Following the FDA’s PAT (Process-Analytical-Technology) initiative in the early 2000s, numerous studies have been conducted utilizing full spectrum near infrared (NIR) sensing technology to monitor moisture in granulation and drying processes….
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.
To determine the endpoint for Top Spray Granulation using NIR technology. To establish the correlation between the Moisture Content (expressed as Loss on Drying), the Particle Size Distribution (PSD) 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.
Controlled release coatings of ethylcellulose were applied to drug loaded sugar spheres with three different processes: dry powder layering, aqueous Wurster coating and organic solvent based Wurster coating. Comparative analysis of the three processes showed that the dry powder layering process was able to apply the ethylcellulose coatings in a faster, more efficient process than the traditional spray coating systems and still achieve controlled release.
To compare the binding properties of spray dried maltodextrin versus agglomerated maltodextrin of three different dextrose equivalence (DE) in a model acetaminophen granulation system utilizing a top drive wet granulation process where the binder was added dry and cold water was used as the binding solution.
For many multi-particulate applications, the required particle size to achieve the proper drug load or to avoid poor mouth-feel has become very small, oftentimes in the 50-300 micron range. When these particles need to be taste masked, the amount of coating required can exceed 400% weight gain to properly taste mask the particles. Those high coating weight gains can lead to several processing problems, including extremely long processing times, agglomeration issues and large amounts of organic solvents. This study focused on an alternative method for taste masking small particles, utilizing a dry polymer coating technique.