes.

After cleaning, the polymeric cartridges are taken out from ultrasonic cleaning machine and dried in hot air oven at a temperature ranging between 40 °C and 120
°C.

Finally, the polymeric cartridges are cooled to a temperature ranging between 20 °C and 30 °C for a time period in the range of 30 minutes to 180 minutes.

(b) coating the cleaned polymeric cartridge using the coating composition provided by the present disclosure:-

A) Process for base coating;

The base polymer of the present disclosure used for base coat is mixed in first solvent for a time period ranging between 10 minutes and 120 minutes.

The cleaned polymeric cartridge, obtained from step 1, is coated with the base coat, as provided by the present disclosure, using known coating methods like dipping, spraying, using pipette or suitable methods.

Preferably, the coating is done using the micro spray coating technique.

The polymeric cartridges after coating is cured in the temperature ranging between 80 °C and 100 °C for a time period in the range of 30 minutes to 120 minutes in air circulated hot oven.

The cured polymeric cartridges are taken from the hot air oven and cooled to a temperature ranging between 25 °C and 35 °C for a time period in the range of 10 minutes to 20 minutes.

B) Process for top coating:

The hydrophilic polymer used for top coat in the present disclosure is mixed in second solvent(s) for a time period ranging between 10 minutes and 180 minutes.

The base coated polymeric cartridge, obtained from step 2, is coated with the composition of the top coat, as provided by the present disclosure, using known coating methods like dipping, spraying, using pipette or suitable methods.

Preferably, the coating is done using the micro spray coating technique.

The polymeric cartridges after top coating is cured at a temperature ranging between 80 °C and 100 °C for a time period in the range of 10 hours to 14 hours in air circulated hot oven.

The cured polymeric cartridges are taken from the hot air oven and cooled to a temperature ranging between 25 °C to 35 °C for a time period in the range of 10 minutes to 60 minutes.

3. Ultrasonic cleaning process:

Coated polymeric cartridges, obtained from step 2, are cleaned by water at a temperature ranging between 30 °C and 40 °C using ultrasonic cleaning machine for a time period in the range of 1 minute to 30 minutes.

The coated polymeric cartridges are dried by known methods of drying.

Preferably, the drying is carried under air circulated oven or laminar bench.

Finally the drying is carried out under hot air oven at a temperature ranging between 30 °C and 50 °C for a time period in the range of 30 minutes to 60 minutes.

The present disclosure provides a lubricous polymeric cartridge for smooth delivery of intraocular lens to be used in the intraocular lens delivery system.

The present disclosure also provides an intraocular lens delivery system comprising the coated polymeric cartridges obtained by the process of the present disclosure.

In accordance with the present disclosure, there is also provided a kit comprising a base polymer, a hydrophilic polymer, a first solvent, a second solvent and sprayers.

The present disclosure will now be explained with the help of some of the following examples:

EXAMPLES:

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description.
Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

Example 1:-

Polypropylene cartridge was cleaned with distilled water at 35°C using ultrasonic cleaning machine for 10 minutes. After cleaning the cartridges were taken out from ultrasonic cleaning machine and dried in hot air oven at 60 °C. The cartridge was then taken out from the oven and cooled at room temperature for one hour.

10.0 grams of Polypropylene graft maleic anhydride (chlorine free) was mixed in a mixture of 100.0 grams of methyl cyclohexane and 75.0 grams of butyl acetate for 30 minutes to obtain a base coat. The base coat was applied to the cartridge by micro spray coating technique followed by curing in air circulated hot oven for one hour at 90 °C. The cartridge was then cooled at room temperature for 20 minutes.

4.0 grams of Polyether hydrophilic polyurethane was mixed in a mixture of 150.0 grams of tetrahydrofuran and 150.0 grams of ethanol for 50 minutes to obtain a top coat. The top coat was applied on the base coated cartridge by microspray coating technique followed by curing in air circulated hot oven for twelve hours at 90 C. The coated cartridge was then cooled at room temperature for one hour.

Coated Polyproylene cartridge was cleaned with distilled water at 35°C using ultrasonic cleaning machine for 10 minutes. It was initially dried under air circulated oven or laminar bench and then dried in hot air oven at 40 °C for 30 minutes.

Testing details of the coated polymeric cartridges:

• Injection force test was done to evaluate the coating performance of the polymeric cartridges provided by the present disclosure. The values are as shown in the table below:

Table 1

Lens Diopters Injection Force value (Aurolab-C200)(N)

D15 5.46
D20 6.615
D25 8.9
D30 10.98

Evaluation:

The coated polymeric cartridges of the intraocular lens delivery system of the present disclosure is lubricous in nature and helps in the smooth and efficient delivery of the intraocular lens injecting through it. The lubricous nature of the polymeric cartridges as provided by the present disclosure is proved from the following observations:

■ During injection - No lens breakages
■ During injection - No lens scratches
■ During injection - require less injection force
■ During injection - lens smooth delivery

Cytotoxicity test: The cytotoxicity study was done using the ISO Elution method -single strength Minimum Essential Medium (IX MEM) Extract.

