FIELD OF THE INVENTION
The present invention relates to the field of ophthalmic composition comprising polyherbal components along with pharmaceutically acceptable mucoadhesive polymer as ocular lubricant, in particular to cure, mitigate or prevent pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans.
BACKGROUND OF THE INVENTION
Inflammatory and allergic conditions of the eye and dry eye disease (DED), also known as keratoconjunctivitis sicca, are common ophthalmological disorders affecting millions of people worldwide. It has long been recognized that atmospheric pollution and work-related stress and strain exert a critically damaging influence on eye health. Chronic Allergic Conjunctivitis (CAC) and Dry Eye Disease (DED) are the most common inflammatory disorders of the anterior ocular surface and one does not preclude the coexistence of the other.
Inflammatory and Allergic Conditions of the Eye
Exposure to allergens may produce signs and symptoms of ocular allergy in individuals predisposed to allergy. Medical therapy for allergic conjunctivitis usually consists of topical vasoconstrictors; vasoconstrictor / antihistamine combinations and corticosteroids, symptoms controlled by vasoconstrictor or antihistamine combination are typically short-term management modalities and incomplete. Histamine is only one of many mediators released in the acute allergic reaction; other mediators may provoke allergic signs and symptoms. Blockade of these other mediators, such as prostaglandins either at susceptible steps in their synthesis or at the end-organ receptors could produce better total symptom control. Topical corticosteroids produce symptomatic relief because of their anti-inflammatory effect produced by inhibition of prostaglandin synthesis. However, prolonged use of these agents has been associated with potentially serious side effects, including increased intraocular pressure, cataract formation, delayed wound healing and steroid enhanced infections.

Consequently, physicians have pointed out the need for alternative therapy. This warrants sufficient knowledge of herbal medicines to make an informed judgment. Furthermore, increased patient demand for natural therapies is a key driver for greater integration of alternative therapy within conventional medicine, to address patients' needs and preferences.
Typical Signs and Symptoms of Allergic Conjunctivitis:
i. Redness in both eyes
ii. Itching and burning of both the eyes and surrounding tissues
iii. Watery discharge
iv. Grittiness and foreign body sensation in the eyes
v. Painful and swollen conjunctiva
vi. Blurred vision
vii. Acute discomfort in bright sunlight light (photophobia)
Dry Eye Disease (DED)
The symptoms of DED including ocular burning, stinging, grittiness, and blurred vision are often exacerbated by environmental conditions such as prolonged computer use, prolonged television viewing, air-conditioning, winter heating, low humidity and a dusty or windy outdoor environment. Additionally, other factors, such as hormonal imbalance, systemic medications, eye surgeries, ocular trauma, radiation therapy and aging also contribute to DED. Since dry eye disease is common in the elderly, they should be well informed regarding vision-related problems, so that elderly people do not take such eye conditions as inevitable and 'normal' effects of aging. Dry Eye Disease can be caused due to deficient tear production and/or increased evaporation of tears. Meibomian gland dysfunction is the most common cause of evaporative dry eye disease, a condition associated with lipid insufficiency and poor lipid spreading over the ocular surface, which results in a failure to form a homogeneous tear film.

Abnormal Tear Film - Causes and Contributors: i. Dry environment
ii. Aging - leading to aqueous deficiency
iii. Hormonal changes
iv. Autoimmune disease
v. Contact lens usage
vi. Eye surgery, LASIK vii. Anti-histamine use viii. Alcohol use
ix. Computer use
x. Environmental aggressions
Dry eye can be hard to diagnose because there are such a wide variety of possible causes and contributors to the condition. On top of that, not everyone experiences the same dry eye symptoms. This condition is particularly widespread among patients using computers for long period of time continuously per day, driving and reading for prolonged hours. These patients have typical symptoms of keratoconjunctivitis sicca or dry eye, which include feelings of eye dryness, burning, watering, redness, pain, headache, irritation, foreign body sensation and signs of conjunctival hyperemia. Dry eye disease is also common among post-menopausal women due to hormonal changes following the cessation of a woman's menstrual cycle that marks the end of fertility.
It is known that blinking coats the eye with tears; therefore, dry eye disease symptoms are worsened by activities in which the rate of blinking is reduced. As mentioned above, these activities include prolonged reading, computer usage, driving or watching television.
Most people who have inflammatory conditions of the eye and dry eye disease experience itchy, scratchy, stingy, irritation, stickiness, pain, redness and tired

eyes, if the condition is left untreated or becomes severe, it can produce complications that can cause eye damage, resulting in impaired vision or possibly in the loss of vision. The damage to the eye surface resulting from these common ophthalmological disorders increases ocular discomfort and both eyes usually are affected. Although it appears that dry eye may result from a number of unrelated pathogenic causes, all presentations of the syndrome share a common effect, that is the breakdown of the natural tear film, which results in dehydration of the exposed outer surface of the eye and hence the above-mentioned symptoms occur.
According to the International Dry Eye Workshop (IDEW; 2007), "Dry Eye is a multifactorial disease of the tear film and the ocular surface that results in symptoms of discomfort, visual disturbance, tear film instability and damage to the ocular surface. It is accompanied by increased osmolality of the tear film and inflammation of the ocular surface." The International Dry Eye Workshop (2007) guidelines also underscored the fact that the core mechanism of dry eye disease could be deranged and ocular surface health can be restored by early intervention [IDEW-2007. Ocul Surf. 2007;5(2):75-92]. Hence, our understanding of dry eye has evolved from considering: i. Tear volume insufficiency
ii. Tear film instability [Tear film stability is maintained by the coordinated functions of the outer lipid monolayer with its critical composition and the contents of aqueous interface. iii. Increased Tear Film Osmolarity [Expected Range of value: Normal = < 312 mOsm/Kg); Borderline dry eye = 312 - 323 mOsm / Kg; Moderate/severe dry eye = > 323 mOsm/ Kg]. iv. Underlying ocular surface inflammation due to altered tear composition
The Tear Film
The pre-ocular tear film plays a vital role in nourishing, lubricating and
protecting the ocular surface exerting its physiological functions at the normal

