Effects of lubricant-mixing time on prolongation of dissolution time and its prediction by measuring near infrared spectra from tablets

Drug Development and Industrial Pharmacy

Volumn 38, Issue 4, 2012, Pages 412-419

  Abe, Hiroyuki ^a   Otsuka, Makoto ^a  

^a MUSASHINO UNIVERSITY   (Japan)

Author keywords

Chemometrics; Disintegration; Lubrication; Magnesium stearate; Partial least squares; Process analytical technology

Indexed keywords

LACTOSE; MAGNESIUM STEARATE; POTATO STARCH; THEOPHYLLINE;

ARTICLE; CHEMOMETRIC ANALYSIS; DRUG MIXTURE; DRUG SOLUBILITY; LUBRICATION; NEAR INFRARED SPECTROSCOPY; POWDER; PREDICTIVE VALUE; SURFACE PROPERTY; TABLET COMPRESSION; TABLET DISINTEGRATION TIME; TABLET FORMULATION; WETTABILITY;

DRUG COMPOUNDING; LUBRICANTS; MODELS, CHEMICAL; PREDICTIVE VALUE OF TESTS; SOLUBILITY; SPECTROSCOPY, NEAR-INFRARED; STEARIC ACIDS; TABLETS; TIME FACTORS;

EID: 84857603311     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2011.608679     Document Type: Article

References (34)