The in vitro study was conducted to evaluate IOL cartridge for potential cytotoxic effects following the guidelines of International Organization for Standardization 10993:
Biological Evaluation of Medical Devices, Part 5: Tests for In vitro Cytotoxicity. A single preparation of the test article was extracted in single strength Minimum Essential
Medium (IX MEM) at 37 °C for 24 hours. The negative control, reagent control, and positive control were similarly prepared. Triplicate monolayers of L-929 mouse fibroblast cells were dosed with each extract and incubated at 37°C in presence of 5% C02 for 48 hours. Following incubation, the monolayers were examined microscopically for abnormal cell morphology and cellular degeneration. The test extract showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was less than a grade 2 (mild reactivity).

The test details for determining cytotxicity are as follows:

1) Extraction Vehicle:- Single strength Minimum Essential Medium supplemented with 5% fetal bovine serum, 2% antibiotics (100 units/mL penicillin, 100 ug/mL streptomycin and 2.5 ^ig/mL amphotericin B) and 1% (2 mM) L-glutamine (IX MEM)

2) Negative Control Article:- High density polyethylene (HDPE)

3) Negative Control Article Stability Testing:- Marketed product; stability characterized by its labeling.

4) Negative Control Article, Purity and Composition:- HDPE; Purity: Meets USP
<661> Polyethylene Containers, Multiple Internal Reflectance, Thermal Analysis,

Heavy Metals, and Non-Volatile Residue; Composition: Neat CAS #: 9002-88-4.

5) Reagent Control Article;- 1 X MEM

6) Reagent Control Article Stability Testing:- Stable for the duration of the study.

7) Reagent Control Article, Composition:- IX MEM: Composition: 92% Gibco MEM w/Earle's Salts, 5% fetal bovine serum, 2% antibiotics (100 units/mL penicillin, 100 |ig/mL streptomycin and 2.5ug/mL amphotericin B), and 1% (2 mM) L-Glutamine.

8) Positive Control Article:- Plasticized vinyl containing 10,1 O'-oxybisphenoxarsine

9) Positive Control Article Strength, Purity, Composition or other characteristics:- Composition: Di(2-ethylhexyl) phthalate (33%), epoxidized soybean oil (2.5%), organocalcium-zinc soap blend (0.5%), chelator (0.5%), polyvinyl chloride resin (62%), Vinyzene BP-5-2 in DEHP (arsenic in DEHP; 1.5%), stearoylbenzoylmethane (0.05%), ultramarine blue color (0.0 1 %). Note: Vinyzene BP-5-2 in DEHP contains 10,1 O'-oxybisphenoxarsine.

Extraction procedure: A single preparation of the test article and each of the controls were subjected to the following extraction conditions as described below.

Table 1

The extracts were continuously agitated during extraction.

Table 2

Test System and Justification of Test System

Mammalian cell culture monolayer consisting of L-929 mouse fibroblast cells (ECACC Cat# 85 103 1 15, or equivalent source) were used. In vitro mammalian cell culture studies have been used historically to evaluate cytotoxicity of biomaterials and medical devices.

Test System Management

L-929 mouse fibroblast cells were propagated and maintained in IX MEM at 37'C with 5% carbon dioxide (CO2). For this study, 10 cm2 wells were seeded, labeled with passage number and date, and incubated at 37°C with 5% C02 to obtain sub-confluent monolayers of cells prior to use. Aseptic procedures were used in the handling of the cell cultures.

Method:

Triplicate culture wells were selected which contained a sub-confluent cell monolayer. The growth medium contained in the triplicate cultures was replaced with 2 mL of the test extract in each well. Similarly, the growth medium in triplicate 10 cm wells was replaced with 2 mL of the reagent control, the negative control and the positive control extract. The wells of each plate were labeled with the appropriate lab number or control and the replicate number. Each plate was labeled with the test code and the dosing date.
The wells were incubated at 37°C with 5% C02 for 48 hours.

Following incubation, the cultures were examined microscopically (100X) to evaluate cellular characteristics and percent lysis.

Table 3

The color of the test medium was observed to determine any change in pH. A color shift toward yellow indicates an acidic pH range and a color shift toward magenta to purple indicates an alkaline pH range.

For the test to be valid, the reagent control and the negative control must have had a reactivity of none (grade 0) and the positive control must have been a grade 3 or 4.

The test sample met the requirements of the test if the biological response was less than or equal to grade 2 (mild).

Results:- No cytotoxicity or cell lysis was noted in any of the test wells. No pH shift was observed at 48 hours. The reagent control, negative control and the positive control performed as anticipated.

Conclusion:- The test extract showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was less than a grade 2 (mild reactivity). The individual reactivity grades are as shown in Table 4.

Table 4 - Reactivity Grades For Elution Testing

Note: A, B and C denotes replicates

Anecdotal studies: The following table represents the details of anecdotal studies using the cartridge prepared in accordance with the present disclosure:
The test was conducted on both male and female patients with implanted lens model FH5600AS and lens dioptor ranging from 18.0 to 22.0. The required incision size was in the range of 2.2 mm to 3.0 mm.