level. It is well known that, Tear Film abnormalities result in Dry Eye Disease. Abnormal tear film can be caused by number of conditions which alter its composition and affect its stability with marked increases in osmolarity, resultant increase in the expression of cytokines leading to aqueous deficiency, mucin abnormalities, inflammation and irritation of the ocular surface with attendant tear breakup time (TBUT) less than (eye) blink rate.
Artificial tears are the first line of therapy for dry eye disease (DED) and are the most frequently used treatment approach for this common condition. Natural tears play an important role in keeping the eyes healthy, keeping the surface of the eyes clean and moist to counter dry eye, and help protect the eyes from debris and bacteria. Although tears may appear to be nothing more than water, their actual composition is quite complex. They are composed of water, carbohydrates, lipids, electrolytes, lysozymes (enzymes that act like natural antibiotics to kill bacteria and viruses), lactoferrin (proteins that prevent or slow bacterial growth), binding proteins and vitamins.
The tear film is a basic three-layer film that consists of:
(a) Outer-most Lipid foil) layer: Lubricates and prevents tear evaporation.
It is secreted by the Meibomian glands. Its key function is:
i. To reduce the evaporation of the aqueous layer
ii. To increase the surface tension and assist in vertical stability of the tear film iii. To lubricate the eyelids
(b) Middle Aqueous (water) layer: Nourishes and protects the cornea.
The middle layer is secreted by lacrimal gland and has following functions:
i. To supply atmospheric oxygen to the avascular corneal epithelium
ii. Anti- bacterial function
iii. To reduce the irregularities of anterior corneal surface iv. To clean away the debris from the ocular surface

(c) Inner Mucin layer: Helps tears to adhere to the eye surface.
The inner layer is secreted by the conjunctiva goblet cells.
i. It converts the corneal epithelium from hydrophobic to hydrophilic state.
Irritation and Inflammation in Dry Eye Disease (DED)
Inflammation is the major underlying cause of ocular surface diseases and dry eye. Ophthalmologists have addressed several approaches to cure, mitigate or prevent inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans. One common approach has been to supplement and stabilize the tear film using so-called artificial tears. Therefore, ophthalmologists recommend that you apply 'artificial tears' several times per day for dry eyes. These ocular lubricants manage and adequately address the '4 Step Vicious Cycle' of Dry Eye Disease; namely:
Step 1: Decreased tear production and increased evaporation
Leading to
Step 2: Subclinical ocular damage Resulting in
Step 3: Development of signs and symptoms of dry eye disease (DED)
Advances to
Step 4: Clinical ocular damage, decreased tear production & increased
evaporation
Eye Lubricants - Muco-adhesive Polymers
An eye lubricant may be helpful. Ophthalmic solutions containing muco-adhesive polymers have been found to be particularly effective and are well tolerated. These agents by reducing dryness and discomfort protect the outer

surface of the eye, moisturizing and healing the eye and preventing the development of clinical ocular damage. The artificial tears help in keeping the outer surface of the eyes moist and lubricated; they soothe, heal and protect the eyes, reduce the risk of eye infection, wash away foreign particles, and also reduce eye fatigue, dryness, discomfort and irritation. Furthermore, eye lubricants provide optimum viscosity and tear film stability.
Common ophthalmological disorders and dry eye may afflict an individual in varying severity. Commonly, in mild cases, a patient may experience burning, grittiness, itchiness, a feeling of dryness, and persistent irritation such as is often felt by small foreign body lodging between the eye surface and eye lid; or just a foreign-body-sensation (FBS) in the eye. However, in severe cases, vision may be substantially impaired. Common ophthalmological disorders and dry eye cause fatigue when reading or working on a computer.
Nature has been a source of medicinal treatment for thousands of years and herbal medicine continues to play an essential role in the primary health care of 80% of the World population, according to an estimate of the World Health Organization (WHO) Herbal ocular formulations are used extensively in India and have been authenticated by the Central Council of Indian Medicine (COM).
The time has come to standardize these eye drops with modern understanding, scientific methodologies and reference to the underlying pathology in ocular conditions.
U.S. Patent. No. 4,421,740 discloses an artificial tear composition formed by an aqueous hypotonic solution of lecithin, a phospholipid, and a viscosity-adjusting agent.
Aside from the above efforts, which are directed primarily towards the alleviation of symptoms associated with dry eye, also known are methods and

compositions directed to treatment of the dry eye condition. For example, U.S. Pat. No. 5,041,434 discloses the use of sex steroids, such as conjugated estrogens, to treat dry eye condition in post-menopausal women.
It is noteworthy that, there are several herbal eye drops formulations available in India to manage inflammatory and allergic conditions of the eye and for alleviating the symptoms of dry eye disease, these formulations are temporarily effective and often require repeated application; hence, they are unable to satisfactorily manage ocular disorders. Although most of these products contain similar ingredients, the present invention differs from these herbal eye drops by the addition of the eye lubricant, mucoadhesive polymer in the formulation; hence, in its mechanisms of action. Furthermore, although use of artificial tears has met with some success, problems in the treatment of dry eye nevertheless remain. The use of tear substitutes (artificial tears) is temporarily effective and often requires repeated application over the course of a patient's waking hours. It is not uncommon for a patient to have to apply artificial tear solution about ten or more times over the course of the day. Further, use of steroids and other potentially harmful agents for treatment of dry eye disease causes serious adverse effects.
The Present invention Polyherbal Eye Drops with Pharmaceutically Acceptable Mucoadhesive Polymer
In view of the foregoing facts, there is a clear need for an effective, preventive and curative modality for inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans that is capable of alleviating symptoms of these common eye disorders and discomfort, are safe and effective, and are both inexpensive and convenient to administer.
The present inventor has surprisingly found that the poly-herbal composition of the present invention along with pharmaceutically acceptable muco-adhesive polymer as ocular lubricant effectively mitigates the symptoms of

inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans. The use of said poly-herbal composition in the form of eye drops stimulates the lacrimal gland that leads to the natural flow of tears from the eyes which provides essential cleansing, soothing, healing and cooling to the eyes.
The present innovation is theorized to work through a unique twofold mechanism of action: firstly, the formulation binds to the ocular surface epithelial cells and adds volume to the tear film, restructuring the tear film in a manner that it provides long-lasting protection to the eye surface; secondarily, the increased contact time results in better ocular bioavailability and prolonged residence of the beneficial herbal actives in the pre-corneal area of the eye -nourishing, lubricating and protecting the ocular surface. These lubricant eye drops spread rapidly, efficiently and evenly over the cornea to minimize friction between the upper eyelid and the ocular surface.
Further, the said innovative pH balanced hypo-osmolar poly-herbal eye drops composition is found to be safe, sterile, stable, isotonic, buffered, well preserved and effective for sufficiently long time.
This eye drops formulation is designed to protect against eye strain and tear film loss by keeping eyes moist and nourished. This innovative poly-herbal eye drops offers an efficacious and safe preventive and curative modality to manage all the symptoms of inflammatory and allergic conditions of the eye and dry eye disease; as its basic (poly-herbal) formulation is clinically and scientifically proven. As evidenced in a preliminary, single blind, prospective, randomized Clinical Trial, this formulation is extremely effective in cases of burning eyes, allergic conjunctivitis, general irritation, foreign-body sensation and tired eyes. Furthermore, the beneficial properties of the herbal actives included in the formulation in low concentrations, provide mild but significant protective effects observed on inflammation, and other symptoms of ocular

