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This study aimed to prove that particle sizes could be measured accurately in line with roll compaction when compared to offline measurements and determining the resulting physical characteristics such as flowability and density.
The purpose of this study was to identify the critical process attributes needed to switch from a high shear wet granulation batch process to a twin-screw wet granulation continuous process.
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.
The evaluation of the tableting properties of granulates obtained by roller compaction (RC) of binary mixtures prepared with different contents of paracetamol fine powder and using different commercial types of mannitol
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 main purpose of this investigation was to demonstrate the use of an NIR filter photometer as an in-line process analytical tool to monitor and characterize absorbances for various events (binder addition, powder addition, equilibrium state, etc.) throughout the dry powder-layering process.
The main purpose of the present study was to continue the investigation using placebo blends and commonly used active pharmaceutical ingredients to further ascertain the suitability of the NIR filter photometer for the in-line measurement of moisture during rotor granulation.
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….
Evaluate different commercial grades of mannitol to be used in dry granulation by roller compaction (RC), for comparing the compactability of dry granules obtained.
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.
To follow the coating pan process by means of NIR technology and to determine the weight gain and the coating thickness of the coated tablets in real time.
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 develop and introduce several novel processing methods which can be done with conical rotor technology. These methods include spherical granulation, powder layering, and solution/suspension coating.
To develop a method to quickly and efficiently coating dry polymer onto beads using rotor processing without the use of organic solvents.
Challenges exist in developing a robust continuous twin screw granulation process. One of the past challenges encountered has been the formation of “noodle-like” granules at the end of the extruder.
Since most pharmaceutical ingredients (API) have low density and poor flowability, wet granulation is practiced extensively for ease of handling. Wet granulation can be achieved by means of high shear mixers, fluid beds and twin-screw granulators.
To follow the wurster coating process trend using NIR technology and to determine realtime the deviations from the correct process path.
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.