Sirius SDi2The next generation of real timesurface dissolution imaging

Figure 1. IDR experiments using compact flow cell. 3 mg compact oftheophylline in simulated gastric fluid flowing at 0.8 mL/min.Absorbance data of theophylline in solution at A) 280 nm and B)255 nm, obtained from a single experiment.

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The Sirius SDi2 is designed specifically to accelerate your pre-formulation and formulation development. The next generationof UV imaging from Sirius, the SDi2 is used for investigating physical processes occurring at the solid-liquid interface duringdissolution. As well as measuring intrinsic dissolution and release rates of drug products, the SDi2 is ideal for quantifyingswelling, erosion and disintegration kinetics of a range of whole dosage forms. The SDi2 uses a powerful 4.2 megapixelActiPix™ detector to record ultraviolet and visible light intensity data in real-time and in two dimensions. It produces highresolution videos that record dynamic processes as they happen. The SDi2 uses a fully integrated fluidics system with achoice of two different flow cells to cover a broad range of applications and sample types.

Measure IDR (intrinsic dissolution rate) of API

Figure 3. Obscuration images of an extended release dosageform in a pH shift experiment from gastric to intestinal pH,using 520 nm LED at 1) t=0 and 2) t=6 hours. Width of tabletcan be measured from experimental onset.

Measure rate of swelling for extendedrelease dosage forms

Figure 5. UV absorbance images of 3D printed Warfarin & Eudragittablet in 0.1 M HCl at A) t=1 and B) t=60 minutes at 255 nm. Tablet sizereduces, while drug concentration in solution increases, indicated bydark blue to light blue false colour change in dissolution medium. FDM3D printed tablets produced by Dr. Basel Arafat and Dr. MohammedAlbedAlhnan , The School of Pharmacy and Biomedical Sciences,UCLAN, Preston, UK.

Measure erosion & drug release fromwhole dosage forms

Compact Flow Cell

Figure 2. Compact flow cell with direction ofdissolution medium flow

Whole dosage flow cell

Figure 4. Wholedosage flow cell withcapsule, showingdirection of dissolutionmedium flow

• Designed aroundwell-established USPapparatus 4 cell(flow-throughdissolution)

• A unique insight intomechanistic detailwhilst using familiar,widely accepteddissolution apparatus

• Designed around the original Nelson and Shah flowcell for dissolution under laminar flow (Nelson, K. G.;Shah, A. C., J Pharm Sci 1975, 64 (4), 610-4).

• Small volume cell uses minimal sample amount, idealfor research or early development

A

B

Direction of flow IDRzone

A B

Sample

FEATURES BENEFITS

Visualisation of physical phenomena in real-time

Provides a unique insight into the mechanistic understanding of thedissolution/release process as it happens. Applications include:

• IDR• Surface swelling• Disintegration/erosion rates• Cumulative mass loss/drug release• Concentration gradients• Diffusion properties• Microenvironmental pH changes (using pH sensitive dye)

Use of linear velocity flow enables steady state conditions, ensuringreproducible results.

Compact flow cell• Minimal sample requirements• Small cell volume• Compatible with a variety of sample typest

For use in research and early development where compoundavailability is limited. With a design based around Nelson and Shahflow-through cell, intrinsic dissolution rates of poorly soluble drugs canbe measured in minutes, rather than hours or days. Study powders,suspensions, creams, gels, liquids, granules, crystals, stents, implantsand transdermal patches.

Whole dosage flow cell• Compatible with variety of dosage forms

For use in formulation and development of final dosage form. Designis based on USP apparatus 4 flow cell, using equivalent linear velocitieswith the added benefit of real-time visualisation. Study tablets,powder/gel capsules and extended release formulations.

Dual wavelength capability A selection of narrow bandwidth LEDs provide the light sources,including 4 UV wavelengths and one in the visible range. Twowavelengths can be selected, allowing the user to study drugconcentration in solution and solid state effects or drug versusexcipient behaviour in a single experiment.

Fully integrated and automated fluidics system• Use one or two media per experiment• Open or closed loop• Use biorelevant media• Multiple flow rates per experiment

Highly flexible and automated fluidics system has been designed forease of use. Default methods are provided, for example, to study theeffect of pH change from gastric to intestinal media in a singleexperiment and using physiologically relevant flow rates. Standardfittings give users the freedom to add their own analytics inline ifrequired.

Raman Compatible Ideal for early development stages with limited compound availabilities

cam

era c

hip

Waste

Buffer

Option to recirculate

Option to use Whole Dosage Flow Cell or Compact Flow Cell

Figure 6: Schematic of SDi2instrumentation. Up to twodifferent wavelength LEDs areused to alternately illuminatesample in chosen flow cell.Sample absorbance orobscuration is recorded usingthe Actipix™ camera chip.Buffer is heated to 37°C beforeentering the flow cell. Uponexiting the flow cell, buffer withdissolved material is eitherpassed to waste, orrecirculated.

Distributed by:

SAMPLE CAPABILITY

Compact cell 3 mm diameter compact 3-10 mg sample amount

Whole dosage cell Wire frame tablet holder20 mm maximum tablet length

FLOW CELLSWhole dosage cell volume 60.3 mL

Whole dosage viewing area 28 mm height x 24 mm

Whole dosage path length 28 mm at centre

Compact cell volume 1.54 mL

Compact cell viewing area 4 mm height x 26 mm width

Compact cell path length 9 mm

pH range 1.0-10.0

OPTICS

Available Wavelengths ultraviolet: 255, 280, 300 and 320 nm ±5 nmVisible: 520 nm ±5 nmDual wavelength capability

FLUIDICSWhole dosage cell flow rate 6.2 – 24.6 mL/min

Compact cell flow rate 0.8 – 2.2 mL/min

Media volumes Determined by userUp to two different media can be used in a single experiment

CAMERAFrame rate 1 frame per second per wavelength

Effective pixel size (resolution) 13.75 nm

TEMPERATURE CONTROLRange Ambient to 37 ºC

SOFTWAREVideo export Windows media video

Data export Microsoft Excel

SYSTEMOperating temperature range 5-40 °C

Input voltage 100-240 V ~1.2 A, 50/60 Hz )

Dimensions (H x W x D) 375 mm x 750 mm x 345 mm

Press type Manual compact press with load cell

TECHNICAL SPECIFICATION

Sirius AnalyticalRiverside, Unit 12, Forest Row Business Park, Forest Row, East Sussex, RH18 5DW, UK

Telephone: +44 (0) 1342 820720Fax: +44 (0) 1342 820725Email: sirius@sirius-analytical.comweb: www.sirius-analytical.com