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Pharmaceutical quality by design: Successful scale-up of pellets coating process performed based on process optimization conducted at lab scale equipment. The independent variables selected were air volume X 1spray rate X 2 and atomization air pressure X 3. Optimization and characterization of controlled release pellets coated with an experimental latex: Linear scale-up from lab pgcg to pilot scale assumed that the occupancy was the same and the distribution plate in each piece of equipment is geometrically similar.

The pareto chart was plotted of process variables vs RPN. The agglomerates Y 2 formation was equally influenced by the linear models of spray rate X 2atomization air pressure X 3 and spray rate-atomization air pressure X 2 X 3.

The pellets coating in the bottom spray is ggpcg very critical process than other pelletization techniques because it involved number of process variables which are directly or indirectly affecting the product quality. As per the literature, there are selected gocg process parameters-product temperature [], humidity [9], 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.

Formulating extended release drug pellets using CPS tec

Process parameters for enteric coating of preliminary trials Process glcg Values Batch Size gm Air distribution plate B Wurster column height mm Nozzle tip diameter 1. Analysis of particle coating by spouted bed process. Glcg Quality Press; The response Y i in each trial was measured by carrying out a multiple factorial regression analysis using the quadratic model: Identification and characterization of factors controlling tablet coating uniformity in a Wurster hpcg process.


Trials were performed to understand behavior of process parameters on pellets quality. This study indicated that atomization air pressure governed the fines generations, as pressure increased, fines generation increased proportionately.

The reading displayed on the screen was noted as the LOD of the sample. SEM images of enteric coated pellets of-a F13, b F14, c F17 and d F19 The agglomerates Y 2 formation was equally influenced by the linear models of spray rate X 2atomization air pressure X 3 and spray rate-atomization air pressure X 2 X 3.

This is an open access article under the CC BY license http: Therefore, variables ranked based on RPN value. The process variables gpcy and gpc identification performed based on previous experience and literature before conducting the preliminary trials. 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.

Initial trials were performed by varying the process parameters to understand the impact on product quality. J Food Eng ; The desired spray rate was achieved in 1 h after start coating by slowly ramp up the pump rpm and after wards ran the process on constant spray rate.

The range of independent variables under study is shown in table 2 pgcg with their low, medium, and high levels, which were selected based on the results from preliminary experimentation. As in the lab scale, one has to follow sequential approach to set the parameter for the scale up. The QbD based enteric coating process development given promising output which used in scale up activity.

Spray rate, atomization air pressure, and air volume were the key coating process parameters.


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Her area of interest is developing novel pelletization techniques and coating applications for modified release of the pharmaceutical drug products for oral drug delivery. The RPN threshold below 60 ranked low risk, ranked gpxg risk and above 80 ranked high-risk process gpcgg.

Only the unknown factor will be the mass effect. 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.

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Experimental validation of DoE trials was undertaken by fabrication of optimized process variables. DS was determined from the common region of successful operating ranges for multiple CQAs discussed in table 2. The development of the product 11. normally done in 6″ Wurster with the batch size 0.

In scale up of pellets, physical and chemical parameters reproduced based on process ran as per scale up factor calculation.

From the lab to pilot although there is single spray nozzle, but the nozzle is much bigger and can permit higher spray rate. CFM value was scaled up.

The results table 4 showed that the percentage fines generation varied from 0. Successful pellet coating process optimization at lab level using small scale Wurster is half work done.

Int J Pharm ; The aim of this work was to optimize process variables for enteric 11. pellets processing. Qualitative description of the Wurster-based fluid-bed coating process. Nevertheless, once the effect of variables are studied and understood in lab model, it will make the analysis much easier. The variables come under each set provided in fig.