A systematic approach for optimizing the blending process of a direct- compression tablet formulation

Pharmaceutical Technology

Volumn 22, Issue 3, 1998, Pages 158-170

  Hwang, Ruey Ching ^a   Gemoules, Mary K ^a   Ramlose, Daniel S ^a  

^a MALLINCKRODT PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AVICEL PH 302; GENERIC DRUG; LACTOSE; MAGNESIUM STEARATE; MICROCRYSTALLINE CELLULOSE; TALC; UNCLASSIFIED DRUG;

ARTICLE; LUBRICATION; POWDER; SAMPLING; TABLET COMPRESSION; TABLET FORMULATION; TABLET PROPERTY;

EID: 0031924747     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. R.T. Lantz and J.B. Schwartz, "Mixing," in Pharmaceutical Dosage Forms, Tablets, Vol. 2, Lieberman, Lachman, and Schwartz, Eds. (Marcel Dekker, 2nd ed., New York, 1990), pp. 1-71.
2. FDA, "Guide to Inspections of Oral Solid Dosage Forms Pre/Post-approval Issues for Development and Validation," January 1994.
3. PDA Technical Report, "Blending Uniformity Analysis: Validation and In-Process Testing," draft, 30 April 1997.
4. US v. Barr Laboratories Cons. Docket 92-1744 (AMW), Court Ruling, 4 February 1993.
5. J. Berman, A. Schoeneman, and J.T. Shelton, "Unit Dose Sampling - A Tale of Two Thieves," Drug Dev. Ind. Pharm. 22 (11), 1121-1132 (1996).
6. J.T. Carstenson and C.T. Rhodes, "Sampling in Blending Validation," Drug Dev. Ind. Pharm. 19 (20), 2699-2708 (1993).
7. S. Bolton et al., "Is It Necessary to Take Small Blend Samples to Assess Drug Uniformity?" Pharm. Dev. Technol. 2 (3), 297-299 (1997).
8. C.F. Harwood and K. A. Walanski, "Monitoring the Mixing of Powders," ACS Division of Organic Coatings and Plastic Chemistry 33 (2), T305-T315 (1964).
9. C. Schofield, "The Definition and Assessment of Mixture Quality in Mixtures of Particulate Solids," Powder Technol. 5, 169-180 (1976).
10. C.F. Harwood and T. Ripley, "Errors Associated with the Thief Probe for Bulk Powder Sampling," J. Powder Bulk Solids Technol. 1, 20-29 (1977).
11. S. Mohan et al., "Unit-Dose Sampling and Blend Content Uniformity Testing," Pharm. Technol. 21 (4), 116-125 (1997).