Influence of Process Parameters on Content Uniformity of a Low Dose Active Pharmaceutical Ingredient in a Tablet Formulation According to GMP

1. L. M. Vercaigni and G. G. Zhanel, Clinical significance of bioequivalence and interchangeability of narrow therapeutic range drugs: Focus on warfarins, J. Pharm. PharmSci. 1 (1998) 92-94.Search in Google Scholar

2. A. K. Wittkowsky, Generic warfarin: Implications for patient care, Pharmacotherapy 17 (1997) 640-643; DOI: 10.1002/j.1875-9114.1997.tb03741.x.Search in Google Scholar

3. A. Jaffer and L. Bragg, Practical tips for Warfarin dosing and monitoring, Clev. Clin. J. Med. 70 (2003) 361-371; DOI: 10.3949/ccjm.70.4.361.10.3949/ccjm.70.4.361Search in Google Scholar

4. United States Court of Appeals, Third Circuit. Court decision in re: Warfarin sodium antitrust litigation, 391 F.3d 516, December 2004; https://bulk.resource.org/courts.gov/c/F3/391/391.F3d.516.02-3758.02-3757.02-3755.02-3603.html; access date October 15, 2013.Search in Google Scholar

5. H. Halkin, A. Shapiro, D. Kurnik, R. Loebstein, V. Shalev and E. Kokia, Increased warfarin doses and decreased international normalized ratio response after nationwide generic switching, Clin. Pharmacol. Ther. 74 (2003) 215-221; DOI: 10.1016/S0009-9236(03)00166-8.10.1016/S0009-9236(03)00166-8Search in Google Scholar

6. C. N. Swenson and G. Fundak, Observational cohort study of switching warfarin sodium products in a managed care organization, Am. J. Health-Syst. Pharm. 57 (2000) 452-455.10.1093/ajhp/57.5.452Search in Google Scholar

7. A. E. Sawoniak, A. F. Shalansky, P. J. Zed and R. Sundreji, Formulary considerations related to warfarin interchangeability, Can. J. Hosp. Pharm. 55 (2002) 215-218.Search in Google Scholar

8. A. Franc, B. Žaludek, R. Goněc, M. Maleček, H. Tkadlečková and A. Petrovičová, Method of Producing Dosage Units of a Solid Drug Form Containing Warfarin Sodium Salts as Active Component, WO Pat. 2005034919 17 October 2003.Search in Google Scholar

9. A. Franc, M. Rabišková and R. Gonĕc, Impregnation: a progressive method in the production of solid dosage forms with low content of poorly soluble drugs, Eur. J. Parent Pharm. Sci. 16 (2011) 85-93.Search in Google Scholar

10. L. Z. Benet and J. E. Goyan, Bioequivalence and narrow therapeutic index drug, Pharmacotherapy 15 (1995) 433-440; DOI: 10.1002/j.1875-9114.1995.tb04379.x.Search in Google Scholar

11. The »Barr Laboratories« Court decision, United States District Court for the District of New Jersey, Civil action No. 92-1744, January 2004; http://www.navigategmp.com/pdf/BarrLabs.pdf; access date October 19, 2013.Search in Google Scholar

12. J. Berman, D. E. Elinski, C. R. Gonzales, J. D. Hofer, P. J. Jimenez, J. A. Planchard, R. J. Tlachac and P. F. Vogel, Blend uniformity analysis: Validation and in-process testing. Technical Report No. 25. PDA (Parenteral Drug Association), PDA J. Pharm. Sci. Technol. 51 (1997) S1-99.Search in Google Scholar

13. FDA Guidance for industry, ANDAs: Blend Uniformity Analysis, Draft guidance, August 1999; http://www.fda.gov/OHRMS/DOCKETS/98fr/992635gd.pdf; access date October 19, 2013.Search in Google Scholar

14. FDA Guidance for industry, Powder Blends and Finished Dosage Units - Stratified In-process Dosage Unit Sampling and Assessment, Draft guidance, October 2003; http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0493-gdl0001.pdf; access date October 19, 2013.Search in Google Scholar