distress. These herbal actives can have cumulative and synergistic effects; thus, topical application of the present innovative formulation in the eyes of afflicted patients, exerts obvious therapeutic effect with no toxicity as observed in clinical studies.
OBJECTS OF THE INVENTION
The Objectives of the Present Invention are:
To provide a novel ophthalmic poly-herbal composition along with
pharmaceutically acceptable mucoadhesive polymer as ocular lubricant, in
particular to cure, mitigate or prevent pain, inflammatory and allergic
conditions of the eye and dry eye disease (DED) in humans.
Yet another objective of the present invention is to provide safe, sterile, stable, isotonic, buffered, well preserved and effective ophthalmic poly-herbal composition along with pharmaceutically acceptable mucoadhesive polymer as ocular lubricant, in particular to cure, mitigate or prevent pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans.
Yet another objective of the present invention is to provide a method of preparing an ophthalmic poly-herbal composition along with pharmaceutically acceptable mucoadhesive polymer as ocular lubricant, in particular to cure, mitigate or prevent pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans.
Yet another objective of the present invention is to provide a method in particular to cure, mitigate or prevent pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in humans by administering the composition of the present invention in the form of eye drops.

SUMMARY OF THE INVENTION
The present invention provides a novel ophthalmic poly-herbal composition along with pharmaceutical^ acceptable mucoadhesive polymer as ocular lubricant, in particular to cure, mitigate or prevent pain, inflammatory and allergic conditions of the eye and dry eye disease (DED). The said composition comprises of a mixture of aqueous distillates of eleven traditionally used ingredients that sum up to impart potency to the formulation and make it a useful adjunct in various ocular pathologies: aqueous extracts of Haridra (Curcuma longa; Turmeric), Nimba (Azadirachta indica; Neem), Vibhitaka (Terminalia belericha; Belliric Myrobalan)), Amalaki (Emblica officinalis; Indian gooseberry), Rasount (Berberis aristata; Indian Barberry), Haritaki (Terminalia chebula; Chebulic Myrobalan), Mamira (Thalictrum foliolosum; Gold Thread Root), Tulsi Patra (Ocimum sanctum; Holy Basil), Pudina (Mentha arvensis; Corn Mint ), Yamini (Trachyspermum amm'i; Bishop's weed or Carom), Gulabjal (Rosa damascene; Rose Water), Madhu (Honey), at least one preservative and pharmaceutically acceptable mucoadhesive polymer or combinations thereof. The composition is effective, safe, and also acts as an anti-inflammatory, analgesic, anti-oxidant and anti-microbial modality.
The ophthalmic poly-herbal composition of the present innovation refreshes, irrigates and revitalizes tired eyes, lubricates and cools sensitive eyes and gives relief to red and uncomfortable eyes resulting from smoky environments, computer work and contact lens wear. The present composition is extremely effective in treating pain, inflammatory and allergic conditions of the eye and symptoms of dry eye disease (DED) in humans; such as, red eyes, watery eyes, burning and itching eyes, allergic conjunctivitis, general irritation, foreign-body sensation and tired eyes.
Further, a method of preparing the said composition is disclosed in the present invention.

DETAILED DESCRIPTION OF THE INVENTION
The extracts of herbal products and Ayurvedic, Siddha and Unani formulations are mixtures of natural constituents. It is claimed that such a mixture provides a therapeutic advantage, since the constituents may be 'synergistic' in action or may produce a balance to counteract adverse effects of any one constituent. This may provide more efficacy than the known constituent used alone.
The present innovation provides a novel ophthalmic polyherbal composition which is effective for prevention and treatment of common ophthalmic disorders including chronic allergic conjunctivitis, significant eye fatigue and dry eye disease. The said composition comprises of aqueous extracts of Haridra {Curcuma longa; Turmeric), Nimba (Azadirachta indica; Neem), Vibhitaka (Terminalia belericha; Belliric Myrobalan)), Amalaki (Emblica officinalis; Indian gooseberry), Rasount (Berberis aristata; Indian Barberry), Haritaki (Terminalia chebula; Chebulic Myrobalan), Mamira (Thalictrum foliolosum; Gold Thread Root), Tulsi Patra (Ocimum sanctum; Holy Basil), Pudina (Mentha arvensis; Corn Mint ), Yamini (Trachyspermum ammi; Bishop's weed or Carom), Gulabjal (Rosa damascene; Rose Water), Madhu (Honey), at least one preservative and pharmaceutically acceptable mucoadhesive polymer or combinations thereof. The composition is effective, safe, and also acts as anti¬inflammatory, analgesic, anti-oxidant and anti-microbial. Accordingly, such composition is able to treat dry eye disease along with its symptoms.
Further, a method of preparing said composition is disclosed in the present invention.
The present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are included within the scope of the present invention. The examples are provided to illustrate particular aspects of the invention and do not limit the scope of the present invention as defined by the claims. The headings used

throughout this disclosure are provided for convenience and are not to be construed to limit the scope of invention in any way. Embodiments illustrated under any heading may be combined with embodiments illustrated under any other heading.
The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, which comprises a list of components and does not include only those components but may include other components not expressly listed or inherent to said composition. In other words, one or more elements in a composition/method proceeded by "comprises" does not, without more constraints, preclude the existence of other elements or additional elements in the composition/method.
LIST OF ACCOMPANYING FIGURES:
Figure 1: Evaluation of pH of formulations having different polymers
Figure 2: Evaluation of Osmolarity of formulations having different polymers
(mOsM/kg using osmometer) Figure 3: Evaluation of Viscosity of formulations having different polymers
using Bob and Cup Rheometer Figure 4: Evaluation of Turbidity of formulations having different polymers
using Turbidimetry Figure 5: Evaluation of Anti-drying Properties of formulations having
different polymers using temperature control chamber Figure 6: Evaluation of Comfort Score of formulations having different
polymers in volunteers Figure 7: Left photograph: Ocular surface hyperemia & Right photograph: Swollen eye lids representing the symptoms of inflammatory and allergic conditions of the eyes of patients included in the Clinical Trial. Figure 8: Ocular surface hyperemia representing the symptoms of inflammatory and allergic conditions of the eyes of a patient included in the Clinical Trial.

