Determination of carbamazepine polymorphic contents in double-layered tablets using transmittance- and reflectance-near-infrared spectroscopy involving chemometrics

Drug Development and Industrial Pharmacy

Volumn 36, Issue 12, 2010, Pages 1404-1412

  Otsuka, Makoto ^a   Fukui, Yuya ^b  

^a MUSASHINO UNIVERSITY   (Japan)

^b KOBE PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

Carbamazepine polymorph; Chemometrics; Double layered tablet; Fourier transformed near infrared spectroscopy; Principal component regression analysis

Indexed keywords

CARBAMAZEPINE;

ACCURACY; ARTICLE; CALIBRATION; CHEMOMETRICS; CONTENT ANALYSIS; CORRELATION ANALYSIS; DIFFERENTIAL SCANNING CALORIMETRY; NEAR INFRARED REFLECTANCE SPECTROSCOPY; NEAR INFRARED SPECTROSCOPY; NEAR INFRARED TRANSMITTANCE SPECTROSCOPY; PROCESS ANALYTICAL TECHNOLOGY; STRUCTURE ANALYSIS; TABLET FORMULATION; TECHNOLOGY; X RAY DIFFRACTION;

ANTICONVULSANTS; CALIBRATION; CARBAMAZEPINE; CHEMISTRY, PHARMACEUTICAL; POWDERS; REGRESSION ANALYSIS; SPECTROSCOPY, NEAR-INFRARED; TABLETS; TECHNOLOGY, PHARMACEUTICAL; X-RAY DIFFRACTION;

EID: 78149372237     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2010.487262     Document Type: Article

References (50)

