Surelease® Ethylcellulose Dispersion Type B NF
Surelease is a complete, sustained release, aqueous coating system utilizing ethylcellulose as the rate controlling polymer for drug release. The dispersions are a unique combination of film-forming polymer, plasticizer and stabilizers; that can be used for sustained release coating and taste masking applications. This established technology provides reliable and reproducible release profiles that are consistent from the laboratory, to pilot and production scale processes.
Product LiteratureGeneral Information Product Recon Sheet Product Brochure Published Posters Published White Papers / Articles
Surelease® Product InformationView and Download
Overview of Surelease Ethylcellulose Dispersion Type B NF, including key characteristics, packaging and stability.
Tech Bulletin: Introducing Surelease® | Opadry® for Taste-MaskingView and Download
Introduction to Taste-Masking with Surelease and Opadry
Tech Bulletin: Surelease® | Opadry® for Taste-Masking 2View and Download
Taste-masking with Surelease® and Opadry: Impact of Substrate Morphology
AAPS 2004 - Comparative Study of Theoretical Versus Actual Weight Gain for a Surelease® Barrier Membrane on Coated PelletsView and Download
This poster reprint outlines an analytical method to determine the quantity of ethylcellulose applied during coating, on multiparticulates.
AAPS 2006 - Hypromellose as a Pore Former in Aqueous Ethylcellulose Dispersion: Stability and Film PropertiesView and Download
Effect of HPMC as a pore-former on: stability of Surelease; quality of the free films prepared from these mixtures, and interactions between the HPMC and EC dispersion.
AAPS 2006 - Influence of Plasticizer Type on the Film Properties of a Fully-Formulated Aqueous Ethylcellulose DispersionView and Download
AAPS 2006 - Modulation of Drug Release from Hypromellose (HPMC) Matrices: Suppression of the Initial Burst EffectView and Download
Method to minimize a burst of drug release typically observed in the early phases of release of highly soluble actives from METHOCEL matrices.
AAPS 2007 - Identification and Influence of Critical Coating Process Parameters on Drug Release from a Fully Formulated Aqueous Ethylcellulose DispersionView and Download
Identify and study the influence of critical film coating process parameters for Surelease, on drug release behavior and process response variables.
AAPS 2007 - Influence of Hydrophilic Pore-Formers on Dipyridamole Release from Aqueous Ethylcellulose Film-Coated PelletsView and Download
Effect of incorporating water-soluble polyvinyl alcohol (PVA) and polyethylene glycol (PEG) as a pore former into Surelease films, and influence on drug release.
AAPS 2008 - Application of Surelease® in Preparation of Theophylline Extended Release Inert Matrix Tablets by Spray GranulationView and Download
Surelease Application Data document
AAPS 2008 - Influence of Post Coating Thermal Treatment on Film Properties and Drug Release from Ethylcellulose Barrier Membrane Coating SystemsView and Download
Post coating treatment can affect both physico-mechanical properties of EC films and drug release from EC-coated multi-particulates.
AAPS 2011 - Barrier Membrane Coating of Hydrophilic Matrices of Sparingly Soluble Drug, Acetaminophen: A Strategy to Reduce Possible Food EffectView and Download
Application of a barrier membrane (BM) coating consisting of Surelease and a pore-former, Opadry.
AAPS 2012 - Barrier Membrane Coated Hydrophilic Matrices: Robustness of Metoprolol Tartrate Release under Biorelevant Test Conditions – Impact of Media CompositionView and Download
Joint poster - Ernst Moritz Arndt University & Colorcon
AAPS 2012 - Barrier Membrane Coated Hydrophilic Matrices: Robustness of Metoprolol Tartrate Release under Biorelevant Test Conditions – Impact of pH and Mechanical StressView and Download
Joint poster - Ernst Moritz Arndt University & Colorcon.
AAPS 2013 - Investigation of Taste Masking Performance of an Aqueous Ethylcellulose DispersionView and Download
Evaluating the use of Surelease on taste masking of acetaminophen immediate release granules.
AAPS 2014 - A QbD Investigation into the Effect of Ethylcellulose Viscosity Variation on the Drug Release of Metoprolol Tartrate Extended Release MultiparticulatesView and Download
Study showing that viscosity variation, within the manufacturer’s specifications for ETHOCEL Premium grades, has minimal impact on drug release for extended release multiparticulates.
AAPS 2014 - Fluid Bed Nozzle Spray Characterization of an Aqueous Ethylcellulose Dispersion for Particle Taste Masking ApplicationsView and Download
Data from this study can be utilized to determine optimal spray conditions for the taste-masking of particles of various sizes in a fluid-bed coater at both laboratory and production scale.
AAPS 2016 - Effect of Surelease® Coating Conditions and Seal-coat on a Highly Soluble, Cationic DrugView and Download
Production of a sustained drug release multiparticulate dosage form showed no slowdown in dissolution even with cold and wet process conditions. Seal coating the beads after drug layering essentially eliminated the need to cure.
AAPS 2016 - Use of Raman Microscopy to Visualize the Integrity of a Barrier Membrane Coating for Taste-Masking of Acetaminophen Granules in Chewable TabletsView and Download
Study of the effect of substrate morphology and particle characteristics in maintaining the integrity of coating throughout the process of chewable tablet manufacture.