Figure 9: REDNESS - Grading Scale of Eye Redness symptom of inflammatory and allergic conditions of the eye and dry eye disease (DED) in Poly-herbal Eye Drops-treated Group and Olopatidine-treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. Figure 10: ITCHING - Grading Scale of Eye Itching symptom of inflammatory and allergic conditions of the eye and dry eye disease (DED) in Poly-herbal Eye Drops-treated Group and Olopatidine-treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. Figure 11: WATERING - Grading Scale of Eye Watering symptom of inflammatory and allergic conditions of the eye and dry eye disease (DED) in Poly-herbal Eye Drops-treated Group and Olopatidine-treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. Figure 12: Symptoms of inflammatory and allergic conditions of the eye and dry eye disease (DED) in Poly-herbal Eye Drops-treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. Figure 13: Symptoms of inflammatory and allergic conditions of the eye and dry eye disease (DED) in Olopatidine Eye Drops- treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. Figure 14: Symptoms of pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in Polyherbal Eye Drops- treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. [FBS= Foreign Body Sensation].
Figure 15: Symptoms of pain, inflammatory and allergic conditions of the eye and dry eye disease (DED) in Olopatidine Eye Drops- treated Group at Day 0 (start of the Clinical Study), 7 Days, 14 Days and 21 Days of the Study. [FBS= Foreign Body Sensation].
COMPOSITIONS:
Embodiments of the present invention provides a composition (or polyherbal composition) comprising an aqueous extracts of: Haridra {Curcuma longa; Turmeric), Nimba (Azadirachta indica; Neem), Vibhitaka (Terminalia

belericha; Belliric Myrobalan)), Amalaki (Emblica officinalis; Indian gooseberry), Rasount (Berberis aristata; Indian Barberry), Haritaki (Terminalia chebula; Chebulic Myrobalan), Mamira (Thalictrum foliolosum; Gold Thread Root), Tulsi Patra (Ocimum sanctum; Holy Basil), Pudina (Mentha arvensis; Corn Mint ), Yamini (Trachyspermum ammi; Bishop's weed or Carom), Gulabjal (Rosa damascene; Rose Water), Madhu (Honey) at least one preservative and pharmaceutically acceptable mucoadhesive polymer or combinations thereof. Further, method of preparation of said composition is herein disclosed.
In one embodiment of the present invention, the said composition comprises
the aqueous extracts of the components in the following range:
Turmeric (Haridra) - 2 to 10 % v/v
Neem (Nimba) - 2 to 10 % v/v
Vibhitaka-2tol0%v/v
Amla (Amalaki) - 2 to 10 % v/v
Rasount-2 to 10% v/v
Haritaki-2 to 10% v/v
Mamira-2 to 10% v/v
Tulsi Patra - 0.1 to 7 % v/v
Pudina -0.1 to 7% v/v
Yamini-0.1 to 7 % v/v
Honey - 2 to 20 % v/v
Preservative - 0.01 to 5 % v/v
Polymer-0.01 to 5% v/v
In yet another embodiment of the present invention, the said composition comprises the aqueous extracts of the components in the following range: Turmeric (Haridra) - 4 to 7 % v/v Neem (Nimba) - 4 to 7 % v/v Vibhitaka - 4 to 7 % v/v

Amla (Amalaki) - 4 to 7 % v/v Rasount - 4 to 7 % v/v Haritaki - 4 to 7 % v/v Mamira - 4 to 7 % v/v Tulsi Patra - 1 to 4 % v/v Pudina - 1 to 4 % v/v Yamini - 1 to 4 % v/v Honey-5 to 15% v/v Preservative - 0.01 to 1 % v/v Polymer-0.1 to 1 % v/v
In yet another embodiment of present invention, the preservative is benzalkonium chloride.
In yet another embodiment of present invention, the polymer is selected from Hydroxyl propyl methyl cellulose (HPMC), polyvinyl pyrolidone, Sodium hyaluronate, PEG 400, Carboxy methyl cellulose sodium, Glycerol or combinations thereof.
In yet another embodiment of present invention, the said composition further comprises additional components selected from aq. extracts of Alum, Camphor, Rose water or combinations thereof.
In yet another embodiment of present invention, the said composition further comprises aq. extracts of Alum, Camphor and Rose water. In yet another embodiment of present invention, the said composition comprises aqueous extract Alum in the range of 0.1 to 5 % v/v
In yet another embodiment of present invention, the said composition comprises aqueous extract Camphor in the range of 0.1 to 5 % v/v

In yet another embodiment of present invention, the said composition comprises aqueous extract rose water q.s.
In yet another embodiment of the present invention, the said composition comprises the aqueous extracts of the components in the following range:
Turmeric (Haridra) - 2 to 10 % v/v Neem (Nimba) - 2 to 10 % v/v Vibhitaka-2tol0%v/v Amla (Amalaki) - 2 to 10 % v/v Rasount-2to 10% v/v Haritaki-2to 10% v/v Mamira-2to 10% v/v Tulsi Patra - 0.1 to 7 % v/v Pudina-0.1 to 7 % v/v Yamini-0.1 to 7 % v/v Alum-0.1 to 5% v/v Camphor - 0.1 to 5 % v/v Rose water- q.s. Honey - 2 to 20 % v/v Preservative - 0.01 to 5 % v/v Polymer-0.01 to 5% v/v
In yet another embodiment of the present invention, the said composition comprises the aqueous extracts of the components in the following range: Turmeric (Haridra) - 4 to 7 % v/v Neem (Nimba) - 4 to 7 % v/v Vibhitaka - 4 to 7 % v/v Amla (Amalaki) - 4 to 7 % v/v Rasount - 4 to 7 % v/v Haritaki - 4 to 7 % v/v