1. FDA Papers. (1985). Guidelines: Manufacturing and controls for INDs and NDAs, Pharm Tech Japan, 1:835-50.
2. Haleblian JK. (1975). Characterization of habits and crystalline modification of solids and their pharmaceutical applications. J Pharm Sci, 64:1269-88.
3. Otsuka M, Matsuda Y. (1995), Polymorphism, pharmaceutical aspects. In: Swarbrick J, Boylan JC, eds. Encyclopedia of pharmaceutical technology, vol. 12. New York: Marcel Dekker, 305-26.
4. Garg A, Singh S, Rao VU, Bindu K, Balasubramaniam J. (2009). Solid state interaction of raloxifene HCl with different hydrophilic carriers during co-grinding and its effect on dissolution rate. Drug Dev Ind Pharm, 35(4):455-70.
5. Umeda Y, Fukami T, Furuishi T, Suzuki T, Tanjoh K, Tomono K. (2009). Characterization of multicomponent crystal formed between indomethacin and lidocaine. Drug Dev Ind Pharm, 5(7):843-51.
6. Yoshino H, Hagiwara Y, Kobayashi S, Samejima M. (1984). Estimation of polymorphic transformation degree of pharmaceutical raw materials. Chem Pharm Bull, 32:1523-36.
7. Kaneniwa N, Otsuka M, Hayashi T. (1985). Physicochemical characterization of indomethacin polymorphs and the transformation kinetics in ethanol. Chem Pharm Bull, 33: 3447-55.
8. Ahmed H, Buckton G, Rawlins DA. (1996). The use of isothermal microcalorimetry in the study of small degree of amorphous content of a hydrophobic powder. Int J Pharm, 130:195-201.
9. Black DB, Lovering EG. (1977). Estimation of the degree of crystallinity in digoxin by X-ray and infrared methods. J Pharm Pharmacol, 29:684-7.
10. Taylor LS, Zografi G. (1998). The quantitative analysis of crystallinity using FT-Raman spectroscopy. Pharm Res, 15:755-61.
11. Liu J, Nagapudi K, Kiang YH, Martinez E, Jona J. (2009). Quantification of compaction-induced crystallinity reduction of a pharmaceutical solid using (19)F solid-state NMR and powder X-ray diffraction. Drug Dev Ind Pharm, 9:1-7.
12. Berridge JC, Jones P, Roberts-McIntosh AS. (1991). Chemometrics in pharmaceutical analysis. J Pharm Biomed Anal, 9:597-604.
13. Porter SC, Felton LA. (2010). Techniques to assess film coatings and evaluate film-coated products. Drug Dev Ind Pharm, 36(2):128-42. (Review)
14. Müller J, Knop K, Thies J, Uerpmann C, Kleinebudde P. (2010). Feasibility of Raman spectroscopy as PAT tool in active coating. Drug Dev Ind Pharm, 36(2):234-43.
15. Kuentz M, Rothenhäusler B, Röthlisberger D. (2006). Time domain 1H NMR as a new method to monitor softening of gelatin and HPMC capsule shells. Drug Dev Ind Pharm, 32(10):1165-73.
16. Paulson W, ed. (2002). Regulatory Leeway sought for process analytical technology. The Gold Sheet, vol. 36. Chevy Chase, MD: Elsevier.
17. Process Analytical Technology (PAT) Initiative, U.S. Food and Drug Administration Center for Drug Evaluation and Research Home Page. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088843.htm (May 13, 2010).
18. Siesler W, Ozaki Y, Kawano S, Heise HM. (2001). Near-infrared spectroscopy: Principles, instruments, applications. Weinheim: Wiley-VCH.
19. Martents H, Næs T. (1989). Multivariate calibration. New York: John Wiley & Sons.
20. Drennen JK, Lodder RA. (1990). Nondestructive near-infrared analysis of intact tablets for determination of degradation products. J Pharm Sci, 79:622-7.
21. 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, 13:616-21.
22. Norris T, Aldridge PK, Sekulic SS. (1997). Determination of end-points for polymorph conversions of crystalline organic compounds using on-line near-infrared spectroscopy. Analyst, 122:549-52.
23. Patl 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.
24. Otsuka M, Kato F, Matsuda Y. (2000). Comparative evaluation of the degree of indomethacin crystallinity by chemoinformetrical fourier-transformed near-infrared spectroscopy and conventional powder X-ray diffractometry. AAPS Pharmsci, 2(1): Article 9. http://www.pharmsci.org/ [accessed May 25, 2010].
25. Otsuka M, Kato F, Matsuda Y. (2001). Determination of indomethacin polymorphic contents by chemometric nearinfrared spectroscopy and conventional powder X-ray diffractometry. Analyst, 126:1578-82.
26. Fukui Y, Otsuka M. (2010). Determination of the crystallinity of cephalexin in pharmaceutical formulations by chemometrical near-infrared spectroscopy. Drug Devel Ind Pharm, 36(1):72-80.
27. Bull CR. (1991). Compensation for particle size effects in near infrared reflectance. Analyst, 116:781-6.
