Lyotherm2Thermal Analyser

Lyotherm2 is a unique cutting edge technology pioneeredby Biopharma Technology Ltd with the help of ProfessorLouis Rey as a solution to some of the most difficultchallenges faced by freeze drying R&D scientists

Lyotherm2

Biopharma Technology Ltd has used Lyotherm2 to analyseover 500 different formulations, from small drug molecules tolarge complex biomolecules for biopharmaceutical companiesworldwide

This method is sensitive to endothermic and exothermic processes

Measures the difference in temperaturebetween a sample and a reference as heatis applied or removed from the system.

Differential Thermal Analysis

and exothermic processes

Exotherms

•Crystal transitions•Crystallization

Endotherms

•Melting•Transitions in the frozen state

Impedance analysis is fixed frequency dielectric analysis

It can provide an indication of the mobility of a sample in

Impedance Analysis (ZSinφ)

of the mobility of a sample in its frozen state, as

demonstrated in a study carried out by Professor

Louis Rey*

*Freeze-Drying/ Lyophilization of pharmaceutical and biological products. Vol 137, “Drugs and the pharmaceutical sciences” series. 2nd edition, Eds L. Rey, J.C. May, Marcel Dekker Inc., New York

Benefits of Using Lyotherm2

• It can help improve old and develop new formulations

• It can provide essential data to develop cycles on a rational scientific basis

• It can save valuable development time and money• It can save valuable development time and money• Enables rapid determination of frozen state

behaviour• Archives data for future reference• Not limited to freeze-drying research but to all frozen

state applications

AdvantagesLyotherm2 performs a similar function to DSC (differential scanning

calorimetry) as it has a built in differential thermal analyser which

identifies significant thermal events.

The advantage of Lyotherm2 is that it combines DTA with an Impedance

Analysis (ZSinφ) function, which can provide an indication of the

mobility of a sample in its frozen state. Thus giving a more complete

picture of the events occurring within your product than thermal analysis

alone.

Lyotherm2 System Components

Aluminium heating block designed to distribute heat evenly, minimising variation

between samples

Dewar for rapid cooling by Liquid

Nitrogen

System Components

DTA Probes (Sample and Reference)

Impedance probe (ZSinφ) Lyotherm2 Control Box

1. Load 3ml samples into 2 individual sample holders

2. Load a 3ml reference (solvent) sample for DTA analysis

3. Place probes into 4. Place and secure

Assay Procedure

3. Place probes into sample holders

4. Place and secure sample holders into

block

5. Initiate data logging using Lyotherm2 software

6. Lower heating block into

Assay Procedure

6. Lower heating block into Dewar 1/3 filled with LN2

7. When sample and reference are below -100°C, switch on heating.

Graphical plots of both the ZSinϕand DTA values are available

tracking the raw data.

Data Recording

Near-linear cooling rates are provided by the thermally

distributing design of the sample holding block.

Real-time analysis of both

ZSinϕ and DTA give results

during the analysis,

updated every 5 seconds.

This provides usable data

Data Analysis

This provides usable data

before the analysis is

finished.

The software package

allows you to export

your data directly to

Microsoft Excel for easyE

lect

rica

l Im

ped

ance

Z (

kOh

ms)

Del

ta-T

(°C

) (E

nd

o D

ow

n)

Data Analysis

data interpretation and

graph manipulation

Temperature (°C)

Ele

ctri

cal I

mp

edan

ce Z

(kO

hm

s)

Determination of critical temperatures and / or annealing

step requirement

‘Trial and Error’ Cycle resulting in loss of product

New cycle based on actual

parameters

Problem Solved

Lyotherm2 provides you with essential information on the critical temperatures of your formulation, enabling you to get

the best results from your product

Biopharma House, Winnall Valley Road, Winchester SO23 0LD, UK

Tel: +44 (0)1962 841092 Web: www.btl-solutions.net