Mamira - 4 to 7 % v/v Tulsi Patra - 1 to 4 % v/v Pudina - 1 to 4 % v/v Yamini - 1 to 4 % v/v Alum-0.1 to 1 %v/v Camphor - 0.1 to 2 % v/v Rose water- q.s. Honey-5 to 15% v/v Preservative - 0.01 to 1 % v/v Polymer-0.1 to 1 % v/v
In yet another embodiment of the present invention, the said composition
comprises the aqueous extracts of the components in the following range:
Turmeric (Haridra) - 4.5 to 5.5 % v/v
Neem (Nimba) - 4.5 to 5.5 % v/v
Vibhitaka - 4.5 to 5.5 % v/v
Amla (Amalaki) - 4.5 to 5.5 % v/v
Rasount - 4.5 to 5.5 % v/v
Haritaki - 4.5 to 5.5 % v/v
Mamira - 4.5 to 5.5 % v/v
Tulsi Patra - 2 to 4 % v/v
Pudina - 1 to 3 % v/v
Yamini - 1 to 3 % v/v
Alum - 0.4 to 0.7 % v/v
Camphor - 0.2 to 0.5 % v/v
Rose water- q.s.
Honey - 8 to 12 % v/v
Preservative - 0.01 to 0.04 % v/v
Polymer - 0.2 to 0.6 % v/v

In yet another embodiment of present invention, the preservative is benzalkonium chloride.
In yet another embodiment of present invention, the polymer is selected from Hydroxyl propyl methyl cellulose (HPMC), Polyvinyl pyrolidone, Sodium hyaluronate, PEG 400, Carboxy methyl cellulose sodium, Glycerol or combinations thereof.
In yet another embodiment of the present invention, the said composition
comprises the aqueous extracts of the components in the following range:
Turmeric (Haridra) - 4.5 to 5.5 % v/v
Neem (Nimba) - 4.5 to 5.5 % v/v
Vibhitaka - 4.5 to 5.5 % v/v
Amla (Amalaki) - 4.5 to 5.5 % v/v
Rasount - 4.5 to 5.5 % v/v
Haritaki - 4.5 to 5.5 % v/v
Mamira - 4.5 to 5.5 % v/v
Tulsi Patra - 2 to 4 % v/v
Pudina - 1 to 3 % v/v
Yamini - 1 to 3 % v/v
Alum - 0.4 to 0.7 % v/v
Camphor - 0.2 to 0.5 % v/v
Rose water- q.s.
Honey - 8 to 12 % v/v
Benzalkonium chloride - 0.01 to 0.04 % v/v
Hydroxy Propyl Methyl Cellulose (HPMC) - 0.2 to 0.6 % v/v
In yet another embodiment of present invention, the said composition improves
the clarity of vision and heals the eyes. It also helps in reducing inflammation,
redness, dryness, irritation and watering of eyes.

In yet another embodiment of present invention, the said composition provides
relief from irritation and infections along with long-term benefits of sharper
vision and healthier eyes.
In yet another embodiment of present invention, the said composition prevents
and mitigates common ophthalmic disorders including chronic allergic
conjunctivitis, significant eye fatigue and dry eye disease effectively.
In yet another embodiment, a method of treating common ophthalmic disorders
including chronic allergic conjunctivitis, significant eye fatigue and dry eye
disease by administering the composition of present invention to the patient in
need thereof.
In yet another embodiment, a composition of present invention is administered
by topical route such as ophthalmic formulations.
In yet another embodiment, a composition of present invention is administered
as eye drops, suspensions, emulsions, solutions etc.
In yet another embodiment of the present invention, the components of the
present composition (herbs) or its extracts thereof are commercially available
and procured from market.
In yet another embodiment of the present invention, the present composition is
synergistic in nature and produces surprising results.
METHOD OF PREPARATION:
The General Procedure for Preparing the Present Composition is as Follows: a) Weighing extracts of Haridra {Curcuma longa; Turmeric), Nimba (Azadirachta indica; Neem), Vibhitaka (Terminalia belericha; Belliric Myrobalan)), Amalaki (Emblica officinalis; Indian gooseberry), Rasount (Berberis aristata; Indian Barberry), Haritaki (Terminalia chebula; Chebulic Myrobalan), Mamira (Thalictrum foliolosum; Gold Thread Root), Tulsi Patra (Ocimum sanctum; Holy Basil), Pudina (Mentha arvensis; Corn Mint ), Yamini (Trachyspermum ammi; Bishop's weed or Carom), Gulabjal (Rosa damascene; Rose Water), Alum, Kapoor (Camphor), Madhu (Honey) one by one in a

mixing tank with continuous stirring for 15 to 30 minutes to produce a solution.
b) Adding weighted quantity of Benzalkonium Chloride and Hydroxy Propyl Methyl Cellulose (HPMC) to above solution with continuous stirring for 10 to 30 minutes.
c) Adjusting the pH of the solution obtained in Step b) - between 6.5 to 8.5 by adding solution of sodium hydroxide (10% w/v).
d) Transferring the solution obtained in Step c) from mixing tank to pressure vessel.
e) Filtering the solution as obtained in Step d) by pre-filter and Nitrogen gas to obtain the final composition of present invention.
NOTE: The Pressure of nitrogen gas should not exceed 0.8 Kg./sq. cm, and pre-filter should be preferably of 0.45 micron size.
EXPERIMENTAL DATA
EXAMPLE 1: Selection of compatible polymers in the polyherbal
composition of present invention: Fifteen (15) various polymers and polymer combinations were attempted to make the compatible/anti-drying formulation for present composition. However, due to the development of precipitation, change in color and other unacceptable variations, seven (7) of them were taken for further development and studies. The said seven different variants were shortlisted and carried forward for analysis, which is mentioned below, along with their reference codes:
Poly-Herbal Preserved Eye Drops Formulation (*)
DX010: (*) + 0.3% Hydroxy Propyl Methyl Cellulose (HPMC) DX020: (*) + 0.15% polyvinyl pyrolidone