15. FDA Guidance for industry, Powder Blends and Finished Dosage Units - In-process Bend and Dosage Unit Inspection (Sampling and Evaluation) for Content Uniformity, Revised draft guidance, January 2004; http://www.fda.gov/ohrms/dockets/dailys/04/jan04/013004/03D-0493_emc-000003-01.pdf; access date October 19, 2013.Search in Google Scholar

16. FDA reference material, Oral Solid Dosage Forms Pre/post Approval Issues (1/94), Guide to inspections of oral solid dosage forms, pre/post approval issues for development and validation, January 1994. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074928.htm; access date 19 October, 2013.Search in Google Scholar

17. P. Cholayudth, Establishing acceptance limits for probability of passing multiple stage tests in process validation through a process capability approach, J. Valid. Tech. 15 (2009) 77-90.Search in Google Scholar

18. J. S. Bergum and H. Li, Acceptance limits for the new ICH USP 29 content-uniformity test, Pharm. Tech. 31 (2007) 90-100.Search in Google Scholar

19. J. Kushner, Incorporating Turbula mixers into a blending scale-up model for evaluating the effect of magnesium stearate on tablet tensile strength and bulk specific volume, Int. J. Pharm. 429 (2012) 1-11; DOI: 10.1016/j.ijpharm.2012.02.040.10.1016/j.ijpharm.2012.02.040Search in Google Scholar

20. J. Zheng, Formulation and Analytical Development for Low-Dose Oral Drug Products, John Wiley & Sons, New Jersey 2009, pp. 169-196.10.1002/9780470386361Search in Google Scholar

21. J. Hilden, M. Schrad, J. Kuehne-Willmore and J. Sloan, A first-principles model for prediction of product dose uniformity based on drug substance particle size distribution, J. Pharm. Sci. 101 (2012) 2364-2371; DOI: 10.1002/jps.23130.10.1002/jps.23130Search in Google Scholar

22. Y. Pu, M. Mazumder and C. Cooney, Effects of electrostatic charging on pharmaceutical powder blending homogeneity, J. Pharm. Sci. 98 (2009) 2412-2421; DOI: 10.1002/jps.21595.10.1002/jps.21595Search in Google Scholar

23. J. Muselík and A. Franc, Evaluation of content uniformity of tablets with a low content of the active ingredient with a narrow therapeutic index, Ces. Slov. Farm. 61 (2012) 271-275.Search in Google Scholar

24. D. M. Taylor, Measuring techniques for electrostatistics, Electrostatics 51-52 (2001) 502-508.10.1016/S0304-3886(01)00107-3Search in Google Scholar

25. H. Martens and M. Martens, Modified jack-knife estimation of parameter uncertainty in bilinear modeling by partial least squares regression (PLSR), Food Qual. Prefer. 11 (2000) 5-16; DOI: http://dx.doi.org/10.1016/S0950-3293(99)00039-7.10.1016/S0950-3293(99)00039-7Search in Google Scholar

26. A. Franc, J. Muselík, R. Máslová and J. Hadrabová, Content uniformity of warfarin-containing mixtures and tablets, Ces. Slov. Farm. 62 (2013) 177-181.Search in Google Scholar

27. M. Perrault, F. Bertrand and J. Chaouki, An investigation of magnesium stearate mixing in a Vblender through gamma-ray detection, Powder Technol. 200 (2010) 234-245.10.1016/j.powtec.2010.02.030Search in Google Scholar

28. H. Yang, How many batches are needed for process validation under the new FDA Guidance?, PDA J. Pharm. Sci. Technol. 67 (2013) 53-62; DOI: 10.5731/pdajpst.2013.00902.10.5731/pdajpst.2013.0090223385564Search in Google Scholar

29. Camo software website, Classical DoE methods and PLS-ANOVA, Specific methods for analyzing designed data; http://www.camo.com/resources/classical-doe-methods-pls-anova.html; access date October 19, 2013.Search in Google Scholar

30. Camo software. User’s manual to Unscrambler X software, v.1.3. Search in Google Scholar