DESC:FIELD OF THE INVENTION
The invention relates to an anti-microbial film-forming composition for disinfecting and protecting body surface such as skin before the surgical procedure, more particularly, to an anti-microbial drug-loaded polymer nano-microparticle suspension that forms a thin layer on skin upon evaporation of alcohol solvent, and the film can be removed by gentle washing. The film formed can sterilize the skin surface and retain the sterility for a prolonged period of up to 24 h. This invention helps to control infection during and after the surgery.

BACKGROUND ART
Disinfecting body parts, especially skin before surgery is a critical initial step for avoiding infection. Typically, in operation theatres, iodine solution (Povidone), spirit, or isopropyl alcohol, with or without antimicrobial agents such as benzalkonium chloride, chlorohexidine is used for sterilizing the area of surgery. However, one of the major limitation of this procedure is the temporary nature of such disinfection method. If any contaminant falls onto the treated skin or such microbes come in contact with the skin during the surgery, that area will be contaminated again because no protective layer is available to hinder such contamination. One of the most appropriate method of protection is to form a barrier layer with anti-microbial properties on the skin that will create both physical and functional protective barrier on the skin. This invention disclose a product and process of making the same that can keep the area of application protected for 24 hrs by sustained release of antimicrobial drug from nano-micro polymeric nanoparticles loaded with the drug.

OBJECT OF THE INVENTION
Infection caused by microbial contaminants during the surgery in operation theatres is a major health burden for patients and hospitals. Such infections will cause prolongation of wound healing process and time to recovery after the surgery. Many times hospital-bound infections are caused by drug-resistant pathogens that are difficult to treat using normal antibiotics or anti-septics. In major surgeries such as cardio-thoracic surgery, gastro- or ortho-surgery, such an additional burden of infection will cause tremendous problems and exorbitant costs due to the requirement of broad-spectrum antibiotics and repeated opening of the stitched area to remove accumulated fluid. All such difficulties can be avoided by preventing the incidence of infection at the surgical table. One of the simple method is to properly disinfect the skin and more importantly, retain the protection throughout the surgical procedure. Thus one of the key object of the present invention is to create a functional and physical barrier with polymer solution that can be applied on the skin for disinfection and prolonged protection. This remains the object of the invention.

SUMMARY OF THE INVENTION
In accordance with the above, the main object of the present invention is to provide a polymer thin film with anti-microbial drugs that can protect body parts from micro-organisms.

Another object of the present invention is to provide a polymer nano-micro particle composition wherein the nano-microparticles are loaded with antimicrobial agents.

In an aspect, the present invention provides a polymer nano-microparticle composition, comprising anti-microbial agents wherein 60-90% of the solvent medium is selected from ethyl alcohol or isopropyl alcohol and the remaining is water.

In an aspect, the present invention provides an anti-microbial polymer composition of nano-microparticles of said polymer loaded with anti-microbial agents comprising;
i. The polymer in an amount of 0.1-5%w/v;
ii. Anti-microbial agents in an amount of 0.05-20%w/v;
iii. Pharmaceutically acceptable excipients in suitable proportion;
wherein said anti-microbial composition comprises 60-95% of the non-aqueous medium.

In another aspect, the polymer is selected from polyvinyl pyrrolidone (0.5-3%w/v), polyethylene glycol (0.2-3%w/v), hydroxypropyl methylcellulose (0.1-5%w/v), methyl cellulose (0.1-5%w/v), ethyl cellulose(0.1-5%w/v), alginate (0.1-2%w/v), poloxamer (0.1-2%w/v) hydroxy ethyl cellulose (0.1 -5%w/v) polyvinyl alcohol, chitosan, Polymethacrylates, Hydroxy ethyl cellulose or combinations thereof.

In another aspect, the present invention provides a polymer nano-microparticle composition, comprising anti-microbial agents selected from Chlorhexidine gluconate (5-30% Solution, equivalent to 0.5-3% w/v of Chlorhexidine gluconate), benzalkonium chloride (5-30% Solution, equivalent to 0.5-3% w/v), iodine (1%-20%w/v), Cetrimide (0.5-3% w/v), and combinations thereof.

In yet another aspect, the present invention provides a polymer nano-microparticle composition, comprising anti-microbial agents, wherein the solid content contains thin-film forming polymers, plasticizer, emollient, moisturizer, gel-forming material, and other excipients to make a smooth clear composition that can be applied on the skin.