DX030: (*) + 0.3% Sod. Hyaluronate (120 kDa) DX040: (*) + 1.0% PEG 400
DX050: (*) + 0.5% Carboxy methyl cellulose (CMC) DX060: (*) + 0.3% HPMC and 0.2% Glycerol DX061: (*) + 0.2% HPMC and 0.1% Glycerol
Methodology: Calculated amount of polymer was weighed and added to prepare the present composition, vortexed and stored. Assessment of properties of the innovative Poly-herbal Eye Drops with added Mucoadhesive Polymer
was done taking the Poly-herbal composition prior to addition of mucoadhesive polymer as control:
1. Comparison of pH - pH was measured of all formulations with pH Meter
2. Comparison of Osmolarity - Osmolarity was measured of al formulation with Osmometer
3. Comparison of Viscosity - Viscosity was measured with Rheometer at 25
±1°C.
4. Comparison of Turbidity by UV-VIS Spectrophotometer at 500nm -Turbidity was measured based on % transmittance by UV-VIS Spectrophotometer at 500nm. Water was taken as reference with 100 % transmittance.
5. Comparing Anti-drying Property - The anti-drying property of newly prepared formulations was compared to the Control (Poly-herbal Formulation) by exposing them to controlled temperature and humidity chamber:
i. lOOul of each formulation were poured in pre-weighed aluminum discs
of similar dimensions. ii. The discs were weighed again. iii. The formulations were exposed to 25 ± 2°C and humidity (45± 5%) for
lh. iv. After lh the discs were weighed again.

v. The % loss of water was calculated based on weight loss calculations. vi. The data was statistically evaluated.
EXAMPLE 1.1: Evaluation of the pH of formulations having different
polymers:
Table 1

Formulation pH STD DEV
MilliQ Water 6.82 0.177
CONTROL 7.54 0.079
DX010 7.52 0.043
DX020 7.5233 0.015
DX030 7.52 0.026
DX040 7.503 0.011
DX050 7.2966 0.072
DX060 7.4333 0.057
DX061 7.5133 0.032
The respective graph of Table 1 is given below as Figure 1.
EXAMPLE 1.2: Evaluation of the osmolality of the formulations having different polymers (mOsM/kg using osmometer)
Table 2

Formulation Osmolarity STD DEV
CONTROL 221 2
DX010 225.66 1.527
DX020 221.33 0.577
DX030 228.33 1.1547
DX040 252.66 0.577

DX050 DX060 DX061

247 1.73
223.33 0.577
228.33 2.081

The respective graph of Table 2 is given below as Figure 2.
EXAMPLE 1.3: Evaluation of viscosity of the formulations having different polymers using Bob and Cup Rheometer
Table 3:

Formulation Viscosity at 25.4°C (cP)

STD DEV

CONTROL 0.3903
DX010 2.3167
DX020 0.1095
DX030 5.0366
DX040 0.5226
DX050 2.2966
DX060 2.8666
DX061 0.2893

0.054793552
0.051316014
0.030715034
0.0288675
0.047342722
0.037859389
0.028867513
0.118938359

The respective graph of Table 3 is given below as Figure 3.

EXAMPLE 1.4: Evaluation of Turbidity of the formulations having different
polymers using Turbidimetry
Table 4
FORMULATION % ~STD
TRANSMITTANCE DEV
100.22
0.215174
93.33
0.404145
MILLIQ WATER CONTROL

DX010 94.7733 0.005774
DX020 94.46 0.261534
DX030 93.993 0.023094
DX040 93.66 0.07
DX050 85.96 0.017321
DX060 51.186 0.44411
DX061 77.47 0.548088
The respective graph of Table 4 is given below as Figure 4.
EXAMPLE 1.5: Evaluation of anti-drying property of the formulations having
different polymers using temperature control chamber: Table 5:

Formulation

Avg % Loss of water

CONTROL

55.319 ±2.217

DX010
DX020
DX030
DX040 DX050

43.291 ±1.938
50.155 ±6.436
34.753 ±2.989
45.020 ±6.014 46.568 ±5.714

DX060 DX061

41.281 ±4.616 42.492 ±2.709

The respective graph of Table 5 is given below as Figure 5.
EXAMPLE 1.6: Evaluation of the Comfort of the Selected Formulations in Volunteers (after instilling the eye drops into the eyes of the Volunteers):

Two formulations were selected based on their water retention property with formulation DX030 retaining highest amount of water followed by DX010. These two along with control formulation were subjected to a suitability testing in 15 volunteers. The eye drops were randomly instilled into the eyes of volunteers and graded according a Scale Scoring from 0 to 6 (Table 6).
Table 6: Comfort Score

FEELING SCORE
Intolerable 0
Irritation 0
Tolerable 1
Moderate irritation 2
Mild irritation 3
Acceptable (initial sting sensation) 4
Comfortable 5
Good 6
The respective graph of Table 6 is drawn under Figure 6.
CONCLUSIONS
1. All formulations have pH in the range of 6.4 to 7.4.
2. Adding polymers to control composition does not drastically affect the osmolarity of formulation and the osmolarity of all formulation ranges in 220- 230 except for formulation DX040 and DX050 with osmolalities 252 ± 0.577 and 247 ± 1.73 respectively.
3. Turbidity measurement done indirectly by measuring % Transmittance (% T) with UV-Spectrophotometer confirms that formulation DX010, DX020, DX030, DX040 do not show any formation of precipitation as % T is equal or more than CONTROL.

4. While formulation DX050, DX060 and DX061 have % T reduced with lowest in case of DX060 (51.186 ± 0.44).
5. Formulation DX030 is able to hold maximum amount of water after lh followed by formulation DX010.
The Anti-drying Property is measured using Temperature Control Chamber. The formulations were exposed to 25 ± 2°C and humidity (45± 5%) for lh. The per cent decrease in Loss of Water was highly significant (p<0.01) in all the test formulations except DX060 (p<0.05) and DX020 (NS) as compared to the CONTROL. [NS=Not significant]
6. DX030 and DX010 are tolerated similar to the CONTROL formulation.
7. Most of the volunteers stated their satisfaction between Comfort and Good in all the test formulations {that is: Poly-herbal preserved eye drops formulation + Different polymers).
EXAMPLE 2:
The below formulation is prepared as per the general procedure of preparation
comprising aqueous extracts of (in v/v)

Haridra (Curcuma longa) 5%
Nimba (Azadirachta indica) 5%
Vibhitaki (Terminalia belericha) 5%
Amalaki (Emblica officinalis) 5%
Rasount (Berberis aristata) 5%
Haritaki (Terminalia chebula) 5%
Mamira (Thalictrum foliolosum) 5%
Tulsipatra (Ocimum sanctum) 3%
Pudina (Mentha aryensis) 2%
Yamani (Trachyspermum ammi) 2%

