Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy

Sekulic, Sonja; Wakeman, John M.; Doherty, P.; Hailey, Perry A.

doi:10.1016/s0731-7085(98)00025-9

Cited by 130 publications

(81 citation statements)

References 8 publications

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“…2,6 In this paper, similarity calculation was used instead. The procedure compares spectra recorded after per tumbling with sample spectra assumed to be homogeneous as standards.…”

Section: Discussionmentioning

confidence: 99%

“…3 In recent years, many articles of NIR spectroscopy for the powder blends have been reported. Sekulic and Hailey developed an on-line method of monitoring blend homogeneity with dynamic data collection bȳ ber-optic and qualitative tools of analyzing homogeneity [4][5][6] ; Berntsson focused on quantitative analysis of the process [7][8][9] ; others were interested in determining the end point of blending. [1][2][3]10 In these studies, the active components were single species and their pharmacologic e®ects were clear.…”

Section: Introductionmentioning

confidence: 99%

“…Calibration set for quantitative methods should be extremely large to represent all spectral variations, which cost lots of money and time. Hence, qualitative methods like spectral similarity, 13 moving block of standard deviation 6 and the mean square 2 were used to determine the end point of blending process for herbal medicines.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Characterization of herbal powder blends homogeneity using near-infrared spectroscopy

2014

J. Innov. Opt. Health Sci.

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Homogeneity of powder blend is essential to obtain uniform contents for the tablets and capsules. Near-infrared (NIR) spectroscopy with¯ber-optic probe was used as an on-line technique for monitoring the homogeneity of pharmaceutical blend during the blending process instead of the traditional techniques, such as high performance liquid chromatograph (HPLC) method. In this paper NIRS with a SabIR di®use re°ectance¯ber-optic probe was used to monitor the blending process of coptis powder and lactose (excipient) with di®erent contents, and further qualitative methods, like similarity, moving block of standard deviation and mean square were used for calculation purposes with the collected spectra after the pretreatment of multiplicative signal correction (MSC) and second derivative. Correlation spectrum was used for the wavelength selection. Four di®erent coptis were blended with lactose separately to validate the proposed method, and the blending process of \liu wei di huang" pill was also simulated in bottles to verify this method on multiple herbal blends. The overall results suggest that NIRS is a simple, e®ective and noninvasive technique can be successfully applied to the determination of homogeneity in the herbal blend.

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“…2,6 In this paper, similarity calculation was used instead. The procedure compares spectra recorded after per tumbling with sample spectra assumed to be homogeneous as standards.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Characterization of herbal powder blends homogeneity using near-infrared spectroscopy

2014

J. Innov. Opt. Health Sci.

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“…There is a need for reliable models to predict process end-point, which may vary between diOE erent blend compositions, and between multiple runs of identical blends (El-Hagrasy et al 2001). Several authors have described either at-line (Wargo & Drennen 1996) or in-line (Hailey et al 1996 ;Sekulic et al 1998 ;El-Hagrasy et al 2001) NIR systems for qualitatively predicting mixing end-point. These systems typically measure the variation in NIR spectra in both the time and wavelength domains and the blend is considered to be homogenous when the spectra converge to constant variance.…”

Section: Process Monitoringmentioning

confidence: 99%

Predictive and correlative techniques for the design, optimisation and manufacture of solid dosage forms

Hardy

Cook

2003

Journal of Pharmacy and Pharmacology

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There is much interest in predicting the properties of pharmaceutical dosage forms from the properties of the raw materials they contain. Achieving this with reasonable accuracy would aid the faster development and manufacture of dosage forms. A variety of approaches to prediction or correlation of properties are reviewed. These approaches have variable accuracy, with no single technique yet able to provide an accurate prediction of the overall properties of the dosage form. However, there have been some successes in predicting trends within a formulation series based on the physicochemical and mechanical properties of raw materials, predicting process scale-up through mechanical characterisation of materials and predicting product characteristics by process monitoring. Advances in information technology have increased predictive capability and accuracy by facilitating the analysis of complex multivariate data, mapping formulation characteristics and capturing past knowledge and experience.

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“…9) The in-line NIRS system is used to determine the end of the blending process so that blending can be terminated at the optimum time for each production batch according to in-line data. [10][11][12][13][14][15] Previous studies have used an NIRS system to monitor the homogeneity of a lubricant. 16,17) However, the blend uniformity of lubricant as well as the change in the flatting state of the lubricant must be monitored during the lubrication process.…”

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confidence: 99%

Application of Terahertz Attenuated Total Reflection Spectroscopy to Detect Changes in the Physical Properties of Lactose during the Lubrication Process Required for Drug Formulation

Dohi

Momose

Yamashita

et al. 2017

CHEMICAL & PHARMACEUTICAL BULLETIN

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Manufacturing the solid dosage form of an orally administered drug requires lubrication to enhance manufacturability, ensuring that critical quality attributes such as disintegration and dissolution of the drug product are maintained during manufacture. Here, to evaluate lubrication performance during manufacture, we used terahertz attenuated total reflection (THz-ATR) spectroscopy to detect differences in the physical characteristics of the lubricated powder. We applied a simple formulation prepared by blending granulated lactose as filler with magnesium stearate as lubricant. A flat tablet was prepared using the lubricated powder to acquire sharp THz-ATR absorption peaks of the samples. First, we investigated the effects of lubricant concentration and compression pressure on preparation of the tablet and then determined the effect of the pressure applied to samples in contact with the ATR prism on sample absorption amplitude. We focused on the differences in the magnitudes of spectra at the lactose-specific frequency. Second, we conducted the dynamic lubrication process using a 120-L mixer to investigate differences in the magnitudes of absorption corresponding to the lactose-specific frequency during lubrication. In both studies, enriching the lubricated powder with a higher concentration of magnesium stearate or prolonging blending time correlated with higher magnitudes of spectra at the lactose-specific frequency. Further, in the dynamic lubrication study, the wettability and disintegration time of the tablets were compared with the absorption spectra amplitudes at the lactose-specific frequency. We conclude that THz-ATR spectroscopy is useful for detecting differences in densities caused by a change in the physical properties of lactose during lubrication.Key words terahertz pulsed spectroscopy; attenuated total reflection; lubrication; lactose; magnesium stearate; evanescent waveThe manufacture of the tablet or capsule form of an orally administered drug requires blending of a lubricant with granules or other excipients, including the active pharmaceutical ingredient (API). This important process enhances the flow of the powder, 1) and thereby helps optimize manufacturing processes such as tableting and encapsulation. Factors such as the type of blender, rotation speed, lubrication time, batch and equipment size can affect the quality attribute of a drug product.2,3) The factors are generally determined according to scale-up theories to maintain the same physicochemical properties of a lubricated powder when changes are made to the equipment or production scale of the lubrication process. 4-7)However, even when using the same manufacturing conditions, we must consider variations in lubrication performance among batches of lubricated powders that are caused, for example, by differences in the physical characteristics of the lubricant or the physical characteristics of granules that are manufactured before the lubrication process. 8)To conduct real-time monitoring of the uniformity of the blended powder dur...

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Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy

Cited by 130 publications

References 8 publications

Characterization of herbal powder blends homogeneity using near-infrared spectroscopy

Characterization of herbal powder blends homogeneity using near-infrared spectroscopy

Predictive and correlative techniques for the design, optimisation and manufacture of solid dosage forms

Application of Terahertz Attenuated Total Reflection Spectroscopy to Detect Changes in the Physical Properties of Lactose during the Lubrication Process Required for Drug Formulation

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