The deployment of oral multiunit pellet formulation has gained significant attention in recent years conferring to numerous applications, especially in achieving modified release and acid resistance property. Glatt wurster hs coating process in a fluidized bed terry flowers. When coating using a solution or a suspension, the liquid serves to transport the solids to the surface of the particles. The pept results, such as the particle velocity, the cycle time distribution. The model 3200 wurster unit is equipped with a 32 fluidization plate and 3 proprietary nozzles for coating capabilities with the ability to make 75 to 300 kg batches. Wurster fluid bed coating coating place specialty chemical. Tablets made of microcrystalline cellulose are coated with hydroxypropyl cellulose polymer and advantia prime polymeric mixture film in labscale fluidbed environment with a wurster tube. The entire coating process is conduc mechanically operated acorn galvanized iron stainless steel or copper. Jan 31, 20 this video gives an indepth explanation on the glatt wurster hs process. The process parameters are inlet air temperature 3540c eudragit. The wurster coating process can be applied to a range of core materials in numerous particle sizes and shapes.
Nowadays usfda also demanding for a scientific approach for scale activity based on development batches. This is the technique in which fluid bed system utilizes rotating disk to add centrifugal force to the forces of fluidization and gravity and offers very rapid mixing. An improved wurster coater in which conditioned fluidizing gas, drawn through a coating chamber bowl from a plenum by a vacuum fan, is directed through a perforated gas distribution plate through one or more wurster tubes. On the optimization of the fluidized bed particulate. Vectors tapered wurster capacity without negatively of the process. The ecoat process can be divided into these four distinct zones. The wurster process can use a wide variety of coating materials permitting great flexibility in product design. The wurster process is used commercially for particles coating from less than 100 m to tablets. Sugar coating was one of the earliest methods, and the process is still widely used in the confectionery industry. Because of opportunities in generic business in indian pharma industry. Coating process is widely used in many diverse industries. The wurster containers available in the size that 100500g to 800 kg batch size can run. Nov 20, 2017 this animation shows the wurster coating process within a fluid bed. The wurster process has been used for years to coat.
Spray nozzle for film coating of tablets aqueous or organic. Part of the expertise in pharmaceutical process technology series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference this book covers the theoretical concepts involved in fluidization, also providing a description of. All process parameters should be proportional to the base area of wurster column compared with lab model column. International congress of chemical and process engineering chisa 2012. Wurster process figure 2a features a columnar coating chamber which is divided into two zones namely the. However, the wurster coater has been associated with problems of pellet agglomeration during the coating process. Glatt wurster hs coating process in a fluidized bed youtube. Coating these small particles using aqueous dispersions of acrylic polymers eudragit rsrl 30 d and. Abstract different aspects that influence the fluidized bed particulate coating process have been investigated. Schematic illustration of wurster fluidised bed coating process and powdered glidant addition suspension of microparticles in an easytoswallow liquid is one approach to develop sustainedrelease formulations for children and patients with swallowing difficulties. The bottomspray wurster fluidbed method is very popular in the pharmaceutical industry for active layering and for coating to modify or control drug release because it produces a superior film compared with other coating techniques. Bottom spray process is the most commonly used fluid bed process for coating in pharmaceutical industry. Process validation is applicable to the manufacture of pharmaceutical dosage forms.
However, there are significant differences between the two types of fluidbed coatings. Droplet impact phenomena in fluidized bed coating process. Our extensive experience allows us to guarantee efficient and effective manufacturing processes, creating optimal and high quality services for our customers. Particle motion, coating and drying in wurster fluidized beds. As well known there are many types of fluidized bed coaters most preferrably called as fluidizedbed spraycoating fbsc among european academics. Coating is an effective way of masking the taste or odor of a particular drug to make a palatable product. The process can easily be converted by exchanging the process insert for a bottom spray wurster coating process to coat dried pellets. Pdf paniculate coating process in a fluidized bed involves different sub processes including particle wetting, spreading and also. Production size wurster coaters with multiple coating partitions have two very critical process challenges to overcome. The wursterbased fluidbed coating process is often treated as just another fluidbed coating process. It employs a cylindrical chamber in which tablets are suspended by air and a coating solu. This study investigated an innovative concept in coating mps particle sizes.
The wurster coating process relies upon a continuous conditioned gas stream which moves the product such as powders, granules, seeds, beads, pellets or tablets past one or more spray nozzles for purposes of coating, layering, and ultimately drying the finished product. Sep 21, 2012 pellet coating is traditionally carried out using the wurster coater, a bottomspray fluid bed coater 1,3. Coating can take place as top spray, tangential spray, bottom spray wurster process or rotor process, depending from which direction the particles are being sprayed. Differential air streams move the bed of particulate upward inside the chamber as it is coated with a material to create a coreshell structure. Wurster based coating process involved air volu me, product temperature, spray r ate and atomization air pressure are th e high risk process variables whic h. Additionally, it shows the key technical elements glatt wurster hs coating process in a fluidized bed on vimeo. Continuous pellet coating in a wurster fluidized bed process. This allows several layers of the film to form, creating a homogeneous, stable coating around the separated particle. The granulating solution is applied at a rate less than or equal to its evaporation rate. The objective of this work was to study the coating process of nifedipine extended release pellets using opadry and opadry ii, in a fluid bed coater with a wurster insert. The variables studied were the inlet air temperature and the coating suspension flow rate.
