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http://www.gohsenol.

com

GOHSENOLTM EG series
for Ophthalmic drugs

Feb 2015

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Overview
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What is GOHSENOLTM EG ?
“GOHSENOLTM EG” is a highly purified polyvinyl alcohol
(PVA) . All grades comply with major pharmacopoeias.

Chemical Structure
CH2-CH CH2-CH
m n m+n=100
OH OCOCH3

Pharmacopoeia conformable to
 United States Pharmacopoeia (USP)
 European Pharmacopoeia (EP)
 Japanese Pharmaceutical Excipients (JPE)

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Regulatory Information
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CAS No. 25213-24-5


HS Code. 39053000
JPE*1 Self-Imposed GMP No. GAB 0130001
Drug Master File (Type Ⅳ) No.26119
COS/CEP under registration
The following Certificates / Statements available
BSE/TSE Free Radiation Free
OVI Free Melamine Free
Gluten Free Allergens statement
GMO Free Residual Solvent
Endotoxins*2 Microbiological test*2
*1 Japanese Pharmaceutical Excipients
*2 available on request

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Product list http://www.gohsenol.com

GOHSENOLTM EG
Granule (P) and Powder (PW) Types
Degree of Viscosity *1, *2
Products Hydrolysis (Center value) Main applications
[mol%] [mPa・s]

EG-05P 4.8-5.8 (5.3)


EG-40P 86.5-89.0 40.0-46.0 (43.0) Ophthalmic Solution, Emulsifier
EG-48P 45.0-52.0 (48.5)
EG-05PW 4.8-5.8 (5.3)
EG-30PW 86.5-89.0 27.0-33.0 (30.0) Ophthalmic Solution
EG-40PW 40.0-46.0 (43.0)
*1. 4% aqueous solution at 20 ℃
*2. indicated as general values. We have viscosity standards fulfilling requirements of USP,
EP and JPE.
The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Application examples
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Target Area  Example (Image)


Non-Solid formulation
 Thickener
 Emulsifier
 Dispersing Agent

Main Role for PVA


High viscosity types offer better thickening property, therefore,
these grades are suitable for a viscosity enhancer of
Ophthalmic formulation.
PVA has also surfactant ability, it is used for the production of
Ophthalmic medicine.
The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
How it works, http://www.gohsenol.com

In the case of Dry Eyes


PVA basis ophthalmic drug helps relieve the
symptoms and irritation caused by dry eyes in
people who do not produce enough of their own
tears or because the tear film in the eye is unstable.
It can also be used as a lubricant for artificial eyes.
It belongs to a class of medicines called artificial
tears.
The main ingredient polyvinyl alcohol works by
forming a moist and lubricating film over the eye.

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
PVA & Ocular APIs http://www.gohsenol.com

• PVA is used as a thickener, emulsifier


– 0.1 to 4% of PVA is formulated.
• Formulated APIs
Fluorometholone Brimonidine Tartrate
Levobunolol hydrochloride Naphazoline hydrochloride
Lysozyme hydrochloride Sulfacetamide sodium
Neostigmine methylsulfate
Oxybuprocaine
hydrochloride
Rebamipide
Tacrolimus hydrate
Fluorometholone
Timolol maleate Timolol maleate

Tropicamide

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Inactive ingredients http://www.gohsenol.com

Viscosity Enhancer MaximumConcentration (%)

Polyvinyl alcohol 1.4


Preservative Solutions Agent Maximum Concentration (%)
Benzalkonium chloride 0.01
Benzethonium chloride 0.5
Chlorobutanol 0.004
Phenylmercuric acetate 0.004
Phenylmercuric nitrate 0.01
Thimerosal 0.1- 0.2
Methylparaben 0.04
Propylparabens 0.013
Antioxidant Maximum Concentration (%)
Ethylenediaminetetraacetic acid 0.1
Sodium metabisulfite 0.1
Thiourea 0.1
Sodium bisulfite 0.1

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.
Commercialized drugs using with PVA No.1
Product
API Therapy Active Inactives
(Manuf.)
in1mL
Neostigmine Methylsulfate
MYPILIN 0.05mg
Ophthalmic sodium chloride 6.5mg Benzalkonium chloride
Ophthalmic
Solution Calcium chloride hydrate polyvinyl alcohol
regulation
(NIHON 0.3mg (partially saponified )
agent
TENGANYAKU Sodium bicarbonate pH adjustor
KENKYUSYO ) 0.03mg
Neostigmine Potassium L-aspatate
Methylsulfate 3.5mg

NEOVENOL
Ophthalmic polyvinyl alcohol
Solution in1 mL Benzalkonium chloride
Opththalmic
0.4% Oxybuprocaine Chlorobutanol
anesthetic
(NIHON Hydrochloride Acetic acid
drug
TENGANYAKU 4 mg Sodium acetate hydrate
KENKYUSYO ) Tonicity agent
Oxybuprocaine
Hydrochloride
Commercialized drugs using with PVA No.2
Product
API Therapy Active Inactive
(Manuf.)

