The Wurster Pro provided two major advantages over the standard Wurster process. It allowed the anti tacking agent, talc, to be removed from the coating solution and added in a powder form. It also permitted processing at an increased spray rate and thus, reduced the overall processing time. The Wurster Pro process was scalable and highly reproducible.
NIR spectroscopy provided significant advantages over offline moisture measurement in terms of time required for sample analysis without a drop off in accuracy. This allows real time moisture data to be taken throughout the entire batch without the need for sampling the product and allowing for quicker responses to process upsets than would otherwise be possible with traditional offline moisture measurements.
A new pharmaceutical water dispersible coating product has been formulated, which is useful for low temperature processes. Trials have been held at laboratory and production scale in order to assess equivalent finished coated product. During the coating process, the tablet bed temperature was maintained at temperatures lower than 30oC…
The issue with Mesalazine is that’s its mostly supplied as very fine powder with extremely poor flowability, and wet granulation is most often used to meet the challenge. However, Mesalazine is prone to degradation by several pathways (e.g. oxidation to oxidation and forms quinoneimine), especially if brought into contact with water.
Three different spherical core materials for use in API layering processes; sugar/starch spheres, microcrystalline cellulose (MCC) spheres and novel maltodextrin/starch (M/S)
spheres were coated with 40% Acetaminophen in a dry powder layering process. The three core materials were evaluated both before and after the drug layering for sphericity, aspect ratio, particle size distribution and friability. The novel maltodextrin/starch spheres either equaled or out-performed the more established sugar/starch and MCC spheres in each category.
To determine the endpoint for drying using NIR technology. To establish the correlation between the Moisture Content of the mixture and the response of the NIR device. To find a mathematical and statistical approach to the in-process control using derivative method, PCA calculation and trend approach.
Bottom Spray Wurster technology is commonly used in the pharmaceutical industry as a method for applying active and functional coatings, including sustained release and enteric polymer coatings, to multi-particulate substrates. Typically aqueous dispersion of polymers are diluted and are mixed with appropriate glidant, such as talc, to reduce blocking and agglomeration during the drying of the polymer solution on the surface of the multi-particulate. These solutions and suspensions are applied via air atomizing spray guns. The need to dilute the solution can increase the application time needed for proper drug release or enteric protection.
Processing heat sensitive products below body temperatures with aqueous based coating solutions is challenging. HPMC or PVA based coating formulations typically require film forming temperatures above 40°C. The goal of this study was to evaluate the coating quality of a modified, starch based polymer utilizing various solids percentages at process bed temperatures lower than 35°C for different tablet compositions and batch loads.
Bottom Spray Wurster technology is commonly used as a method for applying functional coatings to multi-particulate substrates. Typically, antitack agents are added to dilute solutions or suspensions of polymer to reduce blocking during the drying of the polymer coat. Having to add antitack agents to the solution can create sedimentation and plugging in the solution lines. This study focuses on the scaling ability of a modified Wurster gun process to efficiently coat multi-particulate cores utilizing a polymer solution without anti-tack agents in solution, but with the anti-tack agents added via dry powder application through the modified Wurster spray gun.