Alum 0.5%
Kapoor (Camphor) 0.3%
Madhu (Honey) 10%
Gulab Jal (Rose Water) q.s.
Benzalkonium chloride 0.02%
Hydroxy Propyl Methyl Cellulose (HPMC) 0.3%
EXAMPLE 3:
The below formulation is prepared as per the general procedure of preparation comprising aqueous extracts of (in v/v)

Haridra {Curcuma longa) 3%
Nimba (Azadirachta indica) 3%
Vibhitaki (Terminalia belericha) 4%
Amalaki (Emblica officinalis) 3%
Rasount (Berberis aristata) 3%
Haritaki (Terminalia chebula) 3%
Mamira (Thalictrum foliolosum) 3%
Tulsipatra (Ocimum sanctum) 1%
Pudina (Mentha aryensis) 1%
Yamani (Trachyspermum ammi) 1%
Alum 0.2%
Kapoor (camphor) 0.2%
Madhu (honey) 5%
Gulab jal (rose water) q.s.
Benzalkonium chloride 0.01%
Hydroxy Propyl Methyl Cellulose (HPMC) 0.1%

EXAMPLE 4:
Aqueous extracts of (in v/v)

Haridra {Curcuma longa) 7%
Nimba (Azadirachta indica) 6%
Vibhitaki (Terminalia belericha) 8%
Amalaki (Emblica officinalis) 7%
Rasount (Berberis aristata) 7%
Haritaki (Terminalia chebula) 7%
Mamira (Thalictrum foliolosum) 7%
Tulsipatra (Ocimum sanctum) 5%
Pudina (Mentha aryensis) 4%
Yamani (Trachyspermum ammi) 4%
Alum 1%
Kapoor (camphor) 0.5%
Madhu (honey) 15%
Gulab jal (rose water) q.s.
Benzalkonium chloride 0.05%
Hydroxy Propyl Methyl Cellulose (HPMC) 0.3%
EXAMPLE 5: Clinical Trial at All India Institute of Medical Sciences (AIIMS), New Delhi 110029, India.
A Prospective, Randomized, Comparative Clinical Trial conducted at Dr. Rajendra Prasad Centre for Ophthalmic Sciences (Dr. R P Centre), All India Institute of Medical Sciences (AIEVIS), New Delhi 110029, India.
Evaluation of Present composition of Example 2 in the Management of Various Ophthalmic Disorders

A randomized, open labeled, comparative clinical trial was conducted in patients suffering from various common ophthalmic disorders including chronic allergic conjunctivitis and significant eye fatigue with the present poly¬herbal eye drops preparation/composition.
Experimental studies evidenced that the Polyherbal Eye Drops were found to be safe, did not show any toxicity in rabbit-eye (Experimental animal). Permission obtained from Institute Ethical Committee to conduct Clinical Trials after submitting all relevant documents.
Patients and Methods:
Patients who were suffering from various common ophthalmic disorders including chronic allergic conjunctivitis and significant eye fatigue and visiting Dr. R. P. Center, OPD regularly were enrolled in the Study. The grading of allergic conjunctivitis was observed through Slit Lamp Examination.
Total number of subjects for which Institute
Ethics Committee permission obtained - 100
Total number of subjects enrolled - 110
Total number of subjects completed Study - 94
All patients were randomly divided into Two Main Treatment Groups:
Group A: receiving the Present Composition - Poly-herbal Eye Drops (n=55) Group B: receiving reference drug - Olopatadine Eye Drops (n=30)
In addition, two small Groups were studied for common symptoms of ocular discomfort:
Group C: Cross-over of patients from Poly-herbal Eye Drops-treated Group to Olopatidine-treated Group (n=5)

Group D: Cross-over of patients from Olopatidine -treated Group to Poly-herbal Eye Drops - treated Group (n=4)
Patients were randomly assigned to the Treatment Groups of the Study.
Patients self-administered one drop of the assigned study agent in each eye:
Group A - Poly-herbal Eye Drop Composition - four times daily to each eye
for 21 Days GROUP B - Olopatadine Eye drops two times daily to each eye for 21 Days
Patient's follow-up was done at 1 week (7 Days), 2 weeks (14 Days) and 3 weeks (21 Days) after the initiation of the study (0 Day). Ocular itching was graded by the patients, and ocular redness was evaluated by the investigator using a Slit Lamp Microscope. Complete medical history was recorded from all patients prior to initiation of the study.
Results & Conclusion:
1. A marked improvement was observed in majority of Study Subjects with the treatment of the present formulation in most cases. There were no side effects observed during the course of the study and the poly-herbal eye drops was well tolerated by the patients. The herbal eye drops preparation of present invention has a useful role in a variety of allergic inflammatory and fatigue ophthalmic disorders. The data from this study are presented in Figures 7-15.
2. The present composition was found to be as effective as Olopatadine (A standard allopathic drug for the treatment of allergic inflammatory and fatigue ophthalmic disorders).

3. However, in some cases, the Poly-herbal formulation showed more effectiveness in reducing itching and watery eyes as compared to Olopatadine. No significant side effects were observed in the Poly-herbal formulation-treated Group of Trial subjects; however, in case of Olopatadine 3.33% of patients complained about some allergic reaction.
4. Overall, the results of this study show that the present formulation is effective in reducing the signs and symptoms associated with inflammatory and allergic conditions of the eye, fatigue ophthalmic disorders and dry eye disease (DED) and is safe when used by patients suffering with these eye conditions.
5. Thus, from the above Clinical Study it is concluded that, the present poly-herbal composition showed a beneficial role in the management of inflammatory and allergic conditions of the eye (allergic conjunctivitis) eye fatigue and dry eye disease allergic without any side effects as that experienced with Olopatadine, a standard anti-allergic and eye toning agent.

