Indian Patents. 272804:"OPHTHALMIC COMPOSITION COMPRISING PHENYLEPHRINE"

Title of Invention	"OPHTHALMIC COMPOSITION COMPRISING PHENYLEPHRINE"
Abstract	The present invention provides a stable and efficacious ophthalmic composition for topical application comprising a mydriatic agent and a viscoelastic polymer, and also methods of preparing such a composition for human and veterinary administration.

Full Text	OPHTHALMIC COMPOSITION COMPRISING PHENYLEPHRINE FIELD OF INVENTION The present invention provides an ophthalmic composition for topical application comprising a mydriatic agent and a viscoelastic polymer, and also methods of preparing such a composition for human and veterinary administration. BACKGROUND OF INVENTION The dilatation of pupil (mydriasis) has different indications e.g. fundus examinations, old age refractions, for visual gain in cataract etc. (Mydriasis-use of phenylephrine (a dose-response concept) , Chawdhary S, Angra SK, Zutshi R, Sachdev MS, Indian Journal of Ophthamology, 1984, vol 32, issue 4,213-16) Phenylephrine is recommended as a vasoconstrictor, decongestant and mydriatic for a wide variety of ophthalmic conditions and procedures. A mydriatic is an agent which induces dilation of the pupil. Some of its uses are for pupillary dilation in uveitis, for many surgical procedures and for refraction without cycloplegia. It may also be used for fundoscopy and other diagnostic procedures such as provocative test in patients with narrow profile of anterior chamber angle, differential diagnostics and pupil dilation in ophthalmic surgery for preoperative preparation. Phenylephrine is a very unstable compound in solution and is found to degrade in the presence of light and upon atmospheric contact. Phenylephrine hydrochloride and solutions containing the drug are subject to oxidation and should be stored in tight, light-resistant containers. Solutions of the drug must not be used if they are brown or contain a precipitate. However, oxidation of the drug resulting in loss of activity may occur without a color change being evident. In the prior art, various compositions comprising phenylephrine have been prepared. However, none address problem of oxidation. Considering all above shortcomings of Prior art, the applicant has developed a simple and industrially viable composition with increased shelf life. OBJECT OF THE INVENTION An object of the present invention is to provide an ophthalmic composition comprising phenylephrine, a mydriatic agent and a viscoelastic agent. Yet another object of the invention is to provide a process for the preparation of the ophthalmic drug. DETAILED DESCRIPTION OF THE INVENTION The present invention provides an ophthalmic composition comprising phenylephrine, a viscoelastic agent, an osmolality agent, an ophthalmically acceptable salt, a buffering agent and water. The phenylephrine may be present in the range of 0.15%w/v - 10% w/v. Phenylephrine may be in the form of pharmaceutically acceptable salt such as the salt of inorganic acid hydrochloride, bicarbonate, sulfate, nitrate etc or salt of organic acid such as tartarate, acetate, etc. The composition comprises a viscoelastic agent that is preferably selected from the group .of carboxyl methyl cellulose, poly vinyl alcohol, hydroxy propyl methyl cellulose (HPMC), hydroxy ethyl cellulose, povidone, dextran, etc. In general, the amount of the viscoelastic agent, i.e. such as HPMC contained in the composition is 0.1-3%, preferably 0.2-1%, and most preferably 0.2-0.5%. The viscosity of the composition of the present invention may be 0.1-10 cps, preferably 0.5-5 cps, and most preferably 1-3 cps. This relatively low viscosity ensures that the product is comfortable, does not cause blurring, and is easily processed during manufacturing, transfer and filling operations The composition optionally further includes at least one ophthalmically acceptable salt in an amount required to bring osmolality of the composition into an ophthalmically acceptable range. Such salt include those having sodium, potassium or ammonium cation and chloride, citrate, ascorbate, borate, phosphate, bicarbonate, sulfate, thiosulfate or bisulfite anion; preferred salt include sodium chloride, potassium chloride, sodium thiosulfate, sodium bisulfite and ammonium sulfate, with sodium chloride being especially preferred. Other solutes suitable for adjustment of osmolality include sugar, for example dextrose, lactose, xylitol, mannitol and glycerine. The composition as described herein above also comprises a buffering agent and/or an agent for adjusting osmolality in amounts whereby the solution is substantially isotonic and has a physiologically acceptable pH. The composition also includes an agent for normalizing the osmolality such as sodium citrate. Ophthalmicaly acceptable osmolality lies within the limits of 150-1150 mOsm, preferably within 250-450 mOsm, most preferably within the limits of 