28. Aucott LS Garthwaite PH. (1988). Transformations to reduce the effect of particle size in near-infrared spectra. Analyst, 113:18491-54.
29. Norris KH, Williams PC. (1984). Optimization of mathematical treatments of raw near-infrared signal in the measurement of protein in hard red spring wheat, I. Influence of particle size. Cereal Chem, 61:158-65.
30. Franke P, Gill I, Luscombe CN, Rudd DR, Waterhouse J, Jayasooriya A. (1998). Near-infrared mass median particle size determination of lactose monohydrate: Evaluating several chemometric approaches. Analyst, 123:2043-6.
31. Otsuka M, Mouri Y, Matsuda Y. (2003). Chemometric evaluation of pharmaceutical properties of antipyrine granules by near-infrared spectroscopy. AAPS PharmSciTech, 4(3):Article 47, 334-40. http://www.pharmascitech.org (May 13, 2010).
32. Otsuka M. (2004). Comparative particle size determination of phenacetin bulk powder by using Kubelka-Munk theory and principle component regression analysis based on near-infrared spectroscopy, Powder Tech, 141:244-50.
33. Morisseau K, Rhodes CT. (1997). Near-infrared spectroscopy as a nondestructive alternative to conventional tablet hardness testing. Pharm Res, 14:108-11.
34. Kirsch JD, Drennen JK. (1999). Nondestructive tablet hardness testing by near-infrared spectroscopy: A new and robust spectral best-fit algorism. J Pharm Biomed Anal, 19: 351-62.
35. Ebube NK, Thosar SS, Roberts RA, Kemper MS, Rubnovitz R, Martin DL, et al. (1999). Application of near-infrared spectroscopy for nondestructive analysis of Avicel powders and tablets. Pharm Dev Technol, 4:19-26.
36. Chen Y, Thosar SS, Forbess RA, Kemper MS, Rubinovitz RL, Shukla AJ. (2001). Prediction of drug content and hardness of intact tablets using artificial neural network and near-infrared spectroscopy. Drug Dev Ind Pharm, 27:623-31.
37. Otsuka M, Yamane I. (2006). Prediction of tablet hardness based on near infrared spectra of raw mixed powders by chemometrics. J Pharm Sci, 95:1425-33.
38. Kahela P, Aaltonen R, Lewing E, Anttila M, Kristoffersson E. (1983). Pharmacokinetics and dissolution of two crystalline forms of carbamzepine. Int J Pharm, 14:103-20.
39. Otsuka M, Hasegawa H, Matsuda Y. (1999). Effect of polymorphic forms of bulk powders on pharamcetutical properties of carbamazepine granules. Chem Pharm Bull, 47:852-6.
40. Radtke G, Knop K, Lippold BC. (2006). Important parameters for the manufacture of slow-release matrix pellets with an aqueous dispersion of quaternary poly(meth)acrylates in the rotary fluidized bed. Drug Dev Ind Pharm, 32(3):287-96.
41. Otsuka E, Abe H, Aburada M, Otsuka M. (2010). Nondestructive prediction of the drug content of an aspirin suppository by near-infrared spectroscopy. Drug Dev Ind Pharm, March 24.
42. Gabrielsson J, Sjöström M, Lindberg NO, Pihl AC, Lundstedt T. (2006). Robustness testing of a tablet formulation using multivariate design. Drug Dev Ind Pharm, 32(3):297-307.
43. Gabrielsson J, Sjöström M, Lindberg NO, Pihl AC, Lundstedt T. (2006). Multivariate methods in the development of a new tablet formulation: Excipient mixtures and principal properties. Drug Dev Ind Pharm, 32(1):7-20.
44. Tian L, Zhang Y, Tang X. (2008). Sustained-release pellets prepared by combination of wax matrices and double-layer coatings for extremely water-soluble drugs. Drug Dev Ind Pharm, 34(6):569-76.
45. Kelmann RG, Kuminek G, Teixeira HF, Koester LS. (2008). Preliminary study on the development of nanoemulsions for carbamazepine intravenous delivery: An investigation of drug polymorphic transition. Drug Dev Ind Pharm, 34(1):53-58.
46. Patterson JE, James MB, Forster AH, Rades T. (2008). Melt extrusion and spray drying of carbamazepine and dipyridamole with polyvinylpyrrolidone/vinyl acetate copolymers. Drug Dev Ind Pharm, 34(1):95-106.
47. Kaneniwa N, Yamaguchi T, Watari N, Otsuka M. (1984). Hygroscopicity of carbamazepine crystalline powders. Yakugaku Zasshi, 104:184-90.
48. Iwamoto M, Kawano S, Uozumi J. (1994), Introduction of near infrared spectroscopy. Tokyo: Sachi Syobou Co.
49. Gottfries J, Depui H, Fransson M, Jongeneelen M, Josefson M, Langkilde FW, et al. (1996). Vibrational spectroscopy for the assessment of active substance in metoprolol tablets: A comparison between transmission and diffuse reflectance nearinfrared spectrometry. J Pharm Biomed Anal, 14:1495-503.
50. Cournoyer A, Simard JS, Cartilier L, Abatzoglou N. (2008). Quality control of multi-component, intact pharmaceutical tablets with three different near-infrared apparatuses. Pharm Dev Technol, 13(5):333-43.