EUDRAGIT® polymers have been widely known for their sustained release properties when used in coating and matrix applications. This study explores the use of EUDRAGIT® RS PO in a novel dry powder layering process to achieve sustained release pellets. Further a need of reducing the particle size of commercially marketed EUDRAGIT® RS PO is investigated.
To investigate the effect of different plasticizer systems on the release profile of Theophylline multi-particulate beads coated with micronized RSPO polymer in dry form.
The purpose of this study was to take an existing Wurster process that created enteric coated omeprazole beads on a Wurster and transfer it to a conical rotor to reduce the processing time and pieces of equipment required to complete the process.
Site-specific delivery and controlled release of active pharmaceutical ingredients (APIs) have resulted in a high demand for modified-release products. Sustained-release beads can deliver stable levels of drugs, which result in less-frequent dosing. For consistent drug delivery, it is imperative for the bead coating to be uniformly applied. In this study, Raman Chemical Imaging (RCI) coupled with optical microscopy was applied to investigate API and polymer coating thicknesses in commercial sustained-release beads. This approach was compared to scanning electron microscopy (SEM) and dissolution data obtained for the same batch.
To study the particle size and shape changes during coating of ibuprofen coated beads and determine if process changes could be detected.
The purpose of this study was to determine the effect of two different plasticizer systems on the film formation and overall processablilty of Eudragit E PO during a dry powder coating.
The purpose of this study was to investigate the taste masking of acetaminophen beads with EUDRAGIT® E PO powder utilizing a novel, low temperature rotor-granulator process.
To study the particle size and shape changes during rotor spheronization of starch and lactose and powder layering of ibuprofen onto sugar cores.
To study the effects on particle size and shape for high-shear granulation using differing means of binder activation.
To develop a novel process for applying methylmethacrylates (MMA) to multi-particulates using a rotor processor.
To compare two methods for applying a sustained release polymer to acetaminophen beads and identify processing time, efficiency, solvent usage and dissolution results.
To develop a method for quickly and efficiently coating dry polymer onto beads using a rotor processor without the use of organic solvents.
To compare two methods for applying a sustained release polymer to acetaminophen beads and identify processing time, efficiency, solvent usage and dissolution results.
To evaluate the capability of a simple modification to an existing sampling port on a fluid bed dryer for monitoring moisture uptake and loss using effusivity sensor. The goal was to provide a method to profile a typical granulation and drying process in a fluid bed and to develop the criteria for end-point determination.
This study compared two processes used for the rapid production of high active content spherical beads: 1. Spherical Granulation without the use of a core particle, and 2. Dry Powder Layering, utilizing a core particle. Both approaches use a minimum of a simple binder solution to show the application efficiency, size uniformity, content uniformity and total process time to manufacture spherical beads suitable for coating for modified release.
To compare two processes, an established Wurster coating process for producing 100 – 300 micron Omeprazole coated beads and a Novel Rotor process for producing 100-300 micron Omeprazole coated beads to determine if advantages were present in either approach.
Traditional starch granulations require starch paste preparation which takes time and presents a hazard to the operator in terms of steam heating and the handling of the very hot liquids.
The development of a powder coating methodology including the utilization of a new type of fluidized bed apparatus is reported. Several different polymer systems were tried and
compared to solvent-based techniques using acetaminophen as a model drug. Process parameters are described and the performance of the polymer coating system relative to solvent based coating system is compared.
To evaluate the appropriateness of various PAT tools for characterizing particles at the beginning and end of a granulation/spheronization process.
Use of effusivity as a non-destructive method to determine the effects of compression forces on the thermal property changes in the products from two pharmaceutical compaction
processes.
