Surelease® Dispersión de Etilcelulosa Tipo B NF
El producto Surelease es un sistema completo de recubrimiento acuoso de liberación sostenida, que utiliza la etilcelulosa como polímero controlador de la tasa de liberación del activo. La dispersión es una combinación única de un polímero formador de la película, plastificante, y estabilizante: los que pueden ser utilizados como recubrimientos para liberación sostenida y enmascaramiento del sabor. Esta tecnología asegura un perfil de liberación confiable y reproducible en laboratorio en procesos a escala piloto hasta producción.
- La liberación del activo se obtiene en principio por difusión a través de la membrana semipermeable del Surelease
- La tasa de liberación del active se modifica aumentando o disminuyendo la cantidad de Surelease aplicado (espesor del film)
- Liberación del activo uniforme independiente del pH
- Aplicación del enmascaramiento del sabor
El ajuste fácil de los perfiles de liberación facilita significativamente el ahorro del tiempo tanto en desarrollo como en producción. Además, la optimización de los procesos asegura la complete coalescencia del recubrimiento, que puede eliminar la necesidad del curado. El Surelease también es seguro para utilizarse con componentes que cumplen con los requisitos de la mayoría de las farmacopeas y para la aprobación del registro de productos a nivel mundial.
Literatura del producto
Información General Hoja de Reconstitución del producto Folleto del producto Posters publicados Artículos / Papers publicadosInformación General
Surelease® Product Information
Descargar Documento Enviar por e-mailOverview of Surelease Ethylcellulose Dispersion Type B NF, including key characteristics, packaging and stability.
Tech Bulletin: Introducing Surelease® | Opadry® for Taste-Masking
Descargar Documento Enviar por e-mailIntroduction to Taste-Masking with Surelease and Opadry
Tech Bulletin: Surelease® | Opadry® for Taste-Masking 2
Descargar Documento Enviar por e-mailTaste-masking with Surelease® and Opadry: Impact of Substrate Morphology
Hoja de Reconstitución del producto
Folleto del producto
Surelease® Product Information Brochure
Descargar Documento Enviar por e-mailIntroduction to the Surelease platform of aqueous ethylcellulose dispersions.
Posters publicados
AAPS 2004 - Comparative Study of Theoretical Versus Actual Weight Gain for a Surelease® Barrier Membrane on Coated Pellets
Descargar Documento Enviar por e-mailThis 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 Properties
Descargar Documento Enviar por e-mailEffect 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 Dispersion
Descargar Documento Enviar por e-mailAAPS 2006 - Modulation of Drug Release from Hypromellose (HPMC) Matrices: Suppression of the Initial Burst Effect
Descargar Documento Enviar por e-mailMethod 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 Dispersion
Descargar Documento Enviar por e-mailIdentify 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 Pellets
Descargar Documento Enviar por e-mailEffect 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 Granulation
Descargar Documento Enviar por e-mailSurelease Application Data document
AAPS 2008 - Influence of Post Coating Thermal Treatment on Film Properties and Drug Release from Ethylcellulose Barrier Membrane Coating Systems
Descargar Documento Enviar por e-mailPost 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 Effect
Descargar Documento Enviar por e-mailApplication 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 Composition
Descargar Documento Enviar por e-mailJoint 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 Stress
Descargar Documento Enviar por e-mailJoint poster - Ernst Moritz Arndt University & Colorcon.
AAPS 2012 - Stability of Ethylcellulose Barrier Membrane Coated Hydrochlorothiazide Matrices Comprising Starch 1500® or Lactose as Filler
Descargar Documento Enviar por e-mailStarch 1500 contributed to robustness of the barrier membrane coated matrix tablets.
