Title of Invention	EXTENDED RELEASE FORMULATION OF CYCLOBENZAPRINE
Abstract	The present invention provides an extended release formulation comprising therapeutically effective amount of cyclobenzaprine, at least one water soluble polymeric release retardant, and at least one pharmaceutically acceptable excipient; optionally along with non-polymeric release retardant. The invention further relates to method of preparation for extended release cyclobenzaprine formulation which exhibits unique dissolution profile formulation over desirable time period.

Title of Invention

EXTENDED RELEASE FORMULATION OF CYCLOBENZAPRINE

Abstract

The present invention provides an extended release formulation comprising therapeutically effective amount of cyclobenzaprine, at least one water soluble polymeric release retardant, and at least one pharmaceutically acceptable excipient; optionally along with non-polymeric release retardant. The invention further relates to method of preparation for extended release cyclobenzaprine formulation which exhibits unique dissolution profile formulation over desirable time period.

Full Text	FORM 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 PROVISIONAL SPECIFICATION (See section 10 and rule 13] 1. Title of the invention: "Extended release formulation of Cyclobenzaprine" 2. Macleods Pharmaceuticals Ltd., an Indian Company, having its Registered Office at 304 - Atlanta Arcade, Opp. Leela Hotel, Marol Church Road, Andheri (East), Mumbai - 400 059, Maharashtra, India. 3. The following specification describes the invention. EXTENDED RELEASE FORMULATION OF CYCLOBENZAPRINE TECHNICAL FIELD: The present invention provides an extended release dosage form of Cyclobenzaprine, a skeletal muscle relaxant and method of preparation of the same. BACKGROUND OF INVENTION: Many therapeutic agents are most effective when made available at a constant rate at or near the absorption site. The absorption of therapeutic agents thus made available generally results in desired plasma concentrations leading to maximum efficacy and minimum toxic side effects. Much effort has been devoted to developing matrix tablet based and multi-particulate capsule based drug delivery systems for oral applications. US Patent 7287793 discloses a multiparticulate pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release beads, wherein said extended release beads comprise active containing core particles comprising a skeletal muscle relaxant and extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said dosage form when dissolution tested using USP apparatus 2 at 50 rpm in 900ml of 0.1 N HCL at 37°C, exhibit a drug release profile substantially corresponding to the following pattern: After 2 hrs, not more than about 40% of the total active is released, After 4 hrs, from about 40-65% of the total active is released, After 8 hrs, from about 65-85% of the total active is released, Water insoluble controlled release membrane can also comprise water-soluble polymer. 1 BRIEF DESCRIPTION OF THE INVENTION: The present invention provides an extended release dosage form of Cyclobenzaprine, a skeletal muscle relaxant. According to present invention the extended release dosage form may be in the form of 1) Inert core coated with first drug layer with binder, further comprise a water soluble seal coat and a control release coating of water insoluble polymer, or 2) Core containing drug along with binder and filler which further comprise of control release coating of water soluble polymer, or 3) Core containing drug along with binder and filler and further comprise of water insoluble polymer coating, or 4) A controlled release core comprising drug, binder, filler, control release water insoluble polymer and coated with nonfunctional water soluble coating, or 5) Core in the form of tablet comprising binder, filler, lubricant, control release water soluble polymer and a water soluble seal coat and a final coating comprising mixture of water soluble and water insoluble polymer, or 6) Core in the form of 4 minitablets comprising binder, filler, lubricant, control release water soluble polymer and a water soluble seal coat. Out of 4 minitablets three tablets were given controlled release coating comprising mixture of water soluble and water insoluble polymer with different percentage to provide extended release. Fourth tablet provide an initial dose. The core is then finally filled in to the capsules. 2 The present invention can be illustrated by the following examples: A: Examples of core comprising pellets Example 1 - Drug & Functional Coating on Inert Pellets (F1-F4) • Core Pellets - MCC or sugar spheres • Drug layer - Cyclobenzaprine HC1 - HPMC - DBP - Water • Seal Coating - HPMC - DBP - Water • Functional Coating - Ethyl Cellulose - DBS - Water Finally the coated beads are filled into capsules Formula -1) Core Pellets coated with drug. Ingredients (mg per tablet) Batch No. Fl F2 F3 F4 Drug coating Solution Sugar spheres (18-20 mesh) Cyclobenzaprine HC1 HPMC E-5 LV Water* 98.5 10 1.5 37 87 20 3.0 74 75.5 30 4.5 111 64 40 6 128 Total weight (mg) 110 110 110 110 Seal coat (2 % weight gain) HPMC E-5 LV Polyethylene glycol-400 Water* 2.0 0.2 qs 2.0 0.2 qs 2.0 0.2 qs 2.0 0.2 qs Control release coating (1^ % weight gain) Ethyl cellulose (30 % dispersion) Dibutyl sebacate Water* 14.44 1.26 qs 14.44 1.26 qs 14.44 1.26 qs 14.44 1.26 qs * Not present in the end product. Process: 1. Inert core pellets are coated with drug solution. 