300-400 mOsm The composition of the invention optionally further includes at least one ophthalmically acceptable pH adjusting agent and/or buffer, including an acid such as acetic, boric, citric, lactic, phosphoric and hydrochloric acid; a base such as sodium hydroxide, sodium phosphate, sodium borate, sodium citrate, sodium acetate, sodium lactate and tris-hydroxymethylaminomethane, triethanolamine; and a buffer such as citrate/dextrose, sodium bicarbonate and ammonium chloride, or an amino acid. Such an acid, base and/or buffer is preferably included in an amount required to maintain pH of the composition in an ophthalmically acceptable range. The pH of the composition of the present invention may be between 3-8, preferably within the range of 4-7 and most preferably in the range of 4.0-5.5. The amount of salt, buffer required for adjusting the osmolality and the pH, respectively is well known to those skilled in the art. The composition of the present invention is preferably packaged in opaque plastic container, one that can be presented in the form of eye drops packed in glass vial preferably amber colored, BFS plastic vial desirably opaque or three-piece plastic vial preferably opaque. In another embodiment, the composition of the present invention may be prepared by a process comprising a. preparing an aqueous solution of the HPMC, buffering agent, osmolality agent b. adding Phenylephrine to that solution as in step a) A solution of HPMC, buffering agent and osmolality agent may be prepared by simple admixture, with agitation as appropriate, of the ingredients. Buffering agents and agents for adjustment of osmolality can be added at any stage but are preferably present in solution with the HPMC before addition of the Phenylephrine The aqueous solution containing HPMC, buffering agent and osmolality agent is first prepared, and the Phenylephrine is added to that solution with agitation until it is fully dissolved. Processes for preparing an ophthalmic composition of the invention are preferably conducted in a sterile environment so as to provide a sterile product. ADVANTAGES Composition of the type as illustrated by the present invention has been found to be substantially stable and efficacious to the compositions without viscoelastic agent. EXAMPLES The invention is described in detail herein below with respect to the following examples, which are provided merely for illustration and are not intended to restrict scope of invention in any manner. Any embodiments that may be apparent to a person skilled in the art are deemed to fall within the scope of present invention. Example 1: Preparation of composition(Table Removed)Procedure: Water for injection was heated to 70-80°C, HPMC was dissolved by slow addition and continuous stirring till it dissolved completely. The temperature was brought to 25-30 C and then Disodium EDTA, Citric acid and sodium citrate; BKC was added one by one. Before the addition of sodium metabisulfite the solution was bubbled with 0.22 micron filtered nitrogen gas. Phenylephrine was then dissolved and pH was adjusted with dilute solution of sodium hydroxide. The contents were stirred for 30 min and filtered using 0.22 micron filter and packed in plastic vial aseptically. Example 2: Effect of composition on dilation of eye in rabbits. The composition of Example 1 was prepared. Another composition similar to that of Example 1 was prepared but, without HPMC. The effect of composition with HPMC was compared with the composition without HPMC. The mydriatic effect of the composition was studied by examining the pupil dilatation activity in New Zealand albino rabbits weighing about 2.5-3 kg and is given in Table 1. The rabbits were divided in to two groups of 6 each. Left eye of each rabbit was kept as control and one drop of 0.9% sodium chloride isotonic saline solution was instilled. In the right eye one drop of composition of present invention with viscoelastic and without viscoelastic agent was instilled. The pupil size, light reflux, corneal reflux and state of conjunctiva was observed and recorded at 0 minute (Control value), 15 min, 30 min, 45 min, 60 min, then at hourly interval for 6 hrs. The results are provided in table 1. Table-1(Table Removed)The above table measures dilation of the pupil and the time required for dilation of the pupil. An increase in the value of dilation and decrease in the time required for dilation shows enhanced efficacy of the composition. The period of peak dilation indicates the duration of efficacy of the drug while the time to reach peak dilation is indicated by time of peak dilation. Lower the peak dilation time indicates the higher efficacy. The results suggest that • Maximum pupil dilatation observed with the composition of present invention was 7.8 ± 0.6 mm, while the composition without the viscoelastic agent showed 6.5 ± 1.2. • Time for peak dilatation was 1 hr with composition containing