In yet another aspect, the present invention discloses a method of preparing the polymer nanoparticle composition loaded with anti- microbial agents comprising.
i. Heating the purified water to a temperature of 75°C± 2°C and adding the first polymer part-by-part to the heated water at same temperature with stirring until complete dispersion of the polymer;
ii. Adding second polymer with suitable excipient to the above solution with stirring until a homogenous blend is obtained;
iii. Cooling the above mixture to room temperature with stirring;
iv. Adding the third polymer to IPA and homogenizing the mixture followed by adding the fourth polymer with stirring until complete dissolution;
v. Adding suitable anti-microbial agents –IPA –polymer to the above mixture and maintaining the solution at room temperature until formation of nano particle of drug loaded polymeric micellar suspension;
vi. Homogenizing the above suspension with high-shear homogenizer until uniform dispersion of polymeric nano-microparticle loaded with anti-microbial agents is obtained.

The dispersion of polymeric nano-microparticle loaded with anti-microbial agents obtained by the process of the present invention is in the form of suspension or a solution.

In another aspect, the the polymer nano-microparticle containing anti-microbial agents of the present invention has di-modal particle size distribution ranging from 1-100nm, and 100-1000nm or tri-modal distribution ranging from: 1-50nm, 50-500nm, and 500-2000nm.

Yet another aspect of the present invention discloses a polymer nano-microparticle compoistion comprising anti-microbial agents, wherein upon application on the skin, the alcohol-water solvent-mixture evaporate within 1-3 minutes, leaving the polymer nano-microparticle forming a thin layer or film on the skin surface, and the antimicrobial agent that is released from nano-microparticle provides the anti-septic protection to skin/area of application, for a prolonged duration up to 24 hrs.

In an aspect, the polymer nano-microparticle composition of the present invention comprises anti-microbial agents, wherein the polymer film formed can be washed off by gentle rubbing after the disinfection purpose during the surgery.
In another aspect, the present invention provides a polymer nano-microparticle composition comprising anti-microbial agents, which can be easily applied on any body parts and surfaces using an applicator where the composition was sealed.

In an aspect the present invention provides a polymer nano-microparticle composition comprising , anti-microbial agents, wherein the thin-film forming polymer is formed by mixing of polyvinyl pyrrolidone, polyethylene glycol, polyvinyl alcohol, hydroxypropyl methylcellulose, methyl cellulose, ethyl cellulose, alginate, chitosan, polymethacrylates, poloxamer, hydroxy ethyl cellulose, and combinations thereof ; plasticizer, emollient, moisturizer, gel-forming material, and other excipients until a smooth clear composition is obtained that can be applied on the skin.

The present invention discloses a unique composition of nano-micro sized drug loaded polymeric particles that can be applied on the skin by spreading, or spraying and that forms a thin nano-micro film of protective polymer film containing anti-microbial agents. After the application of the composition on the skin, the alcohol contents from the liquid part evaporate within 1-3 minutes leaving a continuous thin polymer film containing anti-microbial drugs on the skin. This protective layer has dual functions of instantly disinfecting the skin as well as retaining the prolonged protection for up to 24 hrs such that for the entire duration and after the surgery, the area of interest will remain protected from contamination.

DESCRIPTION OF THE FIGURES
Figure 1: DLS spectrum showing the dual size distribution of drug loaded polymer nano-micro particle suspension as prepared in Example 1.
Figure 2: DLS spectrum showing the triple distribution of the drug loaded polymer nano-micro particle suspension Example 2
Figure 3: DLS spectrum showing the dual size distribution of drug loaded polymer nano-micro particle suspension Example 3.
Figure 4: DLS spectrum showing the dual size distribution of drug loaded polymer nano-micro particle suspension Example 4.
Figure 5:Anti-bacterial activity of polymer nano-micro particle film done by disc diffusion method.The formulation and the control samples (CH- were dropped on a paper disc, which was placed in a bacterial cultural medium (Agar gel plate) streaked with known amount of bacteria (E.coli and S.aureus). Antimicrobial study (24 Hr) of polymer film containing Chlorhexidine (CH) (Test samples- B,C, & BC) by disc diffusion method in E.coli and S.aureus. Where IPA-Isopropyl alcohol, Chlorhexidine, ADH2O-Water are taken as control.
Figure 6: Prolonged (24 hour) antimicrobial activity (Coated on surface)-Polymer was coated on the glass slide and exposed to the atmosphere (in laboratory) for 22 hours. After 22 hours, known amount of bacterial culture was added on the formulation coated slide (S. aureus and E.coli) and exposed to 3 hours. The bacterial culture was further collected from the from the glass slide, streaked in a bacterial culturing plate and incubated for 24 hours. Compared the result against 70% IPA (Control)
Figure 7: Real-time (8 hours) antibacterial study of polymeric nano-microparticle solution by spread plate method.The formulation was applied in the palm of an individual and allowed them to do the normal routine works. After each time point, the bacterial count was analyzed by rubbing the fingers in a bacterial cultural media (Agar gel plate). The plate was incubated for 24 hours and checked for the presence of bacterial growth. The same procedure was done for the control (70% IPA).
Figure 8: SEM images of layer formed on the surface in the range of 9-10um
Figure 9: SEM images of layer formed on the surface in the range of 10-12um
Figure 10: Method of application of disinfectant solution using a pre-filled applicator having terminal sponge material that offers a thin layer distribution over the skin surface.