2. Drug coated pellets are seal coated with HPMC solution. 3. Seal coated pellets are coated with Ethyl Cellulose. 4. Ethyl Cellulose coated pellets are filled in suitable size capsule shell. Example 2 - Core pellets containing drug & coating with water-soluble polymer (F5-F8) Ingredients (mg per tablet) Batch No. F5 F6 F7 F8 Cyclobenzaprine HCl MCCPHIOI HPMC E-5 LV Water* 10 120 1.2 qs 20 110 1.2 qs 30 100 1.2 qs 40 90 1.2 qs Total weight (mg) 131.2 131.2 131.2 131.2 Water-soluble coat (20%) HPMC K4 M 23.67 23.67 23.67 23.67 Polyethylene glycol-400 2.63 2.63 2.63 2.63 Water* qs qs qs qs * Not present in the end product. Process: 1) Cyclobenzaprine HCl, MCC PH 101 and HPMC is mixed & granulated with water to form a plastic mass. 2) This mass was Extruded & Spheronized. 3) Coat the drug spheres with water-soluble HPMC solution. Example 3 - Core pellets containing drug & Coating with water insoluble polymer (F9-F16). Ingredients (mg per tablet) Batch No. F9 F10 Fll F12 Cyclobenzaprine HCl MCCPH 101 HPMC E-5 LV Water* 10 120 1.2 qs 20 110 1.2 qs 30 100 1.2 qs 40 90 1.2 qs Total weight (mg) 131.2 131.2 131.2 131.2 Water insoluble coat (14%) Hydrogenated vegetable oil Dibutyl sebacate 16.52 1.84 16.52 1.84 16.52 1.84 16.52 1.84 Ingredients (mg per tablet) Batch No. F13 F14 F15 F16 Cyclobenzaprine HCl MCCPH 101 HPMC E-5 LV 10 120 1.2 20 110 1.2 30 100 1.2 40 90 1.2 5 Water* qs qs qs qs Total weight (mg) 131.2 131.2 131.2 131.2 Water insoluble coat (14%) Hydrogenated castor oil Dibutyl sebacate 16.52 1.84 16.52 1.84 16.52 1.84 16.52 1.84 * Not present in the end product. Process: 1) Cyclobenzaprine HCL MCC PH 10land HPMC is mixed & granulated with water to form a plastic mass. 2) This mass was Extruded & Spheronized. 3) Coat the drug spheres with water insoluble polymer dispersion. Example 4-Core pellets containing controlled release drug and coating with non¬functional coating (F17-F20). Ingredients (mg per tablet) Batch No. F17 F18 F19 F20 Cyclobenzaprine HCl MCC PH 101 HPMC E-5 LV Ethyl cellulose (30% dispersion) Water* 10 120 1.2 10 qs 20 110 1.2 10 qs 30 100 1.2 10 qs 40 90 1.2 10 qs Total weight (mg) 141.2 141.2 141.2 141.2 Water-soluble coat (1.6 %) HPMC E-5 LV Polyethylene glycol-400 Water* 2.0 0.2 qs 2.0 0.2 qs 2.0 0.2 qs 2.0 0.2 qs * Not present in the end product. 6 Process: 1) Cyclobenzaprine HCl, MCC PH 101, and HPMC was mixed & granulated with Ethyl cellulose solution to form a plastic mass. 2) This mass was Extruded & Spheronized. 3) Coat the drug spheres with HPMC solution. B: Examples of core comprising tablet or minitablets. Example 5: CR oral tablets in capsules (F1-F8) 1) a) Core tablets using HPMC K4 MCR Ingredients (mg per tablet) Batch No. Fl F2 F3 F4 Cyclobenzaprine HCl Mannitol HPMC K4M CR P.V.P.K30 I.P.A Magnesium Stearate 10 87.3 5 6.5 qs 1.2 20 77.3 5 6.5 qs 1.2 30 67.3 5 6.5 qs 1.2 40 57.3 5 6.5 qs 1.2 Total weight 110 110 110 110 1) b) Core tablets using PEO-WSR Ingredients (mg per tablet) Batch No. F5 F6 F7 F8 Cyclobenzaprine HCl Mannitol Polyethylene oxide-WSR P.V.P.K30 10 87.3 5 6.5 20 77.3 5 6.5 30 67.3 5 6.5 40 57.3 5 6.5 7 I.P.A Magnesium Stearate qs 1.2 qs 1.2 qs 1.2 qs 1.2 Total weight no no 110 no 2) Seal Coating Opadry clear YS - IR 7006 [HPMC Based) - 1.5% on core 3) Ethyl Cellulose + HPMC Coating - 6% on seal coating Composition - Ethyl Cellulose HPMC DBS Acetone Water Process: 2. Dry mix Cyclobenzaprine, Mannitol, HPMC K4M C or PEO-WSR. 3. Dissolve PVP K30 in I.P.A to get clear solution 4. Granulate the dry mix of step 1 with the binder solution of step 2 5. Wet mill, dry & size the granules. 6. Dried granules are lubricated with magnesium Stearate and compressed to tablets using suitable punches. 7. Compressed tablets are seal coated with Opadry and finally coated with EC + HPMC coating solution. Example 6: Multi tablets in capsules (F9-F12) 1) Core tablets Ingredients (mg per tablet) Batch No. F9 F10 Fll F12 Cyclobenzaprine HC1 Mannitol HPMC K4M CR P.V.P.K 30 I.P.A Magnesium Stearate 10 87.3 5 6.5 qs 1.2 20 77.3 5 6.5 qs 1.2 30 67.3 5 6.5 qs 1.2 40 57.3 5 6.5 qs 1.2 Total weight * 110 110 110 110 * Four mini tablets weighing approximately 27.5 mg have to be compressed. 2) Seal Coating Opadry clear YS - IR 7006 [HPMC Based) - 1.5% on core tablets. 3) Ethyl Cellulose + HPMC Coating (85:15) - 1 tablet without CR coat, second with 6%, third with 9 % and fourth tablet with 12 % CR coat on seal coated tablets. Composition - Ethyl Cellulose HPMC DBS Acetone Water 9 Process: 1. Dry mix Cyclobenzaprine, Mannitol, HPMC K4M CR, 2. Dissolve PVP K30 in I.P.A to get clear solution 3. Granulate the dry mix of step 1 with the binder solution of step 2 4. Wet mill, dry & size the granules. 5. Dried granules are lubricated with magnesium Stearate and compressed to mini tablets using suitable punches. 6. Compressed mini tablets are seal coated with Opadry and finally coated with EC + HPMC coating solution. 10 11