AAPS 2020 - Investigating the Use of Absolute Exhaust Humidity Control as a Control Parameter for Multiparticulate CoatingView and Download
AAPS 2021 - Drug Release Stability of Propranolol Hydrochloride ER Multiparticulates using Ethylcellulose DispersionsView and Download
CRS 2005 - Evaluation of Alternative Plasticizers for Surelease® for Modified Release Film-CoatingView and Download
Effects of various plasticizers on the thermal and physical properties of ethylcellulose.
CRS 2005 - Predictability of Drug Release from Multiparticulate Systems Coated with an Aqueous Ethylcellulose DispersionView and Download
Drug release from drug layered beads varying in substrate size, and Surelease coating level.
CRS 2006 - Effect of Hypromellose as a Pore-Former in Aqueous Ethylcellulose Dispersion: Characterization of Dispersion PropertiesView and Download
Interactions between the HPMC and Surelease EC dispersion.
CRS 2007 - Application of an Aqueous Ethylcellulose Dispersion in Multiple-Unit Pellet SystemsView and Download
Investigate drug release from compressed multiple-unit pellet systems, coated with Surelease
CRS 2007 - Effect of Hypromellose as a Pore-Former on Drug Release from Aqueous Ethylcellulose Film-Coated Dipyridamole-Loaded Non-Pareil BeadsView and Download
CRS 2007 - Investigation of the Relationship between Formulation Variables and Drug Release in Aqueous Ethylcellulose CoatingView and Download
Effect of pore-former on the drug release of various actives from drug layered beads coated with Surelease.
CRS 2009 - Influence of Coating System Type on Acetaminophen Release from Ethylcellulose Barrier Membrane Coated MultiparticulatesView and Download
ADS adapted from 2009 CRS poster,The Influence of Coating System Type on Acetaminophen Release from Ethylcellulose Barrier Membrane Coated Multiparticulates
CRS 2009 - Investigation of Aqueous Ethylcellulose Dispersion in ER Metformin Inert MatricesView and Download
CRS 2010 - Influence of Hydrophilic Pore-Formers on Metoprolol Succinate Release from Mini-tabs Coated with Aqueous Ethylcellulose DispersionView and Download
CRS 2010 - Stability of a Sparingly Soluble BCS Class I API Ethylcellulose Coated MultiparticulateView and Download
Investigating the long term stability, curing effects and release kinetics of a sparingly soluble BCS Class I API, layered on nonpareil beads and coated with Surelease.
CRS 2011 - Barrier Membrane Coating of Hydrophilic Matrices: A Strategy to Reduce Drug Release Variability and Possible Food EffectView and Download
Application of a barrier membrane (BM) coating with Surelease including a pore-former (Opadry system); with near zero order drug release profiles obtained.
CRS 2011 - Barrier Membrane Coating of Hydrophilic Matrices: Influence of Tablet Shape and Geometry on Drug ReleaseView and Download
An opportunity for tailoring the drug release profile in addition to rebranding of existing products,and creating distinctive formulations.
CRS 2011 - Influence of Aqueous Ethylcellulose Coating on the Performance of Hydrophilic Polyethylene Oxide Mini-Matrices Containing a Freely Water Soluble DrugView and Download
CRS 2012 - Barrier Membrane Coating of Hydrophilic Matrices of a Very Soluble Drug, Metoprolol Tartrate at High Dose: A Strategy to Eliminate the Initial Burst ReleaseView and Download
Application of barrier membrane (BM) coating, using Surelease with a pore-former, Opadry; elimination of the burst effect, followed by near zero order release.
CRS 2013 - Barrier Membrane Coating of Hydrophilic Matrices: A Simplified Strategy to Attain Zero Order Drug ReleaseView and Download
Alternative formulation strategy for dosage forms where zero order release of drug is desired
CRS 2015 - Taste-masking Performance from Coated Granules & Chewable TabletsView and Download
Taste-masking of a bitter drug, acetaminophen (APAP) was achieved by application of a Surelease and HPMC-based Opadry combination coating.
CRS 2018 - Application of Barrier Membrane Coating to Reduce the Weight of Metformin HCI Extended Release TabletsView and Download
Published White Papers / Articles
Bitter to Better: Formulation Strategies for Effective Taste MaskingView and Download
April 2018 Article Tablets and Capsules Magazine, Author Charles Vesey
CRS 2021 - Evaluation of Formulated Ethylcellulose Aqueous Dispersions to Develop Controlled Release Multiparticulate Formulation of Freely Soluble Drug, Propranolol HydrochlorideView and Download
Film Coating for Pediatric Oral Solid Dosage FormsView and Download
Getting the Right Coating for Pediatric Tablet Formulations
Film Coating for Taste-masking of Pediatric Oral Solid Dosage FormsView and Download
Case study on the use of Surelease® and Opadry® in the Development of a Paediatric Form of Raltegravir
On Drug DeliveryView and Download
Taste-masking interview from On Drug Delivery July 2015 edition. Taste-masking and the positive impact on medication adherence. Review of pH dependent and independent film coating options.
- Drug release is primarily by diffusion through the Surelease semipermeable membrane
- Rate of drug release is modified by increasing or decreasing the amount of Surelease applied (film thickness)
- Uniform drug release independent of pH
- Taste masking application
The easy adjustment of release profiles provides significant time savings both in development and production. Furthermore, process optimization ensures the coating is fully coalesced, which may eliminate the need for a curing step. Surelease is also safe to use with components that meet the requirements of major pharmacopeia, and registered product approvals worldwide.