In-line quantification of drug and excipients in cohesive powder blends by near infrared spectroscopy

Liew, Celine Valeria; Karande, A.D.; Heng, Paul Wan Sia

doi:10.1016/j.ijpharm.2009.11.011

Cited by 68 publications

(26 citation statements)

References 34 publications

(48 reference statements)

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“…The NIR results may be communicated through OPC (Open Platforms Communication) to process control devices. There are commercially available software that make predictions with the PAT method and also collect data from [63][64][65] process sensors.…”

Section: Methods Implementationmentioning

confidence: 99%

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

Romañach

Román-Ospino

Alcalà

2016

Methods in Pharmacology and Toxicology

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The pharmaceutical industry uses procedures to describe all the instructions needed to perform a process in a consistent manner. Procedures are based on process knowledge and the desire to consistently meet desired specifications. This chapter proposes a procedure for the development of NIR partial least squares (PLS) calibration models for pharmaceutical applications. The chapter captures the lessons learned for more than a decade in studies where NIR spectroscopy has been used for quantitative determinations of drug concentration, moisture, polymorphs, and other important applications. Two examples of recent initiatives to develop NIR calibration models in a more efficient manner reducing the number of calibration samples are also discussed. The procedure differs from previously published guidelines since it is based on specific examples of method validations for pharmaceutical processes and provides clear instructions for method development and validation. The procedure and tutorial should advance the implementation of near infrared spectroscopic (NIRS) quantitative methods in the pharmaceutical industry.

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Section: Methods Implementationmentioning

confidence: 99%

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

Romañach

Román-Ospino

Alcalà

2016

Methods in Pharmacology and Toxicology

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“…In Figure 9.18, a quantitative determination of API is performed during the blend process. Since 2007, a large number of publications have been written about NIRS and the blend process [150][151][152][153][154][155][156][157][158][159][160]. The use of this spectroscopy for blend monoriting has therefore been fully demonstrated.…”

Section: Powder Blendingmentioning

confidence: 99%

Near Infrared Spectroscopy in Drug Discovery and Development Processes

Roggo¹,

Dégardin²,

Ulmschneider³

2012

Physico-Chemical Methods in Drug Discovery and Development

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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.…”

mentioning

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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In-line quantification of drug and excipients in cohesive powder blends by near infrared spectroscopy

Cited by 68 publications

References 34 publications

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

Near Infrared Spectroscopy in Drug Discovery and Development Processes

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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