In conclusion, the wursterbased coating process is a highly complex process, and sufficient attention should be directed toward optimization of the process. The films may be applied using waterbased solutions, aqueous dispersions, or organic solvents. In a wurster type fluidized bed apparatus for applying a coating liquid to a particulate feed material which comprises a distribution of particle sizes including larger particles, smaller particles and fines, said apparatus including a container, a distribution plate, at least one wurster tube spaced above said distribution plate and defining a central upbed region and a surrounding. Hatsoff to him for conceiving this method at a time when neither coating process nor fluidized bed drier was a routine item. Coating of particles is an important unit operation in the pharmaceutical industry. An airatomizing nozzle in the center of the distribution plate introduces the coating solution. Choose from a wide variety of coating materials including pure metals, metallic alloys, metallic blends, carbides and selffluxing materials, tailored to gas or liquid fuel systems. Application of failure mode effect analysis in wurster. The fluidized bed coating, specifically wurster technique is commercially utilized for pellet manufacturing, which is a complex process involving too many variables. Development, optimization, and scaleup of process parameters. Wurster coating fluid bed nozzle from spraying systems co. Thus, the particles remain dry through the entire process. Extended or modified release formulations are becoming more and more common within the pharmaceutical industry due to their advantages for patient compliance and efficacy. Glatt air techniques the wurster hs processing insert, patented by glatt in 1992, provides significant improvements over conventional wurster coating technologies through increased productivity, high spray rates, increased yields and applications with fine particles.
Dale wurster in 1950 and hence it was commonly known as wurster process. The process works on the principal of opposites attract. The fluidbed process often is used for coating and powdered layering pelletizing applications. In order to determine favorable process conditions concentration, wurster tube position. Wurster coating, synonymous with fluid bed microencapsulation, is the encapsulation of discrete particles in a fluidized bed using bottom spray application. Mechanism of wurster coating process the wurster process widely use in the pharmaceutical industry powder coating and pellets coating. Maronga s on the optimization of the fluidized bed particulate coating process 1998. Wurster coating job work, wurster coating machine manufacturers. Diverting the particles around the spray nozzle allows for a much faster spray rate to be achieved, lowering process times and decreasing the attrition normally found in longer wurster coating processes. Our largest model wurster unit, the model 4600, is fitted with 7 proprietary nozzles and a 46 fluidization plate for batches of 150 to 800 kg. Largerscale batches must be monitored carefully, as any mistake could result in costly product waste.
Oct 20, 2008 the wurster based fluidbed coating process is often treated as just another fluidbed coating process. In order to determine favorable process conditions concentration, wurster tube position, inlet air. Fluid bed precision coater coating process technique. These methods can all be performed in a single, modern fluidized bed system. Systems have been developed for use with a variety of coating formulations, including aqueousorganic solvents, hot saturated solutions and hot melts. The process done in the gxr35 rotor was completed in 6 hours and re.
The perforated gas distribution plate defines three concentric gas flow zones. Nov 11, 2019 this study investigated an innovative concept in coating mps particle sizes. The modcos dryer in the new multilab or the gpcg 10 series fluidized bed can be used for continuous drying downstream of the process. Numerical simulation of twophase flow in a wurster coating. Fluid bed wurster hs coating systems from glatt air techniques source. Dry coating is the technique of making a tablet within a tablet. The aim of this study is to determine favorable process conditions for the coating of placebo tablets. Fluid bed wurster hs coating systems from glatt air techniques. The injected air causes the fluid to evaporate and dries the layer of film. First a basic understanding of pellet motion in a wurster fluidized bed was established by conducting a series of experiments using the positron emission particle tracking pept technique. Pdf fluidization control in the wurster coating process.
Fluidized bed coating glatt integrated process solutions. First a basic understanding of pellet motion in a wurster fluidized bed was established by conducting a series of experiments using the. So out off whole coating assembly, wurster column is a functional area for quality coating. Coating process operation used to either modify colour, give protection, for taste masking or to create a modified release form in pharmaceutical production. This is the technique in which fluid bed system utilizes rotating disk to add. The nozzle sprays upward providing concurrent application of coating to the particles.