Full Text

FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rule 13]

1. Title of the invention: "Extended release formulation of Cyclobenzaprine"
2. Macleods Pharmaceuticals Ltd., an Indian Company, having its Registered Office at 304 - Atlanta Arcade, Opp. Leela Hotel, Marol Church Road, Andheri (East), Mumbai - 400 059, Maharashtra, India.
3. The following specification describes the invention.

EXTENDED RELEASE FORMULATION OF CYCLOBENZAPRINE
TECHNICAL FIELD:
The present invention provides an extended release dosage form of Cyclobenzaprine, a skeletal muscle relaxant and method of preparation of the same.
BACKGROUND OF INVENTION:
Many therapeutic agents are most effective when made available at a constant rate at or near the absorption site. The absorption of therapeutic agents thus made available generally results in desired plasma concentrations leading to maximum efficacy and minimum toxic side effects. Much effort has been devoted to developing matrix tablet based and multi-particulate capsule based drug delivery systems for oral applications.
US Patent 7287793 discloses a multiparticulate pharmaceutical dosage form of a
skeletal muscle relaxant providing a modified release profile comprising a population
of extended release beads, wherein said extended release beads comprise active
containing core particles comprising a skeletal muscle relaxant and extended release
coating comprising a water insoluble polymer membrane surrounding said core,
wherein said dosage form when dissolution tested using USP apparatus 2 at 50 rpm in
900ml of 0.1 N HCL at 37°C, exhibit a drug release profile substantially corresponding
to the following pattern:
After 2 hrs, not more than about 40% of the total active is released,
After 4 hrs, from about 40-65% of the total active is released,
After 8 hrs, from about 65-85% of the total active is released,
Water insoluble controlled release membrane can also comprise water-soluble polymer.
1

