DESC:Field of the Invention
The present invention relates to eye drop composition(s) comprising mixture of herbs and process for preparation of said composition(s). More specifically, present invention relates to stable and efficacious eye drop composition(s) comprising mixture of judiciously selected herbs and vitamin(s) for the treatment of eye disorders.

Background of the Invention
Eye disorders are most prevalent problems in today’s era mainly due to advancement in technologies and changing pollution levels. Modern lifestyle characterized by long hours of working on computers, electronic gadgets, exposure to immense levels of pollution, smoke, dust, malnutrition has tremendously increased common eye problems. These problems include drying or excess watering of eyes, irritation, inflammation, reddening, eye infections, erythema, occasional injury involving infection or aneurism, sensation to rub eyes vigorously and swollen or sagging of skin around the eyes.
Most people neglect these as minor problems and do not take preventive action or treatment. Such situation may lead to serious problems like bursting of eye vessels, loss of vision which may lead to costly and long term treatments including laser corrections.
In current medical practice, people are normally prescribed to use different types of eye drops containing gum like substances with/without anti-inflammatory and anti-infective drugs. Since these eye drops provide quick hydration and relief due to synthetic drug content therein, many patients keep using them without medical advice, leading to addiction associated with acquiring resistant infections to such medications.
In last few years inclination towards use of eye drops made up of various herbs which are known to possess anti-microbial, anti-inflammatory activity and humectant properties has been increased to avoid adverse effects of synthetic drugs in eye drops. Consumers today wish to use nondrug based products for eye problems which require long term and repeated usage for treating infections, dryness, irritation resulting from long hours of exposure to computers, electronic gadgets, dust and contaminants in the atmosphere. For example, herb like Neem has identified to possess anti-bacterial properties and used in various ophthalmic medications, such as Vaepilai Kalikkam, which contains Neem leaves in cow’s butter for treatment of pricking pain in eyes, Qatoor Bara-e-Dard gosh which is an eye drop composition of Neem leaves used for treating eye problems. Vartti is an ayurvedic eye drop composition containing Raktachandan (Pterocarpus santalinus) powder for the treatment of eye itching, eye injury and cataract. Itone® is an eye drop preparation available in market, contains Neem, Sobhanjna, Punarnava, Shwetachandana, Madhu (Honey), Tulsi, Camphor (Karpuram) and other herbal ingredients, indicated for treatment of computer vision syndrome.
The important aspect of many herbal eye drops available in market today is that they are prepared by processing multiple herbs mix along with salts and minerals via distillation process. The labels of such eye drops claim the content as ‘herb extracts in the range of 0.3 % to 3 % obtained in the distillate’, which includes herbs like Neem, Shobhanjna, Bhringaraj, Punarnava, Nirgundi, Tulsi leaves, Rose, Triphala, Haridra, Rasanjan, Palash, Onion juice, Ginger juice, Lemon juice, Camphor (Karpuram), Mint (Mentha piperata), Saindhava laban (Rock salt) and Madhu (Honey) along with salts and minerals.
Most of these herbs except Rose (Rosa centifolia Linn) and Mint (Mentha spicata Linn and other species) do not possess any distillable volatile components in appreciable proportions. Further, it is also known that salts and minerals do not have any distillate contributing components. Therefore even if such eye drops provide some distillable components, their proportions seems to be infinitesimally small. Such distillates are also insoluble or sparingly soluble in aqueous base medium of these eye drops and hence are not expected to provide relief from various common eye problems described above as herbs which are devoid of useful volatile compounds cannot be extracted at the fullest by distillation process.
Therefore, there is an unmet need for polyherbal eye drop composition(s) containing essential herbal components in sufficient quantities to treat common eye disorders. In light of this, inventors of the present invention surprisingly found that polyherbal eye drops prepared by controlled warm infusion technique contains essential components of judiciously selected useful herbs in sufficient amount required for treating common eye disorders and thus provides promising tool to resolve limitations and problems cited above.

