IDR Imaging

Real-time UV and visible light intensities are captured by the Surface Dissolution Imaging instrument providing a detailed, spatial view of the dissolution process directly at the solid-solution interface; a view that is unattainable with conventional dissolution methods. This allows for the measurement of drug concentration and monitoring of the physical dissolution processes in a single experiment.

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Introduction

The Intrinsic Dissolution Rate (IDR) is a measure of the rate of dissolution of a pure active pharmaceutical ingredient (API) where the conditions of surface area, temperature, agitation/stirring speed, medium pH and ionic strength are all kept constant. A well-defined surface area is presented to the dissolution medium by preparing a flat tablet disc of specific size. IDR is important during the development of new drug molecules as it is possible to predict potential problems using small quantities of material.

It has applications in evaluating drug solubility in accordance with the biopharmaceutics classification system (BCS), comparison of the dissolution rate during salt selection or polymorph screening to choose the best candidate, and setting specifications for particle size in order to achieve complete dissolution of the required dose within the typical gastrointestinal transfer time. Disc IDR imaging can be applied to promising drug candidates to guide early development efforts to improve a drug’s in vivo characteristics.

Sample submission details

20 – 50 mg of dry compound is required for this assay.

Key deliverable

The IDR (mass/time/area) for each sample is determined for the chosen buffer system. Images of the dissolution process are recorded. A full study report is provided.

Experiment overview

In the disc method, the drug powder is compressed into discs of fixed diameter. Theoretically, this results in an exact and constant surface area that is in contact with the dissolution medium during the full time of the experiment, and this is the major advantage of this method. The miniaturized commercially available device, the SDi2 (Surface Dissolution Imaging) platform, is used to record images of the dissolution process at the surface of the compact and is able to rank-order DIDR (µg/min/cm2) and visualise the dissolution of APIs and salts during early development.

The Surface Dissolution Imaging IDR measurement is based on flow-through dissolution and direct UV imaging of the flow-cell. The technique records the release of material directly from the surface of a 3mm compacted disc of API and from near downstream to calculate IDRs. The instrument comprises a sample flow cell, pump system, light source and ActiPix detector, and control and data analysis software. The ActiPix detector uses a complementary metal oxide semiconductor (CMOS) image sensor containing over 4 million pixels for recording light transmission through the flow cell. Light at pre-selected single wavelengths (selected between 255 – 520 nm) is flashed at pre-set time intervals and is used to illuminate the flow cell.

A pump is used to flow buffer at a pre-set controlled temperature through the flow cell. The transmitted light in the presence of flowing medium is captured by the detector during the sample run and the light intensity at each pixel is converted into an absolute absorbance. The images collected for the duration of the experiment are used to create a movie that provides a detailed view of the dissolution process at the solid–liquid interface and downstream of the compact.  Applying proprietary software tools then allows extraction of standard disc intrinsic dissolution rate values of (mass/time/area) which are easily calculated from the volumetric flow rate and the absorbance values downstream of the compact.

Resources

Design and development of a novel diffusion cell for advanced UV imaging to characterise pharmaceutical formulations

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Tailored on demand anti-coagulant dosing: An in vitro and in vivo evaluation of 3D printed purpose-designed oral dosage forms

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Effect of preparation method on the surface properties and UV imaging of indomethacin solid dispersions

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Development of a novel method utilising dissolution imaging for the measurement of swelling behaviour in hydrophilic matrices

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UV imaging in pharmaceutical analysis

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Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging

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Application of UV Imaging in Formulation Development

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Variable-focus microscopy and UV surface dissolution imaging as complementary techniques in intrinsic dissolution rate determination

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Microenvironmental pH measurement during sodium naproxenate dissolution in acidic medium by UV/vis imaging

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Simultaneous UV Imaging and Raman Spectroscopy for the Measurement of Solvent-Mediated Phase Transformations During Dissolution Testing

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Detection of poor acid resistance of enteric coats using the SDI

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AAPS Advanced imaging, detection and prediction of initial gel formation and swelling of hypromellose compacts

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Direct imaging of the dissolution of salt forms of a carboxylic acid drug

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Evaluation of in vitro tests to reduce animal testing in drug toxicology studies

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Faster Dissolution Methods

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Low Volume Dissolution Assays

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The effect of dissolution media, torque and flow speed

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AAPS Understanding drug release mechanisms of metformin using complementary in vitro dissolution tools

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Visualising the release patterns of promethazine across microparticulate systems

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Use of SDI to assess dissolution characteristics - John Comer (Pion)

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Application of the SDI in Pharmaceuticals - Mei Wong (Pfizer)

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Characteristics of Felodipine ‐ HPMCAS Solid Dispersions

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SDi Digest

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Understanding drug release mechanisms from diclofenac tablets using the SDi2

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Validation of the SDi2 intrinsic dissolution rate measurement

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Using SDi2 to characterise swelling and drug release profiles

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SDi2 Brochure

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Biorelevant drug release of Metformin dosage forms using complementary in vitro tools

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Assay part number

Gold Standard SDI2 Compact Cell Assay in Aqueous Buffer

1811101

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Gold Standard SDI2 Compact Cell Assay in Biorelevant Media

1811102

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Gold Standard SDI2 Compact Cell Assay with Excipients

1811104

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Platinum Standard SDI2 Compact Cell Assay in Aqueous Media

1811111

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Platinum Standard SDI2 Compact Cell Assay in Biorelevant Media

1811112

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Platinum Standard SDI2 Compact Cell Assay with Excipients

1811114

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