BRIEF DESCRIPTION OF THE INVENTION:
The present invention provides an extended release dosage form of Cyclobenzaprine, a
skeletal muscle relaxant.
According to present invention the extended release dosage form may be in the form of
1) Inert core coated with first drug layer with binder, further comprise a water soluble seal coat and a control release coating of water insoluble polymer, or
2) Core containing drug along with binder and filler which further comprise of control release coating of water soluble polymer, or
3) Core containing drug along with binder and filler and further comprise of water insoluble polymer coating, or
4) A controlled release core comprising drug, binder, filler, control release water insoluble polymer and coated with nonfunctional water soluble coating, or
5) Core in the form of tablet comprising binder, filler, lubricant, control release water soluble polymer and a water soluble seal coat and a final coating comprising mixture of water soluble and water insoluble polymer, or
6) Core in the form of 4 minitablets comprising binder, filler, lubricant, control release water soluble polymer and a water soluble seal coat. Out of 4 minitablets three tablets were given controlled release coating comprising mixture of water soluble and water insoluble polymer with different percentage to provide extended release. Fourth tablet provide an initial dose.
The core is then finally filled in to the capsules.
2

The present invention can be illustrated by the following examples:
A: Examples of core comprising pellets
Example 1 - Drug & Functional Coating on Inert Pellets (F1-F4)
• Core Pellets - MCC or sugar spheres
• Drug layer

- Cyclobenzaprine HC1
- HPMC
- DBP
- Water
• Seal Coating
- HPMC
- DBP
- Water
• Functional Coating
- Ethyl Cellulose
- DBS
- Water
Finally the coated beads are filled into capsules Formula -1) Core Pellets coated with drug.

Ingredients (mg per tablet) Batch No.

Fl F2 F3 F4
Drug coating Solution
Sugar spheres (18-20 mesh) Cyclobenzaprine HC1 HPMC E-5 LV Water* 98.5 10 1.5 37 87 20 3.0 74 75.5 30 4.5 111 64
40
6
128

Total weight (mg) 110 110 110 110
Seal coat (2 % weight gain)
HPMC E-5 LV Polyethylene glycol-400 Water* 2.0 0.2 qs 2.0 0.2
qs 2.0 0.2 qs 2.0 0.2 qs
Control release coating (1^ % weight gain)
Ethyl cellulose (30 % dispersion)
Dibutyl sebacate
Water* 14.44 1.26
qs 14.44
1.26
qs 14.44
1.26
qs 14.44 1.26 qs
* Not present in the end product.
Process:
1. Inert core pellets are coated with drug solution.
2. Drug coated pellets are seal coated with HPMC solution.
3. Seal coated pellets are coated with Ethyl Cellulose.
4. Ethyl Cellulose coated pellets are filled in suitable size capsule shell.
Example 2 - Core pellets containing drug & coating with water-soluble polymer
(F5-F8)

Ingredients (mg per tablet) Batch No.

F5 F6 F7 F8
Cyclobenzaprine HCl MCCPHIOI HPMC E-5 LV Water* 10 120 1.2 qs 20 110 1.2 qs 30 100 1.2 qs 40 90 1.2 qs
Total weight (mg) 131.2 131.2 131.2 131.2
Water-soluble coat (20%)

HPMC K4 M 23.67 23.67 23.67 23.67
Polyethylene glycol-400 2.63 2.63 2.63 2.63
Water* qs qs qs qs
* Not present in the end product. Process:
1) Cyclobenzaprine HCl, MCC PH 101 and HPMC is mixed & granulated with water to form a plastic mass.
2) This mass was Extruded & Spheronized.
3) Coat the drug spheres with water-soluble HPMC solution.
Example 3 - Core pellets containing drug & Coating with water insoluble polymer

(F9-F16).

