FILM COATINGS

®
amb II
High Performance Moisture Barrier Film Coating

Aqueous Fully Formulated PEG-free

Immediate Release System
• Proven protection from environmental moisture
• Superior coating productivity with ease-of-use
• High gloss finish with well
defined logos
 amb II
®

High Performance Moisture Barrier Film Coating

High Performance Moisture Barrier Film Coating

Many active pharmaceutical ingredients and solid oral Enhanced Product In-Use Integrity
dosage tablets are sensitive to moisture potentially
causing degradation or poor product performance.
Immediate release (IR) film coating systems provide
essential protection and are especially useful when
tablets are removed from their original packaging.

Opadry® amb II, high performance moisture barrier film

coating is the first fully formulated PVA-based immediate
release system without polyethylene glycol (PEG) that
delivers the three-fold advantage of high productivity,
low impurity levels and a superior tablet finish.

Proven Product Protection Guard Your Tablets fro

Over a Longer Period m Moisture
of Time
The rate and level of moisture uptake provides
Fig 1. Moisture Uptake
a measureable indicator into the performance of
moisture barrier film coatings. Opadry amb II films 5
were characterized using a novel on-tablet testing
method.1 As shown in Figure 1, the rate of moisture 4
Moisture uptake (%)

uptake compared to uncoated tablets demonstrates

3
the superior in-use functionality of this coating. Uncoated - 25°C/60%RH

2
Opadry amb II - 25°C/60%RH

0
0 200 400 600 800 1000 1200
Time (min)

Fig 2. Effect of Film Coating Weight Gain

Reliable Barrier 300

On-tablet analysis proves that coating with

On-Tablet WVTR ( g/day/mm2)

250

Opadry amb II at the recommended 4% weight 200

gain offers the most reliable and consistent
150
moisture barrier performance
(See Figure 2). 100

50

0
2 3 4
Weight Gain (%)

Reference
1. To D. et al. A Novel Method to Evaluate On-Tablet Moisture Barrier Performance of Opadry® Film Coating Systems. 2014 AAPS Poster
Superior Coating Productivity
Opadry amb II provides the perfect balance of barrier protection,
time savings in production and ease-of-use. Fast
and si er coating
gn
•O
 ne step dry powder - ready to use in 45 minutes more ificantly
mois
protec ture
• High productivity - low viscosity t
Opadr ion with
y amb
II
Fig 3. On-Tablet WVTR 40ºC / 75% RH, 4% WG
700

Typical 48" Pan Coating

600
System Avg. Spray rate % Coating
g/min Solids Time (min)
500
On-Tablet WVTR ( g/day/mm2)

Opadry 340 15 125.5

400 Opadry amb 172.5 20 185.5
Opadry amb II 275 20 116.4
300

200

100

0
Opadry Opadry amb Opadry amb II
(HPMC) (PVA) (PVA, no PEG)

Coating dispersion applied using recommended process parameters

Low Impurity Levels

Opadry amb II is formulated without PEG to reduce potential interaction with sensitive drugs.
Studies of the Opadry amb II powder show:
•F  ormic acid and formaldehyde residues exhibited no measurable increase after six months
accelerated stability (40°C/75%RH)
• Peroxide levels remained undetectable after twelve months (30°C/65%RH)

Glossy Finish and Well-Defined Logos

Tablets coated with Opadry amb II
create a high gloss finish with distinctly
defined logos.

• Available in clear and pigmented formulas

•A
 pproved for pharmaceutical use

From Core to Coating, Your Supplier of Choice

 amb II
®

High Performance Moisture Barrier Film Coating

Deliver High Performance

Products - with Colorcon
Choose Colorcon, leader in pharmaceutical
solid oral dose solutions, as a formulation
partner of choice in every phase of your
product development.

Film Coatings:
• Optimized formulations specifically for your
application and regulatory needs including
customized colors and color matching
• Innovative products for mechanical integrity,
gloss, pearlesence and environmental protection
• Tablet design concepts, consulting and services
to build a strong brand image and stand out
from the competition.

Formulation Technologies:
• Full range of functional excipients
• Technologies for development and production of
delayed/enteric release and extended/controlled
release tablets and multiparticulates
• HyperStart® service and extensive applications
data to provide starting formulations to save you
development time and money
• Extensive formulation know-how and technical
support to achieve the exact drug release
profile desired.

Contact your Colorcon representative or call:

North America Europe/Middle East/Africa
+1-215-699-7733 +44-(0)-1322-293000
Latin America India China
+54-11-5556-7700 +91-832-6727373 +86-21-61982300
© BPSI Holdings LLC, 2016. The information contained in this document is a proprietary
to Colorcon, Inc. and may not be used or dissminated inappropriately
You can also visit our website at All trademarks, except where noted are property of BPSI Holdings LLC. The information

www.colorcon.com contained in this document is not intended as legal advice, and should not be relied upon
for that purpose.

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