PA・IODO
washing
Solution In 1mL
Eye wash &
(NIHON Iodine 2mg Potassium iodide
disinfectant
TENGANYAKU Polyvinyl alcohol 80mg
Iodine KENKYUSYO )
Polyvinyl
Alcohol

In 1mL
Neostigmine methylsufate
Benzalkonium
0.05mg
MYPILIN chloride
Ophthalmic sodium chloride6.5mg
(NIHON polyvinyl alcohol
regulation Calcium chloride hydrate
TENGANYAKU (partially
KENKYUSYO ) drug 0.3mg
saponified)
Sodium bicarbonate 0.03mg
pH adjustor
Potassium L-aspatate 3.5mg
Neostigmine Methylsulfate
Sodium Chloride
Calcium Chloride Hydrate
Sodium Bicarbonate
Potassium L−Aspartate
Commercialized drugs using with PVA No.3
Product
API Therapy Active Inactive
(Manuf.)

NEOVENOL Benzalkonium chloride


0.4% chlorobutanol
Ophthalmic Oxybuprocaine
(NIHON polyvinyl alcohol
anesthetic hydrochloride
TENGANYAKU Acetic acid
drug 4mg in 1 ml
KENKYUSYO ) Sodium acetate hydrate
Tonicity agent
Oxybuprocaine
hydrochloride

Benzalkonium chloride
Sodium dihydrogen
MIROL phosphate、
0.5% Dibasic sodium phosphate
Sales Glaucoma, Levobunolol hydrate、
: Kaken Pharma ocular Hydrochloride Tonicity agent、
manufactured
: Kyorin Pharma
hypertention 5.0mg in 1ml polyvinyl alcohol (partially
saponified)、
Sodium pyrosulfite、
edetate disodium、
Levobunolol
pH adjustor
Hydrochlorid
e
Commercialized drugs using with PVA No.4
Product
API Therapy Active Inactive
(Manuf.)
potassium chloride
Sodium hydrogen phosphate
( CH2CH ) - ( CH2CH )
sodium phosphate, dibasic
| | Rohto
OH OCOCH3 polyvinyl alcohol Hypromellose
C Cube
(partially Sodium hyaluronate
moisture Contact lens
saponified) 1% polysorbate80
cushion fitting agent
sodium chloride Polyoxyethylenepolyoxypropylene
(Rohto)
0.44% glycol
edetate disodium
Polyvinyl Alcohol Hydrochloric polyexanide
Sodium chloride menthol、pH adjustor

thimerosal 0.005%.
citric acid;
edetate disodium;
a sterile
polyvinyl alcohol 1.4%;
topical
OCUFEN® flurbiprofen potassium chloride;
nonsteroidal
(Allergan, sodium 0.03% purified water;
anti-
Inc.) (0.3 mg/mL). sodium chloride;
inflammator
Sodium (±)-2-(2- sodium citrate.
y product
fluoro-4- May also contain hydrochloric
biphenylyl) acid and/or sodium hydroxide to
propionate adjust pH
dihydrate
Commercialized drugs using with PVA No.5
Product
API Therapy Active Inactive
(Manuf.)

polyvinyl alcohol 14 mg/mL,


ALBALON benzalkonium chloride,
® Eye constricts the disodium edetate,
naphazoline
Drops vascular citric acid,
naphazoline hydrochloride
hydrochloride (Allergan, system of the sodium citrate,
1 mg/mL
4,5,-dihydro-2-(1- Inc.) conjunctiva sodium chloride,
naphthalenylmeth sodium hydroxide
yl)-1H-imidazole purified water.
hydrochloride

