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Pharmaceuticals

Characterization offers wide scope for Thermal Analysis and Calorimetry
A Pharmaceutical Dossier has to be established, requiring physical characterization of the API and the pharmaceutical dosage form (PDF). Characterization offers wide scope for thermal analysis and calorimetry.
Setaram provides an extensive range of equipment for:

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- salt choice,
- polymorphism screening,
- crystallinity,
- determination of solubility and its kinetics,
- stability as a function of temperature and humidity,
- amorphous content.

As the PDF is the association of an API with an excipient, the latter should be chosen in accordance with:
- industrial manufacturing process constraints,
- good physical-chemical compatibility with regard to stability, dissolution and bioavailability,
- shelf life.
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Pharmaceuticals
SETARAM offers a complete solution
Most thermal analysis of pharmaceutical products require high-sensitivity instruments because:

- only small amounts of sample are usually available;
- transitions and transformations involve very low energy levels and are therefore difficult to observe.
Setaram's range of high sensitivity, original technology thermal analysis instruments offers the pharmaceutical world unique measuring possibilities.

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- Setsys Evolution, coupled with our Wetsys: study of hydroscopicity phenomena and water content determination.

- MicroDSC III: compatibility between the API and different excipients.

- TSC II: differentiate two polymorphs, detection of very low level of amorphous phase and stability study at the end of the formulation process.

- C80: determination of heat of solution of two crystalline forms, heat correlated directly with melting heat.

- DSC 131: purity of your drug.

- SENSYS: salt form characterization.
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Customer Testimonials
Customer Testimonials X
Applications of Thermal Analysis at Eli Lilly
(Indianapolis, IN − SA)
Tera L. Deal & Bradley M. Campbell

‘We purchased a Setaram micro DSC III and micro DSC VII about two years ago. "These microcalorimeters have several advantages over their competitor’s instrumentation and rapidly became two important assets of our laboratory. A first advantage of the micro DSC III and VII is the removable cells allowing for relatively easy sample preparation and cleaning, which leaves more time for laboratory experiments rather than housekeeping. Another advantage is the excellent hardware and software. The high sensitivity, stable baseline and low background noise mean that analysis only requires a small amount of costly sample, keeping costs to a minimum. The user-friendly software also allows for quick turnaround of accurate results, making this instrumentation an essential productive laboratory tool.’

Jeff Rachford, owner of an international microcalorimetry consulting firm (Thermalcal), built his labs at Eli Lilly and Eastman Kodak around Setaram instruments. The combination of high sensitivity, and versatility, unique to the Setaram line, resulted in Rachford's group succesfully supporting the entire drug development process, from discovery, formulations, launch, and post launch for both small and large molecule systems.
Some references
Some references X
Abbott Laboratories – USA
Eli Lilly – USA
GlaxoSmithKline – UK
Pfizer – USA
Sanofi-Aventis – France
Kanagawa University – Japan
Facultad de Farmacia de Sevilla – Spain
University of Naples – Italy

High-sensitivity DSC and isothermal microcalorimetry (-20 to 120°C) with in-situ mixing possibilities

High-sensitivity DSC and isothermal microcalorimetry (-20 to 120°C) with in-situ mixing possibilities
 
µDSC3 evo
µDSC3 evo is the lastest generation of the most popular microcalorimeter of Setaram. Its high sensitivity and versatility makes this instrument a star in many industrial and academic research laboratories all around the world.
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Reaction, isothermal and scanning calorimeter (ambient to 300°C)

Reaction, isothermal and scanning calorimeter (ambient to 300°C)
 
C80
Using SETARAM's exclusive 3D-Sensor calorimetric sensor, the C80 offers in-situ calorimetric measurement possibilities on mixtures, solid or liquid interactions with liquid or gas.
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An innovative line of Thermal Analyzers (-120 / 830°C) with 3D-Inside technology: DSC, High Pressure DSC, Robot DSC, TG-DSC-EGA

An innovative line of Thermal Analyzers (-120 / 830°C) with 3D-Inside technology: DSC, High Pressure DSC, Robot DSC, TG-DSC-EGA
 
