Dissertation Process Analytical Technology

Dissertation Process Analytical Technology-82
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.An appropriate at-line measurement procedure and a NIR calibration model were established for determination of the actual API content.

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.An appropriate at-line measurement procedure and a NIR calibration model were established for determination of the actual API content.

The effect of varying process parameters on resulting granulate particle size was systematically investigated by means of a Design of Experiments (Do E) study, performed as several fractional factorial designs.

The developed statistical model obtained from this study could accurately predict the median granulate size (D50) in dependence on the process parameters inlet air temperature and product temperature in the investigated ranges.

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.

Two distinct models were developed: one focusing on measurements of individual tablets and one using a rotating sample cup as a measuring device, which allows the simultaneous measurement of a larger surface area of several tablets.

Principal Component Analysis proves the specificity of both final models for the API.

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 addition, the candidate will present findings at conferences, in scientific publications, and enable industry-wide adaptation of technological advances.

IMA Active and VIAVI Solutions have the pleasure of inviting you to the symposium “PAT and Qb D in the solid dosage manufacturing: NIR integration from an engineering perspective”. (Founder at Optimal) Martin graduated in engineering with an honours degree from the University of Bath in the late 1970’s, when still we wrote with quill pens and electricity was a new novelty.

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