benzalkonium chloride 0.004%


edetate disodium;
noncardioselec polyvinyl alcohol 1.4%;
BETAGAN tive beta- potassium phosphate,
® adrenoceptor monobasic;
levobunolol HCl
(Allergan, blocking agent, purified water;
0.25% or 0.5%.
levobunolol HCl Inc.) equipotent at sodium chloride;
(-)-(S)-5-[3-(tert- both beta1 and sodium metabisulfite;
Butylamino)-2- beta2 receptors. sodium phosphate, dibasic;
hydroxypropoxy]- hydrochloric acid or sodium
3,4-dihydro-1(2H)-
hydroxide to adjust pH
naphthalenone
hydrochloride.
Commercialized drugs using with PVA No.6
Product
API Therapy Active Inactive
(Manuf.)
benzalkonium chloride 0.005%
edetate disodium;
polysorbate 80;
polyvinyl alcohol 1.4%;
BLEPH®-10 bacteriostatic
sulfacetamide purified water;
(Allergan, agents and
N- sodium 10% sodium phosphate dibasic;
Inc.) the spectrum
Sulfanilylaceta (100 mg/mL) sodium phosphate monobasic;
of activity
mide sodium thiosulfate;
monosodium hydrochloric acid and/or sodium
salt hydroxide to adjust pH (6.8 to
monohydrate. 7.5).

benzalkonium chloride 0.005%.


edetate disodium;
polysorbate 80;
polyvinyl alcohol 1.4%;
FML FORTE a topical anti- fluorometholone
purified water;
(Allergan, Inc.) inflammatory 0.25%.
sodium chloride;
product (suspension)
sodium phosphate, dibasic;
Fluorometholone: sodium phosphate, monobasic;
9-Fluoro-11ß, 17- Sodium hydroxide to adjust the
dihydroxy-6 - pH.
methylpregna-1,4-
diene-3,20-dione
Commercialized drugs using with PVA No.7
Product
API Therapy Active Inactive
(Manuf.)

Benzalkonium chloride
0.005%.
edetate disodium;
a topical Gentamicin hypromellose;
anti- sulfate equivalent polyvinyl alcohol 1.4%;
PRED-G®
inflammator to 0.3% polysorbate 80;
Prednisolone (Allergan,
y/anti- gentamicin base; purified water;
acetate: 11ß,17,21- Inc.)
Trihydroxypregna-
infective prednisolone sodium chloride;
1,4-diene-3,20-dione combinatio acetate (microfine sodium citrate, dihydrate.
21-acetate. n product suspension) 1%. May contain sodium
hydroxide and/or
the sulfate salt of hydrochloric acid to adjust
gentamicin C1, pH (5.4 to 6.6).
gentamicin C2, and
gentamicin C1A
which are produced
by the growth of
Micromonospora
purpurea.
Commercialized drugs using with PVA No.8
Product
API Therapy Active Inactive
(Manuf.)
Mucosta
ophyalimic Polyvinyl alcohol ( partially
suspension saponified )
UD2% Sodium Citrate
In 1ml
(2RS)- 2(- 4 - Sodium Chloride
Dry eye Rebamipide
Chlorobenzoylami 〔Rebamipide Potassium Chloride
no)- 3(- 2 - oxo -
20m
(JAN)〕 Hydrochloride
1,2- Sodium hydride
dihydroquinolin-
Otsuka Purified Water
4-yl)propanoic
acid Pharma

Citric Acid,
Edetate Disodium,
Flurbiprofen Polyvinyl Alcohol 1.4%,
Sodium topical Potassium Chloride,
Ophthalmic nonsteroidal Purified Water,
Solution USP,
anti- Flurbiprofen Sodium Chloride,
0.03%
inflammatory sodium 0.03% Sodium Citrate.
Bausch & product for Hydrochloric Acid and/or Sodium
Sodium (±)-2-(2- Lomb ophthalmic Hydroxide may be added to adjust
fluoro-4- Incorporated pH (6.0 – 7.0).
biphenyl)- PRESERVATIVE : Thimerosal
propionate 0.005%.
dihydrate
Commercialized drugs using with PVA No.9
Product
API Therapy Active Inactive
(Manuf.)

polyvinyl alcohol;
an alpha-2 brimonidine sodium chloride;
ALPHAGAN
selective tartrate 2.0 mg sodium citrate dihydrate;
® Eye
adrenergic (equivalent to citric acid monohydrate;
Drops
agonist for 1.32 mg as purified water.
ophthalmic brimonidine free Hydrochloric acid and/or
Allergan
use base) sodium hydroxide may be
5-bromo-6-(2- added to adjust pH (6.3-6.5).
imidazolidinylideneamin
o) quinoxaline L-tartrate
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Thank you for your attention


The Nippon Synthetic Chemical Industry Co., Ltd.
Acetyl and Fine Chemicals Dept.
Basic Products Segment

Shibaura Renasite Tower,


9-1, Shibaura 3-chome, Minato-ku, Tokyo,
108-0023, Japan
TEL : +81-3-6436-2813
FAX : +81-3-6436-2820
Sample bottle
Content : 500g

The Nippon Synthetic Chemical Industry Co.,Ltd Basic Products Segment Acetyl and Fine Chemicals Dept.