Advanced search
Publication Cover
Pharmaceutical Development and Technology Volume 11, 2006 - Issue 3
Submit an article Journal homepage
179
Views
17
CrossRef citations to date
0
Altmetric
Research Article

Evaluation of Risk and Benefit in the Implementation of Near-Infrared Spectroscopy for Monitoring of Lubricant Mixing

Arwa S. El Hagrasy Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
,
Shih-Ying Chang Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
&
San Kiang Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
Pages 303-312 | Received 29 Oct 2005, Accepted 17 Dec 2005, Published online: 07 Oct 2008

REFERENCES

  • 1. FDA. Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance. September 2004.
  • Wargo D.J., Drennen J.K. Near-infrared spectroscopic characterization of pharmaceutical powder blends. J. Pharm. Biomed. Anal 1996; 14: 1415–1423, [INFOTRIEVE], [CSA]
  • Sekulic S.S., Ward H.W., II, Brannegan D.R., Stanley E.D., Evans C.L., Sciavolino S.T., Hailey P.A., Aldridge P.K. On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. Anal. Chem 1996; 68: 509–513, [CSA], [CROSSREF]
  • El-Hagrasy A.S., Morris H.R., D'Amico F., Lodder R.A., Drennen J.K., III. Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J. Pharm. Sci 2001; 90(9)1298–1307, [INFOTRIEVE], [CSA], [CROSSREF]
  • Ufret C., Morris K. Modeling of powder blending using on-line near-infrared measurements. Drug Dev. Ind. Pharm 2001; 27(7)719–729, [INFOTRIEVE], [CSA], [CROSSREF]
  • Berntsson O., Danielsson L.-G., Langerholm B., Folestad S. Quantitative in-line monitoring of powder blending by near-infrared reflection spectroscopy. Powder Technol 2002; 123: 185–193, [CSA], [CROSSREF]
  • Popo M., Romero-Torres S., Conde C., Romañach R.J. Blend uniformity analysis using stream sampling and near infrared spectroscopy. AAPS Pharm. Sci. Tech 2002; 3(3)11, [CSA]
  • Lowery M., Ginsburg J., Flynn B., Baroff A., Garcia T., MacDonald B. An examination of dynamic and static near-infrared measurements of pharmaceutical blends. Near Infrared Spectroscopy, Proceedings of the International Conference. 1999
  • El-Hagrasy A.S., D'Amico F., Drennen J.K., III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation. J. Pharm. Sci 2006; 95(2)392–406, [INFOTRIEVE], [CSA], [CROSSREF]
  • El-Hagrasy A.S., Delgado-Lopez M., Drennen J.K., III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part II: Qualitative near-infrared models for prediction of blend homogeneity. J. Pharm. Sci 2006; 95(2)407–421, [INFOTRIEVE], [CSA], [CROSSREF]
  • El-Hagrasy A.S., Drennen J.K., III. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. J. Pharm. Sci 2006; 95(2)422–434, [INFOTRIEVE], [CSA], [CROSSREF]
  • Duong N.-H., Arratia P., Muzzio F., Lange A., Timmermans J., Reynolds S. A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in Bohle bin-blender. Drug Dev. Ind. Pharm 2003; 29(6)679–687, [INFOTRIEVE], [CSA], [CROSSREF]
  • Brone D., Alexander A., Muzzio F.J. Quantitative characterization of mixing of dry powders in V-blenders. AIChE J 1998; 44(2)271–278, [CSA], [CROSSREF]
  • Chowhan Z.T., Linn E.E. Mixing of pharmaceutical solids. I. Effect of particle size on mixing in cylindrical shear and V-shaped tumbling mixers. Powder Technol 1979; 24: 237–244, [CSA], [CROSSREF]
  • Wong L.W., Pilpel N. Effect of particle shape on the mixing of powders. J. Pharm. Pharmacol 1990; 42: 1–6, [INFOTRIEVE], [CSA]
  • Poux M., Fayolle P., Bertrand J., Bridoux D., Bousquet J. Powder mixing: Some practical rules applied to agitated systems. Powder Technol 1991; 68: 213–234, [CSA], [CROSSREF]
  • Rippie E.G. L. Lachman, H.A. Lieberman, J.L. KanigMixing. The Theory and Practice of Industrial Pharmacy, . Philadelphia, Lea & Febiger 1987; 3–20
  • Prescott J.K., Barnum R.A. On powder flowability. Pharm. Technol 2000; 24(10)60–84, [CSA]

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.