Advanced search
Publication Cover
Drug Development and Industrial Pharmacy Volume 27, 2001 - Issue 4
Submit an article Journal homepage
492
Views
18
CrossRef citations to date
0
Altmetric
Research Article

The Development of a Blend-Sampling Technique to Assess the Uniformity of a Powder Mixture

Thomas P. Garcia
,
Simon J. Wilkinson Glaxo Wellcome Limited, New Product Introduction—Pharmaceutical Technology, Temple Hill, Dartford, Kent, DA15AH, UK
&
Jerry F. Scott Glaxo Wellcome Limited, New Product Introduction—Pharmaceutical Technology, Temple Hill, Dartford, Kent, DA15AH, UK
Pages 297-307 | Published online: 30 Apr 2001

REFERENCES

  • Berman J., Planchard J. A. Blend uniformity and unit dose sampling. Drug Dev. Ind. Pharm. 1995; 21(11)1257–1283
  • Harwood C. F., Walanski K. A. Monitoring the mixing of powders. ACS Div. Org. Coatings Plastic Chem. 1973; 33(2)508–515
  • Schofield C. The definition and assessment of mixture quality in mixtures of particulate solids. Powder Technol. 1976; 15: 169–180
  • Muzzio F., Robinson P., Wightman C., Brone D. Sampling practices in powder blending. Int. J. Pharm. 1997; 155: 153–178
  • Lantz R. L., Jr., Schwartz J. B. Pharmaceutical Dosage Forms—Tablets, H. A. Liebermann, L. Lachman, J. B. Schwartz. 2nd Ed., Marcel Dekker, New York 1989; 2: 27–32
  • Harwood C. F., Ripley T. Errors associated with the thief probe for bulk powder sampling. J. Powder Bulk Solids Technol. 1977; 11: 20–29
  • Berman J., Schoeneman A., Shelton J. T. Unit dose sampling—a tale of two thieves. Drug Dev. Ind. Pharm. 1996; 22(11)1121–1132
  • Garcia T., Elsheimer B., Tarczynski F. Examination of components of variance for a production scale, low dose powder blend and resulting tablets. Drug Dev. Ind. Pharm. 1995; 21(18)2035–2045
  • Garcia T., Taylor M., Pande G. Comparison of the performance of two sample thieves for the determination of the content uniformity of a powder blend. Pharm. Dev. Technol. 1998; 3(1)7–12
  • Carstensen J. T., Dali M. V. Blending validation and content uniformity of low-content, noncohesive powder blend. Drug Dev. Ind. Pharm. 1996; 22(4)285–290
  • Blend uniformity analysis: validation and in-process testing, Technical Report No. 25. PDA J. Pharm. Sci. Technol. 1997; 51(S3)
  • Guidance for Industry, ANDAs: Blend Uniformity Analysis. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). August 1999, OGD
  • Mohan S., Rankell A., Rehm C., Bhalani V., Kukarni A. Unit dose sampling and blend content uniformity testing. Pharm. Technol. April 1997; 116–125
  • Carstensen J. T., Rhodes C. T. Sampling in blending validation. Drug Dev. Ind. Pharm. 1993; 19(20)2699–2708
  • Tanino T., Yoshida T., Sumi Y., Ohtani S., Mizuta T. Evaluation of blend uniformity: effect of granulation sample size. J. Jpn. Soc. Pharm. Mach. Eng. 1999; 8: 5–14

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.