WE CLAIM:
1. A composition comprising aqueous extracts of:
a) Turmeric {Curcuma longa)
b) Neem (Azadirachta indica)
c) Vibhitaka (Terminalia belericha)
d) Amalaki (Emblica officinalis)
e) Rasount (Berberis aristate)
f) Haritaki {Terminalia chebula)
g) Mamira (Thalictrum foliolosum) h) Tulsi Patra (Ocimum sanctum) i) Pudina (Mentha aryensis)
j) Yamini (Trachyspermum ammi)
k) Madhu (Honey)
1) Preservative
m) Mucoadhesive Polymer
2. The composition as claimed in Claim 1, further comprising additional components selected from extracts of Alum, Camphor, Rose water or combinations thereof.
3. The composition as claimed in Claim 1, wherein the composition comprises of:

a) Turmeric (Curcuma longa) - 2 to 10 % v/v
b) Neem (Azadirachta indica) - 2 to 10 % v/v
c) Vibhitaka (Terminalia belericha) - 2 to 10 % v/v
d) Amalaki (Emblica officinalis) - 2 to 10 % v/v
e) Rasount (Berberis aristate) - 2 to 10 % v/v
f) Haritaki (Terminalia chebula) - 2 to 10 % v/v
g) Mamira (Thalictrum foliolosum)- 2 to 10 % v/v h) Tulsi Patra (Ocimum sanctum)- 0.1 to 7 % v/v

i) Pudina {Mentha aryensis)- 0.1 to 7 % v/v
j) Yamini (Trachyspermum ammi)- 0.1 to 7 % v/v
k) Madhu (Honey) - 2 to 20 % v/v
1) Preservative - 0.01 to 5 % v/v
m) Polymer - 0.01 to 5 % v/v
4. The composition as claimed in Claim 2, wherein the amount of:
Alum-0.1 to 5% v/v; Camphor - 0.1 to 5 % v/v; Rose water- q.s.
5. The composition as claimed in Claim 3, wherein the amount of:
a) Turmeric {Curcuma longa) - 4 to 7 % v/v
b) Neem (Azadirachta indica) - 4 to 7 % v/v
c) Vibhitaka (Terminalia belericha) - 4 to 7 % v/v
d) Amalaki (Emblica officinalis) - 4 to 7 % v/v
e) Rasount (Berberis aristate) - 4 to 7 % v/v
f) Haritaki {Terminalia chebula) - 4 to 7 % v/v
g) Mamira (Thalictrum foliolosum)- 4 to 7 % v/v h) Tulsi Patra (Ocimum sanctum)- 1 to 4 % v/v i) Pudina (Mentha aryensis)- 1 to 4 % v/v
j) Yamini (Trachyspermum ammi)- 1 to 4 % v/v k) Madhu (Honey) - 5 to 15 % v/v 1) Preservative - 0.01 to 1 % v/v m) Polymer - 0.1 to 1 % v/v
6. The composition as claimed in Claim 4, wherein the amount of:
Alum-0.1 to 1 %v/v Camphor - 0.1 to 2 % v/v Rose water- q.s.

7. The composition as claimed in Claims 1, 3 or 5, wherein the preservative is benzalkonium chloride.
8. The composition as claimed in Claims 1, 3 or 5, wherein the polymer is selected from hydroxyl Propyl Methyl Cellulose (HPMC), Polyvinyl pyrolidone, Sodium hyaluronate, PEG 400, Carboxy Methyl Cellulose Sodium, Glycerol or combinations thereof.
9. The composition as claimed in Preceding Claims, wherein the composition comprises of:
Turmeric - 4.5 to 5.5 % v/v
Neem-4.5to5.5%v/v
Vibhitaka - 4.5 to 5.5 % v/v
Amla-4.5to5.5 % v/v
Rasount - 4.5 to 5.5 % v/v
Haritaki - 4.5 to 5.5 % v/v
Mamira - 4.5 to 5.5 % v/v
Tulsi Patra - 2 to 4 % v/v
Pudina - 1 to 3 % v/v
Yamini - 1 to 3 % v/v
Alum - 0.4 to 0.7 % v/v
Camphor - 0.2 to 0.5 % v/v
Rose water- q.s.
Honey - 8 to 12 % v/v
Benzalkonium chloride - 0.01 to 0.04 % v/v
Hydroxypropylmethyl cellulose (HPMC) - 0.2 to 0.6 % v/v
10. The composition as claimed in Claim 9, wherein the composition
comprises of:
Turmeric - 5 % v/v Neem - 5 % v/v

Vibhitaka - 5 % v/v
Amla - 5 % v/v
Rasount - 5 % v/v
Haritaki - 5 % v/v
Mamira - 5 % v/v
Tulsi Patra - 3 % v/v
Pudina - 2 % v/v
Yamini - 2 % v/v
Alum - 0.5 % v/v
Camphor - 0.3 % v/v
Rose water- q.s.
Honey- 10% v/v
Benzalkonium chloride - 0.02 % v/v
Hydroxypropylmethyl cellulose (HPMC) - 0.3 % v/v
11. A method of preparing the composition as claimed in Preceding Claims, wherein the said method comprises the following steps:
a) Weighing extracts of Haridra (Curcuma longa; Turmeric), Nimba
(Azadirachta indica; Neem), Vibhitaka (Terminalia belericha; Belliric
Myrobalan)), Amalaki (Emblica officinalis; Indian gooseberry), Rasount
(Berberis aristata; Indian Barberry), Haritaki (Terminalia chebula; Chebulic
Myrobalan), Mamira (Thalictrum foliolosum; Gold Thread Root), Tulsi
Patra (Ocimum sanctum; Holy Basil), Pudina (Mentha arvensis; Corn Mint),
Yamini (Trachyspermum ammi; Bishop's weed or Carom), Gulabjal (Rosa
damascene; Rose Water), Alum, Kapoor (Camphor), Madhu (Honey) one
by one in a mixing tank with continuous stirring for 15 to 30 minutes to
produce a solution.
b) Adding weighted quantity of Benzalkonium Chloride and HPMC to above
solution with continuous stirring for 10 to 30 minutes.

c) Adjusting the pH of the solution obtained in Step b) between 6.5 to 8.5 by adding solution of sodium hydroxide (10% w/v).
d) Transferring the solution obtained in Step c) from mixing tank to pressure vessel.
e) Filtering the solution as obtained in Step d) by pre-filter and Nitrogen gas to obtain the final composition of present invention.

12. The method as claimed in Claim 11, wherein Pressure of nitrogen gas should not exceed 0.8 Kg./sq. cm, and pre-filter should be preferably of 0.45 micron size.
13. The composition as claimed in Claims 1 to 10, for use in treatment of dry eye disease or the symptoms associated with dry eye diseases such as inflammation, irritation, infections and watering of eyes.
14. A method of treatment of dry eye disease by administering the composition
as claimed in Claims 1 to 10 to the patient in need thereof.
15. The composition as claimed in Claims 1 to 10, administered as ophthalmic
composition in the form of eye drops.