In line NIR quantification of film thickness on pharmaceutical pellets during a fluid bed coating process

Lee, Min‐Jeong; Seo, Da-Young; Lee, Hea-Eun; Wang, In-Chun; Kim, Woo‐Sik; Jeong, Myung-Yung; Choi, Guang J.

doi:10.1016/j.ijpharm.2010.10.022

Cited by 97 publications

(34 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…XRD gave a slightly greater value than DSC, especially when the form II content was lower than 50%. This type of observation was reported previously, 26 and might be a common feature whenever two or more off-line characterization methods are employed together. Figure 8 shows two PLS-based calibration plots.…”

Section: Basic Analysis and Characterizationsupporting

confidence: 74%

“…This is in agreement with the findings of a previous pellet-coating study. 26 Thus, the quality of the correlation (represented by R 2 ) is not strongly dependent upon the absolute values of a targeted attribute determined by an appropriate off-line characterization. Instead, it is primarily associated with the consistency in the change of the relevant attribute (the form II content, in this case).…”

Section: Calibration Modelsmentioning

confidence: 99%

See 1 more Smart Citation

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Lee

Seo

Wang

et al. 2012

Journal of Pharmaceutical Sciences

Self Cite

View full text Add to dashboard Cite

Section: Basic Analysis and Characterizationsupporting

confidence: 74%

Section: Calibration Modelsmentioning

confidence: 99%

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Lee

Seo

Wang

et al. 2012

Journal of Pharmaceutical Sciences

Self Cite

View full text Add to dashboard Cite

“…The simplest way to calibrate an in-line method is to acquire real-time spectra through the entire process length along with collecting samples at regular intervals. The response values obtained through reference methods are correlated with the spectral data, considering the process time as a link between the two [38][39][40]. More extensive calibrations also evaluate the effect of sample presentation, changing process, and formulation parameters, to challenge the robustness of the methods.…”

Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

View full text Add to dashboard Cite

Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

show abstract

“…The particle sizes of drug-layered cores ranged from 470 to 540 μm while the drug layer ranged from 123 to 130 μm because of the high drug loading (80% w/w). The smooth surface of drug-layered cores is essential to the uniformity of outer EC coating and the reproducibility of drug release from the obtained pellets (35,36). Therefore, the current drug-layering approach has the following advantages: (1) simple formulation without other excipients, (2) high-layering efficiency (97%), (3) good morphology, and (4) short process time.…”

Section: Drug Layeringmentioning

confidence: 99%

Model Drug as Pore Former for Controlled Release of Water-Soluble Metoprolol Succinate from Ethylcellulose-Coated Pellets Without Lag Phase: Opportunities and Challenges

Wang¹,

Dai²,

Chang

et al. 2014

AAPS PharmSciTech

View full text Add to dashboard Cite

Abstract. The objective of the present study was to evaluate the feasibility of using model drug metoprolol succinate (MS) as a pore former to modify the initial lag phase (i.e., a slow or non-release phase in the first 1-2 h) associated with the drug release from coated pellets. MS-layered cores with high drug-layering efficiency (97% w/w) were first prepared by spraying a highly concentrated drug aqueous solution (60% w/w, 70°C) on non-pareils without using other binders. The presence of MS in ethylcellulose (EC) coating solution significantly improved the coating process by reducing pellets sticking, which often occurs during organic coating. There may be a maximum physical compatibility of MS with EC, and the physical state of the drug in the functional coating layer of EC/MS (80:20) was simultaneously crystalline and noncrystalline (amorphous or solid molecule solution). The lag phase associated with hydroxypropylcellulose (HPC) as a pore former was not observed when MS was used as a pore former. The drug release from EC/ MS-coated pellets was pH independent, inversely proportional to the coating levels, and directly related to the pore former levels. The functional coating layer with MS as a pore former was not completely stabilized without curing. Curing at 60°C for 1 day could substantially improve the stability of EC/MScoated pellets. The physical state of the drug in the free film of EC/MS (85:15) changed partially from amorphous to crystal when cured at 60°C for 1 day, which should be attributed to the incompatibility of the drug with EC.

show abstract

In line NIR quantification of film thickness on pharmaceutical pellets during a fluid bed coating process

Cited by 97 publications

References 26 publications

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Quantitative In-Line Monitoring of Solvent-Mediated Polymorphic Transformation of Sulfamerazine by Near-Infrared Spectroscopy

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Model Drug as Pore Former for Controlled Release of Water-Soluble Metoprolol Succinate from Ethylcellulose-Coated Pellets Without Lag Phase: Opportunities and Challenges

Contact Info

Product

Resources

About