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
AAPS 2006 - Hypromellose as a Pore Former in Aqueous Ethylcellulose Dispersion: Stability and Film PropertiesView and Download Send by Email
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 2007 - Identification and Influence of Critical Coating Process Parameters on Drug Release from a Fully Formulated Aqueous Ethylcellulose DispersionView and Download Send by Email
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 Send by Email
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 - Influence of Post Coating Thermal Treatment on Film Properties and Drug Release from Ethylcellulose Barrier Membrane Coating SystemsView and Download Send by Email
Post coating treatment can affect both physico-mechanical properties of EC films and drug release from EC-coated multi-particulates.
AAPS 2014 - A QbD Investigation into the Effect of Ethylcellulose Viscosity Variation on the Drug Release of Metoprolol Tartrate Extended Release MultiparticulatesView and Download Send by Email
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 Send by Email
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 Send by Email
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 Send by Email
Study of the effect of substrate morphology and particle characteristics in maintaining the integrity of coating throughout the process of chewable tablet manufacture.
CRS 2009 - Influence of Coating System Type on Acetaminophen Release from Ethylcellulose Barrier Membrane Coated MultiparticulatesView and Download Send by Email
ADS adapted from 2009 CRS poster,The Influence of Coating System Type on Acetaminophen Release from Ethylcellulose Barrier Membrane Coated Multiparticulates
CRS 2011 - Barrier Membrane Coating of Hydrophilic Matrices: A Strategy to Reduce Drug Release Variability and Possible Food EffectView and Download Send by Email
Application of a barrier membrane (BM) coating with Surelease including a pore-former (Opadry system); with near zero order drug release profiles obtained.
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 Send by Email
Application of barrier membrane (BM) coating, using Surelease with a pore-former, Opadry; elimination of the burst effect, followed by near zero order release.
Published White Papers / Articles
- 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.
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