Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging

Ellison, Christopher D.; Ennis, Bryan J.; Hamad, Mazen L.; Lyon, Robbe C.

doi:10.1016/j.jpba.2008.04.020

Cited by 55 publications

(27 citation statements)

References 25 publications

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“…The differences in compaction force were expected since several studies have also shown that compaction pressure affects NIR spectra. [17][18][19][20][21][22] However, the effect of strain is a new observation discussed in this study. At 8 kN the spectra from the three strain levels are clearly separated confirming the results shown in Figure 3(a).…”

Section: Resultsmentioning

confidence: 85%

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra

et al. 2016

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This study describes changes observed in the near-infrared (NIR) diffuse reflectance (DR) spectra of pharmaceutical tablets after these tablets were subjected to different levels of strain (exposure to shear) during the mixing process. Powder shearing is important in the mixing of powders that are cohesive. Shear stress is created in a system by moving one surface over another causing displacements in the direction of the moving surface and is part of the mixing dynamics of particulates in many industries including the pharmaceutical industry. In continuous mixing, shear strain is developed within the process when powder particles are in constant movement and can affect the quality attributes of the final product such as dissolution. These changes in the NIR spectra could affect results obtained from NIR calibration models. The aim of the study was to understand changes in the NIR diffuse reflectance spectra that can be associated with different levels of strain developed during blend shearing of laboratory samples. Shear was applied using a Couette cell and tablets were produced using a tablet press emulator. Tablets with different shear levels were measured using NIR spectroscopy in the diffuse reflectance mode. The NIR spectra were baseline corrected to maintain the scattering effect associated with the physical properties of the tablet surface. Principal component analysis was used to establish the principal sources of variation within the samples. The angular dependence of elastic light scattering shows that the shear treatment reduces the size of particles and produces their uniform and highly isotropic distribution. Tablet compaction further reduces the diffuse component of scattering due to realignment of particles.

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Section: Resultsmentioning

confidence: 85%

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra

et al. 2016

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“…In addition, Avicel The point of indentation stresses the local intermolecular bond strength that exists between the powdered granules of the pellet by measuring the amount of force per millimeter required to indent the surface of the pellet. The greater the force required to cause an indentation within the pellet surface, the greater the bond strength between the powder granules (25). The greater the hardness, the greater amount of energy is required to break these bonds and revert a pellet back to a powder form that releases a drug (25).…”

Section: Differential Scanning Calorimetry Of Edta-mpeg In Situ Hot Mmentioning

confidence: 99%

“…The greater the force required to cause an indentation within the pellet surface, the greater the bond strength between the powder granules (25). The greater the hardness, the greater amount of energy is required to break these bonds and revert a pellet back to a powder form that releases a drug (25). The matrix hardness of Formulation 1 was the least satisfactory because of the low weight concentration of EDTA and the high weight concentration of mPEG.…”

Section: Differential Scanning Calorimetry Of Edta-mpeg In Situ Hot Mmentioning

confidence: 99%

Physicomechanical Characterization and Optimization of EDTA–mPEG and Avicel®–EDTA–mPEG In Situ Melt Dispersion Mini-Pellets

et al. 2013

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Abstract. The purpose of this study was to develop a physicomechanically customizable oral metal chelatory in situ hot melt dispersion mini-pellet entity which could be utilized within a binary drug delivery system. Avicel ® RC/CL type R-591 was included within the in situ hot melt dispersion mini-pellet formulations to determine the physicomechanical effect this compound would have on the mini-pellet formulations. The physicomechanical properties of the hot melt in situ mini-pellet formulations were mathematically fitting to regression curves. Physicomechanical adjustment of the in situ hot melt dispersion mini-pellet formulations could be mathematically predicted with the derived regression curve equations. The addition of Avicel ® RC/ CL type R-591 increased the physicomechanical properties such as matrix hardness and increased total disintegration of the in situ hot melt dispersion mini-pellet formulations. The utilization of a physicomechanically customizable oral metal chelatory in situ hot melt dispersion mini-pellet entity within a binary drug delivery system would to achieve a synergistically enhance the activity of a drug-carrying entity or a permeation enhancing entity within a single drug delivery unit. The experimental results indicated that weights of the pellets that achieved optimal hardness ranged between 35 and 45 mg. The melt-dispersion formulations disintegrated within shorter time periods and maintained higher ethylenediaminetetraacetic acid (EDTA) concentrations whereas melt-dispersion formulations which included Avicel ® had superior physicomechanical properties. Disintegration times ranged between 1,000 s for melt-dispersions containing EDTA and methyloxy polyethylene glycol 2000 (mPEG) only, to >6,000 s for melt-dispersions comprising EDTA, mPEG, and Avicel ® .

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“…Ellison et al [37] investigated the possibility of using NIRCI for tablet density mapping. In pharmaceutical processing, the lubricant Mg stearate can affect compaction efficiency based on blend time and amount of Mg stearate used.…”

Section: Density Of Tablets and Roller Compactionmentioning

confidence: 99%

NIR Imaging Applications in the Pharmaceutical Industry

Gerich¹,

Dubois²,

Kidder³

2010

Raman, Infrared, and Near‐Infrared Chemical Imaging

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Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging

Cited by 55 publications

References 25 publications

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra

Effect of Shear Applied During a Pharmaceutical Process on Near Infrared Spectra

Physicomechanical Characterization and Optimization of EDTA–mPEG and Avicel®–EDTA–mPEG In Situ Melt Dispersion Mini-Pellets

NIR Imaging Applications in the Pharmaceutical Industry

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