The Glatt’s R&D model, GPCG , for the pharmaceutical, chemical and food industry, has been introduced in India. GPCG PRO / PLUS. WST/G PRO / PLUS. Fluid bed systems. We set the standard. GPCG PRO. WSG PLUS. GPCG PLUS. WSG PRO. GRANULATING. COATING. GPCG 1. inch Wurster. 6 inch Wurster. 2 liter Granulator/Dryer/Coater. mm Rotor. 50 – g. – g. – g. – g. GPCG
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A full factorial design was applied to develop design space and determine control strategy for pantoprazole enteric coating process, have promising yield, assay and reduced process time.
Meurice Research and Development a.s.b.l.
In table 3, values of CPPs during lab scale and pilot scale are given. Updated risk assessment Following completion of process development studies, a greater understanding of the risks to product yield and assay associated with coating process been developed in DS which covered all validated range of process variables. Positive signs indicate an increase in the response value while negative signs demonstrate a decrease in the response value.
Scale up of pantoprazole enteric coated pellets After successful optimization trials, values of CPPs were finalized and covered in lab scale CS. Quality by design i: Pellet size was measured using sonic sifter sieving analysis. Analysis of particle coating by spouted bed process. Risk associated with process gcg and mitigated discussed in fig.
The dispersion had stirred for 30 min using mechanical stirrer Remi Elektrotechnik Ltd, India and strained through mesh screens. The correlation coefficients R 2 for all three responses indicated good fits to the raw data.
For assay, results were observed in the range of The comparative SEM images of enteric coated pellets of optimized process parameters run at lab and scale up presented in fig. Not only optimization of formulation variables performed in previous work required in this case but optimization of coating processes also the potential impact on pellets quality.
As in the lab scale, one has to follow sequential approach to set the parameter for the scale up. Response surface plots interpretation The results indicated that the fines Y 1 generation was significantly influenced by the linear models of spray rate X 2atomization air pressure X 3 and in small percentage of air volume X 1in addition to the interactive model of the quantity of spray rate-atomization air pressure X 2 X 3.
DS was determined from the common region of successful operating ranges for multiple CQAs discussed in table 2. Impact of process variables on dissolution in acidic condition already studies in preliminary trial and concluded variation in process parameters no affect on dissolution.
All the process variables again show their significance in scale up model also. She is passionate about her recent patent on developing Cannabinoids as a drug delivery system using lipid based systems as an alternative to growing opioid epidemic.
A design matrix comprising 10 experimental runs including 2 centre points was constructed.
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Photomicrographs of gold coated enteric coated pellets were obtained using a scanning electron microscope SEM; Phenom, Netherlands. The quadratic response surface gpcv CQAs as a function of selected variables was given in fig. Overall, the coating zone increases from lab to pilot scale. However, lower correlation coefficients were obtained for fines 0. Wurster column base area considered for theoretical factor calculation in scaling up activity.
Using a systematic approach to select critical process parameters. The aim of this work was to decide the ranges of CPPs involved in enteric coating process.
The particle size of vpcg granular pellets was measured to be within a size range of microns as shown in table 2. Maronga SJ, Wnukowski P. Coating of multiparticulates using molten materials: The amount of impact is not defined, which leads to the question, does even a small impact to a CQA mean that the parameter is critical?
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Process variables involved in Wurster based pellets coating process. S T P Pharm Sci ;9: In future, due to any reason process parameters need to change for commercial batches then based on DS it is possible without taking the prior approval supplement. Neha Chavan is a Formulation Scientist for Glatt Air Techniques, Pharmaceutical Services Division and has been a frequent speaker and presenter at pharmaceutical conferences. There are some scientific theoretical factors involved in scale up activity.
Performance improvement through proactive risk assessment: The hpcg of independent variables under study is shown in table 2 along with their low, medium, and high levels, which were selected based on the 1. from preliminary experimentation. As per the literature, there gppcg selected gpcb process parameters-product temperature , humidity , inlet air flow , atomization air pressure , spray rate [14,16], column height [11,] responsible for the product quality however others like nozzle tip diameter, filter bags type and drying time are also important based on practical experience.
Pharmaceutical quality by design: Hence, value of correlation coefficients found less than 0.
Atomization Air Pressure bar 0. Failure mode scores could range from 1 to .
Pareto chart showing RPN scores for the coating process parameters for pantoprazole enteric coated pellets before and after risk mitigation Therefore, variables ranked based on RPN value. Formulation and process considerations.
The pellets coating in the bottom spray is considered very critical process than other pelletization techniques because it involved number of process variables which are directly or indirectly affecting the product quality. The acceptable range of material attributes was determined basing on the knowledge space from screening design and DS, the detail information was explained in fig.