Optimization of fluid bed formulations of metoprolol granules and tablets using an experimental design Optimization of fluid bed formulations

Drug Development and Industrial Pharmacy

Volumn 35, Issue 9, 2009, Pages 1072-1081

  Tomu, I ^a   Alecu, C ^b   Rus, L L ^b   Leuuta, S E ^a  

^a IULIU HATIEGANU UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^b SC Polipharma Industries SRL ^*  (Romania)

Author keywords

Experimental design; Fluid bed granulation; Metoprolol tartrate; Optimization; Resolution V

Indexed keywords

METOPROLOL TARTRATE; SILICON DIOXIDE;

AIR TEMPERATURE; ARTICLE; CRUSHING STRENGTH; DENSITY; DISPERSION; DRUG GRANULE; DRUG MANUFACTURE; DRUG RELEASE; DRUG SOLUBILITY; FLOW RATE; HUMIDITY; NEBULIZATION; POWDER; TABLET DISINTEGRATION; TABLET FORMULATION; TABLET MACHINE;

ADRENERGIC BETA-ANTAGONISTS; ALGORITHMS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DESICCATION; DRUG COMPOUNDING; HARDNESS TESTS; METOPROLOL; POWDERS; PRESSURE; SOFTWARE; SOLUBILITY; TABLETS; TEMPERATURE;

EID: 70350683750     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040902774149     Document Type: Article

References (24)

1. Sweetman SC. (2002). Martindale: The complete drug reference. 35th ed. London: Pharmaceutical Press, 931-932
2. Niazi SK. (2004). Handbook of pharmaceutical manufacturing formulations compressed solid products, Vol.1. London: CRC PRESS, 139-140
3. Aulton ME. (2001). Pharmaceutics: The science of dosage form design. 2nd ed. Churchill Livingstone Publisher: London, 365-366
4. Rambali B, Baert L, Thone D, Massart DL. (2001). Using experimental design to optimize the process parameters in fluidized bed granulation. Drug Dev Ind Pharm, 27(1):47-55. (Pubitemid 32195360)
5. Hu X, Cunningham J, Winstead D. (2008). Understanding and predicting bed humidity in fluidized bed granulation. J Pharm Sci, 97(4):1564-1577
6. Hlinak AJ, Saleki-Gerhardt A. (2000). An evaluation of fluid bed drying of aqueous granulations. Pharm Dev Technol, 5(1):11-17.
7. Dacanal GC, Menegalli FC. (2008). Experimental study of fluidized bed agglomeration of acerola powder. Braz J Chem Eng, 25(1):51-58
8. Rambali B, Baert L, Massart DL. (2001). Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale. Int J Pharm, 220(1-2):149-160 (Pubitemid 32476851)
9. Rambali B, Van Aelst S, Baert L, Massart DL. (2003). Using deepest regression method for optimization of fluidized bed granulation on semi-full scale. Int J Pharm, 258(1-2):85-94.
10. Faure A, York P, Rowe RC. (2001). Process control and scale-up of pharmaceutical wet granulation processes: A review. Eur J Pharm Biopharm, 52(3):269-277
11. Cryer SA, Scherer PN. (2003). Observations and process parameter sensitivities in fluidbed granulation. AIChE J, 49(11):2802-2809
12. Gao JZ H, Jain A, Motheram R, Gray DB, Hussain MA. (2002). Fluid bed granulation of a poorly water soluble, low density, micronized drug: Comparison with high shear granulation. Int J Pharm, 237(1-2):1-14.
13. Eriksson L, Johansson E, Kettaneh-Wold N, Wikstrom C, Wold S. (2000). Design of experiments: Principles and applications. Umeå: Umetrics Academy Inc., 85-93.
14. MODDE 6. (2001). Software for design of experiments and optimization: User2s guide and tutorial. Umeå: Umetrics Academy Inc., 129-156
15. Parikh DM. (2005). Handbook of pharmaceutical granulation technology. New York, London: Taylor & Francis Group, 513-534
16. European Pharmacopoeia (2007). 6th ed, CD version.
17. Rudnic EM, Schwartz JB. (2005). Oral solid dosage forms. In Remington: The science and practice of pharmacy. Philadelphia: Lippincott Williams & Wilkins Press, 916-917
18. Dilip PM. (2005). Handbook of pharmaceutical granulation technology. 2nd ed. New York: Taylor & Francis Group, LLC, 513-534
19. Capes CE. (1980). Particle size enlargement. New York: Elservier, Inc.
20. Merkku P, Lindqvist AS, Leiviska K, Ylirussi J. (1994). Influence of granulation and compresion process variable on flow rate of granules and tablet properties with special reference to weight variation. Int J Pharm, 102:117-125
21. USP 31. The United States Pharmacopeia. 31th ed; 2008, CD version.
22. Armstrong NA. (2006). Pharmaceutical experimental design and interpretation. 2nd ed. London: Taylor & Francis Group, LLC, 118-129
23. Behzadi SS, Klocker J, Hüttlin H, Wolschann P, Viernstein H. (2005). Validation of fluid bed granulation utilizing artificial neural network. Int J Pharm, 291(1-2):139-148
24. Chaplin G, Pugsley T, Winters C. (2005). Monitoring the fluidized bed granulation process based on S-statistic analysis of a pressure time series. AAPS PharmSciTech, 6(2):198-201.