The results are as follows:

Table 5:

The post operative complications -1 day data are as follows:

No. of Patients Study Parameters

IOL: Intraocular Lens

TECHNICAL ADVANTAGES

A coated polymeric cartridge for smooth delivery lens to be used in intraocular lens delivery system, particularly coatings for polypropylene cartridge, and a method for coating the polymeric cartridges ; the composition, method and the intraocular lens delivery system as described in the present disclosure has several technical advantages including but not limited to the realization of:

• the coating composition for the polymeric cartridges to be used for the intraocular lens delivery system as provided by the present disclosure is safe and cost effective;

• the coating process for the polymeric cartridges to be used for the intraocular lens delivery system as provided by the present disclosure is simple, non hazardous and cost effective;

• the polymeric cartridges provided by the present disclosure is lubricous thereby facilitating the smooth delivery of lens in the eye during surgery; thus reducing trauma and speeds healing in the patients; and

• the intraocular lens delivery system comprising the coated polymeric cartridges provided by the present disclosure facilitates the smooth delivery of the lens through a small incision in the eye.

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

The use of the expression "at least" or "at least one" suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

While considerable emphasis has been placed herein on the particular features of this disclosure, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other modifications in the nature of the disclosure or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

We claim:

1. A coating composition for coating a polymeric cartridge of an intraocular lens delivery system; said composition comprising:

(a) a base coat comprising a base polymer(s) dissolved in at least one first solvent and

(b) a top coat comprising a hydrophilic polymer(s) dissolved in at least one second solvent(s).

2. A coating composition as claimed in claim 1, wherein the base polymer is at least one selected from the group consisting of Polypropylene- graft-maleic anhydride (chlorine free), chlorinated Polypropylene- graft-maleic anhydride and poly ethylene glycol.

3. A coating composition as claimed in claim 1, wherein the base polymer is polypropylene- graft-maleic anhydride (chlorine free).

4. A coating composition as claimed in claim 1, wherein the first solvent is at least one selected from the group consisting of hydrocarbons, esters, alcohols, anhydrides and ketones.

5. A coating composition as claimed in claim 1, wherein the first solvent is a mixture of methyl cyclohexane and butyl acetate.

6. A coating composition as claimed in claim 1, wherein the percentage of base polymer ranges between 6.0 % and 8.0 %; hydrocarbon solvent ranges between 45.0 % and 63.0 % and ester solvent ranges between 45.0 % and 63.0 % of the total composition of the base coat.

7. A coating composition as claimed in claim 1, wherein the polymer used for top coat is at least one selected from the group of hydrophilic polymers consisting of polyurethane and its co-polymer, poly (vinylpyridine), polyacrylamide and poly amines.

8. A coating composition as claimed in claim 1, wherein the hydrophilic polymer is a co-polymer of polyether and polyurethane.

9. A coating composition as claimed in claim 1, wherein the second solvent is at least one selected from the group of polar solvents consisting of alcohols, ethers, anhydrides and ketones.

10. A coating composition as claimed in claim 1, wherein the second solvent is a mixture of tetrahydrofuran and ethanol.

11. A coating composition as claimed in claim 1, wherein the percentage of hydrophilic polymer ranges between 1.0 % and 3.0 %, the percentage of ether solvent ranges between 48.0 % and 68.0 % and the percentage of alcohol solvent ranges between 31.0 % and 49.0 % of the total composition of the top coat.

12. A method for coating a polymeric cartridge of an intraocular lens delivery system; said method comprising the following steps:

(a) cleaning the polymeric cartridge using water in the temperature range of 30 °C to 40 °C in ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying in hot air oven at a temperature ranging between 40 °C and 120 °C and cooling at room temperature;

(b) Coating the cleaned polymeric cartridge by the process comprising the following steps:

i) applying the base coat by mixing the base polymer in the first solvent for a time period ranging between 10 minutes to 120 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 30 minutes to 120 minutes in air circulated hot oven and cooling at room temperature; and

ii) applying the top coat by mixing the hydrophilic polymer in second solvent(s) for a time period ranging between 10 minutes and 180 minutes followed by curing at a temperature ranging between 80 °C and 100 °C for a time period in the range of 10 hours and 14 hours in air circulated hot oven and cooling at room temperature; and

(c) cleaning the coated polymeric cartridge by water at a temperature ranging between 30 °C and 40 °C using ultrasonic cleaning machine for a time period ranging between 1 minute and 30 minutes followed by drying under hot air oven at a temperature ranging between 30 °C and 50 °C for a time period ranging between 30 minutes to 60 minutes.

13. A method as claimed in claim 12, wherein in step (b) the coating is applied by at least one coating method selected from the group consisting of micro spray coating, dipping and using pipette.

14. A coated polymeric cartridge as prepared by the method of claim 12.

15. An intraocular lens delivery system comprising the coated polymeric cartridge of claim 14.

16. A kit comprising a base polymer, a hydrophilic polymer, a first solvent, a second solvent and sprayers.