DETAILED DESCRIPTION OF THE INVENTION
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated.

The present invention relates to a polymer nano-microparticle composition with a miscible alcohol-water solvent system wherein the nano-microparticles are loaded with antimicrobial agents.

The present invention is for disinfecting the skin area before surgical procedures or cleaning the wounded surfaces to remove microbiological and chemical contamination.

It is an embodiment of present invention to provide an improved composition for disinfecting the skin before surgery by providing a thin protective layer of polymer containing nano-microparticles loaded with antimicrobial agents.
In one embodiment of the present invention, the nano-microparticle size distribution of drug-loaded polymeric particles is intended for sustained drug retention on the skin for prolonged protection of anti-microbial properties up to 24 hrs.

In one embodiment of the present invention, upon application of the polymer composition comprising the nano-microparticles, and spreading throughout the area of interest on skin, the solvent part containing 60-90% IPA instantly sterilize the area and upon solvent evaporation in 1-3 minutes, a thin layer of polymer nano-microparticle loaded with anti-microbial drug cover the area. This dried film protects the sterilized skin for a period of up to 24 hrs.

Accordingly, the present invention relates to anti-microbial polymer composition of nano-microparticles of said polymer loaded with anti-microbial agents comprising;
i. The polymer in an amount of 0.1-5%w/v;
ii. Anti-microbial agents in an amount of 0.05-20%w/v;
iii. Pharmaceutically acceptable excipients in suitable proportion;

wherein said anti-microbial composition comprises 60-95% of the non-aqueous medium.

The composition of the present invention may be in the form of a solution or suspension.

In one embodiment, the anti-microbial agents are selected from Chlorhexidine gluconate (5-30% Solution, equivalent to 0.5-3% w/v of Chlorhexidine gluconate), benzalkonium chloride (5-30% Solution, equivalent to 0.1-3% w/v), iodine (1%-20%w/v), Cetrimide (0.5-3% w/v), and combinations thereof.

In another embodiment, the polymer is selected from polyvinyl pyrrolidone (0.5-3%w/v), polyethylene glycol (0.2-3%w/v), hydroxypropyl methylcellulose (0.1-5%w/v), methyl cellulose (0.1-5%w/v), ethyl cellulose(0.1-5%w/v), alginate (0.1-2%w/v), poloxamer (0.1-2%w/v) hydroxy ethyl cellulose (0.1 -5%w/v) polyvinyl alcohol, chitosan, Polymethacrylates, Hydroxy ethyl cellulose or combinations thereof.

In an embodiment, the pharmaceutically acceptable excipients are selelcted from moisturizers, emollients, plasticizers gel-forming agents and other excipients to make smooth clear composition that can be applied on the skin.

In another embodiment, the pharmaceutical excipients are selected from moisturizer such as glycerine, hyaluronic acid, propylene glycerol, sorbitol, urea, alpha-hydroxy acids, beeswax, propylene glycol dioleate, or combinations thereof.
In another embodiment, the present invention relates to a polymer nano-microparticle composition comprising an emollient component, which is selected from isopropyl palmitate, stearic acid, oleic acid, linoleic acid or combinations thereof.

In one of the preferred embodiment, the present invention discloses a polymer nano-microparticle composition comprising , Chlorhexidine gluconate solution 5-40% (Equivalent to 0.5-4% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (0.5-3 %w/v), HPMC E50 (0.5-3%w/v, PEG 400 (0.05-5% w/v), Glycerine (0.05 -2.5 % w/v), IPA (60-90% v/v) and water (40-20% v/v).