viscoelastic agent, while it was 2 hrs for the composition without the viscoelastic agent. • Maximum dilatation was 1 hr in both the compositions • The recovery (time for pupil size to return to normal value) was faster with composition of the present invention. The data suggest that with the composition of present invention maximum pupil dilatation (7.8 ± 0.6 mm) is greater at a shorter time and the recovery is faster indicating enhanced efficacy of composition of present invention. It also indicates that the composition as prepared in Example 1 acts synergistically, in comparison to the composition without HPMC. Example 3 It was found that addition of HPMC improves the appearance and controls the level of impurities in the phenylepherine composition and hence it increased the overall shelf life of the product as described in Table -2 Table-2 (Table Removed) The results suggest that • The solution remained colorless after 6 month of stability at accelerated condition with composition with viscoelastic agent as compared to composition without viscoelastic agent. • The solution showed diminished level of impurities during stability studies at accelerated condition with composition with viscoelastic agent as compared to composition without viscoelastic agent. • The solution showed higher level of sodium metabisulfite after 6 months of stability at accelerated condition with composition with viscoelastic agent as compared to composition without viscoelastic agent. • The solution shows increased stability in pH during stability studies at accelerated condition with composition with viscoelastic agent as compared to composition without viscoelastic agent. We claim: 1. An ophthalmic composition comprising phenylephrine, a viscoelastic agent, an osmolality agent, a buffering agent and water. 2. A composition as claimed in claim 1 wherein phenylephrine is present in a range of 0.15% w/v -10% w/v. 3. A composition as claimed in claim 1 wherein phenylephrine is a salt selected from hydrochloride, bicarbonate, sulfate, nitrate, tartarate and acetate. 4. A composition as claimed in claim 1 wherein the viscoelastic agent is selected from a group comprising carboxyl methyl cellulose, poly vinyl alcohol, hydroxy propyl methyl cellulose, hydroxy ethyl cellulose, povidone and dextran. 5. A composition as claimed in claim 1 and 4 wherein the viscoelastic agent is hydroxy propyl methyl cellulose 6. A composition as claimed in claim 1 wherein the viscoelastic agent is in the range of 0.1-3%, more preferably in the range of 0.2-1%, most preferably in the range of 0.2-0.5%. 7. A composition as claimed in claim 1 wherein viscosity of the composition is in the range of 0.1-10 cps, 8. A composition as claimed in claim 1 wherein viscosity of the composition is in the range of 0.5-5 cps, 9. A composition as claimed in claim 1 wherein viscosity of the composition is in the range of 1 -3 cps. 10. A composition as claimed in claim 1 wherein the osmolality agent is selected from the group comprising salt and sugar 11. A composition as claimed in claim 10 wherein the salt is selected from group comprising sodium, potassium or ammonium cation and chloride, citrate, ascorbate, borate, phosphate, bicarbonate, sulfate, thiosulfate or bisulfite anion 12. A composition as claimed in claim 10 wherein the sugar is selected from group comprising dextrose, lactose, xylitol, mannitol and glycerine. 13. A composition as claimed in claim 10 wherein osmolality agent is selected from group comprising sodium chloride, potassium chloride, sodium thiosulfate, sodium bisulfite and ammonium sulfate 14. A composition as claimed in claim 1 wherein buffering agent is selected from group comprising acid such as acetic, boric, citric, lactic, phosphoric and hydrochloric 15. A composition as claimed in claim 1 wherein buffering agent is selected from group comprising base such as sodium hydroxide, sodium phosphate, sodium borate, sodium citrate, sodium acetate, sodium lactate 16. A composition as claimed in claim 1 wherein buffering agent is selected from group comprising tris-hydroxymethylaminomethane, triethanolamine, dextrose, sodium bicarbonate, ammonium chloride and amino acid. 17. A composition as claimed in claim 1 wherein osmolality of the composition is in the range of 300-400 mOsm 18. A composition as claimed in claim 1 wherein pH of the composition is 4-5.5. 19. A composition as claimed in claim 1 wherein the container is selected from a group comprising colored or opaque, plastic and glass containers. 20. A process of preparation of composition as claimed in claim 1, comprising steps of a. preparing an aqueous solution of the HPMC, buffering agent, osmolality agent ,anti oxidants and chelating agents b. adding Phenylephrine to that solution as in step a) 21. An ophthalmic composition and a process of preparation of composition substantially as herein described with reference to the foregoing examples.

