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Application of process analytical te...

Hausman-Manning, Debra Sue.

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Application of process analytical technology to pharmaceutical processes.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Application of process analytical technology to pharmaceutical processes./
作者:	Hausman-Manning, Debra Sue.
面頁冊數:	226 p.
附註:	Source: Dissertation Abstracts International, Volume: 66-03, Section: B, page: 1419.
Contained By:	Dissertation Abstracts International66-03B.
標題:	Health Sciences, Pharmacy. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3168763
ISBN:	0542053489

Application of process analytical technology to pharmaceutical processes.
Hausman-Manning, Debra Sue.

Application of process analytical technology to pharmaceutical processes. - 226 p.

Source: Dissertation Abstracts International, Volume: 66-03, Section: B, page: 1419.

Thesis (Ph.D.)--University of Cincinnati, 2005.

Process Analytical Technology (PAT) was utilized for on-line evaluation of drug hydration state and its effect on final product quality, as well as the effect of blending parameters on low dose blend and tablet uniformity.

ISBN: 0542053489Subjects--Topical Terms:

1017737
Health Sciences, Pharmacy.

Application of process analytical technology to pharmaceutical processes.
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500 $a Source: Dissertation Abstracts International, Volume: 66-03, Section: B, page: 1419.
500 $a Chair: Adel Sakr.
502 $a Thesis (Ph.D.)--University of Cincinnati, 2005.
520 $a Process Analytical Technology (PAT) was utilized for on-line evaluation of drug hydration state and its effect on final product quality, as well as the effect of blending parameters on low dose blend and tablet uniformity.
520 $a Experiments were conducted to elucidate the relationship between risedronate sodium (RS) hydration state and the physical stability of tablets containing RS. The RS crystal lattice contains channels occupied by water which is removed by drying processes at temperatures below the boiling point of water, causing a reversible contraction of the crystal lattice. In this study, RS was wet granulated followed by fluid bed drying and compression into tablets. During drying, RS solid-state form was continuously monitored using on-line Raman spectroscopy. It was determined that final granulation moisture had a significant effect on change in RS hydration state measured by Raman and on change in tablet thickness over time. In addition, change in RS hydration state during fluid bed drying, measured by on-line Raman, was correlated to the increase in tablet thickness and subsequent loss of tablet integrity. Evaluation of RS solid-state during drying with Raman enabled establishment of relationships between fundamental hydration dynamics associated with RS and final product performance attributes.
520 $a On-line Raman was also used to evaluate the effect of blending parameters on uniformity of a low dose, 1%, blend of azimilide dihydrochloride. Parameters investigated were blend time, blender speed, azimilide placement in the blender, filler particle size and density, multiple tablet components, and sampling. At the 8qt scale used, there was no effect of azimilide placement in the blender on time to reach uniformity. However, there was an effect of filler particle size/density and blender speed on time to reach uniformity. On-line Raman analysis of blend uniformity provided more information about the blending process as compared to traditional thief sampling and off-line analysis, due to the feasibility of large numbers of samples across the run (sampling every 20 seconds) and the availability of spectral information on all blend components. Raman measurements of blend uniformity from univariate and multivariate analyses were significantly correlated to HPLC blend thief sample and tablet sample results.
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