In another preferred embodiment, the present invention discloses a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5%w/v, PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), IPA (70% v/v) and water (30% v/v).

In another preferred preferred embodiment, the present invention discloses a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20-40% (Equivalent to 2-4% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (1.5-5 %w/v), HPMC E50 (1-5%w/v, PEG 400 (0.5% w/v), Glycerine (0.1-0.8 % w/v), IPA (6-900% v/v) and water (40-10% v/v).

In yet another preferred embodiment, the present invention discloses a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (0.5 %w/v), HPMC E50 (1.5%w/v, PEG 400 (1% w/v), Glycerine (0.5 % w/v), IPA (70% v/v) and water (30% v/v).

In a specific embodiment, the present invention discloses a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (1%w/v), HPMC E50 (2.5-%w/v, PEG 400 (0.5% w/v), Glycerine (1% w/v), IPA (70% v/v) and water (30% v/v).

In another specific embodiment, the present invention relates to a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (0.5 %w/v), HPMC E50 (2-%w/v, PEG 400 (0.1% w/v), Glycerine (1% w/v), IPA (70% v/v) and water (30% v/v).

In another preferred embodiment, the present invention discloses a polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5-%w/v, PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), poloxamer (0.5% w/v) IPA (70% v/v) and water (30% v/v).

In another specific embodiment, the present invention discloses polymer nano-microparticle composition comprising Chlorhexidine gluconate solution 20% (Equivalent to 2% w/v of Chlorhexidine gluconate) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5-%w/v, PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), poloxamer (0.1% w/v) IPA (70% v/v) and water (30% v/v).

In yet another embodiment, the present invention relates to a method of preparing the polymer nanoparticle composition loaded with anti- microbial agents comprising.
i. Heating the purified water to a temperature of 75°C± 2°C and adding the first polymer part-by-part to the heated water at same temperature with stirring until complete dispersion of the polymer;
ii. Adding second polymer with suitable excipient to the above solution with stirring until a homogenous blend is obtained;
iii. Cooling the above mixture to room temperature with stirring;
iv. Adding the third polymer to IPA and homogenizing the mixture followed by adding the fourth polymer with stirring until complete dissolution;
v. Adding suitable anti-microbial agents –IPA –polymer to the above mixture and maintaining the solution at room temperature until formation of nano particle of drug loaded polymeric micellar suspension;
vi. Homogenizing the above suspension with high-shear homogenizer until uniform dispersion of polymeric nano-microparticle loaded with anti-microbial agents is obtained.

The dispersion of polymeric nano-microparticle loaded with anti-microbial agents obtained by the process of the present invention is in the form of suspension or a solution.

In another embodiment, the polymer nano-microparticle containing anti-microbial agents of the present invention has di-modal particle size distribution ranging from 1-100nm, and 100-1000nm or tri-modal distribution ranging from: 1-50nm, 50-500nm, and 500-2000nm.

In an embodiment, the present invention relates to a method of forming a thin layer of polymer nano-microparticles loaded with the anti-microbial agents by way of application on to the skin surface using an appropriate applicator for skin disinfection

In yet another embodiment, the present invention relates to a method of disinfecting skin surface of patients by applying single or multiple layers of the polymer nano-microparticles loaded with antimicrobial agents before or after the surgical procedures.

Several examples are set forth below to further illustrate the nature of the invention and the manner of carrying it out. However, the invention should not be considered as being limited to the details thereof.
EXAMPLES
Example 1:
Ingredients Amount
Chlorhexidine gluconate 0.5-4% w/v
PVP K30 1.5-5 %w/v
HPMC E50 1-5%w/v
PEG 400 0.5% w/v
Glycerine 0.1-0.8 % w/v
IPA 60-90% v/v
water 40-10% v/v

Example 2:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 1.2 %w/v
HPMC E50 1.5%w/v
PEG 400 0.5% w/v
Glycerine 0.5 % w/v
IPA 70% v/v
water (30% v/v

Example3:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 0.5 %w/v
HPMC E50 1.5%w/v
PEG 400 1% w/v
Glycerine 0.5 % w/v
IPA 70% v/v
water 30% v/v
Example 4:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 1.0 %w/v
HPMC E50 2.5%w/v
PEG 400 0.5% w/v
Glycerine 1.0 % w/v
IPA 70% v/v
water 30% v/v