Full Text

OPHTHALMIC COMPOSITION COMPRISING PHENYLEPHRINE
FIELD OF INVENTION
The present invention provides an ophthalmic composition for topical application comprising a mydriatic agent and a viscoelastic polymer, and also methods of preparing such a composition for human and veterinary administration.
BACKGROUND OF INVENTION
The dilatation of pupil (mydriasis) has different indications e.g. fundus examinations, old age refractions, for visual gain in cataract etc. (Mydriasis-use of phenylephrine (a dose-response concept) , Chawdhary S, Angra SK, Zutshi R, Sachdev MS, Indian Journal of Ophthamology, 1984, vol 32, issue 4,213-16)
Phenylephrine is recommended as a vasoconstrictor, decongestant and mydriatic for a wide variety of ophthalmic conditions and procedures. A mydriatic is an agent which induces dilation of the pupil. Some of its uses are for pupillary dilation in uveitis, for many surgical procedures and for refraction without cycloplegia. It may also be used for fundoscopy and other diagnostic procedures such as provocative test in patients with narrow profile of anterior chamber angle, differential diagnostics and pupil dilation in ophthalmic surgery for preoperative preparation.
Phenylephrine is a very unstable compound in solution and is found to degrade in the presence of light and upon atmospheric contact. Phenylephrine hydrochloride and solutions containing the drug are subject to oxidation and should be stored in tight, light-resistant containers. Solutions of the drug must not be used if they are brown or contain a precipitate. However, oxidation of the drug resulting in loss of activity may occur without a color change being evident. In the prior art, various compositions comprising phenylephrine have been prepared. However, none address problem of oxidation.
Considering all above shortcomings of Prior art, the applicant has developed a simple and industrially viable composition with increased shelf life.