Objectives of the Invention
The principal objective of present invention is to formulate safe and effective polyherbal eye drop composition(s) for the treatment of various eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation.
Another objective of present invention is to formulate safe and effective vitamin(s) containing polyherbal eye drop composition(s) for treatment of eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation.
Further objective of the invention is to develop a process for preparation of polyherbal eye drop composition(s) by controlled warm infusion technique to improve extraction efficiency for essential non-volatile components in the herbs.
Yet another objective of the invention is to develop a process for preparation of polyherbal eye drop composition(s) containing vitamin(s) by controlled warm infusion technique.

Summary of the Invention
The present invention provides polyherbal eye drop composition(s) for treatment of eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation and process for preparation of said composition(s) by controlled infusion technique.
The invention provides eye drop composition(s) comprising combination of herbs including, but not limited to, Neem (Azadirachta indica A.Juss.), Triphala {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)}, Sobhanjana (Moringa oleifera Lam.), Punarnava (Boerhaavia diffusa Linn.), Yastimadhu (Glyzeriza glabra Linn) root aqueous extract, Raktachandan (Pterocarpus santalinus Linn.f.), Kumari (Aloe vera Tourn.ex Linn.) and Natural camphor (Cinnamomum camphora Nees and Eberm.) which are reported to consist of chemical components known for antimicrobial and anti-inflammatory properties, namely Azadirachtin, Nimbin, Chebulinic acid, Galic acid, Tannins, Moringa oil, Ursolic acid, saponins further enriched with natural source of vitamin A alone and in combination with vitamin E. These herbs also contain carbohydrates, starches and cellulose which provide increased viscosity as well as wetting properties to the composition and thus eliminate the need of adding chemical cellulosic derivatives in the composition to provide relief in dry eyes.
Polyherbal eye drop composition(s) of present invention further comprise excipients including, but not limited to, organic/inorganic base vehicles, solubilizers, deodorizers, decolorizers, preservatives, wetting agents, dispersing/suspending agents and pH adjusting agents.
Present invention further provides process for preparation of polyherbal eye drop composition(s) wherein herbs processed by controlled infusion technique at specified temperature with specified period of contact to obtain specific infusion in purified and pasteurized water, with clarification of resultant infusion, if required which is further diluted to make up the predetermined volume and sterilized to obtain final eye drop composition. The polyherbal eye drop composition(s) thus obtained are stable, safe and effective over existing marketed herbal eye drop preparations.