Example 5:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 0.5%w/v
HPMC E50 2.0%w/v
PEG 400 0.1% w/v
Glycerine 1.0 % w/v
IPA 70% v/v
water 30% v/v

Example 6:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 1.2%w/v
HPMC E50 1.5%w/v
PEG 400 0.5% w/v
Glycerine 0.5 % w/v
Poloxamer 0.5% w/v
IPA 70% v/v
water 30% v/v
Example 7:
Ingredients Amount
Chlorhexidine gluconate 2% w/v
PVP K30 1.2%w/v
HPMC E50 1.5%w/v
PEG 400 0.5% w/v
Glycerine 0.5 % w/v
Poloxamer 0.1% w/v
IPA 70% v/v
water 30% v/v

Example 8
1L of disinfectant solution was prepared by, first heating purified water (200ml) in a magnetic stirrer hot plate (75°C± 2°C). Dissolving first polymer, 12g of PVP (1.2%w/v), in preheated purified water at 300-500rpm and 75°C± 2°C. Ensure the complete dissolution of the polymer by clarity check. Adding second polymer HPMC(15g, 1.5%w/v) at 75°C± 2°C (by part-by-part addition) with stirring (300- 500rpm) and continue the stirring for 10-15 minutes. Addition of third polymer PEG(5g, 0.5%w/v) with moisturizer Glycerine(5g, 0.5%w/v) to the HPMC-PVP solution under stirring at 300-600rpm. Continue the stirring for 30min to ensure complete dispersion of all polymers to form a homogenous blend. Stop the heating and bring down the temperature of the polymeric blend to room temperature 21± 4°C with stirring continued at 150-250rpm. Add 100ml of chlorhexidine gluconate solution to 70% isopropyl alcohol (700ml) and homogenize the sample for 15-20 min and ensure the absence of any undissolved material. Add the IPA-chlorhexidine gluconate to the polymeric solution of maintained at 21± 4°C on continuous magnetic stirring at 500rpm. The Nano-microparticles of drug loaded polymer suspension will be formed at this step. After the addition of complete IPA-chlorhexidine gluconate to the polymer blend, homogenize the sample with high-shear homogenizer at 4000rpm for 30-40minutes. Ensure the uniform dispersion of polymeric nano-microparticle suspension.

Example 9
1L of disinfectant solution was prepared by first heating the purified water in a magnetic stirrer hot plate (75°C± 2°C). Disperse first polymer, HPMC(15g, 1.5%w/v), in preheated purified water at 300-500rpm and 75°C± 2°C. Ensure the complete dispersion of the polymer by visually. Addition of second polymer PEG (5g, 0.5%w/v) with moisturizer Glycerine (5g, 0.5%w/v) to the HPMC dispersion under stirring at 300-600rpm. Continue the stirring for 30min to ensure complete dispersion of all polymers to form a homogenous blend. Stop the heating and bring down the temperature of the polymeric blend to room temperature 21± 4°C with stirring continued at 150-250rpm. Dissolve third polymer 12g of PVP (1.2%w/v) in isopropyl alcohol( 700ml, 70%v/v) and homogenize the sample for 15-20 min and ensure the absence of any undissolved material. Add 100ml of chlorhexidine gluconate (20%, equivalent to 2% w/v of chlorhexidine gluconate) solution to isopropyl alcohol-PVP solution and homogenize the sample for 15-20 min and ensure the absence of any undissolved material. Add the IPA-chlorhexidine-PVP gluconate to the polymeric solution maintained at 21± 4°C on continuous magnetic stirring at 500rpm. The Nano-microparticles of drug loaded polymer suspension will be formed at this step. After the addition of complete IPA-chlorhexidine gluconate-PVP to the polymer blend, homogenize the sample with high-shear homogenizer at 4000rpm for 30-40minutes.