Ingredients (mg per tablet) Batch No.

F9 F10 Fll F12
Cyclobenzaprine HCl MCCPH 101 HPMC E-5 LV Water* 10 120 1.2 qs 20
110
1.2
qs 30 100 1.2 qs 40 90 1.2
qs
Total weight (mg) 131.2 131.2 131.2 131.2
Water insoluble coat (14%)
Hydrogenated vegetable oil Dibutyl sebacate 16.52 1.84 16.52 1.84 16.52 1.84 16.52 1.84

Ingredients (mg per tablet) Batch No.

F13 F14 F15 F16
Cyclobenzaprine HCl MCCPH 101 HPMC E-5 LV 10 120 1.2 20
110
1.2 30
100
1.2 40 90 1.2

5

Water* qs qs qs qs
Total weight (mg) 131.2 131.2 131.2 131.2
Water insoluble coat (14%)
Hydrogenated castor oil Dibutyl sebacate 16.52 1.84 16.52 1.84 16.52 1.84 16.52 1.84
* Not present in the end product. Process:
1) Cyclobenzaprine HCL MCC PH 10land HPMC is mixed & granulated with water to form a plastic mass.
2) This mass was Extruded & Spheronized.
3) Coat the drug spheres with water insoluble polymer dispersion.
Example 4-Core pellets containing controlled release drug and coating with non¬functional coating (F17-F20).

Ingredients (mg per tablet) Batch No.

F17 F18 F19 F20
Cyclobenzaprine HCl
MCC PH 101
HPMC E-5 LV
Ethyl cellulose (30% dispersion)
Water* 10 120 1.2 10 qs 20
110
1.2
10
qs 30
100
1.2
10
qs 40 90 1.2 10 qs
Total weight (mg) 141.2 141.2 141.2 141.2
Water-soluble coat (1.6 %)
HPMC E-5 LV Polyethylene glycol-400 Water* 2.0 0.2 qs 2.0 0.2
qs 2.0 0.2 qs 2.0 0.2 qs
* Not present in the end product.
6

Process:
1) Cyclobenzaprine HCl, MCC PH 101, and HPMC was mixed & granulated with Ethyl cellulose solution to form a plastic mass.
2) This mass was Extruded & Spheronized.
3) Coat the drug spheres with HPMC solution.
B: Examples of core comprising tablet or minitablets.
Example 5: CR oral tablets in capsules (F1-F8) 1) a) Core tablets using HPMC K4 MCR

Ingredients (mg per tablet) Batch No.

Fl F2 F3 F4
Cyclobenzaprine HCl
Mannitol
HPMC K4M CR
P.V.P.K30
I.P.A
Magnesium Stearate 10
87.3
5
6.5 qs 1.2 20
77.3
5
6.5 qs 1.2 30
67.3
5
6.5 qs 1.2 40
57.3
5
6.5 qs 1.2
Total weight 110 110 110 110
1) b) Core tablets using PEO-WSR

Ingredients (mg per tablet) Batch No.

F5 F6 F7 F8
Cyclobenzaprine HCl
Mannitol
Polyethylene oxide-WSR
P.V.P.K30 10
87.3
5
6.5 20
77.3
5
6.5 30
67.3
5
6.5 40
57.3
5
6.5
7

I.P.A
Magnesium Stearate qs 1.2 qs
1.2 qs 1.2 qs 1.2
Total weight no no 110 no
2) Seal Coating
Opadry clear YS - IR 7006 [HPMC Based) - 1.5% on core
3) Ethyl Cellulose + HPMC Coating - 6% on seal coating
Composition - Ethyl Cellulose HPMC DBS Acetone Water
Process:
2. Dry mix Cyclobenzaprine, Mannitol, HPMC K4M C or PEO-WSR.
3. Dissolve PVP K30 in I.P.A to get clear solution
4. Granulate the dry mix of step 1 with the binder solution of step 2
5. Wet mill, dry & size the granules.
6. Dried granules are lubricated with magnesium Stearate and compressed to tablets using suitable punches.
7. Compressed tablets are seal coated with Opadry and finally coated with EC + HPMC coating solution.