Detailed description of the Invention
Present invention relates to polyherbal eye drop composition(s) comprising mixture of herbs, specifically useful in treating common eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation.
As used herein, the term, “polyherbal” refers to mixture of one or more herbs. Such herbs includes but not limited to Neem (Azadirachta indica A.Juss.), Triphala {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)}, Sobhanjana (Moringa oleifera Lam.), Punarnava (Boerhaavia diffusa Linn.), Yastimadhu (Glyzeriza glabra Linn) root aqueous extract, Raktachandan (Pterocarpus santalinus Linn.f.), Ghritkumari (Aloe vera Tourn.ex Linn.) and Natural camphor (Cinnamomum camphora Nees and Eberm.), Bhringraj, Nirgundi, Tulsi, Satapatri, Yamani, Haritaki (myrobalan), Bibhitaka, Dhatriphata, Hardra, Rose, Rosemary, Mukta and Saindhva laban.
As used herein, the term, “Retinoids” refers to class of chemical compounds that are vitamers of vitamin A or are chemically related to it. Retinoids play important role in vision, regulation of cell proliferation and differentiation, and possess antioxidant activity. Vitamin A is selected from the class of retinoids which includes but not limited to retinol derivatives, all trans retinol compounds, provitamin A-beta-carotene, retinyl palimtate, retinyl acetate, retinol and retinoic acid.
As used herein, the term, “Vitamin E” refers to class of vitamin which have antioxidant activity. Vitamin E is selected from the class of tocopherols which includes but not limited to D-alpha-tocopheryl succinate, alpha-tocopherol, D-alpha-tocopherol, DL-alpha-tocopherol, D-alpha-tocopheryl acetate, DL-alpha-tocopheryl acetate, D-alpha-tocopheryl acid succinate, tocotrienol and 5, 7, 8 trimethyl-tocotrienol.
As used herein, the term, “Solubilizers” refers to agents that increase the solubility of substance. Solubilizer can be selected from the group including, but not limited to, glycol derivatives, castor oil sorbitan esters and polyethoxylated sorbitan esters such as polyoxyethylene sorbitan monooleate and span 80, hydro-alcohols such as sorbitol, glycerin, ethanol, isopropyl alcohol and propylene glycol, lecithin from soybean.
As used herein, the term “Base vehicle” refers to organic/inorganic vehicles used in common practice such as water, C1-C4 alcohols, oils like coconut oil, olive oil, clarified butter.
As used herein, the term “Clarifying agent” refers to the substances used to remove suspended solids from liquids by inducing flocculation (the solids begin to aggregate forming flakes, which either precipitate to the bottom or float to the surface of the liquid, and then they can be removed or collected). Clarifying agent can be selected from the group including, but not limited to, charcoal, high flow super silica, bleaching earth, kaolin, bentonite and can be used either alone or in combination.
As used herein, the term “Dispersing/Suspending agent” refers to the excipients which help active components to stay suspended in the formulation and prevent caking at the bottom of the container. Dispersing/Suspending agent can be selected from the group including, but not limited to, bentonite, carbomer, tragacanth, kaolin, carboxymethyl cellulose sodium, and can be used either alone or in combination.
As used herein, the term “Wetting agent” refers to a chemical that can be added to a liquid to reduce its surface tension and make it more effective in spreading over and penetrating surfaces. Wetting agent can be selected from the group including, but not limited to, sodium lauryl sulphate, poloxamer. Phytosterols in shobhanjana leaves extract used in present invention also have good wetting agent properties as disclosed in literature references.
As used herein, the term “Deodorizers” refers to a substance that masks or neutralizes odors. Deodorizers like lavender oil, lily oil, rosemary oil, rose oil can be used in composition(s) of present invention if required.
As used herein, the term “Decolorizer” refers to a substance that removes the color from formulation. Decolorisers like lower alkyl alcohols can be used in composition(s) of present invention if required.
As used herein, the term “Preservatives” refers to a substance or a chemical that is added to products such as food, beverages, pharmaceutical preparations, biological samples, cosmetics and many other products to prevent decomposition by microbial growth or by undesirable chemical changes. Preservative can be selected from the group including, but not limited to, ascorbic acid, sodium ascorbate, butylated hydroxytoluene, butylated hydroxyanisole, gallic acid and sodium gallate, sulfur dioxide and sulfites, benzalkonium chloride. Tocopherol mentioned in some of the embodiments of present invention also acts as natural preservative.
As used herein, the term, “Moderate temperature” refers to temperatures ranging from 30ºC to 90 ºC.
As used herein, the term, “Controlled infusion technique” refers to extraction of herbs by maceration process using pasteurized water at moderate temperature.
The pH adjusting agents can be selected from, but not limited to, dilute inorganic or organic acids or alkalis and salts thereof like sodium, potassium, calcium or bicarbonate salts.
The polyherbal eye drop composition(s) of the present invention is indicated for treatment of various eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation.
Inventors of the present invention particularly selected anti-oxidants from the class of retinoids and tocopherols. Use of such pro-vitamin(s) or vitamin components provide relief from eye problems. Reported literature have shown that use of vitamin A or vitamin E in eye drops provide relief from injury and inflammation and associated problems. There are various studies showing use of vitamin A and Vitamin E for enhancing topical absorption of the drug as well as provide various eye health benefits such as relief in eye injury.
Polyherbal eye drop composition(s) of present invention contain judiciously selected herbs specifically provide phytosterol group of components which include beta-sitosterol, stigmasterol, campesterol, sitosterol, cholesterol, steroidal saponins. Phytosterols are known to provide surfactant like activity which promotes dissolution of components, improves solubility as well as improves absorption. Such components are not volatile and would be absent in marketed eye drops described above.
According to one embodiment, present invention provides a process for preparation of polyherbal eye drop composition(s). The process includes preparation of extract of selected herbs by controlled infusion at moderate temperature by using pasteurized water, which is further filtered and decolorized by using activated charcoal. Prepared herb extracts is then mixed with other excipients to get final solution, to which pasteurized water is added for volume make up. Finally resulting composition is sterilized by filtration technique.
Following examples are for the purpose of illustration of present invention only and are not intended in any way to limit the scope of the present invention.

