A Comparison of Spherical Core Materials Used for Controlled Release Drug Layering Processes

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.

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Drying PAT Monitoring by NIR: Calibration vs PCA Trend Approach

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.

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Enteric Coating of Multi-Particulates with Dry Powder Application of Glidant Utilizing a Modified Wurster Spray Gun System

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.

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Evaluation of a Novel, High Solids, Film-Coating System for Temperature Sensitive Products

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.

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Novel Dry Powder Application of Anti-Tack Agent Utilizing a Modified Wurster Spray Gun System

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.

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Top Spray Granulation PAT Monitoring by NIR: Calibration vs. PCA Trend Approach

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.

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Controlled Release Coatings of Ethylcellulose on Drug Loaded Multiparticulates – A Comparison of a Novel Rotor Dry Powder Layering Process to a Traditional Wurster BottomSpray Coating Process

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.

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A Comparison of Spray Dried and Agglomerated Maltodextrins of Various Dextrose Equivalence as Binders in Top Drive Acetaminophen Granulations Using Cold Water as the Binding Solution

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.

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A Novel Dry Polymer Coating Technique as an Alternative for Taste Masking Small Multi-Particulate Dosage Forms in the 50-300 Micron Size Range

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.

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A Study on the Effects of Drug Loading Percentage on Content Uniformity in a Powder Layering Process

Dry powder layering of Active Pharmaceutical Ingredients (API) offers several advantages when the amount of drug loading is high, including fast processing times, high yield, high content uniformity and low agglomeration. The process is not often used in low-dose API loading, due to concern that content uniformity may be compromised in processes that may last under 10 minutes. This study focused on whether acceptable content uniformity could be achieved via dry powder layering at low coating levels.

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