OBJECT OF THE INVENTION
An object of the present invention is to provide an ophthalmic composition comprising phenylephrine, a mydriatic agent and a viscoelastic agent.
Yet another object of the invention is to provide a process for the preparation of the ophthalmic drug.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides an ophthalmic composition comprising phenylephrine, a viscoelastic agent, an osmolality agent, an ophthalmically acceptable salt, a buffering agent and water. The phenylephrine may be present in the range of 0.15%w/v - 10% w/v. Phenylephrine may be in the form of pharmaceutically acceptable salt such as the salt of inorganic acid hydrochloride, bicarbonate, sulfate, nitrate etc or salt of organic acid such as tartarate, acetate, etc.
The composition comprises a viscoelastic agent that is preferably selected from the group .of carboxyl methyl cellulose, poly vinyl alcohol, hydroxy propyl methyl cellulose (HPMC), hydroxy ethyl cellulose, povidone, dextran, etc. In general, the amount of the viscoelastic agent, i.e. such as HPMC contained in the composition is 0.1-3%, preferably 0.2-1%, and most preferably 0.2-0.5%.
The viscosity of the composition of the present invention may be 0.1-10 cps, preferably 0.5-5 cps, and most preferably 1-3 cps. This relatively low viscosity ensures that the product is comfortable, does not cause blurring, and is easily processed during manufacturing, transfer and filling operations
The composition optionally further includes at least one ophthalmically acceptable salt in an amount required to bring osmolality of the composition into an ophthalmically acceptable range. Such salt include those having sodium, potassium or ammonium cation and chloride, citrate, ascorbate, borate, phosphate, bicarbonate, sulfate, thiosulfate or bisulfite anion; preferred salt include sodium chloride, potassium chloride, sodium thiosulfate, sodium bisulfite and ammonium sulfate, with sodium chloride being especially preferred. Other solutes suitable for adjustment of

osmolality include sugar, for example dextrose, lactose, xylitol, mannitol and glycerine.
The composition as described herein above also comprises a buffering agent and/or an agent for adjusting osmolality in amounts whereby the solution is substantially isotonic and has a physiologically acceptable pH.
The composition also includes an agent for normalizing the osmolality such as sodium citrate. Ophthalmicaly acceptable osmolality lies within the limits of 150-1150 mOsm, preferably within 250-450 mOsm, most preferably within the limits of 300-400 mOsm
The composition of the invention optionally further includes at least one ophthalmically acceptable pH adjusting agent and/or buffer, including an acid such as acetic, boric, citric, lactic, phosphoric and hydrochloric acid; a base such as sodium hydroxide, sodium phosphate, sodium borate, sodium citrate, sodium acetate, sodium lactate and tris-hydroxymethylaminomethane, triethanolamine; and a buffer such as citrate/dextrose, sodium bicarbonate and ammonium chloride, or an amino acid. Such an acid, base and/or buffer is preferably included in an amount required to maintain pH of the composition in an ophthalmically acceptable range.
The pH of the composition of the present invention may be between 3-8, preferably within the range of 4-7 and most preferably in the range of 4.0-5.5.
The amount of salt, buffer required for adjusting the osmolality and the pH, respectively is well known to those skilled in the art.
The composition of the present invention is preferably packaged in opaque plastic container, one that can be presented in the form of eye drops packed in glass vial preferably amber colored, BFS plastic vial desirably opaque or three-piece plastic vial preferably opaque.
In another embodiment, the composition of the present invention may be prepared by a process comprising
a. preparing an aqueous solution of the HPMC, buffering agent, osmolality agent