The wurster process is used commercially for coating and layering. User requirement specifications are the basic document that covers all the needs of the manufacturing department. Film coating of nifedipine extended release pellets in a. Click the link to view an interactive pdf with the following data for 53992 topspray granulating lance. In a wurstertype fluidized bed apparatus for applying a coating liquid to a particulate feed material which comprises a distribution of particle sizes including larger particles, smaller particles and fines, said apparatus including a container, a distribution plate, at least one wurster tube spaced above said distribution plate and defining a central upbed region and a surrounding. The basic concept in wurster coating is to separate the. It employs a cylindrical chamber in which tablets are suspended by air and a coating solution is introduced into the air stream. The process is flexible enough to coat small particles for use in capsules and tablets, as well as coating the full capsules and tablets. But the principle means of applying a coating to pharmaceutical and. As the particles travel upward, excess moisture is evaporated and removed from the process.
Wurster processing markets coating place specialty. Department of chemical engineering and technology, royal institute of technology, stockholm, sweden. The change over from top spray to bottom spray is achieved without tools and is completed in minutes. Wurster fluid bed contract manufacturing services are the foundation of coating place business. Process data the entire wurster process took approximately 12 hours to complete and resulted in a large dosage form due to the use of a sugar starch core. Validation of pharmaceutical process equipment involves the following four sequential phases 7. Pellets, coating nonuniformity, electrostatic charging, process parameters, wurster, bottom spray fluid bed. On the optimization of the fluidized bed particulate coating process. Substrates include particles smaller than 100 microns, crystals, granules, pellets, and tablets. Fluid bed processing fluid bed granulation and wurster coating in dry stage granulation, the particles only require a slight wetting to become tacky and stick to each other. Study of scale up parameters of fluidized bed coating imedpub.
The coating process was studied using a complete experimental design of two factors at two levels for each polymer. Pilot scale equipment is available at glatts ramsey new jersey process development laboratory for testing and customer inspection. The wurster process coating place specialty chemical. The picture shown at left is a 32 inch tapered wurster accelerator insert, which has a 570l capacity the straight. The original wurster technology source coating place, inc.
Whitepaper automated control strategy for wurster coating. The wursterbased coating process does not contain any fluidbed regions in the traditional sense, as it is a circulating fluidbed process. The wurster process widely use in the pharmaceutical industry powder coating and pellets coating. The coating trials were performed using 100 g starting cores in a. Phenomena involved in the process of coating fluidised solid. Profiles in optimizing the size of fluidized bed in a coating process.
The coating materials atomisation within the fluidised bed is generally carried out using the bottom spray process wurster method. Innovations in pharmacy and pharmaceutical technology. Qualitative description of the wursterbased fluidbed. Click here to download the fluid bed wurster hs coating system brochure in pdf format. The basic concept in a wurster coater or air suspension coater, which can be classed as a precision coater is to. Wurster coating, synonymous with fluid bed microencapsulation, is the encapsulation of discrete particles in a fluidized bed using differential air flow to create a cyclic movement of material.
Coating place has been in the wurster coating industry since its founding in 1976 with the original wurster patent and prototype equipment from dr. The wurster based coating process does not contain any fluidbed regions in the traditional sense, as it is a circulating fluidbed process. The wurster based fluidbed coating process is often treated as just another fluidbed coating process. The wurster process is recognized as the technology for precision application of a film coating onto particulate materials such as powders, crystals, or granules, and other solid ingredients with diameters ranging from 30 m to several centimeters. Wurster definition of wurster by medical dictionary. How to optimize fluid bed processing technology 1st edition. Scale up factors in fluid bed processing wurster coating a. Numerical simulation of twophase flow in a wurster. Pretreatment electro coat bath and ancillary equipment post rinses bake oven. An automated control strategy for wurster coating to reduce dissolution variability due to raw material variations. This video gives an indepth explanation on the glatt wurster hs process. The smaller pans are used for experimental, developmental, and pilot plant operations, the larger pans for industrial production.
Jun 10, 2015 as well known there are many types of fluidized bed coaters most preferrably called as fluidizedbed spray coating fbsc among european academics. Us7147717b2 wurster fluid bed coater with agglomeration. Nonuniformity of pellets coating, effect on the dose release. Glatt wurster hs coating process in a fluidized bed on vimeo.
A twophase cfd simulation regarding the wurster coating process that focuses on moisture distribution was recently published by karlsson et al. A screening of seven key variables in a wurster coating process was evaluated by doptimal design and by analysis of variance. A feasibility study on pellet coating using a highspeed. In the case study below, improvements of spray rate up to 600% were achieved when using the wurster accelerator coating system. The finished tablets had an average acid resistance of 7788% of label claim. The wurster process fluid bed coating is widely used and has become a primary method for the microencapsulating of particles. There are numerous applications of coating, including drug layering, modified release coating, physical and chemical protection, aesthetic purposes, taste masking, and enhanced identification of drugs applications of particle coating. Wurster processes equipped with the accelerator system. This process is also known as electro deposition ed. Qualitative description of the wursterbased fluidbed coating process. Additionally, it shows the key technical elements that are required to perform homogeneous coating results.