An Introduction to Malvern

Spectris Business Overview

› UK plc quoted in London Stock Exchange
› $2.0 billion in sales in 2014
› Over 8,000 people
› 14 operating companies across 4 divisions

Laboratory / Off-line Process / Manufacturing

MATERIALS TEST AND IN-LINE INDUSTRIAL
ANALYSIS MEASUREMENT INSTRUMENTATION CONTROLS

Pharma/life Automotive Process industries General mfg

sciences Aerospace Pulp & paper Distributors
Mining/metals Environmental Energy Machine building
Semiconductors
Materials Analysis:

Materials characterisation – measurement

of attributes that influence product
properties
Elemental and structural analysis -
determination of composition and structure
of materials

Contamination monitoring – measurement

and control of clean environments
Malvern Instruments: Facts and Figures

› Sales of $200m in 2014

› 94% sales outside UK
› CAGR 13%
› Over 28,000 installed systems
› High levels of repeat business
and after sales revenues
› 925 people worldwide
› Direct sales in 15 countries
› More than 50 distributors and
agents
› ISO9001 / 14001 / 18001
 Malvern worldwide

17 dedicated applications
laboratories

27 offices in 15
countries 4 manufacturing operations
across 3 continents
 Malvern’s Characterization Portfolio

► Laser Diffraction ► Imaging ► DLS

► Rheology ► GPC/SEC ► Process Control

 Our goal is to help solve your analytical challenges
through our expertise by presenting solutions to yo
ur characterization requirements
 › Process control › Particle size, shape
and chemical
› Particle size
composition

› Rheology

› Molecular weight

Material relationships
› Zeta potential

› Resonant mass › Particle size,

concentration and
Fluorescence
 Material Relationships

An Example from the Pharmaceutical Industry

Why is particle size control important for the
pharmaceutical industry?

› Particle size relates to critical parameters such as:

 Flowability
 Viscosity
 Content uniformity
 Tablet compressabilty
 Mechanical strength
 Storage stability
 Dissolution dynamics
The process of Pharma tabletting

 Flowability  Mechanical strength

 Content uniformity  Dissolution dynamics
 Tablet compressabilty
Dissolution dynamics

Läkemedel och kristaller

Karin Lilltorp, Soren Lund Kristensen, Particle Analytical APS
Kemiivärlden Biotech, No. 9, September 2013
Dissolution dynamics
› Particle size and the surface area of the drug have significant
influence on the drug dissolution rate
› Finer powders dissolve more rapidly, and those with a narrow size
distribution all dissolve at a similar rate

Noyes-Whitney equation

L
dW/dt rate of dissolution
D diffusion coefficient
A surface area
Cs concentration of material in the diffusion layer
C concentration of material in the bulk liquid
L diffusion layer thickness
Dissolution dynamics

Mathematical Modeling of a Novel Controlled-Release Dosage Form

Dr. David R. Friend Delsys Pharmaceutical Corporation
Drug Development & Delivery, Vol.1 , No. 1, October 2001
Tablet Dissolution behaviour
› Similar particle size distributions
› Different dissolution profiles
Tablet Dissolution behaviour
› Difference in surface roughness
› Lower convexity (edge roughness)
– higher surface area – faster diss
olution

Convexity

Morphologi G3
Tablet coating sprays
› Coatings applied to tablets to provide:
 Colour / patient recognition
 Differential absorption within GI tract
 Ease of swallowing
› Coating spray size helps define:
 Coating thickness
 Coating uniformity
 Transfer efficiency
 Possibility of table bridging
 Coating nozzle
100
5 ml/min
10 ml/min
15 ml/min
80
Cumlative Volume (%)

60

40

20

0
0.1 1 10 100 1000 Spraytec
Droplet Size / Microns
One method of improving product stability is to
use viscosity-modifying excipients

KINEXUS
Material relationship
› Particle size › Particle size and shape
 Flowability  Dissolution Dynamics
 Tablet compressability  Content uniformity
 Mechanical strength
 Dissolution dynamics

› Droplet size
 Spray coating
› Rheology
 Viscosity
 Flow properties