Opadry® II High Performance Film Coating System
Offering short process times and a superior film finish, the Opadry II product range consists of fully formulated dry blend systems for the aqueous film coating of pharmaceutical and nutritional oral solid dosage forms. Opadry II is a high productivity, water soluble, pH independent complete dry powder film coating system containing polymer, plasticizer and pigment which allows for immediate disintegration for fast, active release.
Product Literature
Product Application Data General Information Product Process Parameters Product Recon Sheet Product Brochure Published Posters Published White Papers / ArticlesProduct Application Data
Effect of Coating Process Conditions and Coating Formula Type on the Quantity and Location of Water in Film Coated Tablets
View and Download Send by EmailStudy of process conditions and formula type on tablet moisture gain.
Modern Tablet Film Coatings and Influence on Ease of Swallowing
View and Download Send by EmailThis Application Data Sheet is extracted from a study of esophageal transit times using uncoated and film-coated caplets,oval tablets, plus hard and soft-gelatin capsules. Reprint of poster presented at the American Association of Pharmaceutical Scientists Meeting, 2003.
General Information
Opadry® Cleaning Instructions
View and Download Send by EmailGeneral directions for clean up after use of most Opadry product formulations.
Product Process Parameters
Opadry® II Coating Parameters - Clear (PVA-based) Formulations
View and Download Send by EmailStarting process recommendations for use of Opadry II, clear formulations.
Opadry® II Coating Parameters - Pigmented (PVA-based) Formulations
View and Download Send by EmailStarting process recommendations for Opadry II pigmented formulations.
Product Recon Sheet
Opadry® II - Reconstitution
View and Download Send by EmailMixing procedure and holding instructions for Opadry II coating formulations.
Product Brochure
Opadry® II - Product Information Brochure
View and Download Send by EmailIntroduction to the Opadry II platform of aqueous PVA and HPMC-based immediate release film coating systems.
Published Posters
AAPS 2003 - Modern Tablet Film Coatings and Influence on Ease of Swallowing
View and Download Send by EmailThe objective of this study was to investigate if film coated tablets have shorter mean esophageal transit times and lower incidences of transit delays than those of uncoated tablets, or comparably sized hard or soft gelatin capsules.
AAPS 2005 - Evaluation of a Film Coating that Produces Enhanced Tablet-to-Tablet Film Uniformity
View and Download Send by EmailIn this study, Opadry II (85 series) Clear was shown to have lower coating weight gain standard deviations than a standard clear hypromellose based film coating. Pigmented Opadry II (85 series) achieved similar or better coating color uniformity with a 1/3 savings in processing time.
AAPS 2005 - Investigation into the Flow Properties of Coated and Uncoated Tablets and Its Relevance to Blister Packing Efficiency
View and Download Send by EmailStudy on reducing contamination and improving packaging line efficiency through the application of a fully formulated film coating.
AAPS 2006 - Protection and Processing of a Highly Hygroscopic Herbal Extract by Drug Layering and Film Coating
View and Download Send by EmailStudy of the stability improvements for Echinacea Purpurea beads layered with a moisture PVA and HPMC based barrier film coating.
AAPS 2007 - Reducing Coated Tablet Defects from Laboratory Through Production Scale: Performance of Hypromellose Based and Polyvinyl Alcohol Based Aqueous Film Coating Systems
View and Download Send by EmailThe purpose of this study was to examine the effect of film coating formulations in reducing or preventing coating defects on a soft and friable multivitamin tablet.
AAPS 2008 - Evaluation of Recent Advances in Continuous Film Coating Technology in Reducing or Eliminating Potential Product Losses
View and Download Send by EmailThis study evaluates the performance of Opadry II in a continuous coating process and demonstrates that improvements in continuous coater designs have reduced the need for re-work or discarding of partially coated product.
AAPS 2008 - Scuffing Measurement Methodology and Improved Film Coating Systems
View and Download Send by EmailThis study describes laboratory tests to measure scuffing on film coated tablets and provides process and maintenance recommendations to prevent the occurrence of scuffing.
AAPS 2009 - Determination of Trace Formic Acid and Formaldehyde in Film Coatings Comprising Polyvinyl Alcohol (PVA)
View and Download Send by EmailThis work describes the application of a methodology developed by Amgen to determine the amounts of formic acid and formaldehyde in PVA-based film coatings.