Example 1: Eye drop composition prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 0.03
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 0.03
Sobhanjana leaves powder (Moringa oleifera Lam.) 5.00
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 0.03
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 0.03
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 0.03
Rose aqua (Rosa centifolia Linn.) Q.S.
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 0.03
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.05
Propylene glycol 2.00
Benzalkonium chloride 0.01
Phenylethyl alcohol 0.05

Procedure: Extract of selected herbs was prepared by controlled infusion at moderate temperature by using pasteurized water. Resultant extract was then filtered and decolorized by using activated charcoal. Rose aqua and camphor solution was prepared in water with the help of propylene glycol. Further Aloe vera gel concentrate was prepared. Above prepared solutions were then mixed with other excipients and preservative to get final solution and volume was made up with pasteurized water. Finally the resulting composition was sterilized by filtration technique.

Example 2: Eye drop composition prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 3.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 3.00
Sobhanjana leaves powder (Moringa oleifera Lam.) 0.05
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 3.00
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 3.00
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 3.00
Rose aqua (Rosa centifolia Linn.) Q.S.
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 3.00
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.50
Propylene glycol 5.00
Benzalkonium chloride 0.02
Phenylethyl alcohol 1.00
Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 1.

Example 3: Eye drop composition prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 5.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 5.00
Sobhanjana leaves powder (Moringa oleifera Lam.) 10.00
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 5.00
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 5.00
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 5.00
Rose aqua (Rosa centifolia Linn.) Q.S.
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 5.00
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 1.00
Propylene glycol 10.00
Benzalkonium chloride 2.00
Phenylethyl alcohol 2.00
Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 1.

Example 4: Eye drop composition containing Vitamin A prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 2.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 7.50
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 0.15
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 0.15
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 0.15
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 0.15
Rose oil (Rosa centifolia Linn.) 0.50
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.05
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 0.15
Retinyl palmitate 0.05
Rosemary oil 0.5
Propylene glycol 1.00
Polysorbate 0. 20
Benzalkonium chloride 0.01
Procedure: Extract of selected herbs was prepared by controlled infusion at moderate temperature by using pasteurized water. Resultant extract was then filtered and decolorized by using activated charcoal. Rose aqua and camphor solution was prepared in water with the help of propylene glycol. Further Aloe vera gel concentrate was prepared. Solution of Retinyl palmitate was then prepared in polysorbate. Above prepared solutions were then mixed with other excipients and preservative to get final solution and volume was made up with pasteurized water. Finally the resulting composition was sterilized by filtration technique.

Example 5: Eye drop composition containing Vitamin A prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 2.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 7.50
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 0.15
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 0.15
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 0.15
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 0.15
Rose oil (Rosa centifolia Linn.) 0.50
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.05
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 0.15
Retinol 2.50
Rosemary oil 0.5
Benzalkonium chloride 0.02
Propylene glycol 1.00
Polysorbate 0. 20
Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 4.

Example 6: Eye drop composition containing Vitamin A prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 2.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 7.50
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 0.15
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 0.15
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 0.15
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 0.15
Rose oil (Rosa centifolia Linn.) 0.50
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.05
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 0.15
Retinyl acelate 1.25
Rosemary oil 0.5
Benzalkonium chloride 0.01
Propylene glycol 1.00
Polysorbate 0. 20

Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 4.

Example 7: Eye drop composition containing Vitamin A and E prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 0.15
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 0.30
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 0.15
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 0.15
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 0.15
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 0.15
Rose oil (Rosa centifolia Linn.) 0.50
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.05
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 0.15
Retinoic acid 0.05
D-alpha-tocopheryl succinate 0.30
Rosemary oil 0.50
Benzalkonium chloride 0.01
Propylene glycol 1.00
Polysorbate 0. 20
Procedure: Extract of selected herbs was prepared by controlled infusion at moderate temperature by using pasteurized water. Resultant extract was then filtered and decolorized by using activated charcoal. Rose aqua and camphor solution was prepared in water with the help of propylene glycol. Further Aloe vera gel concentrate was prepared. Solution of Retinoic acid and D-alpha-tocopheryl succinate was then prepared in polysorbate. Above prepared solutions were then mixed with other excipients and preservative to get final solution and volume was made up with pasteurized water. Finally the resulting composition was sterilized by filtration technique.

