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The aims of this study were to confirm the applicability of Ceolus™ in a continuous manufacturing system and to determine the optimum grade. A comparative study was conducted using the Granuformer® Gf-2050 continuous manufacturing system developed by the Freund Corporation.
The starting raw material powder is not soluble in water, so the following series of trials contributes to the development of a “Instantizing for Suspension” top spray granulation process to increase the flowability and suspension characteristics in a solution while using a variety of natural binding agents.
This trial contributes to the development of a novel coating process of very fine powders with diameters of around 30μm. The innovation lies in Freund-Vector’s patented wurster spray system that utilizes an outer sleeve placed around the wurster gun called the Wurster Accelerator. The accelerator creates an adjustable air curtain that diverts product away from the spray nozzle tip, optimizing product movement through the spray zone and reduces processing times.
A process analytical technology (PAT) method relying on near infrared (NIR) diffuse reflectance spectrometry was developed to determine the average coating thickness applied and the weight gained by tablets during coating process. The NIR device was installed inside the pan directly in contact with the cores under processing and relevant spectra were recorded in real time during the entire coat-ing process. The method required principal component analysis (PCA) and partial least squares regression (PLS). The primary methods to calibrate PLS are tablet weight gain and coating thickness, they were carried out using the chemometric methods. The PLS-model was employed as the calibration curve for an online process monitoring and was based on the spectra obtained from the tablets during coating, pretreated with SNV and first derivative, and ordered into one object. This way, the method developed could be advantageously used for in-line PAT monitoring. Additional characterization insights were attained by calibrating the spectra versus the weight gain data obtained from at-line tablet weighing. Overall, the possibility to monitor multiple parameters using just one device and one spectrum was demonstrated.
Wurster coating of multi-particulates with polymer suspensions and solutions is widespread in the pharmaceutical industry. Several formulations for polymer coatings of aqueous dispersions and organic solvent based polymers require glidants such as talc to be suspended into the solutions to cut down on tackiness.
The ability for a powder to be quickly dispersible is a common problem for consumer nutraceuticals and food products – especially in the areas of protein powders, sports drinks and nutritional supplements. Typically, non-processed powders will not be able to break the surface tension of the liquid (typically water), making the powder very difficult to mix without physical forcing the powder into the liquid (usually through vigorous mixing).
This trial contributes to the development of a novel coating process for fine particles with diameters of around 40μm. The innovation lies in the use of Freund-Vector’s patented Wurster spray system that utilizes an outer sleeve placed around the Wurster gun called the Wurster Accelerator. The accelerator creates an air curtain that diverts product away from the spray nozzle tip, optimizing product movement through the spray zone and reduces processing times. The system is suited for the coating of particles ranging from fine powders (~10 micron) up to small pellets (2-3 mm).
The purpose of these study was to develop and introduce several novel processing methods which can be done with the GRANUREX® conical rotor technology. These methods include spherical granulation, powder layering, and solution/suspension coating.
The introduction of spray drying technology into a pharmaceutical manufacturing business can provide new opportunities for product line expansion, business growth, and channels to increase revenue and profits. This can be from creation of new products that cannot be produced any other way. But it can also allow for line extensions of existing products and alternate drug product solutions for known API’s already offered in the market today.
Tablets and capsules dispensed to companion animals are given via a ‘poke down’ method or hidden in an attractive food. Ideally, the tablet or capsule would be voluntarily consumed from the pet owner’s hand or the pet’s bowl, which means veterinary pharmaceutical companies strive to develop products with high palatability.
The GRANUREX® technology offers great flexibility to produce immediate or modified release pellets, granules, or multi-particulates with high API loading with high efficiency and at significantly lower processing times. Based on current processing data available, the process technology is capable to achieve >500% w/w weight gain and product yields of > 95% with high bulk density.
In this case study, Recro Gainesville resolved these concerns by applying a different technology to create a high-drug-load, twice-daily dosage form much more efficiently than a spray coater could.