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SDi2

SDI2 is a unique tool that allows scientists to uncover precisely what’s happening at the solid-liquid interface during the dissolution process. It enables the accurate measurement of intrinsic dissolution and release rates using very small sample amounts in addition to monitoring the swelling, erosion and disintegration processes for a wide range of whole dosage forms. 

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Overview

Ideal for use from pre-formulation through to CMC and final dosage form selection, the SDi2 uses a powerful 4.2 megapixel ActiPixTM detector to capture both ultra-violet and visible light recordings of the dissolution process, as it happens. The SDi2 generates high-resolution 2-D videos that uncover how these dynamic processes take place in real time. The SDi2 combines a fully-integrated fluidics system with a choice of small scale or whole dosage form flow cells. This allows researchers to study a wide range of sample types across the drug development timeline.

Applications

SDI2 gives scientists the ability to...

  • Measure the intrinsic dissolution rate (IDR) of API with small sample amounts compared to conventional methods, making this measurement viable in a pre-formulation labScreen of the dissolution performance of different salts and polymorphs on small batches
  • Study the effect of pH changes and simulated media on drug release from the sample sur-face
  • Rank order the release rates of API from a range of formulations at an early stage
  • Review and compare the mechanical process of dissolution of whole dosage forms held within a flow cell designed around the USP 4 apparatus.
  • Combine SDi2 with Raman spectroscopy to study solution-mediated solid-state changes and their effects on dissolution rate.
  • Optimise the manufacturing process of whole dosage forms to achieve the desired drug release profile Effectively troubleshoot formulation issues with insights that cannot be obtained using conventional dissolution methods

Features

Real-time visualisation

Real-time UV and visible light intensities are captured by the built-in Actipix™ detector providing a detailed, spatial view of the dissolution process directly at the solid-solution interface; a view that is unattainable with conventional dissolution methods. The dual wavelength capability allows for the measurement of drug concentration and monitoring of the physical processes in a single ex-periment.

Flexible data processing tools

While all the imaging area is available for data processing, the most commonly used measurements and calculations are applied to the data by default for ease of use.

Choice of flow cell

The small scale and whole dosage flow cells can be quickly and conveniently exchanged, making the system suitable for a wide range of pharmaceutical development applications.

Automated fluidics

Dissolution media can be automatically changed at a pre-defined time during any experiment, for example, from gastric to intestinal pH media. Built-in flushing and cleaning procedures make for ease of use and help avoid cross contamination in the flow through set-up.

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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Consumables

Compact Holder Assembly

21015-0018

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SDI-2 Accessories Kit

21015-0019

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Whole Dose Cell

21015-0008

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Compact Flow Cell

21015-0007

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SDI-1 Sample Cups (10 Pack)

S1901114

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Analytical Services

Analytical Services

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Products at a glance

Products at a glance

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Analytical Services

Analytical Services

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Resource Library

Resource Library

Latest citations of Pion instruments and services in industry white papers, webinars, videos, and case studies.

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