Example 10
For preparing 1L of disinfectant solution, first heat purified water in magnetic stirrer hot plate (75°C± 2°C). Dissolve first polymer 12g of PVP (1.2%w/v) in preheated purified water at 500rpm and 75°C± 2°C. Ensure the complete dissolution of the polymer by clarity check. Adding second polymer HPMC (15g, 1.5%w/v) to the polymer solution at 75°C± 2°C (by part-by-part addition) with stirring (300- 500rpm) and continue the stirring for 10-15 minutes. Addition of third polymer PEG(5g, 0.5%w/v) with moisturizer Glycerine(5g, 0.5%w/v) to the HPMC-PVP dispersion under stirring at 300-600rpm. Continue the stirring for 20-30 min to ensure complete dispersion of HPMC (stirring at 500rpm). Stop the heating and bring down the temperature of the polymeric blend to room temperature, 21± 4°C with stirring at 150-250rpm. Addition of IPA (700ml, & 70%v/v)to the polymeric blend of at 21± 4°C by part by magnetic stirring at 500rpm. After the addition of complete IPA homogenize the sample with high shear homogenizer at 4000rpm for 30-40minutes. Ensure the uniform dispersion of polymeric blend in the IPA. Addition of chlorhexidine gluconate solution 20% ( equivalent to 2%w/v of chlorhexidine gluconate) and homogenize the sample for 15-20 min and ensure the absences of foreign matters and undissolved material.

Example-11
For preparing 1L of disinfectant solution, first heat purified water in a magnetic stirrer hot plate (75°C± 2°C). Add first polymer HPMC (15g, 1.5%w/v) to solution at 75°C± 2°C (by part-by-part addition) with stirring (300- 500rpm) and continue the stirring for 10-15 minutes. Ensure the complete dispersion of the polymer by clarity visual inspection. Addition of second polymer PEG(5g, 0.5%w/v) with moisturizer Glycerine(5g, 0.5%w/v) to the HPMC solution under stirring at 300-600rpm. Continue the stirring for 30min to ensure complete dispersion of all polymers to form a homogenous blend. Stop the heating and bring down the temperature of the polymeric blend to room temperature 21± 4°C with stirring continued at 150-250rpm. Add third polymer 12g of PVP (1.2%w/v) to isopropyl alcohol (700ml, 70%v/v) and homogenize the sample for 15-20 min and ensure the absence of any undissolved material. Add fourth polymer poloxamer (5g, 0.5% w/v) in the solution of and homogenize the sample. Ensure the complete dissolution. Add 100ml Chlorhexidine gluconate solution 20%( equivalent to 2%w/v of chlorhexidine gluconate) to the IPA-PVP-Poloxamer solution of step-7 and maintained at 21± 4°C on continuous magnetic stirring at 500rpm. The Nano particle of drug loaded polymeric micellar suspension will be formed at this step. Add the IPA-PVP-Poloxamer -Chlorhexidine gluconate to the polymeric solution maintained at 21± 4°C on continuous magnetic stirring at 500rpm. The Nano-microparticles of drug loaded polymer suspension will be formed at this step. After the addition of complete IPA-chlorhexidine gluconate to the polymer blend, homogenize the sample with high-shear homogenizer at 4000rpm for 30-40minutes. Ensure the uniform dispersion of polymeric nano-microparticle suspension.

Although the invention has been described in detail in the foregoing for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be limited by the claims.
,CLAIMS:1. An anti-microbial polymer composition of nano-microparticles of said polymer loaded with anti-microbial agents comprising;
i. The polymer in an amount of 0.1-5%w/v;
ii. Anti-microbial agents in an amount of 0.05-20%w/v;
iii. Pharmaceutically acceptable excipients in suitable proportion;
wherein said anti-microbial composition comprises 60-95% of the non-aqueous medium.

2. The anti-microbial polymer composition as claimed in Claim 1,wherein the solvent medium selected from ethyl alcohol or isopropyl alcohol and water.

3. The anti-microbial polymer composition as claimed in claim 1, wherein the polymer is selected from polyvinyl pyrrolidone (0.5-3%w/v), polyethylene glycol (0.2-3%w/v), hydroxypropyl methylcellulose (0.1-5%w/v), methyl cellulose (0.1-5%w/v), ethyl cellulose(0.1-5%w/v), alginate (0.1-2%w/v), poloxamer (0.1-2%w/v) hydroxy ethyl cellulose (0.1 -5%w/v) polyvinyl alcohol, chitosan, Polymethacrylates, Hydroxy ethyl cellulose or combinations thereof.

4. The anti-microbial polymer composition as claimed in Claim 1, wherein the anti-microbial agents are selected from Chlorhexidine gluconate (0.5-4% w/v ), benzalkonium chloride (0.05-3% w/v), iodine (1%-20%w/v), Cetrimide (0.5-3% w/v), or combinations thereof.

