APPLICATION OF NEAR INFRARED SPECTROSCOPY FOR ENDPOINT DETERMINATION OF BLENDING AND INFLUENCE OF LOADING ORDER
DOI:
https://doi.org/10.22159/ijap.2020v12i6.38916Keywords:
Near-infrared spectroscopy, Partial least square regression, Blend uniformity, Order of powder loadingAbstract
Objective: This study aimed to apply near-infrared spectroscopy along with a thief as a tool to determine the endpoint of the blending process.
Methods: The calibration model was constructed by partial least square regression. The best model was applied to determine the endpoint of the blending process, also the effect of loading order on the endpoint for the blending of the formulation containing a low concentration of the active pharmaceutical ingredient.
Results: The best partial least square regression model yielded the lowest root mean square error of calibration of 1.4004, the lowest root mean square error of prediction of 1.4108 and the highest correlation coefficient of 0.9921. Validation study revealed the reference values were not statistically different from those of the predicted values. The model could predict the endpoint of the blending process with acceptable precision and accuracy. Standard deviation of the content of active pharmaceutical ingredients was ≤ 3% of the target after eighteen minutes of the blending process, which indicated the uniformity of powder blends. Additionally, the model revealed the order of powder loading slightly affected the blending time. The protocol that loaded the active pharmaceutical ingredient first or last needed a longer time to achieve the uniformity of blend.
Conclusion: NIR spectroscopy is the rapid and effective tools that could be applied to study the blending process in the pharmaceutical manufacturing.
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Scheibelhofer O, Balak N, Wahl PR, Koller DM, Glasser BJ, Khinast JG. Monitoring blending of pharmaceutical powders with multipoint NIR spectroscopy. AAPS PharmSciTech 2013;14:234-44.
Alyami H, Dahmash E, Bowen J, Mohammed AR. An investigation into the effects of excipient particle size, blending techniques and processing parameters on the homogeneity and content uniformity of a blend containing the low-dose model drug. PLoS One 2017;12:e0178772.
Barajas MJ, Cassiani AR, Vargas W, Conde C, Ropero J, Figueroa J, Romanach RJ. Near-infrared spectroscopic method for real-time monitoring of pharmaceutical powders during voiding. Appl Spectrosc 2007;61:490-6.
Shi Z, Cogdill RP, Short SM, Anderson CA. Process characterization of powder blending by near-infrared spectroscopy: blend end-points and beyond. J Pharm Biomed Anal 2008;47:738-45.
Biancolillo A, Marini F. Chemometric methods for spectroscopy-based pharmaceutical analysis. Front Chem 2018;6:576.
Otsuka M. Comparative particle size determination of phenacetin bulk powder by using Kubelka-Munk theory and principal component regression analysis based on near-infrared spectroscopy. Powder Technol 2004;141:244-50.
Osborne BG, Fearn T, Hindle PH. Practical NIR spectroscopy with applications in food and beverage analysis. Addison Wesley Longman, Harlow; 1993.
Levasseur-Garcia C. Updated overview of infrared spectroscopy methods for detecting mycotoxins on cereals (corn, wheat, and barley). Toxins (Basel) 2018;10:38.
Kim S, Kano M, Nakagawa H, Hasebe S. Estimation of active pharmaceutical ingredients content using locally weighted partial least squares and statistical wavelength selection. Int J Pharm 2011;421:269-74.
Chavez PF, Sacre PY, De Bleye CD, Netchacovitch L, Mantanus J, Motte H, et al. Active content determination of pharmaceutical tablets using near-infrared spectroscopy as process analytical technology tool. Talanta 2015;144:1352-9.
Debnath S, Predecki P, Suryanarayanan R. Using a glancing angle X-ray powder diffractometry to depth-profile phase transformations during the dissolution of indomethacin and theophylline tablets. Pharm Res 2004;21:149-59.