AAPS 2013 - Investigation of Taste Masking Performance of an Aqueous Ethylcellulose Dispersion
Descargar Documento Enviar por e-mailEvaluating 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 Multiparticulates
Descargar Documento Enviar por e-mailStudy 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 Applications
Descargar Documento Enviar por e-mailData 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 Drug
Descargar Documento Enviar por e-mailProduction 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 Tablets
Descargar Documento Enviar por e-mailStudy of the effect of substrate morphology and particle characteristics in maintaining the integrity of coating throughout the process of chewable tablet manufacture.
AAPS 2021 - Drug Release Stability of Propranolol Hydrochloride ER Multiparticulates using Ethylcellulose Dispersions es
Descargar Documento Enviar por e-mailCRS 2005 - Evaluation of Alternative Plasticizers for Surelease® for Modified Release Film-Coating
Descargar Documento Enviar por e-mailEffects 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 Dispersion
Descargar Documento Enviar por e-mailDrug 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 Properties
Descargar Documento Enviar por e-mailInteractions between the HPMC and Surelease EC dispersion.
CRS 2007 - Application of an Aqueous Ethylcellulose Dispersion in Multiple-Unit Pellet Systems
Descargar Documento Enviar por e-mailInvestigate 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 Beads
Descargar Documento Enviar por e-mailCRS 2007 - Investigation of the Relationship between Formulation Variables and Drug Release in Aqueous Ethylcellulose Coating
Descargar Documento Enviar por e-mailEffect 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 Multiparticulates
Descargar Documento Enviar por e-mailADS 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 Matrices
Descargar Documento Enviar por e-mailCRS 2010 - Influence of Hydrophilic Pore-Formers on Metoprolol Succinate Release from Mini-tabs Coated with Aqueous Ethylcellulose Dispersion
Descargar Documento Enviar por e-mailCRS 2010 - Stability of a Sparingly Soluble BCS Class I API Ethylcellulose Coated Multiparticulate
Descargar Documento Enviar por e-mailInvestigating 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 Effect
Descargar Documento Enviar por e-mailApplication 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 Release
Descargar Documento Enviar por e-mailAn 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 Drug
Descargar Documento Enviar por e-mailCRS 2012 - Barrier Membrane Coating of Hydrophilic Matrices of a Very Soluble Drug, Metoprolol Tartrate at High Dose: A Strategy to Eliminate the Initial Burst Release
Descargar Documento Enviar por e-mailApplication 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 Release
Descargar Documento Enviar por e-mailAlternative formulation strategy for dosage forms where zero order release of drug is desired
CRS 2015 - Taste-masking Performance from Coated Granules & Chewable Tablets
Descargar Documento Enviar por e-mailTaste-masking of a bitter drug, acetaminophen (APAP) was achieved by application of a Surelease and HPMC-based Opadry combination coating.
Artículos / Papers publicados
Bitter to Better: Formulation Strategies for Effective Taste Masking
Descargar Documento Enviar por e-mailApril 2018 Article Tablets and Capsules Magazine, Author Charles Vesey
Film Coating for Pediatric Oral Solid Dosage Forms
Descargar Documento Enviar por e-mailGetting the Right Coating for Pediatric Tablet Formulations
Film Coating for Taste-masking of Pediatric Oral Solid Dosage Forms
Descargar Documento Enviar por e-mailCase study on the use of Surelease® and Opadry® in the Development of a Paediatric Form of Raltegravir
On Drug Delivery
Descargar Documento Enviar por e-mailTaste-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.
Plataforma de soluciones
Colorcon puede ayudarlo a reducir el tiempo en su proyecto al proporcionar la solución adecuada a través de la selección de excipientes y guía del proceso.
Productividad
Bajar el costo total y reducir el tiempo de lanzamiento al mercado
Diseño de disolución
Gestión del ciclo de vida de producto mediante un portfolio para perfiles de liberación modificada y extendida.
Cumplimiento del paciente
Reducir los errores en la medicación y mejorar la adhesión del paciente al tratamiento
Estabilidad
Performance del producto final estable y consistente
Autenticación de producto
Seguimiento y localización