b. adding Phenylephrine to that solution as in step a)
A solution of HPMC, buffering agent and osmolality agent may be prepared by simple admixture, with agitation as appropriate, of the ingredients. Buffering agents and agents for adjustment of osmolality can be added at any stage but are preferably present in solution with the HPMC before addition of the Phenylephrine The aqueous solution containing HPMC, buffering agent and osmolality agent is first prepared, and the Phenylephrine is added to that solution with agitation until it is fully dissolved. Processes for preparing an ophthalmic composition of the invention are preferably conducted in a sterile environment so as to provide a sterile product.
ADVANTAGES
Composition of the type as illustrated by the present invention has been found to be substantially stable and efficacious to the compositions without viscoelastic agent.
EXAMPLES
The invention is described in detail herein below with respect to the following examples, which are provided merely for illustration and are not intended to restrict scope of invention in any manner. Any embodiments that may be apparent to a person skilled in the art are deemed to fall within the scope of present invention.
Example 1: Preparation of composition(Table Removed)Procedure:
Water for injection was heated to 70-80°C, HPMC was dissolved by slow addition and continuous stirring till it dissolved completely. The temperature was brought to 25-30 C and then Disodium EDTA, Citric acid and sodium citrate; BKC was added one by one. Before the addition of sodium metabisulfite the solution was bubbled with 0.22 micron filtered nitrogen gas. Phenylephrine was then dissolved and pH was adjusted with dilute solution of sodium hydroxide. The contents were stirred for 30 min and filtered using 0.22 micron filter and packed in plastic vial aseptically.
Example 2: Effect of composition on dilation of eye in rabbits.
The composition of Example 1 was prepared. Another composition similar to that of Example 1 was prepared but, without HPMC. The effect of composition with HPMC was compared with the composition without HPMC. The mydriatic effect of the composition was studied by examining the pupil dilatation activity in New Zealand albino rabbits weighing about 2.5-3 kg and is given in Table 1. The rabbits were divided in to two groups of 6 each. Left eye of each rabbit was kept as control and one drop of 0.9% sodium chloride isotonic saline solution was instilled. In the right eye one drop of composition of present invention with viscoelastic and without viscoelastic agent was instilled. The pupil size, light reflux, corneal reflux and state of conjunctiva was observed and recorded at 0 minute (Control value), 15 min, 30 min, 45 min, 60 min, then at hourly interval for 6 hrs. The results are provided in table 1.
Table-1(Table Removed)The above table measures dilation of the pupil and the time required for dilation of the pupil. An increase in the value of dilation and decrease in the time required for dilation shows enhanced efficacy of the composition. The period of peak dilation indicates the duration of efficacy of the drug while the time to reach peak dilation is indicated by time of peak dilation. Lower the peak dilation time indicates the higher efficacy.
The results suggest that
• Maximum pupil dilatation observed with the composition of present invention
was 7.8 ± 0.6 mm, while the composition without the viscoelastic agent
showed 6.5 ± 1.2.
• Time for peak dilatation was 1 hr with composition containing viscoelastic
agent, while it was 2 hrs for the composition without the viscoelastic agent.
• Maximum dilatation was 1 hr in both the compositions
• The recovery (time for pupil size to return to normal value) was faster with
composition of the present invention.
The data suggest that with the composition of present invention maximum pupil dilatation (7.8 ± 0.6 mm) is greater at a shorter time and the recovery is faster indicating enhanced efficacy of composition of present invention. It also indicates that the composition as prepared in Example 1 acts synergistically, in comparison to the composition without HPMC.
Example 3
It was found that addition of HPMC improves the appearance and controls the level of impurities in the phenylepherine composition and hence it increased the overall shelf life of the product as described in Table -2

Table-2
(Table Removed)
The results suggest that
• The solution remained colorless after 6 month of stability at accelerated
condition with composition with viscoelastic agent as compared to
composition without viscoelastic agent.
• The solution showed diminished level of impurities during stability studies at
accelerated condition with composition with viscoelastic agent as compared to
composition without viscoelastic agent.
• The solution showed higher level of sodium metabisulfite after 6 months of
stability at accelerated condition with composition with viscoelastic agent as
compared to composition without viscoelastic agent.
• The solution shows increased stability in pH during stability studies at
accelerated condition with composition with viscoelastic agent as compared to
composition without viscoelastic agent.

