Rapid CommunicationsReal-Time Monitoring of Thermodynamic Microenvironment in a Pan Coater
Section snippets
INTRODUCTION
Film coating of tablets is a frequently used unit operation in the pharmaceutical industry. The coating applied can either be nonfunctional (aesthetic) or functional (controlled-release or active coating, etc.) and is performed either in a pan or a fluid-bed coater.1 In pan coating, a batch of tablets gets sprayed on with an atomized coating suspension over a period of time as hot air passes through a cascading layer of tablets. The process parameters of most interest include pan load, pan
MATERIAL AND METHODS
Placebo formulation consisting mainly of microcrystalline cellulose (FMC Company,Philadelphia, Pennsylvania), lactose anhydrous (Kerry Bio-Sciences, Norwich, New Jersey), croscarmellose sodium (FMC Company), and magnesium stearate (Mallinckrodt Chemicals, Saint Louis, Missouri) was compressed into debossed oval-shaped tablets at a target press weight of 200 mg. The formulation of the core tablets consisted of a relatively high amount of magnesium stearate (1.25%, w/w). The tablets were coated
RESULTS
Typical temperature (T) and RH data set obtained from PyroButtons are shown for run #1 in Figures 2 and 3, respectively. The exhaust PyroButton (Opulus) data shown in Figure 2 confirm the exhaust temperature of 44°C. The two freely moving PyroButtons show comparable data to each other, demonstrating good repeatability of the measurement. The data for freely moving PyroButtons show more fluctuations (both T and RH) than the fixed PyroButtons due to their dynamic motion and varying location
CONCLUSIONS
This study demonstrated the utility of PyroButtons in providing a detailed thermodynamic picture of the coating process. It was shown that same exhaust temperature, the most commonly controlled and monitored parameter during coating process, can be attained under different conditions of the tablet bed. This difference in tablet-bed thermodynamic conditions can then result in a different final product quality (visual appearance in this case). The tablet-bed RH was found to be a more sensitive
ACKNOWLEDGEMENTS
The authors would like to thank Elena Zour from Bristol-Myers Squibb and Bela Jancsik from Opulus® for their help and support during this work.
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Cross-linking of poly (vinyl alcohol) films under acidic and thermal stress
2020, European Journal of Pharmaceutical SciencesCitation Excerpt :The “wet” coating conditions is a coating process where a higher concentration (1.5 x dry condition) of the suspension is sprayed at a faster rate to shorten processing cycle time. In this process, the tablets are exposed to higher humidity as compared to the “dry” process (Pandey and Bindra, 2013; Pandey et al., 2014). The higher humidity lead to higher moisture content of the coat which increases the polymer chain mobility as shown by the ssNMR study leading to higher initial ether bond formation for the “wet” process films.
Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules
2016, European Journal of Pharmaceutics and BiopharmaceuticsScale Up of Pan Coating Process Using Quality by Design Principles
2015, Journal of Pharmaceutical SciencesCitation Excerpt :However, monitoring exhaust air temperature does help in determining whether any of the process parameters may have changed or shifted during coating run. The same understanding applies to exhaust air humidity as well, which is a parameter that is not traditionally monitored or recorded, but has gained attention in recent studies.32 Even though exhaust air temperature is an important parameter that must be well-understood and closely monitored during a coating run, it is straightforward from a scale-up perspective as the exhaust air temperature is maintained constant across scales.
Controlling the chemical stability of a moisture-sensitive drug product through monitoring and identification of coating process microenvironment
2014, International Journal of PharmaceuticsCitation Excerpt :In the case of stability results from the 15 in coater experiments, the model predictions were compared to the experimental data. Recent studies by Pandey and co-workers (Pandey and Bindra, 2013; Pandey et al., 2014a; Zacour et al., 2014) have demonstrated the utility of PyroButtons® data loggers in collecting “real-time” T and RH data and providing useful thermodynamic information of the microenvironment experienced by the tablets during the coating process. In this study, the typical temperature and RH profiles recorded by the PyroButtons® moving among the tablets for the three coatings runs in 15 in coater are shown in Figs. 2 and 3.
A commentary on scale-up of pan coating process using microenvironmental control
2014, Journal of Pharmaceutical SciencesCitation Excerpt :Clearly, there is incomplete characterization of the process thermodynamics, even at the macroscopic level. Inadequate control of the inlet air %RH has been shown to have a negative effect on the quality of the coated product, with logo bridging tablet defect observed at a high inlet air %RH.5 An approach for scaling up the coating process that is most routinely used is to utilize established scale‐up rules on individual process parameters.6-9
Excipient-process interactions and their impact on tablet compaction and film coating
2014, Journal of Pharmaceutical SciencesCitation Excerpt :Coating process conditions were kept constant across all batches and were monitored using PyroButton® data loggers (Opulus, Philadelphia, PA). Information on PyroButtons and their relevance to the coating process measurements in terms of logo bridging tablet defects has been established by the authors in other publications.18-20 Trial experiments were conducted to estimate the coating conditions required to achieve a wide range of logo bridging responses across the 12 batches.