Dissertation Process Analytical Technology

Dissertation Process Analytical Technology-49
One of the objectives of this study was to perform a feasibility assessment regarding the development of a NIRS method for end-point determination of the coating process in real time.

One of the objectives of this study was to perform a feasibility assessment regarding the development of a NIRS method for end-point determination of the coating process in real time.

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Higher inlet air temperature has a positive correlation with particle size resulting in increased D50 values, while lower product temperatures yield larger granules.

Besides, a NIRS calibration model applying a fibre optic probe and diffuse reflection measuring mode was developed for in-line moisture monitoring during the granulation process.

Based on this knowledge, reasonable specifications for routine manufacturing can be selected and process windows or design spaces for single unit operations can be implemented.

Project B involves an active coating process of tablet cores in a drum coater, where tablets are layered by a film-coating liquid containing the Active Pharmaceutical Ingredient (API).

In conclusion, near infrared spectroscopy is found to be an appropriate tool for end-point determination of the active coating process, but further optimisation of the manufacturing process itself might be necessary for reducing variability in content uniformity of the film-coated tablets.

The benefit of applying NIRS as a PAT tool in active coating processes compared to conventional HPLC analysis is mainly related to saving of time because the bulk product can directly be processed further without delay between completion of a unit operation and sampling, analysis and release.Finally, in-line moisture monitoring by NIRS turned out to effectively support the scale-up activities to commercial scale.The added value of application of PAT during process development in this project did not save development time, but increased the required understanding of the (inter-) relationships between process parameters and attributes of the produced granulates.The calibration is built upon Partial Least Squares regression of NIR spectra and reference values generated by loss on drying on a halogen dryer.It is possible to predict the water content in the calibrated range with a precision comparable to the one of the reference method.Critical process parameters affecting content uniformity of the API in the final drug product were assessed by means of a Do E study.It was found that content uniformity could be improved by reducing the spray rate, reducing the solid content of the coating suspension by adding water or by increasing the rotation speed of the drum coater. We share our knowledge and peer-reveiwed research papers with libraries, scientific and engineering societies, and also work with corporate R&D departments and government entities. Available from: Next chapter By Vânia Maria Borges Cunha, Marcilene Paiva da Silva, Wanessa Almeida da Costa, Mozaniel Santana de Oliveira, Fernanda Wariss Figueiredo Bezerra, Anselmo Castro de Melo, Rafael Henrique Holanda Pinto, Nelio Teixeira Machado, Marilena Emmi Araujo and Raul Nunes de Carvalho Junior We are Intech Open, the world's leading publisher of Open Access books. Our readership spans scientists, professors, researchers, librarians, and students, as well as business professionals.In-line particle sizing provided insight into the dynamics of particle growth during different phases of fluid bed granulation process: wetting and nucleation, agglomeration and finally a steady-state phase, when agglomeration and attrition are at par.Furthermore, different technologies for particle sizing were compared.


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