Example 6: Multi tablets in capsules (F9-F12) 1) Core tablets

Ingredients (mg per tablet) Batch No.

F9 F10 Fll F12
Cyclobenzaprine HC1
Mannitol
HPMC K4M CR
P.V.P.K 30
I.P.A
Magnesium Stearate 10
87.3
5
6.5 qs 1.2 20
77.3
5
6.5
qs 1.2 30
67.3
5
6.5 qs 1.2 40
57.3 5
6.5 qs 1.2
Total weight * 110 110 110 110
* Four mini tablets weighing approximately 27.5 mg have to be compressed.
2) Seal Coating
Opadry clear YS - IR 7006 [HPMC Based) - 1.5% on core tablets.
3) Ethyl Cellulose + HPMC Coating (85:15) - 1 tablet without CR coat, second
with 6%, third with 9 % and fourth tablet with 12 % CR coat on seal coated
tablets.
Composition - Ethyl Cellulose
HPMC
DBS
Acetone
Water
9

Process:
1. Dry mix Cyclobenzaprine, Mannitol, HPMC K4M CR,
2. Dissolve PVP K30 in I.P.A to get clear solution
3. Granulate the dry mix of step 1 with the binder solution of step 2
4. Wet mill, dry & size the granules.
5. Dried granules are lubricated with magnesium Stearate and compressed to mini tablets using suitable punches.
6. Compressed mini tablets are seal coated with Opadry and finally coated with EC + HPMC coating solution.
10

11

Documents:

534-MUM-2009-ABSTRACT(12-3-2010).pdf

534-MUM-2009-CLAIMS(12-3-2010).pdf

534-MUM-2009-CLAIMS(AMENDED)-(17-6-2014).pdf

534-MUM-2009-CLAIMS(AMENDED)-(5-7-2013).pdf

534-MUM-2009-CLAIMS(MARKED COPY)-(17-6-2014).pdf

534-MUM-2009-CLAIMS(MARKED COPY)-(5-7-2013).pdf

534-MUM-2009-CORRESPONDENCE(12-3-2010).pdf

534-MUM-2009-CORRESPONDENCE(17-6-2014).pdf

534-MUM-2009-CORRESPONDENCE(IPO)-(28-8-2009).pdf

534-MUM-2009-DESCRIPTION(COMPLETE)-(12-3-2010).pdf

534-mum-2009-description(provisional).doc

534-mum-2009-description(provisional).pdf

534-mum-2009-form 1.pdf

534-MUM-2009-FORM 18(22-10-2010).pdf

534-mum-2009-form 2(12-3-2010).pdf

534-MUM-2009-FORM 2(TITLE PAGE)-(12-3-2010).pdf

534-MUM-2009-FORM 2(TITLE PAGE)-(PROVISIONAL)-(12-3-2009).pdf

534-mum-2009-form 2(title page).pdf

534-mum-2009-form 2.doc

534-mum-2009-form 2.pdf

534-mum-2009-form 3.pdf

534-mum-2009-form 5.pdf

534-MUM-2009-REPLY TO EXAMINATION REPORT(5-7-2013).pdf

534-MUM-2009-REPLY TO HEARING(17-6-2014).pdf

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Patent Number

262838

Indian Patent Application Number

534/MUM/2009

PG Journal Number

39/2014

Publication Date

26-Sep-2014

Grant Date

18-Sep-2014

Date of Filing

12-Mar-2009

Name of Patentee

MACLEODS PHARMACEUTICALS LIMITED

Applicant Address

304, ATLANTA ARCADE, OPP. LEELA HOTEL, MAROL CHURCH ROAD, ANDHERI(EAST), MUMBAI

Inventors:

#	Inventor's Name	Inventor's Address
1	AGARWAL RAJENDRA MURLIDHAR	G-2, MAHAKALI CAVES ROAD, SHANTI NAGAR, ANDHERI (EAST), MUMBAI-400093,
2	MAHESHWARI HITESH KUMAR	G-2, MAHAKALI CAVES ROAD, SHANTI NAGAR, ANDHERI (EAST), MUMBAI-400093,
3	RIDHURKAR DEVENDRA	G-2, MAHAKALI CAVES ROAD, SHANTI NAGAR, ANDHERI (EAST), MUMBAI-400093,

PCT International Classification Number

A61K9/20

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA