| Polymers:
Pharma Polymers - a business line of Uman’s business
unit Coatings & Additives - has been supplying methacrylate
polymers to the pharmaceutical all over the world.
Spraypol ™ products and technologies
from Pharma Polymers have been setting benchmarks for controlled
drug release with functional tablet coatings. These contribute
decisively toward improving the efficacy and tolerance of
drugs. Pharma Polymers is now developing
new drug delivery technologies for the targeted release of
active ingredients in the digestive tract, thus opening up
new therapeutic possibilities in, for example, chronic intestinal
disorders.
Spraypol ™ :- a trademark of Pharma
Polymers, offers the complete range of polymers for controlled
release drug formulations. products are approved by the most
important health authorities worldwide and are manufactured
under GMP guidelines.
Spraypol ™ is Pharmaceutical excipients
(drug delivery, enteric coatings, controlled, immediate,
sustained release formulations, solid oral formulations)
We offer the following standard products:
| Polymers |
Common
name |
Availability |
Specifications |
| Spraypol™L
100-55 |
L
100-55 |
Powder |
Pdf
format |
| Spraypol™
L 30 D 55 |
L
30 D 55 |
Aqueous
Dispersion |
Pdf
format |
| pdSpraypol™
L 100 |
L
100 |
Powder |
Pdf
format |
| Spraypol™
S 100 |
S
100 |
Powder |
Pdf
format |
| Spraypol™
E 100 |
E
100 |
Granules |
Pdf
format |
| Spraypol™
E PO |
E
PO |
Powder |
Pdf
format |
• Sample kits are also available.
Contact Us for more information
on how we can help you.
Application benefits of enteric SPRAYPOL™ coatings:
-PH-dependent drug release
-Protection of actives sensitive to gastric fluid
-Protection of gastric mucosa from aggressive actives
-Increase in drug effectiveness
-Good storage stability
-GI and colon targeting
* Spraypol ™ are used in Enteric
Coating
An enteric coating is a barrier applied to oral medication
that controls the location in the digestive system where it
is absorbed. Enteric refers to the small intestine, therefore
enteric coatings prevent release of medication before it reaches
the small intestine.
Most enteric coatings work by presenting
a surface that is stable at the highly acidic pH found in
the stomach, but breaks down rapidly at a less acidic (relatively
more basic) pH. For example, they will not dissolve in the
acidic juices of the stomach (pH ~3), but they will in the
higher pH (above pH 5.5) environment present in the small
intestine.
Detailed product information:
1) Spraypol ™ L 100- 55
100% spray dried free flowing powder of Spraypol ™L30D-55
drying, It is an anionic acrylic copolymer, of "METHACRYLIC
ACID and enthacrylates with- COOH functional group.
Spraypol™ L100-55
is insoluble in gastric fluid and soluble in intestinal track
pH 5.5 and above by formation of salt with Alkalies.
Uses - Sprayppol™
L100-55 is used for enteric coating of tablets,
pellets, pills, crystals and granules, etc.(For Drug delivery
in duodenum)
Appearance - White free flowing powder.
Toxicity - Spraypol™
L100-55 is a high molecular weight polymer. It is
not absorbed by body tissues and is totally safe for human
oral consumption. Tests for toxicological tolerance shows
that it does not have any pronounced physiological action
and is non-toxic.
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kg & 20 kg in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification Of Spraypol ™ L 100- 55
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
White
powder with a faint characteristic odour |
| Solubility |
- |
1
gm of SPRAYPOL™ L 100-55 dissolves in 7 g methanol,
ethanol, isopropyl alcohol and acetone as well as in 1
N Sodium hydroxide to give clear to slightly cloudy solutions.
SPRAYPOL™ L 100-55 is practically insoluble in ethyl
acetate, methylene chloride, petroleum ether and water. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
NLT
95% |
NA |
NA |
NA |
| Loss
on drying |
% |
NMT
5% |
NMT
5% |
NMT
5% |
NA |
| Methacrylic
acid units, based on DS |
% |
46.0- 50.6 |
46.0- 50.6 |
46.0- 50.6 |
46.0- 50.6 |
| Acid
value |
Mg
KOH/gDS |
300-330 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
100-200 |
100-200 |
100-200 |
100-200 |
| Viscosity |
Mm²/s |
15-45 |
NA |
NA |
15-45 |
| Monomers |
% |
Max.100 |
Max.0.1%,
based on DS |
Max.0.01% |
NA |
| Ethyl
Acrylate |
Ppm |
Max
50 |
NA |
NA |
Max
50 |
| Methacrylic
Acid |
Ppm |
Max
50 |
Max
50 |
NA |
Max
50 |
2) Spraypol ™L 30 D 55
Spraypol™ L30D-55 is 30% dispersion of an anionic co-polymers
which conforms to USP/NF , specification as " METHACRYLIC
ACID CO-POLYMER " TYPE C , the Spraypol™ L30D55
is insoluble in gastric fluid and soluble in intestinal tract
pH 5.5 and above by formation of salt with alkalis.
Uses:
Spraypol™ is used for aqueous film coating and enteric
coating of tablets, pills, pellets, crystals and granules.
( Drug Delivery in duodenum)
Appearance :
White milky fluid.
Toxicity - Spraypol™
L30 D55 is a high molecular weight polymer. It is not absorbed
by body tissues and is totally safe for human oral consumption.
Tests for toxicological tolerance shows that it does not have
any pronounced physiological action and is non-toxic.
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kg & 20 kg in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification of sparypol™ L 30 D 55
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
Milky
- white liquid of low viscosity with a faint characteristic
odour |
| Solubility |
- |
The
dispersion is miscible with water in any proportion, the
milky white appearance being retained. A clear or slightly
cloudy, viscous solution is obtained by mixing 1 part
sample with 5 parts acetone The same results are obtained
by mixing with ethanol . Initially the polymer is precipitated
but then dissolves again in the excess organic solvent. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
28.5-31.5 |
28.5-31.5 |
NA |
27.0-33.0 |
| Loss
on drying |
% |
68.5-71.5 |
NA |
68.5-71.5 |
NA |
| Methacrylic
acid units, based on DS |
% |
11.5-15.5 |
NA |
NA |
11.5-15.5 |
| Acid
value |
Mg
KOH/gDS |
300-330 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
3-10 |
Max.
15 |
Max.
15 |
NA |
| Viscosity |
Mm²/s |
3-15 |
NA |
NA |
3-15 |
| pH |
*** |
2.1-3.0 |
NA |
2.0-3.0 |
2.1-3.1 |
| Monomers |
% |
Max.100 |
Max.0.1%,
based on DS |
Max.0.01% |
NA |
| Ethyl
Acrylate |
Ppm |
NA |
NA |
NA |
Max
0.1% |
| Methacrylic
Acid |
Ppm |
NA |
NA |
NA |
NA |
3) Spraypol ™ L 100
An anionic co-polymer of METHACRYLIC ACID and ethacrylates
with – COOH functional group. Spraypol™ L100 is
insoluble in gastric fluid and natural juices, Freely soluble
in intestinal fluid above pH 6.0.
Uses - Enteric coating of tablets, pills,
pellets, granules and powders.(Drug delivery in jejunum)
Appearance - White, fine, free flowing powder.
Toxicity - Spraypol™
L100 is a high molecular weight polymer. It is not absorbed
by body tissues and is totally safe for human oral consumption.
Test for toxicological tolerance show that it does not have
any pronounced physiological action and is non-toxic.
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kg.& 20 kg. in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification of Spraypol™ L 100:
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
White
powder with a faint characteristic odour |
| Solubility |
- |
1
g of SPRAYPOL™ L 100 or SPRAYPOL™ S 100 dissolves
in 7 g methanol, ethanol, in aqueous isopropyl alcohol
and acetone ( containing approx. 3% water), as well as
in 1 N sodium hydroxide to give clear to slightly cloudy
solutions. SPRAYPOL™ L 100 and SPRAYPOL ™S
100 are practically insoluble in ethyl acetate, mehtylene
chloride, petroleum ether and water. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
min.
95.0 |
NA |
NA |
NA |
| Loss
on drying |
% |
max.
5.0 |
max.
5.0 |
max.
5.0 |
max.
10.0 |
| Methacrylic
acid units, based on DS |
% |
46.0-50.6 |
46.0-50.6 |
46.0-50.6 |
38.0-52.0 |
| Acid
value |
Mg
KOH/gDS |
300-330 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
50-200 |
50-200 |
50-200 |
NA |
| Viscosity |
Mm²/s |
10-24 |
NA |
NA |
10-24 |
| Monomers |
% |
Max.500 |
Max.0.1%,
|
Max.0.05% |
NA |
| Ethyl
Acrylate |
Ppm |
NA |
NA |
NA |
Max
0.2% |
| Methacrylic
Acid |
Ppm |
NA |
NA |
NA |
NA |
4) Spraypol ™ S 100
Spraypol™ S100 is an anionic acrylic co-polymer
of "METHACRYLIC acid and ethacrylates with-COOH functional
group. Spraypol™ S100 are resistant to grastric fluid
and natural juices but are freely soluble in intestinal tract
in pH 7.0 and above by formation of salt with alkalis. Sustained
release ( delay release ) effect can be developed using Spraypol™
S100 by matrix method (wet granulation).
Uses - For sustained released
or slow release enteric film coating of tablet, pellets, granules,
pills, powder etc..(Drug Delivery in ileum)
Appearance - White, fine, free flowing powder.
Toxicity - Spraypol™
S100 is a high molecular weight polymer. It is not absorbed
by body tissues and is totally safe for human oral consumption.
Tests for toxicological tolerance show that it does not have
any pronounced physiological action and is non-toxic.
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kgs & 20 kgs in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification of Spraypol™ S 100 :
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
White
powder with a faint characteristic odour |
| Solubility |
- |
1
g of SPRAYPOL™ L 100 or SPRAYPOL™ S 100 dissolves
in 7 g methanol, ethanol, in aqueous isopropyl alcohol
and acetone ( containing approx. 3% water), as well as
in 1 N sodium hydroxide to give clear to slightly cloudy
solutions. SPRAYPOL™ L 100 and SPRAYPOL™ S
100 are practically insoluble in ethyl acetate, mehtylene
chloride, petroleum ether and water. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
min.
95.0 |
NA |
NA |
NA |
| Loss
on drying |
% |
max.
5.0 |
max.
5.0 |
max.
5.0 |
max.
10.0 |
| Methacrylic
acid units, based on DS |
% |
27.6-30.7 |
27.6-30.7 |
27.6-30.7 |
25.0-34.5 |
| Acid
value |
Mg
KOH/gDS |
180-200 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
50-200 |
50-200 |
50-200 |
NA |
| Viscosity |
Mm²/s |
22-52 |
NA |
NA |
22-52 |
| Monomers |
% |
Max.500 |
Max.0.1%,
|
Max.0.05% |
NA |
| Ethyl
Acrylate |
Ppm |
NA |
NA |
NA |
Max
0.2% |
| Methacrylic
Acid |
Ppm |
NA |
NA |
NA |
NA |
* Spraypol ™ are used in Taste, Odour Masking, Moisture
Protection & Immediate Release Coating:
Taste masking is used to mask unpleasant
tastes in pharmaceuticals, vastly improving consumer acceptance,
patient compliance and user satisfaction. An Odour Masking
is a substance that is generally a pleasant smell that is
used to disguise a unpleasant one.
5) Spraypol™ E 100
Spraypol™ E 100 is a cationic copolymer based on dimethylaminoethyl
methacrylate and neutral methacrylic esters. The average molecular
weight of Spraypol™ E 100 is approx. 150,000.Spraypol
E 100are soluble in gastric flui up to pH5,they are swellable
and permeable above pH 5.0
Use : Sraypol™ E 100 are used as taste
and odour masking , insolating coating, transdermal applications
and as moisture protection
Appearance : colourless to yellow tinged
granules with a characteristic amine-like odour.
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kg.& 20 kg. in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification of Spraypol™ E 100
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
Off
white to yellowish granules |
| Solubility |
- |
1
g of SPRAYPOL™ E 100 or SPRAYPOL™ E PO dissolves
in 7 g methanol, ethanol, isopropyl alcohol, acetone,
ethyl acetate. ,methylene chloride or 1 N hydrocholoric
acid to give clear to slightly cloudy solutions. SPRAYPOL™
E 12,5 is mixable with these solvents and with petroleum
ether in a ratio of 1:1.