5. The anti-microbial polymer composition as claimed in claim 1 wherein the excipients include but are not limited to plasticizers such as PEG, propylene glycol, glycerin, hyaluronic acid, emollient such as, liquid paraffin, dimethicone, beeswax, isopropyl palmitate, stearic acid, oleic acid, linoleic acid, moisturizer such as glycerin, and such like.

6. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-5 comprising nano-microparticles containing Chlorhexidine gluconate (2% w/v ) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5%w/v), PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), IPA (70% v/v) and water (30% v/v).

7. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-5 comprising nano-microparticles containing Chlorhexidine gluconate (0.5-4% w/v ) loaded into a mixture of PVP K30 (1.5-5 %w/v), HPMC E50 (1-5%w/v, PEG 400 (0.5% w/v), Glycerine (0.1-0.8 % w/v), IPA (60-90% v/v) and water (40-10% v/v).

8. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-5 comprising nano-microparticles containing Chlorhexidine gluconate ( 2% w/v ) loaded into a mixture of PVP K30 (0.5 %w/v), HPMC E50 (1.5%w/v, PEG 400 (1% w/v), Glycerine (0.5 % w/v), IPA (70% v/v) and water (30% v/v).

9. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-5 comprising nano-microparticles containing Chlorhexidine gluconate (2% w/v ) loaded into a mixture of PVP K30 (1%w/v), HPMC E50 (2.5%w/v, PEG 400 (0.5% w/v), Glycerine (1% w/v), IPA (70% v/v) and water (30% v/v)

10. The anti-microbial polymer composition as claimed in any one of the preceding claims1-5 comprising nano-microparticles containing Chlorhexidine gluconate (2% w/v ) loaded into a mixture of PVP K30 (0.5 %w/v), HPMC E50 (2-%w/v), PEG 400 (0.1% w/v), Glycerine (1% w/v), IPA (70% v/v) and water (30% v/v).

11. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-5 comprising of nano-microparticles containing Chlorhexidine gluconate (2% w/v) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5-%w/v, PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), poloxamer (0.5% w/v) IPA (70% v/v) and water (30% v/v).

12. The anti-microbial polymer composition as claimed in any one of the preceding claims1-5 comprising of nano-microparticles containing Chlorhexidine gluconate (2% w/v) loaded into a mixture of PVP K30 (1.2 %w/v), HPMC E50 (1.5-%w/v, PEG 400 (0.5% w/v), Glycerine (0.5 % w/v), poloxamer (0.1% w/v) IPA (70% v/v) and water (30% v/v)

13. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-12, wherein the polymer nano-microparticle containing anti-microbial agents has di-modal particle size distribution ranging from 1-100nm, and 100-1000nm or tri-modal distribution ranging from: 1-50nm, 50-500nm, and 500-2000nm.

14. A process for preparing the anti-microbial polymer composition s claimed in any one of the preceding claims 1-13 comprising;
i. Heating the purified water to a temperature of 75°C± 2°C and adding the first polymer part-by-part to the heated water at same temperature with stirring until complete dispersion of the polymer;
ii. Adding second polymer with suitable excipient to the above solution with stirring until a homogenous blend is obtained;
iii. Cooling the above mixture to room temperature with stirring;
iv. Adding the third polymer to IPA and homogenizing the mixture followed by adding the fourth polymer with stirring until complete dissolution;
v. Adding suitable anti-microbial agents –IPA –polymer to the above mixture and maintaining the solution at room temperature until formation of nano particle of drug loaded polymeric micellar suspension;
vi. Homogenizing the above suspension with high-shear homogenizer until uniform dispersion of polymeric nano-microparticle loaded with anti-microbial agent is obtained.

15. The process as claimed in claim 14, wherein the dispersion polymeric nano-microparticle loaded with anti-microbial agent is in the form of suspension or a solution.

16. The anti-microbial polymer composition as claimed in any one of the preceding claims 1-15, wherein said composition upon application on the skin surface forms a thin layer of approx 1-20microns on the skin and the antimicrobial agents therein provide anti-septic protection to the skin for a period of up to 8-24 hrs.

17. A method of forming a thin layer of polymer nano-microparticles loaded with the anti-microbial agents as claimed in any one of the preceding claims by way of application on to the skin surface using an appropriate applicator for skin disinfection

18. A method of disinfecting skin surface of patients by applying single or multiple layers of the polymer nano-microparticles loaded with antimicrobial agents as claimed in any one of the preceding claims before or after the surgical procedures.