Tags

Type your tag names separated by a space and hit enter

Sustained release dosage forms dissolution behavior prediction: a study of matrix tablets using NIR spectroscopy.
Int J Pharm. 2009 Dec 01; 382(1-2):1-6.IJ

Abstract

The objective of this study was to predict dissolution behavior of sustained release theophylline matrix tablets using near infrared (NIR) diffuse reflectance spectroscopy and multivariate calibration models. Eudragit NE 30D was used as a granulation binder to prepare theophylline sustained release tablets. A total of 117 tablets from 5 batches containing different proportions of Eudragit NE 30D were scanned using a NIR spectrometer. The release characteristics of the tablets were investigated in the acetate buffer for 4 h. The percentage release at 1, 2, 3 and 4 h was used to build the PLS calibration models. The Mahalanobis distance in principal component space and the 2nd derivative transformation were used for sample selection prior to building a four 4-factor partial least square (PLS) calibration models for predicting 1, 2, 3 and 4 h release rates. For PLS(1h), the standard error of calibration (SEC), and standard error of prediction (SEP) were 2.8 and 3.4%. For PLS(2h), the SEC and SEP were 2.7 and 3.5%. For PLS(3h), the SEC and SEP were 2.6 and 3.5% and for PLS(4h), the SEC and SEP were 3.0 and 3.5%, respectively. For the first time, NIR spectroscopy was successfully applied to predict drug release in the matrix tablets by correlating dissolution profile of each batch to its corresponding Eudragit NE 30D variation in tablet composition.

Links

Publisher Full Text
Aggregator Full Text

Authors+Show Affiliations

Tabasi SH
School of Pharmacy, University of Maryland, 20 N. Pine Street, Baltimore, MD 21201, United States.
Moolchandani V
No affiliation info available
Fahmy R
No affiliation info available
Hoag SW
No affiliation info available

MeSH

BuffersCalibrationChemistry, PharmaceuticalDelayed-Action PreparationsDrug CompoundingExcipientsFeasibility StudiesHydrogen-Ion ConcentrationKineticsLeast-Squares AnalysisMethacrylatesModels, ChemicalPolymersPrincipal Component AnalysisReproducibility of ResultsSolubilitySpectroscopy, Near-InfraredTabletsTechnology, PharmaceuticalTheophylline

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19660535

Citation

Tabasi, Simin Hassannejad, et al. "Sustained Release Dosage Forms Dissolution Behavior Prediction: a Study of Matrix Tablets Using NIR Spectroscopy." International Journal of Pharmaceutics, vol. 382, no. 1-2, 2009, pp. 1-6.
Tabasi SH, Moolchandani V, Fahmy R, et al. Sustained release dosage forms dissolution behavior prediction: a study of matrix tablets using NIR spectroscopy. Int J Pharm. 2009;382(1-2):1-6.
Tabasi, S. H., Moolchandani, V., Fahmy, R., & Hoag, S. W. (2009). Sustained release dosage forms dissolution behavior prediction: a study of matrix tablets using NIR spectroscopy. International Journal of Pharmaceutics, 382(1-2), 1-6. https://doi.org/10.1016/j.ijpharm.2009.07.029
Tabasi SH, et al. Sustained Release Dosage Forms Dissolution Behavior Prediction: a Study of Matrix Tablets Using NIR Spectroscopy. Int J Pharm. 2009 Dec 1;382(1-2):1-6. PubMed PMID: 19660535.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sustained release dosage forms dissolution behavior prediction: a study of matrix tablets using NIR spectroscopy. AU - Tabasi,Simin Hassannejad, AU - Moolchandani,Vikas, AU - Fahmy,Raafat, AU - Hoag,Stephen W, Y1 - 2009/08/04/ PY - 2009/03/16/received PY - 2009/07/23/revised PY - 2009/07/25/accepted PY - 2009/8/8/entrez PY - 2009/8/8/pubmed PY - 2010/2/3/medline SP - 1 EP - 6 JF - International journal of pharmaceutics JO - Int J Pharm VL - 382 IS - 1-2 N2 - The objective of this study was to predict dissolution behavior of sustained release theophylline matrix tablets using near infrared (NIR) diffuse reflectance spectroscopy and multivariate calibration models. Eudragit NE 30D was used as a granulation binder to prepare theophylline sustained release tablets. A total of 117 tablets from 5 batches containing different proportions of Eudragit NE 30D were scanned using a NIR spectrometer. The release characteristics of the tablets were investigated in the acetate buffer for 4 h. The percentage release at 1, 2, 3 and 4 h was used to build the PLS calibration models. The Mahalanobis distance in principal component space and the 2nd derivative transformation were used for sample selection prior to building a four 4-factor partial least square (PLS) calibration models for predicting 1, 2, 3 and 4 h release rates. For PLS(1h), the standard error of calibration (SEC), and standard error of prediction (SEP) were 2.8 and 3.4%. For PLS(2h), the SEC and SEP were 2.7 and 3.5%. For PLS(3h), the SEC and SEP were 2.6 and 3.5% and for PLS(4h), the SEC and SEP were 3.0 and 3.5%, respectively. For the first time, NIR spectroscopy was successfully applied to predict drug release in the matrix tablets by correlating dissolution profile of each batch to its corresponding Eudragit NE 30D variation in tablet composition. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/19660535/Sustained_release_dosage_forms_dissolution_behavior_prediction:_a_study_of_matrix_tablets_using_NIR_spectroscopy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(09)00501-8 DB - PRIME DP - Unbound Medicine ER -