We claim:
1. An ophthalmic composition comprising phenylephrine, a viscoelastic agent, an
osmolality agent, a buffering agent and water.
2. A composition as claimed in claim 1 wherein phenylephrine is present in a
range of 0.15% w/v -10% w/v.
3. A composition as claimed in claim 1 wherein phenylephrine is a salt selected
from hydrochloride, bicarbonate, sulfate, nitrate, tartarate and acetate.
4. A composition as claimed in claim 1 wherein the viscoelastic agent is selected
from a group comprising carboxyl methyl cellulose, poly vinyl alcohol,
hydroxy propyl methyl cellulose, hydroxy ethyl cellulose, povidone and
dextran.
5. A composition as claimed in claim 1 and 4 wherein the viscoelastic agent is
hydroxy propyl methyl cellulose
6. A composition as claimed in claim 1 wherein the viscoelastic agent is in the
range of 0.1-3%, more preferably in the range of 0.2-1%, most preferably in
the range of 0.2-0.5%.
7. A composition as claimed in claim 1 wherein viscosity of the composition is
in the range of 0.1-10 cps,
8. A composition as claimed in claim 1 wherein viscosity of the composition is
in the range of 0.5-5 cps,
9. A composition as claimed in claim 1 wherein viscosity of the composition is
in the range of 1 -3 cps.
10. A composition as claimed in claim 1 wherein the osmolality agent is selected
from the group comprising salt and sugar
11. A composition as claimed in claim 10 wherein the salt is selected from group
comprising sodium, potassium or ammonium cation and chloride, citrate,
ascorbate, borate, phosphate, bicarbonate, sulfate, thiosulfate or bisulfite anion
12. A composition as claimed in claim 10 wherein the sugar is selected from
group comprising dextrose, lactose, xylitol, mannitol and glycerine.
13. A composition as claimed in claim 10 wherein osmolality agent is selected
from group comprising sodium chloride, potassium chloride, sodium
thiosulfate, sodium bisulfite and ammonium sulfate

14. A composition as claimed in claim 1 wherein buffering agent is selected from
group comprising acid such as acetic, boric, citric, lactic, phosphoric and
hydrochloric
15. A composition as claimed in claim 1 wherein buffering agent is selected from
group comprising base such as sodium hydroxide, sodium phosphate, sodium
borate, sodium citrate, sodium acetate, sodium lactate
16. A composition as claimed in claim 1 wherein buffering agent is selected from
group comprising tris-hydroxymethylaminomethane, triethanolamine,
dextrose, sodium bicarbonate, ammonium chloride and amino acid.
17. A composition as claimed in claim 1 wherein osmolality of the composition is
in the range of 300-400 mOsm
18. A composition as claimed in claim 1 wherein pH of the composition is 4-5.5.
19. A composition as claimed in claim 1 wherein the container is selected from a
group comprising colored or opaque, plastic and glass containers.
20. A process of preparation of composition as claimed in claim 1, comprising
steps of
a. preparing an aqueous solution of the HPMC, buffering agent,
osmolality agent ,anti oxidants and chelating agents
b. adding Phenylephrine to that solution as in step a)
21. An ophthalmic composition and a process of preparation of composition
substantially as herein described with reference to the foregoing examples.

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Patent Number

272804

Indian Patent Application Number

2583/DEL/2007

PG Journal Number

18/2016

Publication Date

29-Apr-2016

Grant Date

27-Apr-2016

Date of Filing

10-Dec-2007

Name of Patentee

PROMED RESEARCH CENTRE

Applicant Address

261, UDHYOG VIHAR, PHASE IV, GURGAON-122 001, HARYANA, INDIA

Inventors:

#	Inventor's Name	Inventor's Address
1	HONEY BALA	PROMED RESEARCH CENTRE, 261, UDHYOG VIHAR, PHASE IV, GURGAON-122 001, HARYANA, INDIA.
2	RAHUL HASIJA	PROMED RESEARCH CENTRE, 261, UDHYOG VIHAR, PHASE IV, GURGAON-122 001, HARYANA, INDIA.
3	SATEESH KUMAR CHAUHAN	PROMED RESEARCH CENTRE, 261, UDHYOG VIHAR, PHASE IV, GURGAON-122 001, HARYANA, INDIA.
4	DEEPAK BAHRI	PROMED RESEEARCH CENTRE, 261, UDHYOG VIHAR, PHASE IV, GURGAON -122 001, HARYANA, INDIA

PCT International Classification Number

A61 K 38/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA