DEVELOPING A CONTROLLED RELEASE PRODUCT

The stability of a pharmaceutical product is paramount to the consumer's acceptance of it, as well as to its subsequent efficacy and safety.
Development of new excipients and drug delivery systems can be challenging as effectiveness, and perhaps cost, benefits can be mitigated when quality control problems arise during manufacturing. It is vital, therefore, that manufacturers scientifically assess any potential changes in the structure or character of their products throughout formulation, processing and distribution. That is where texture analysis plays a role in providing real-time information on the effects on physical quality of active ingredients, inactive ingredients and finished products.

The desired goal is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process. Texture analysis instrumentation enables manufacturers to do just this, offering targeted, repeatable testing that produces actionable data.
As the pharmaceutical industry innovates, so materials analysis evolves, developing and adapting to provide new instruments and methodologies for emerging requirements.

  1. Measuring Powder Compressibility and Effect of Tooling Geometry Tablet Hardness and Compactability
  2. Measuring Brinell Hardness
  3. Measure of Mechanical Strength or Failure Behaviour of Tablets
  4. Measuring Tablet Failure (via Diametral Compression)
  5. Measuring Tensile Strength (via Diametral Compression)
  6. Measuring Tensile Strength (via Three Point Bending)
  7. Measuring Shear Failure of Bilayer Tablets
  8. Tablet Disintegration
  9. Tablet Swelling
  10. Tablet Coatings: Adhesion Force

 

Pharmaceutical/Controlled Release

Controlled Release Product Testing

 

ORAL DELIVERY
 powder-compaction  granule-compaction  powder-flow-analysis-crop
Powder compaction
High or low tolerance Powder
Compaction Rigs allow measurement
of the compaction forces of powders.
Granule compaction
Cylinder probes can be used to
assess compressibility/fracture
strength properties of a single
granule or a mono-layer of granules.
Powder Flow Analysis
A Powder Flow Analyser provides a
tool for measurement of flow properties
such as caking, cohesion, flow speed
dependence.
 tablet-hardness  tablet-strength  mini-three-point-bend-rig-pharm
Tablet hardness
Indentation hardness utilises a
spherical probe to apply a specified
load to characterise tabletting
performance of individual
components and mixtures.
Tablet strength
Mechanical strength is an important
determinant of tablet drug release;
diametral compression provides
objective failure behaviour used to
monitor and control the degree of
compaction.
Mini 3 point bend
Allows measurement of mechanical/
tensile strength of small diameter
tablets, indicating ability to withstand
the rigours  of handling, transportation,
dispensing and usage.
 bilayer-rig  tablet-fast-melt-disintegration  tablet-swelling
Bilayer Tablet Shear Rig*
The improved version of this rig
enables tablet layer separation
to be quantified.
Tablet/'Fast Melt' disintegration
Provides a simple means by which
to establish onset, rate and time of
disintegration of fast dissolving tablets
or wafers.
Tablet swelling
Allows determination of dimensional
changes associated with matrix
hydration and swelling by using
small cylinder penetration.
 pellet-swelling  tablet-coating-adhesion-fixture  cylinder-probe-capsule
Pellet swelling
Progressive swelling behaviour
of pellets can be accurately
quantified during a defined
period of liquid absorption.
Tablet coating adhesion
Provides a quantitative measure
of the adhesion strength of the
coating to the tablet surface which
is useful for studying the consequences
of tablet coating formulation change.
Capsule burst strength
Cylinder probes are used for
puncture and compression of
capsules to assess puncture
resistance, burst point and
seal strength.
 capsule-loop-tensile-rig-pharm  tensile-grips-film  film-support-rig
Capsule/loop tensile rig
Measures the force required to split
one half of a hard gel capsule,
highlighting elastic stiffness, tensile
force and elongation at break point.
Tensile grips
Allow the investigation of tensile
properties of candidate films and
thus the clinical performance of
the final drug delivery device
formulation.
Film support rig
Allows the testing of thin, film-like
products to measure burst strength,
resilience and relaxation properties.

 

TRANSDERMAL/DERMAL DELIVERY
 peel-rig-90-deg  flexible-substrate-clamp  peel-strength-rig-bandage
90° peel rig
Peel strength of films or patch
formulations can be investigated
using porcine or synthetic skin
secured to the sliding platform of
a 90 degree peel rig.
Flexible substrate clamp
Offers easier sample mounting and
skin securing for the measurement of
the adhesion of a flexible substrate
material when withdrawn from a
sample.
180° peel test
For determination of the comparative
180° peeling or stripping characteristics
which are essential for the application
of adhesive bandages, dressings or
patches.
 spherical-probe-adhesion-test  peltier-plate  back-extrusion-aqua-cream
Spherical probe adhesion test
A 1" spherical probe is often used to
assess adhesive characteristics such
as 'tack', adhesive cohesion and
work of adhesion of transdermal
patches, wound dressings.
Peltier plate
Adhesive testing performed at
constant temperature (e.g. 35°C
for skin controlled by a Peltier Plate
attached to a texture analyser)
provides a more accurate
measurement.
Back extrusion
Assesses the consistency or
extrudability of such products as gels,
creams and lotions which affects
removal from containers and product
application.
PARENTERAL DELIVERY
 syringe-test-rig1  gel-properties  multiple-indexing-plate
NEW IMPROVED
Universal Syringe Rig*
Allows measurement of the
aspiration and extraction forces
of a wide range of syringe
types and sizes, for the delivery
of injectable cements or
polymers.
Gel properties
Typical measurements include gel
strength, Bloom strength (according
to ISO standard), rupture force,
adhesiveness, gel forming points
and elasticity/brittleness.
Multiple indexing plate
Allows ten adhesive measurements to
be performed and is quickly indexable
and centrally aligned to the next test
region for sample setting determination.
 stent-compression
Stent compression
A cylinder probe compression test
provides a measure of mechanical
strength, rupture force and elasticity
of coronary stents.
PULMONARY DELIVERY MUCOSAL DELIVERY
 inhaler-support-rig  mucoadhesion-rig
Inhaler support rig
Enables the performance of the
metering valve to be assessed
using a hemispherical probe which
best mimics the action of the finger
for drug delivery.
Mucoadhesion rig
Mucoadhesion measurement of solid
dosage forms, semi-solids and even
systems which solidify on contact with
the target organ can be performed.
RECTAL DELIVERY VAGINAL DELIVERY OCULAR DELIVERY
 suppository-penetration  intra-vaginal-rings  contact-lens-compression
Suppository penetration
Enables suppositories to be
accurately evaluated to compare
differences in ingredients,
processing conditions and
behaviour under different
temperature conditions.
Intra-vaginal rings
Measures the compressional force
required to depress vaginal rings
to determine mechanical strength
of the rings before and after drug
release.
Contact lens 
A cylinder probe compression test
provides a measure of mechanical
strength and flexibility/rigidity of
contact lenses.
The Texture Analyser Range

Compare Texture Analysers - take your choice of instrument

compare-plus compare-hd compare-express
taxtplus tahdplus taxt-express
Most popular
single column
Texture Analyser
for universal application
High capacity
versatile
twin column
Texture Analyser
Simple stand-alone
Texture Analyser
with limited capacity
and testing stroke
Capacity 50kg 750kg 10kg
Speed Range 0.01 - 40mm/s 0.01 - 40mm/s 0.01 - 10mm/s
Maximum Data Acquisition 500pps 500pps 400pps
Full Library Test Availability x x
Full Flexibility of
Test Programming
and Data Analysis
x x
Expandability x x
Ease of Use x
Portability x x

Typical measurements include:

  • Powder compaction forces of powders
  • Granule compressibility/fracture strength
  • Indentation hardness
  • Mechanical/tensile strength
  • Tablet layer separation
  • Rate of disintegration
  • Progressive swelling behaviour
  • Adhesion strength
  • Capsule burst strength
  • Film tensile properties 
  • Peel strength
  • Peeling characteristics
  • Adhesive cohesion
  • Extrudability
  • Gel strength
Principle
  • Stable Micro Systems
  • Rudolph Research Analytical
  • Novasina
  • 3NH Colorimeter
  • CENTEC
  • Triowin