AAPS 2009 - Film Coating Process Considerations for the Application of High Productivity, High Solids Concentration Film Coating Formulations
View and Download Send by EmailUsing a Design of Experiments (DOE) approach, this study examines the effect of solids concentration on color uniformity and coating weight variation (CWV) in a batch coating process.
AAPS 2009 - Influence of Film Coating Process Parameters on the Gloss of Tablets Coated with Pigmented Aqueous Film Coating Formulations
View and Download Send by EmailThe purpose of this study was to examine the effects of coating process parameters and dispersion solids concentration on the gloss of tablets coated with single-step, pigmented aqueous film coating formulations.
AAPS 2009 - Maximizing the Gloss of PVA-Based Film Coating Systems
View and Download Send by EmailResults of this study reveal gloss level improvements when PVA-based pigmented film coatings are applied at lower solids content levels.
AAPS 2009 - Use of Maximum Fluid Delivery Rate Measurements to Assess the Productivity of Moisture Barrier Film Coatings
View and Download Send by EmailThe aim of this study was to develop a small-scale method predicting film coating productivity of moisutre barrier film coatings. Maximum fluid delivery rates were used to evaluate the productivity and inherent tack of formulations, Opadry II, Opadry amb and a developmental formulation.
AAPS 2010 - Stability of Six Model Drug Products Coated with PVA-based Opadry® II
View and Download Send by EmailThe purpose of this study was to investigate the influence of PVA-based OpadryII systems on stability and release of immediate release formulations containing six model drugs, after storage at accelerated conditions.
AAPS 2013 - Immediate Release Film Coating of an Acetaminophen Extended Release Matrix Tablet Containing a High Concentration of Polyethylene Oxide Water Soluble Resin
View and Download Send by EmailInvestigation of film coating with Opadry II on hydrophilic matrix tablets
AAPS 2020 - Evaluation of Different Opadry® Film Coating Systems on Tablets Containing Amorphous Solid Dispersion of Itraconazole
View and Download Send by EmailAAPS 2021 - Performance and Stability of an On-Dosage Authentication Technology Using Molecular Tags on the Coated a Model Active
View and Download Send by EmailCRS 2003 - The Influence of Film Coatings on Performance of Hypromellose Matrices
View and Download Send by EmailStudy on the influence of three film coating systems on the performance of hypromellose sustained release matrices, stored under different conditions up to 12 months.
CRS 2006 - Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg ER Hypromellose Matrices
View and Download Send by EmailInfluence of three film coating systems on the performance of Metformin HCl (500mg) extended release (ER) Hypromellose matrices.
SAFYBI 2005 - Coating Moisture-Sensitive Products with Opadry® II
View and Download Send by EmailInfluence of inlet temperature and airflow on moisture uptake by tablet cores using a PVA-based film coating system.
Published White Papers / Articles
Dare to be Different - Use Color and Shape for Unique Tablet Design
View and Download Send by EmailThis article is from Medicine Maker, March 2015 issue.
Film Coating for Pediatric Oral Solid Dosage Forms
View and Download Send by EmailGetting the Right Coating for Pediatric Tablet Formulations
Opadry II Offers:
- Reduced coating process time - a savings of 25% or more compared with conventional film coating formulations
- Increased production capacity - reduced process time frees up film coating equipment
- Superior product appearance - high adhesion polymer formulations provide excellent logo definition on difficult to coat cores
- Wide processing capability - simple to use on all types of coating equipment and substrates
- Easy application - Mixes easily with water into a solution which is usable within 30-45 minutes.
- Greater aqueous film coating uniformity, smooth tablet finish and improved gloss - Due to low viscosity, optimal droplet size
- Single component lowers raw material inventory, QC testing, and documentation costs
Recommended Use
- Suitable for use on a wide variety of tablets containing a wide variety of active pharmaceutical ingredients (APIs)
- Pigmented systems capable of 20% solids solution
Find out how Opadry II can put you on the fast track to greater coating productivity and performance.
Platform Solutions
Colorcon can help to reduce your project time by providing the right solution through excipient selection and process guidance.
Productivity
Lower total cost and reduce time to market
Dissolution Design
Life cycle management through modified delivery profiles and product line extensions
Patient Adherence
Reduce medication errors and improve patient adherence
Stability
Stable and consistent product performance
Product Authentication
Track and trace
