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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Qualitative description of the Wurster-based fluid-bed coating process. The aim of this study was to investigate the influence of process parameters on the pellets quality using an experimental design and risk mitigation performed based on QbD principles for quality product.
Neha Chavan is a Formulation Scientist for Glatt Air Techniques, Pharmaceutical Services Division and has been a frequent speaker and presenter at pharmaceutical conferences.
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. A vital step of optimization is to achieve appropriate response functions for both dependencies and independences. Prior to optimization, historical data were analyzed and several gpccg DoE analyses were done.
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 overall coating zone will remain same in the pilot and commercial scale except the .11 of the Wurster column. In trial F13 and F14, high spray level and low atomization gpch pressure leads to the formation of more agglomerates. The process variables categorization and risk identification performed based on previous experience and literature before conducting the preliminary trials. Enteric coated pellets were placed onto a double-sided carbon tape mounted on studs and sputter-coated JFC, Jeol, Tokyo, Japan with gold.
Yield is an important quality attributes. Additionally, ratios of air volume to plate area and spray rate to air volume maintained. Failure mode and effect analysis: Hence, value of correlation coefficients found less than 0.
Air volume cfm 46 58 70 X 2: 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.
CPP selection has traditionally been difficult because of a lack of a systematic approach to the problem which due to a large number of unit operations and complexity. The desired spray rate was achieved in 1 h after start coating by 1.11 ramp up the pump rpm and after wards ran the process on constant spray rate.
The pellets were coated in Wurster and characterized for assay, dissolution, scanning electron microscopy and loss on drying. 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. Failure to identify critical parameters can result in unexplainable variation during batch processing and lot acceptance .
The response Y i in each gpc was measured by carrying out a multiple factorial regression analysis using the quadratic model:. Pharmaceutical quality by design: The comparative SEM images of enteric coated pellets of optimized process parameters run at lab and scale up presented in fig. Three-dimensional surface plot fig.
Using a systematic approach to select critical process parameters. Combined population balance and thermodynamic modeling of the batch top-spray fluidized bed coating process.
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The aim of this work was to decide the ranges of CPPs involved in enteric coating process. Atomization Air Pressure bar 0. The QbD based enteric coating process development given promising output which used in scale up activity. The results were reproduced during scale up and found 0. The multidimensional combination and interaction of independent variables and process parameters that have been 11 to provide assurance of quality is termed as the design space .
Hydroxypropyl cellulose HPC is used in the formulation as a matrix forming polymer, Microcrystalline Cellulose MCC as the diluent and the pellet former and Propranolol as the Model drug. Optimization and characterization of controlled release pellets coated with an experimental latex: Pellet size was measured using sonic sifter sieving analysis.
From RPN, a critical summary can be drawn up to highlight the areas where the action is mostly needed .
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Comparatively in other trials percentage of agglomerates formation was considerably less. This might be due to some spray dried coating material wet through filter bag and not considered in the calculation of percentage fines.
Quality Risk Management Q9. The resulting equation for all three responses Y 1 finesY 2 agglomerates and Y 3 assay are presented below: Process variables involved in Wurster based pellets coating process.
Dissolution studies were carried out in two stages. Experimental validation of design space The multidimensional combination and interaction of independent variables and process parameters that have been demonstrated to provide assurance of quality is termed as the design space . The RPN must be calculated for each cause of failure. The variables come under each set provided in fig. Linear scale-up from lab scale to pilot scale assumed that the occupancy was the same and the distribution plate in each piece of equipment is geometrically similar.
For chemical characterization, assay is the best test to conclude quality of coating, which is another CQA.