Otsuka Y, Yamamoto M, Abe H, Otsuka M. Effects of polymorphic transformation on pharmaceutical properties of direct compressed tablets containing theophylline anhydrate bulk powder under high humidity. Colloids Surf B 2013;102:931-6.
Maji JK. Near-infrared spectroscopy: a potential new mean of assessing multicomponent polyherbal formulation on way before and after extraction. Int J Pharm Pharm Sci 2017;9:121-9.
Rout SP, Acharya R, Maji JK. Discriminant analysis of shodhana (processing) on baliospermum montanum muell (danti) root samples based on near infrared spectroscopy and multivariate chemometric technique. Int J Pharm Pharm Sci 2017;9:130-5.
Berntsson O, Danielsson LG, Lagerholm B, Folestad S. Quantitative in-line monitoring of powder blending by near-infrared reflection spectroscopy. Powder Technol 2002;123:185-93.
Blanco M, Gozalez Bano R, Bertran E. Monitoring powder blending in pharmaceutical processes by use of near-infrared spectroscopy. Talanta 2002;56:203-12.
Sandler N, Rantanen J, Heinamaki J, Romer M, Marola M, Yliruusi J. Pellet manufacturing by extrusion-spheronization using process analytical technology. AAPS PharmSciTech 2005;6:174-83.
Salameh AK, Taylor LS. Physical stability of crystal hydrates and their anhydrates in the presence of excipients. J Pharm Sci 2006;95:446-61.
Fonteyne M, Soares S, Vercruysse J, Peeters E, Burggraeve A, Vervaet C, et al. Prediction of quality attributes of continuously produced granules using complementary pat tools. Eur J Pharm Biopharm 2012;82:429-36.
El-Hagrasy AS, Morris HR, D’Amico F, Lodder RA, 3rd Drennen JK. Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J Pharm Sci 2001;90:1298-307.
Duong NH, Arratia P, Muzzio F, Lange A, Timmermans J, Reynolds S. A homogeneity study using NIR spectroscopy: tracking magnesium stearate in Bohle bin-blender. Drug Dev Ind Pharm 2003;29:679-87.
Karande AD, Liew CV, Heng PW. Calibration sampling paradox in near-infrared spectroscopy: a case study of a multicomponent powder blend. Int J Pharm 2010;395:91-7.
Vanarase AU, Alcala M, Jerez Rozo JI, Muzzio FJ, Romanach RJ. Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy. Chem Eng Sci 2010;65:5728-33.
Shi T, Chen Y, Liu Y, Wu G. Visible and near-infrared reflectance spectroscopy-an alternative for monitoring soil contamination by heavy metals. J Hazard Mater 2014;265:166-76.
Liu Y, Liu Y, Chen Y, Zhang Y, Shi T, Wang J, et al. The influence of spectral pretreatment on the selection of representative calibration samples for soil organic matter estimation using vis-NIR reflectance spectroscopy. Remote Sens 2019;11:450.
Sun DW. Infrared spectroscopy for food quality analysis and control. Elsevier, New York; 2009.
Barnes RJ, Dhanoa MS, Lister SJ. Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra. Appl Spectrosc 1989;43:772-7.
MJ Adams. Chemometrics in analytical spectroscopy, Royal Society of Chemistry, Cambridge; 1995.
Silva OS, Souza CR, Oliveira WP, Rocha SC. In vitro dissolution studies of sodium diclofenac granules coated with Eudragit L-30D-55 by the fluidized-bed system. Drug Dev Ind Pharm 2006;32:661-7.
Bergum J, Brown W, Clark J, Parks T, Garcia T, Prescott J, et al. Content uniformity discussions: current USP<905>developments regarding<905>and a comparison of two relevant statistical approaches to assess content uniformity. Pharm Eng 2015;35:52-7.
Hogg R. Mixing and segregation in powders: evaluation, mechanisms and processes. KONA Powder Part J 2009;27:3-17.
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