The solid substance is practically insoluble in petroleum
ether and water. The polymer is precipitated from SPRAYPOL™
E 12,5 when mixed with water in a ratio of 1:1. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
min.
98.0 |
NA |
NA |
NA |
| Loss
on drying |
% |
max.
2.0 |
max.
2.0 |
NA |
max.
2.0 |
| Dimethylaminoethyl
units, based on DS |
% |
20.8- 25.5 |
20.8-25.5 |
NA |
NA |
| Alkali
value |
Mg
KOH/gDS |
162-198 |
NA |
NA |
NA |
| Assay
(% Nitrogen) |
% |
4.0-6.0 |
NA |
NA |
4.0-6.0 |
| Particle
size (less than 0.315 mm) |
% |
Min.
90 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
3-6 |
3-6 |
NA |
NA |
| Viscosity |
Mm²/s |
2.5-5.5 |
NA |
NA |
22-52 |
| Monomers |
% |
<3000 |
Max.0.3%,
|
NA |
NA |
| Butyl
Methacrylate |
Ppm |
<1000 |
NA |
NA |
Max
0.1% |
| Methyl
mehtacrylate |
Ppm |
<1000 |
NA |
NA |
Max
0.2% |
| Dimethylaminoethy |
Ppm |
<1000 |
NA |
NA |
NA |
| methacrylate |
|
|
|
|
0.2% |
6) Spraypol™ E PO
Spraypol™ EPO are soluble in gastric flui up to pH5,they
are swellable and permeable above pH 5.0
Use : Sraypol™ EPO are used as moisture
protection, Taste and odour masking.
Appearance :
Shelf Life - Minimum 2 years from the manufacturing
date.
Packing - 5 kg.& 20 kg. in Corrugated
Boxes / HDPE Drums lined with polyethylene.
Specification of Spraypol™ E PO
| Test |
Unit |
Specification |
| |
|
Spec. |
Ph.Eur. |
NF |
JEP |
| Appearance |
- |
Off
white to yellowish powder |
| Solubility |
- |
1
g of SPRAYPOL™ E 100 or SPRAYPOL™ E PO dissolves
in 7 g methanol, ethanol, isopropyl alcohol, acetone,
ethyl acetate. ,methylene chloride or 1 N hydrocholoric
acid to give clear to slightly cloudy solutions. SPRAYPOL™
E 12,5 is mixable with these solvents and with petroleum
ether in a ratio of 1:1.
The solid substance is practically insoluble in petroleum
ether and water. The polymer is precipitated from SPRAYPOL™
E 12,5 when mixed with water in a ratio of 1:1. |
| Identification |
- |
A) IR B) Test of Assay |
| Dry
Substance/ Residue on evaporation |
% |
min.
98.0 |
NA |
NA |
NA |
| Loss
on drying |
% |
max.
2.0 |
max.
2.0 |
NA |
max.
2.0 |
| Dimethylaminoethyl
units, based on DS |
% |
20.8- 25.5 |
20.8-25.5 |
NA |
NA |
| Alkali
value |
Mg
KOH/gDS |
162-198 |
NA |
NA |
NA |
| Assay
(% Nitrogen) |
% |
4.0-6.0 |
NA |
NA |
4.0-6.0 |
| Particle
size (less than 0.315 mm) |
% |
Min.
90 |
NA |
NA |
NA |
| Viscosity/
Apparent viscosity |
mPa.s |
3-6 |
3-6 |
NA |
NA |
| Viscosity |
Mm²/s |
2.5-5.5 |
NA |
NA |
22-52 |
| Monomers |
% |
<3000 |
Max.0.3%,
|
NA |
NA |
| Butyl
Methacrylate |
Ppm |
<1000 |
NA |
NA |
Max
0.1% |
| Methyl
mehtacrylate |
Ppm |
<1000 |
NA |
NA |
Max
0.2% |
| Dimethylaminoethyl
methacrylate |
Ppm |
<1000 |
NA |
NA |
Max
0.2% |
|
