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 LiteratureProduct Application Data General Information Product Process Parameters Product Recon Sheet Product Brochure Published Posters Published White Papers / Articles
Product Application Data
Modern Tablet Film Coatings and Influence on Ease of SwallowingView and Download Send by Email
This 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.
Product Process Parameters
AAPS 2003 - Modern Tablet Film Coatings and Influence on Ease of SwallowingView and Download Send by Email
The 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 UniformityView and Download Send by Email
In 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 2007 - Reducing Coated Tablet Defects from Laboratory Through Production Scale: Performance of Hypromellose Based and Polyvinyl Alcohol Based Aqueous Film Coating SystemsView and Download Send by Email
The 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 LossesView and Download Send by Email
This 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 2009 - Determination of Trace Formic Acid and Formaldehyde in Film Coatings Comprising Polyvinyl Alcohol (PVA)View and Download Send by Email
This 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 FormulationsView and Download Send by Email
Using 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 FormulationsView and Download Send by Email
The 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 - Use of Maximum Fluid Delivery Rate Measurements to Assess the Productivity of Moisture Barrier Film CoatingsView and Download Send by Email
The 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® IIView and Download Send by Email
The 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.
Published White Papers / Articles
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
- 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.
Colorcon can help to reduce your project time by providing the right solution through excipient selection and process guidance.
Lower total cost and reduce time to market
Life cycle management through modified delivery profiles and product line extensions
Reduce medication errors and improve patient adherence
Stable and consistent product performance
Track and trace