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The aim of this study was to optimize pantoprazole enteric coating process based on Quality by Design QbD principle and successful scale up. 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. The coating process variables studied were air volume X 1spray rate X 2 and atomization air pressure X 3versus percentage fines Y 1percentage agglomerates Y 2 and assay Y 3 as responses.
The pellets were coated in Wurster and characterized for assay, dissolution, scanning electron microscopy and loss on drying. When X 2 at low level and X 3 at high level, spray drying increased hence fines increased while X 2 at a high level and X 3 at a low level, agglomeration increased. The optimization performed to decide level of X 2 and X 3 for fines and agglomerated free process.
In scale up of pellets, physical and chemical parameters reproduced based on process ran as per scale up factor calculation. It was concluded that a promising pellets coating process was successfully designed using QbD approach and successfully scale upscale up possible based on complete optimization of process variables, understanding of risk associated with variables and implementation of scale-up factor calculation provided by the vendor.
This is an open access article under the CC BY license http: 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? It is not difficult to imagine the example of an extreme shift of a process parameter having a minor impact on a CQA, whether measurable or not .
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. Failure to identify critical parameters can result in unexplainable variation during batch processing and lot acceptance . 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.
As per the literature, there are selected potential 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.
The FMEA is the best risk management tool can used for Wurster based pellet coating process to categories the risk of process variables. The risk of each failure is prioritized based on the risk priority number RPN. RPN is a decision factor based on three ratings: These ratings are scaled with numbers between 1 and 10 . The RPN must be calculated for each cause of failure. RPN shows the relative likelihood of a failure mode, in that the higher number, the higher the failure mode.
From RPN, a critical summary can be drawn up to highlight the areas where the action is mostly needed . Risk priority numbers RPNs were calculated as the product of occurrence, severity and detectability scores. Failure mode scores could range from 1 to . We ranked S, O and D of as best-case value, as moderate-case value and as worst-case value, and then a maximum RPN of and a minimum RPN of 1 are possible.
In this study pantoprazole enteric coated pellets used to prepare oro dispersible multiunit particulate system MUPS tablet of pantoprazole where enteric coating was a functional coating which decided the acid resistance capacity of pellets. 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.
Successful pellet coating process optimization at lab level using small scale Wurster is half work done.
Successful scale-up of Wurster based coating process at commercial scale is a challenging task. Nowadays USFDA also demanding for a scientific approach for scale activity based on development batches. The development of the product is normally done in 6″ Wurster with the batch size 0. The recommended pilot model is 18″ Wurster where the Wurster column and base plate are much larger. From the lab to pilot although there is single spray nozzle, but the nozzle is much bigger and can permit higher spray rate.
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The batch depth and mass flow density increases. Overall, the coating zone increases from lab to pilot scale. The overall coating zone will remain same in the pilot and commercial scale except the height of the Wurster column. Therefore, the base area of Wurster column plays important role in efficient coating.
All process parameters should be proportional to the base area of Wurster column compared with lab model column. All the process variables again show their significance in scale up model also.
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Nevertheless, once the effect of variables are studied and understood in lab model, it will make the analysis much easier. Just like the variables remaining same in pilot scale also, the same process control will apply. Only the unknown factor will be the mass effect. As in the lab scale, one has to follow sequential approach to set the parameter for the scale up. 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.
Successful scale-up of pellets coating process performed based on process optimization conducted at lab scale equipment. Here attempt to help the industry to plan scale up activity in linear as the demand of regulatory authority to prove extrapolation of design space in commercial scale or in post-approval changes stage.
Pantoprazole sodium sesquihydrate was gifted from Hetero drugs. The dispersion had stirred for 30 min using mechanical stirrer Remi Elektrotechnik Ltd, India and strained through mesh screens. The variables come under each set provided in fig. The process variables categorization and risk identification performed based on previous experience and literature before conducting the preliminary trials. Initial trials were performed by varying the process parameters to understand the impact on product quality.
