In-line ultrasound measurement system for detecting tablet integrity

Leskinen, Jani; Simonaho, Simo-Pekka; Hakulinen, Mikko; Ketolainen, Jarkko

doi:10.1016/j.ijpharm.2010.08.038

Cited by 32 publications

(14 citation statements)

References 14 publications

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“…Moreover, statistical models do not reflect physical properties of the powder compact and thus no fundamental insights about disintegration phenomena can be gained from such models. However, the use of the ultrasound technique provides some very interesting insights into the internal structure of tablets and can be used as a very powerful sensor for in-die measurements during compaction process development [136, 137]. …”

Section: Quantifying Disintegration Mechanismsmentioning

confidence: 99%

A Review of Disintegration Mechanisms and Measurement Techniques

2017

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Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are typically powder compacts consisting of several different excipients in addition to the API. Excipients are added to a formulation in order to achieve the desired fill weight of a dosage form, to improve the processability or to affect the drug release behaviour in the body. These complex porous systems undergo different mechanisms when they come in contact with physiological fluids. The performance of a drug is primarily influenced by the disintegration and dissolution behaviour of the powder compact. The disintegration process is specifically critical for immediate-release dosage forms. Its mechanisms and the factors impacting disintegration are discussed and methods used to study the disintegration in-situ are presented. This review further summarises mathematical models used to simulate disintegration phenomena and to predict drug release kinetics.

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Section: Quantifying Disintegration Mechanismsmentioning

confidence: 99%

A Review of Disintegration Mechanisms and Measurement Techniques

2017

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“…Recently, NIRS calibration models for real-time prediction of powder density (tap, bulk and consolidated) were developed for a pharmaceutical formulation [28]. Moreover, other approaches for monitoring powder bulk densities have been reported in the literature: an analytical ultrasound method [29], an air-coupled acoustic technique [30], photo-acoustic testing [31], acoustic emission measurements [32], microwave measurements [33,34], X-ray based methods [35], thermal effusivity monitoring [36] and electrical tomography [37]. However, quantitative real-time measurement of bulk density variations in a moving powder bed remains a challenge [5].…”

Section: Introductionmentioning

confidence: 99%

Measuring bulk density variations in a moving powder bed via terahertz in-line sensing

Stranzinger

Faulhammer

et al. 2019

Powder Technology

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Monitoring the relative density of static or moving powder inside a process line is essential for manufacturing high-quality products. The aim of this study was to predict density variations in a moving powder bed using terahertz reflection technology. We systematically investigated three grades (varying true density and particle size) of two materials: lactose and silicified microcrystalline cellulose (SMCC). These six powders specifically differ in their compressibility, which can be applied to assess the sensitivity and applicability of our method. The powders were filled into a round container, and terahertz reflection measurements were acquired continuously during the container's rotation. The setup allowed to adjust the relative density by compacting the powders into specific powder bed heights. Each powder was compacted to various relative densities (compression pressures up to 100 kPa). We calculated the surface refractive index based on the in-line terahertz measurements acquired during rotation, which has a linear dependence on the relative density of the powder. This was confirmed by correlating the refractive index values with the theoretical relative densities based on the bulk and true densities of the powder. The coefficient of determination (2) was larger than 0.962 (Lactohale 100) for all six powders, with the highest coefficients for Lactohale 220 (2 = 0.996) and SMCC 50 LD (2 = 0.995). The results suggest that the proposed method can resolve relative densities averaged across the powder bed that are as small as 0.3% (Lactohale 100). The high acquisition rate of the terahertz system (15 Hz) made it possible to determine the powder density in 230 positions uniformly distributed throughout the container, facilitating the investigation of the relative density uniformity in the container as a function of the powder bed height. It was observed that SMCC powders undergo a smaller change in the relative density variations upon compaction than the lactose powders. Moreover, the relative density maps clearly indicate local density differences in the powder bed for all powders. The relative density variations (in the horizontal direction) that were introduced by packing of the container prevailed throughout the compaction process for all samples with the exception of Lactohale 220. The presented approach allows a precise resolution of the spatial distribution of relative density, which facilitates an in-depth analysis of powder behavior upon compaction.

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“…From a more physics‐based‐methods standpoint, diffraction methods have commonly been utilized for particle size determination, and several other techniques can capture particle size related information as well . Information from the process can also be extracted using innovative approaches, such as acoustics, ultrasound, and electrostatic monitoring . Another example is OCT for monitoring inline the coating thickness and the inter‐ and intra‐tablet coating variability during the coating process (both in pan and fluid‐bed coaters) .…”

Section: Process Analysis From the Engineering Point Of Viewmentioning

confidence: 99%

The Future of Pharmaceutical Manufacturing Sciences

Rantanen

Khinast

2015

Journal of Pharmaceutical Sciences

363

152

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The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial‐scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state‐of‐art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular‐based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot‐melt processing and printing‐based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3612–3638, 2015

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In-line ultrasound measurement system for detecting tablet integrity

Cited by 32 publications

References 14 publications

A Review of Disintegration Mechanisms and Measurement Techniques

A Review of Disintegration Mechanisms and Measurement Techniques

Measuring bulk density variations in a moving powder bed via terahertz in-line sensing

The Future of Pharmaceutical Manufacturing Sciences

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