Opadry® II Sistema Completo de Recubrimiento Pelicular Acuoso
Opadry II proporciona tiempos de procesos más cortos y un acabado superior del recubrimiento. El producto es un sistema de recubrimiento acuoso completamente formulado, que consiste en una mezcla seca para formas farmacéuticas y nutricionales sólidas de administración oral. El Opadry II es un sistema de recubrimiento pelicular en polvo seco de alta productividad, hidrosoluble, independiente del pH que contiene un polímero, plastificante y pigmento el que permite una desintegración inmediata para una rápida liberación del activo.
Opadry II Ofrece:
- Reducción de los tiempos de procesos - la reducción llega al 25% o más si se lo compara con recubrimientos convencionales
- Incremento de la capacidad de producción - reduce los tiempos de procesos utilizados en los equipos de recubrimiento
- Apariencia mejorada del producto - formulaciones con polímeros de mayor adhesividad al núcleo tiene como resultado una mejor definición del logo en núcleos difíciles de recubrir
- Extenso potencial para procesos - simple de usar en todos los tipos de equipos de recubrimientos y sustratos
- Fácil aplicación - Se mezcla fácilmente con agua en una solución que debe utilizarse dentro de los 30-45 minutos.
- Gran uniformidad del recubrimiento pelicular, acabado liso del comprimido y brillo mejorado – Debido a la baja viscosidad, el tamaño de la gota es óptimo
- Componente único por lo que resulta en un menor inventario de materias primas, evaluaciones de Control de Calidad costos de la documentación
Usos Recomendados
- Apropiado para utilizarse en una amplia variedad de comprimidos que contienen un amplio rango de principios activos farmacéuticos (APIs)
- Sistemas coloreados apto para soluciones con 20% de sólidos
Encuentre mayor información de cómo el Opadry II puede acelerar los procesos para lograr una mejor productividad y rendimiento.
Literatura del producto
Información de aplicación del producto Información General Parámetros del proceso de productos Hoja de Reconstitución del producto Folleto del producto Posters publicados Artículos / Papers publicadosInformación de aplicación del producto
Effect of Coating Process Conditions and Coating Formula Type on the Quantity and Location of Water in Film Coated Tablets
Descargar Documento Enviar por e-mailStudy of process conditions and formula type on tablet moisture gain.
Modern Tablet Film Coatings and Influence on Ease of Swallowing
Descargar Documento Enviar por e-mailThis 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.
Información General
Opadry® Cleaning Instructions
Descargar Documento Enviar por e-mailGeneral directions for clean up after use of most Opadry product formulations.
Parámetros del proceso de productos
Opadry® II Coating Parameters - Clear (PVA-based) Formulations
Descargar Documento Enviar por e-mailStarting process recommendations for use of Opadry II, clear formulations.
Opadry® II Coating Parameters - Pigmented (PVA-based) Formulations
Descargar Documento Enviar por e-mailStarting process recommendations for Opadry II pigmented formulations.
Hoja de Reconstitución del producto
Opadry® II - Reconstitution
Descargar Documento Enviar por e-mailMixing procedure and holding instructions for Opadry II coating formulations.
Folleto del producto
Opadry® II - Product Information Brochure
Descargar Documento Enviar por e-mailIntroduction to the Opadry II platform of aqueous PVA and HPMC-based immediate release film coating systems.
Posters publicados
AAPS 2003 - Modern Tablet Film Coatings and Influence on Ease of Swallowing
Descargar Documento Enviar por e-mailThe 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
Descargar Documento Enviar por e-mailIn 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
Descargar Documento Enviar por e-mailStudy 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
Descargar Documento Enviar por e-mailStudy 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
Descargar Documento Enviar por e-mailThe 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
Descargar Documento Enviar por e-mailThis 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
Descargar Documento Enviar por e-mailThis 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)
Descargar Documento Enviar por e-mailThis 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
Descargar Documento Enviar por e-mailUsing 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
Descargar Documento Enviar por e-mailThe 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
Descargar Documento Enviar por e-mailResults 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
Descargar Documento Enviar por e-mailThe 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
Descargar Documento Enviar por e-mailThe 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 2011 - Effect of Film Coating on the Stability of ER Metformin Hydrochloride POLYOX™ Matrices
Descargar Documento Enviar por e-mailApplication of PVA-based Opadry II results in enhanced tablet stability and prevented loss of mechanical strength during accelerated storage conditions
AAPS 2013 - Immediate Release Film Coating of an Acetaminophen Extended Release Matrix Tablet Containing a High Concentration of Polyethylene Oxide Water Soluble Resin
Descargar Documento Enviar por e-mailInvestigation 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
Descargar Documento Enviar por e-mailAAPS 2021 - Performance and Stability of an On-Dosage Authentication Technology Using Molecular Tags on the Coated a Model Active es
Descargar Documento Enviar por e-mailCRS 2003 - The Influence of Film Coatings on Performance of Hypromellose Matrices
Descargar Documento Enviar por e-mailStudy 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
Descargar Documento Enviar por e-mailInfluence 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
Descargar Documento Enviar por e-mailInfluence of inlet temperature and airflow on moisture uptake by tablet cores using a PVA-based film coating system.
Artículos / Papers publicados
Atrévase a diferenciarse - Use color y forma para un diseño diferente de su comprimido
Descargar Documento Enviar por e-mailAtrévase a diferenciarse
Film Coating for Pediatric Oral Solid Dosage Forms
Descargar Documento Enviar por e-mailGetting the Right Coating for Pediatric Tablet Formulations
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