1. Iranloye TA, Parrott EL. (1978). Effects of compression force, particle size, and lubricants on dissolution rate. J Pharm Sci, 67:535-539. (Pubitemid 8331318)
2. Perrault M, Bertrand F, Chaouki J. (2011). An experimental investigation of the effect of the amount of lubricant on tablet properties. Drug Dev Ind Pharm, 37:234-242.
3. Shah AC, Mlodozeniec AR. (1977). Mechanism of surface lubrication: influence of duration of lubricant-excipient mixing on processing characteristics of powders and properties of compressed tablets. J Pharm Sci, 66:1377-1378.
4. Kikuta J, Kitamori N. (1994). Effect of mixing time on the lubricating properties of magnesium stearate and the final characteristics of the compressed tablets. Drug Dev Ind Pharm, 20:343-355. (Pubitemid 24095375)
5. FDA (2004). Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Available at http://wwwfda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070305.pdf.
6. Siesler HW, Ozaki Y, Kawano S, Heise HM. 2002). Near-infrared spectroscopy principles, instruments, applications Wiley-VCH, Weinheim, Germany.
7. Morisseau KM & Rhodes CT (1995). Pharmaceutical Uses of Near-Infrared Spectroscopy. Drug Dev Ind Pharm, 21:1071-1090.
8. Martens H, Naes T. 1989). Multivariate calibration. John Wiley & Sons, New York.
9. Buchanan BR, Baxter MA, Chen TS, Qin XZ, Robinson PA. (1996). Use of near-infrared spectroscopy to evaluate an active in a film coated tablet. Pharm Res, 13:616-621. (Pubitemid 26119067)
10. Tatavarti AS, Fahmy R, Wu H, Hussain AS, Marnane W, Bensley D et al. (2005). Assessment of NIR spectroscopy for nondestructive analysis of physical and chemical attributes of sulfamethazine bolus dosage forms. aaps Pharmscitech, 6:E91-E99. (Pubitemid 41630996)
11. Otsuka E, Abe H, Aburada M, Otsuka M. (2010). Nondestructive prediction of the drug content of an aspirin suppository by nearinfrared spectroscopy. Drug Dev Ind Pharm, 36:839-844.
12. Drennen JK, Lodder RA. (1990). Nondestructive near-infrared analysis of intact tablets for determination of degradation products. J Pharm Sci, 79:622-627. (Pubitemid 20222731)
13. Norris K, Williams P. (1984). Optimization of mathematical treatment of raw near-infrared signal in the measurement of protein in hard red spring wheat. I. Influence of particle size. Cereal Chem, 61:158-165.
14. Aucott L, Garthwaite P, Buckland S. (1988). Transformations to reduce the effect of particle size in near-infrared spectra. Analyst, 113:1849-1855.
15. Bull C. (1991). Compensation for particle size effects in near infrared reflectance. Analyst, 116:781-786.
16. Norris T, Aldridge P, Sekulic S. (1997). Determination of endpoints for polymorph conversions of crystalline organic compounds using on-line near-infrared spectroscopy. Analyst, 122:549-552. (Pubitemid 27277822)
17. Frake P, Gill I, Luscombe CN, Rudd DR, Waterhouse J, Jayasooriya UA. (1998). Near-infrared mass median particle size determination of lactose monohydrate, evaluating several chemometric approaches. Analyst, 123:2043-2046. (Pubitemid 28482881)
18. Sarver RW, Meulman PA, Bowerman DK, Havens JL. (1998). Factor analysis of infrared spectra for solid-state forms of delavirdine mesylate. Int J Pharm 167:105-120. (Pubitemid 28341512)
19. Otsuka M, Kato F, Matsuda Y. (2000). Comparative evaluation of the degree of indomethacin crystallinity by chemoinfometrical Fourier-transformed [corrected] near-infrared spectroscopy and conventional powder X-ray diffractometry. aaps Pharmsci, 2:E9.
20. Patel AD, Luner PE, Kemper MS. (2000). Quantitative analysis of polymorphs in binary and multi-component powder mixtures by near-infrared reflectance spectroscopy. Int J Pharm, 206:63-74.
21. Otsuka M, Kato F, Matsuda Y. (2001). Determination of indomethacin polymorphic contents by chemometric near-infrared spectroscopy and conventional powder X-ray diffractometry. Analyst, 126:1578-1582. (Pubitemid 32897043)
22. Otsuka M, Fukui Y. (2010). Determination of carbamazepine polymorphic contents in double-layered tablets using transmittance-and reflectance-near- infrared spectroscopy involving chemometrics. Drug Dev Ind Pharm, 36:1404-1412.
23. Otsuka M, Yamane I. (2006). Prediction of tablet hardness based on near infrared spectra of raw mixed powders by chemometrics. J Pharm Sci, 95:1425-1433. (Pubitemid 44049112)
24. Kirsch JD, Drennen JK. (1999). Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm. J Pharm Biomed Anal, 19:351-362. (Pubitemid 29073493)
25. Donoso M, Ghaly ES. (2004). Prediction of drug dissolution from tablets using near-infrared diffuse reflectance spectroscopy as a nondestructive method. Pharm Dev Technol, 9:247-263. (Pubitemid 39166278)
26. Otsuka M, Tanabe H, Osaki K, Otsuka K, Ozaki Y. (2007). Chemoinformetrical evaluation of dissolution property of indomethacin tablets by near-infrared spectroscopy. J Pharm Sci, 96:788-801. (Pubitemid 46657869)
27. Freitas MP, Sabadin A, Silva LM, Giannotti FM, do Couto DA, Tonhi E et al. (2005). Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: a rapid and nondestructive method. J Pharm Biomed Anal, 39:17-21. (Pubitemid 41112113)
28. Tabasi SH, Moolchandani V, Fahmy R, Hoag SW. (2009). Sustained release dosage forms dissolution behavior prediction: a study of matrix tablets using NIR spectroscopy. Int J Pharm, 382:1-6.
29. Tanigawara Y, Yamaoka K, Nakagawa T, Uno T. (1982). Moment analysis for the separation of mean in vivo disintegration, dissolution, absorption, and disposition time of ampicillin products. J Pharm Sci, 71:1129-1133. (Pubitemid 12032678)
30. Otsuka M, Gao JI, Matsuda Y. (1993). Effects of mixer and mixing time on the pharmaceutical properties of theophylline tablets containing various kinds of lactose as diluents. Drug Dev Ind Pharm, 19:333-348. (Pubitemid 23039438)
31. Hussain MSH, York P, Timmins P. (1988). A study of the formation of magnesium stearate film on sodium chloride using energydispersive X-ray analysis. Int J Pharm, 42:89-95. (Pubitemid 18092096)
32. Hemmateenejad B, Akhond M, Samari F. (2007). A comparative study between PCR and PLS in simultaneous spectrophotometric determination of diphenylamine, aniline, and phenol: Effect of wavelength selection. Spectrochim Acta a Mol Biomol Spectrosc, 67:958-965. (Pubitemid 46809680)
33. Blanco M, Alcalá M, González JM, Torras E. (2006). A process analytical technology approach based on near infrared spectroscopy: tablet hardness, content uniformity, and dissolution test measurements of intact tablets. J Pharm Sci, 95:2137-2144. (Pubitemid 44568525)
34. Short SM, Cogdill RP, Wildfong PL, Drennen JK 3rd, Anderson CA. (2009). A near-infrared spectroscopic investigation of relative density and crushing strength in four-component compacts. J Pharm Sci, 98:1095-1109.