Example 8: Eye drop composition containing Vitamin A and E prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 2.50
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 4.00
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 2.50
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 2.50
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 2.50
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 2.50
Rose oil (Rosa centifolia Linn.) 2.50
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 0.50
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 2.50
Retinyl palmitate 1.25
Alpha tocopherol 1.20
Rosemary oil 2.50
Benzalkonium chloride 0.02
Propylene glycol 1.5
Polysorbate 1.00
Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 7.

Example 9: Eye drop composition containing Vitamin A and E prepared by controlled infusion technique
Ingredients Quantity in % w/v or % v/v
Neem leaves aqueous extract (Azadirachta indica A.Juss.) 5.00
Triphala fruit aqueous extract {Amalaki (Emblica officinalis Gaertn.)+ Harad (Terminalia chebula Retz.)+ Baheda (Terminalia belerica Roxb.)} 7.50
Sobhanjana leaves aqueous extract (Moringa oleifera Lam.) 5.00
Punarnava whole plant aqueous extract (Boerhaavia diffusa Linn.) 5.00
Yastimadhu root aqueous extract (Glyzeriza glabra Linn) 5.00
Raktachandan bark aqueous extract (Pterocarpus santalinus Linn.f.) 5.00
Rose oil (Rosa centifolia Linn.) 5.00
Bhimseni camphor (Cinnamomum camphora Nees and Eberm.) 1.00
Ghritkumari leaves Gel (Aloe vera Tourn.ex Linn.) 5.00
Retinyl acelate 2.50
5,7,8 trimethyl-tocotrienol 2.30
Rosemary oil 5.00
Benzalkonium chloride 0.20
Propylene glycol 2.00
Polysorbate 2.00
Procedure: Polyherbal eye drop with above composition was prepared with similar procedure as described in example 7.
Inventors of the present invention found that, there is improved content of essential dissolved chemical components in the composition(s) of the invention prepared by controlled infusion process as compared to that of by distillation process. Results of which are shown in Table 1 below.
Table 1: Comparative data of physicochemical qualitative and quantitative testing of eye drop compositions
S. No. Parameters Eye drop prepared by controlled infusion process Eye drop prepared by controlled infusion process and fortified with Vitamin E Eye drop prepared by distillation process Marketed eye drop Protocol
1 Description Very pale yellow liquid Light brown clear liquid Colorless liquid Clear colorless liquid Visual
2 pH 4.42 4.24 4.04 5.62 pH meter
3 Total Polyphenols (%w/w) 0.02 0.03 Not detected Not detected By UV Spectrophotometer*
4 Total Bitters (%w/w) 0.039 0.096 Not Detected Not detected By Gravimetry
5 Total Alkaloids (%w/w) 0.022 0.196 Not Detected Not detected By Gravimetry
6 Total Dissolved Solids (%w/w) 2.98 4.38 1.22 0.002 By Gravimetry
7 Total Volatile Content (%w/w) 0.006 0.028 0.001 0.002 By Gravimetry
8 Assay of Beta carotene Positive for Beta carotene Positive for Beta carotene Not detected Not detected By HPTLC*
9 Viscosity 1.156 cps 1.156 cps 0.98 cps 0.98 cps By Ostwald’s Viscometer
10 Vitamin E Not Detected Positive For Vitamin E Not Detected Not Detected USP* method
* UV Spectrophotometer- Ultraviolet Spectrophotometer
* HPTLC- High-Performance Thin-Layer Chromatography
* USP- United States Pharmacopeia
Above data verifies higher levels of total dissolved solids indicating presence of starch/cellulose like materials, useful in providing relief in dry eyes. Presence of starch is also confirmed by color test using Iodine solution. Presence of polyphenols, bitters and alkaloids indicates antioxidant, anti-inflammatory benefits to eyes. The data also shows presence of beta carotene in polyherbal eye drop composition(s) of the invention prepared by controlled infusion process while Beta carotene is absent in composition prepared by distillation process.
The polyherbal eye drop composition(s) prepared with the process as described in the invention was studied for Minimum Inhibitory concentration (MIC) for S. Aureus (Staphylococcus Aureus), E. Coli (Escherichia coli), P. Aeruginosa (Pseudomonas Aeruginosa), K. Pneumoniae (Klebsiella Pneumoniae) and C. Albicans (Candida Albicans) in Soybean Casein Digest agar medium. The medium was incubated at 37º C for 24 hrs-48 hrs for bacteria and 25ºC for 72 hours for fungi after inoculation by streaking method for following concentrations of samples to be tested- 1 mg/ ml, 2.5 mg/ ml, 5 mg / ml, 7.5 mg / ml, 10 mg / ml. Results of the study are presented in below table 2.
Table 2: Study for Minimum Inhibitory concentration (MIC) for selected species
Organisms tested MIC (mg /ml) for sample of eye drop prepared by controlled infusion process MIC (mg /ml) for sample of eye drop prepared by controlled infusion process and fortified with Vitamin E
S. Aureus > 10 > 10
E. Coli > 10 > 10
P. Aeruginosa > 10 > 10
K. Pneumoniae > 10 > 10
C. Albicans > 10 > 10