The SENSYS evo offers the most precise DSC sensor together with a truly symmetrical microbalance to give YOU a combined TG-DSC system with totally unmatched performance. Additionally both measurement sensors are totally independent,so can be operated independently or simultaneously without compromising performance.
SENSYS evo can be used in various configurations:
- DSC in horizontal or vertical mode
- High Pressure DSC(up to 500 bars at 600°C)
- Robotic DSC, with 48 samples, even under pressure
- Simultaneous TG-DSC-coupling to gas analysis (BET, gas sorption, FTIR, MS)




Thermally Stimulated Currents, the solution to accessing the finest structural information

Thermally Stimulated Currents, the solution to accessing the finest structural information
 
TSCII
This thermal analysis method uses MOLECULAR MOBILITY to access structural information that cannot be obtained by any other technique. It also gives access to dynamic parameters (ΔH, ΔS and relaxation time ζ). Properties measured by TSC include polymorphism, crystalline/amorphous rate, purity, glass transition, relaxation phenomena, etc.
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More Thermal Conductivity Testing in less time

More Thermal Conductivity Testing in less time
 
TCi
The C-Therm Technologies TCi is truly a 'one size fits all' thermal conductivity tool. No other instrument can test solids, liquids, powders, and pastes. Within a material type, the technology has the attributes necessary as a lab tool to accelerate your research & development efforts or improve your quality control. As an added bonus, the technology can be migrated to the shop floor to gain insights into your production processes.
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An-easy-to-use Differential Scanning Calorimeter DSC (-170 to 700°C) with a 3-year warranty

An-easy-to-use Differential Scanning Calorimeter DSC (-170 to 700°C) with a 3-year warranty
 
DSC131 evo
DSC131 evo: for testing, QC and academic thermal analysis laboratories. An instrument designed from the ground up to be robust, high performance and above all user friendly featuring market leading intuitive CALISTO software and low operating costs.
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Controlled Humidity Generator

Controlled Humidity Generator
 
Wetsys
Humidity is known to have a significant influence on the stability of many materials. The controlled humidity generator WETSYS can: - deliver a very precise level of relative humidity (RH) from 5 to 95% depending on the temperature - be connected to other SETARAM instruments, and in particular to the SENSYS TG DSC as well as other analysis instrument (RX, GC, etc.) for studies of sorption, hydration, stability, etc.
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A fully automated Sieverts instrument for measuring gas sorption properties of materials

A fully automated Sieverts instrument for measuring gas sorption properties of materials
 
PCTPro-2000
This quality instrument is specifically designed for high precision measurements over a wide range of sample sizes, pressures and temperatures
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PID controlled Cryostat for 4 to 373 K gas sorption measurements

PID controlled Cryostat for 4 to 373 K gas sorption measurements
 
CryoPro
The CryoPro is coupled to the PCTPro-2000 for constant temperature measurements from liquid helium to 100°C and pressures from vacuum to 200 bar.
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Sample attachment for the PCTPro-2000 Sorption Gas Analyzer

Sample attachment for the PCTPro-2000 Sorption Gas Analyzer
 
MicroDoser
The MicroDoser Sample Attachment connects to the PCTPro-2000 to allow measurements on samples from only a few milligrams to gram sizes.
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Stand-alone High Pressure Mass Spectrometer for gas composition analysis from 200 bar to 10-8 mtorr

Stand-alone High Pressure Mass Spectrometer for gas composition analysis from 200 bar to 10-8 mtorr
 
RGAPro
The RGAPro is a residual gas analyzer designed to work with the PCTPro-2000 or any other gas process for real-time compositional analysis of a wide range of gases.
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 Application Notes
Compatibility drug-excipient

Analysis of hydrochloride dihydrate salt

Effect of KCl and NaCl on a thermal properties of gellan gum gels

Mixed gels formed with konjac mannan and xanthan gum

Tg of a solution prior to its freeze-drying

Stability of human growth hormone

Determination of crystalline.amorphous phase

Behaviour of a Drug under Controlled Humidity

Adsorption of CO2 on a drug during its transport in dry ice

Characterization of CTAB-based w/o microemulsions

Engineering Monoclonal Antibodies to Enhance Drugability: A Case Study

See all application notes

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