We varied the levels of all process parameters mentioned in table 1 and concluded the selected critical process parameters CPPs which needs systemic optimization plan to reduce the risk. Process variables involved in Wurster based pellets coating process. Process parameters for enteric coating of preliminary trials. Dissolution studies were carried out in two stages. Dissolution in acidic condition, i. Enteric coated pellets were placed onto a double-sided carbon tape mounted on studs and sputter-coated JFC, Jeol, Tokyo, Japan with gold.
Photomicrographs of gold coated enteric coated pellets were obtained using a scanning electron microscope SEM; Phenom, Netherlands. Accurately weighed pellets 1. The reading displayed on the screen was noted as the LOD of the sample. Initial risk assessment performed using FMEA tool. The pareto chart was plotted of process variables vs RPN. The initial risk assessment of the enteric coating process presented in fig.
Process variables that could potentially impacted enteric coating process were identified and their associated risk was evaluated based on preliminary trials. Conducting design of experiments DoE to evaluate all the variables involved in a Wurster coating process is not feasible. 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. The RPN threshold below 60 ranked low risk, ranked medium risk and above 80 ranked high-risk process variables. The variables ranked as high risk i. Air volume, spray rate and atomization air pressure, and were evaluated by conducting DoE studies to gain process understanding and remaining kept constant. The aim of this work was to decide the ranges of CPPs involved in enteric coating process. Yield is an important quality attributes.
In pellet formulation, yield is reduced either due to fine generation or agglomerates formed. For chemical characterization, assay is the best test to conclude quality of coating, which is another CQA.
Impact of process variables on dissolution in acidic condition already studies in preliminary trial and concluded variation in process parameters no affect on dissolution. Prior to optimization, historical data were analyzed and several screening DoE analyses were done. A 2 3 full factorial design with two center points was performed to screen the effect of process parameters on yield and assay to explore the quadratic response surfaces and for constructing a second-order polynomial models using Design Expert Version 8.
A design matrix comprising 10 experimental runs including 2 centre points was constructed. The response Y i in each trial was measured by carrying out a multiple factorial regression analysis using the quadratic model:. Where Y i is the dependent variable; b 0 is the arithmetic mean response of all trials; and b i is the estimated coefficient for factor X i.
The main effects, X 1X 2and X 3represent the average value of changing factor one at a time; X 1 X 2X 1 X 3and X 2 X 3 represent the interaction terms and the polynomial terms X 1 2X 2 2 and X 3 2 are used to assess nonlinearity . The independent variables selected were air volume X 1spray rate X 2 and atomization air pressure X 3.
The range of independent variables under study is shown in table 2 along with their low, medium, and high levels, which were selected based on the results from preliminary experimentation.
DS was determined from the common region of successful operating ranges for multiple CQAs discussed in table 2. It is expected that operation within the DS space will result in a product possessing the desired CQAs. Optimized process variables s et al. A control strategy CS is designed to ensure that a product of required quality will be produced consistently . The acceptable range of material attributes was determined based on DS.
LOD of enteric coated pellets was targeted less than 1. In scale up of pellets, CPP needs to frame based on linearity function of both i.
Bottom spray fluidized bed processor Wurster technology supplier always designs all capacity equipment in linear scale which help to make scale up activity easy. There are some scientific theoretical factors involved in scale up activity.
Formulating extended release drug pellets using CPS tec
So out off whole coating assembly, Wurster gpgc is a functional area for quality coating. Wurster column base area considered for theoretical factor calculation in scaling up activity. In table 3, values of CPPs during lab scale and pilot scale are given.
Trials were performed to understand behavior of process parameters on pellets quality. Air volume below 45 cfm, pellets didn’t fluidize properly and above 70 cfm pellets impacting on the filter wall and less time spend in Wurster column.
Spray rate, atomization air pressure, and air volume were the key coating process parameters. These parameters were considered as process variables for DoE study.