Composition(s) described in this invention by controlled infusion process with and without vitamin E fortification was also found to meet the requirements of eye irritation test as prescribed for eye drops. Accelerated stability studies of the composition(s) of present invention have also shown satisfactory stability of the eye drops.
,CLAIMS:Claim 1: A polyherbal eye drop composition comprising
(a) mixture of herb extracts prepared by controlled infusion technique;
(b) excipients.
Claim 2: A polyherbal eye drop composition comprising
(a) mixture of herb extracts prepared by controlled infusion technique;
(b) vitamin(s) and
(b) Excipients.
Claim 3: A polyherbal eye drop composition according to claim 1 or 2, wherein said mixture of herb extracts comprises extracts of Neem, Triphala, Sobhanjna, Punarnava, Yastimadhu, Raktachandan, Rose and Ghirtkumari.
Claim 4: A polyherbal eye drop composition of claim 2, wherein vitamin(s) are selected from vitamin A, vitamin E or combination thereof.
Claim 5: A polyherbal eye drop composition of claim 4, wherein vitamin A is selected from retinyl palimtate, retinol, retinyl acetate, retinoic acid or mixtures thereof.
Claim 6: A polyherbal eye drop composition of claim 4, wherein vitamin E is selected from d-alpha-tocopheryl succinate, alpha tocopherol, tocotrienol and 5, 7, 8 trimethyl-tocotrienol or mixtures thereof.
Claim 7: A polyherbal eye drop composition according to claim 1 or 2, wherein excipients include solubilizers, anti-oxidants, preservatives, pH adjusting agents, tonicity modifiers, wetting agents, suspending agents, dispersing agents, deodorizing agents and decolorizing agents.
Claim 8: A process for the preparation of eye drop composition, comprising steps of:
a) preparation of solution of extracts of selected herbs prepared by controlled infusion at moderate temperature by using pasteurized water, followed by filtration and decolorization;
b) mixing of prepared herb extracts solution with other excipients to get final solution;
c) sterilization of resulting composition by filtration.
Claim 9: A process for the preparation of eye drop composition, comprising steps of:
a) preparation of solution of extracts of selected herbs by controlled infusion at moderate temperature followed by filtration and decolorization;
b) preparation of solution of Rose aqua and Camphor in water;
c) preparation of Aloe vera gel concentrate;
d) mixing of prepared solutions along with excipients to give final solution and
e) Sterilization of resultant final solution.
Claim 10: A process for the preparation of eye drop composition, comprising steps of:
a) preparation of solution of extracts of selected herbs by controlled infusion at moderate temperature followed by filtration and decolorization;
b) preparation of solution of Rose aqua and Camphor in water;
c) preparation of Aloe vera gel concentrate;
d) preparation of solution of Vitamin A and/or Vitamin E;
e) mixing of prepared solutions along with excipients to give final solution and
f) Sterilization of resultant final solution.
Claim 11: A polyherbal eye drop composition according to claim 1 or 2, wherein polyherbal eye drop composition is used for treatment of various eye disorders including, but not limited to, smart screen or computer vision syndrome, itchiness, watering of eyes, redness, puffiness, minor wounds in eyes, drying and irritation of eyes, erythema, minor infection, injury, inflammation.