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By Application AutoChem Applications Particle Size in Formulations


PARTICLE SIZE IN FORMULATIONS


MEASURE PARTICLES AND DROPLETS IN SOLID AND LIQUID FORMULATIONS TO OPTIMIZE
PROCESS DEVELOPMENT

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 * Overview
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CONTROLLING PARTICLE SIZE


IN FORMULATIONS & PRODUCT DEVELOPMENT

Particle and droplet size directly influence the bioavailibility and
manufacturability of liquid and solid formulations. For example, the development
of topical products requires tight control of droplet size and a clear
understanding of how the process parameters chosen at each scale influences
stability. Tablets break apart into small particles  during dissolution testing 
and the rate of disintegration directly influences Active Pharmaceutical
Ingredients (API) release rate. Suspensions used to fill meter dose inhalers
require tight control over particle size to ensure efficacy for the patient.


SOLID ORAL DOSAGE FORMULATION


QUANTIFYING DISSOLUTION & DISINTEGRATION

Quantifying tablet disintegration profiles in situ and in real time enables
scientists to reliably understand the breakage and dispersion mechanisms that
govern Active Pharmaceutical Ingredient (API) release rates. This essential
process knowledge can support the prediction of in vivo drug release profiles
during formulation development, and can help identify the root cause of
inconsistencies during release testing.

The resulting mechanistic information complements traditional offline
dissolution testing methods, and can support the development and release of
bioavailable, stable, and manufacturable dosage forms.

ParticleTrack with FBRM technology continuously monitors changes in particle
size and count as capsules an tablets disintegrate and dissolve. The resulting
mechanistic information complements traditional offline dissolution testing
methods and can support the development and release of bioavailable, stable and
manufacturable dosage forms.

ParticleTrack applications include:

 * Quality by Design
 * Disintegration Kinetics
 * Release Mechanism Determination
 * Risk Assessment
 * FDA Compliance
 * Tablet Dissolution for Process Understanding

Request More Information


MONITOR TABLET & GRANULE DISINTEGRATION


SOLID ORAL DOSAGE FORM DEVELOPMENT

Mark Menning of the Nucleo Life Sciences presents the role of in-process
particle measurement to complement traditional API dissolution studies. The use
of in situ particle size and count measurement illustrates efforts to develop
process understanding for solid oral dosage form development. This is
supplemented by case studies from Amgen, AstraZeneca, and Vertex who use this
approach.

 * Monitor Tablet & Granule Disintegration by Mark Menning PhD


EMULSION DROPLET SIZE AND STABILITY


CHOOSE OPTIMIZED PROCESS PARAMETERS

Emulsion droplet size and stability are critical parameters to consider during
the development of a topical or micro-encapsulated product. Characterizing
droplet size effectively allows scientists to solve process bottlenecks and
improve product quality. Traditionally, scientists have relied on offline
particle size analyzers to perform emulsion and suspension characterization.
Offline analysis typically requires sample preparation and sample dilution prior
to analysis which, in the case of emulsions, can significantly change the
droplet size in an emulsion sample within the time required for preparation and
analysis.

The emergence of Process Analytical Technologies (PAT) allows scientists and
engineers to track the rate and degree of change in droplet systems as they
naturally exists in process without the need for sampling or sample preparation:

 * Process Understanding for Emulsions
 * Monitoring Multi-Phase systems (Particles and Droplets)
 * Scaling-Up Emulsions


USING PAT TO OPTIMIZE EMULSIONS

Four case studies present how inline Process Analytical Technologies were used
to understand, control, and optimize emulsion processing. Topics include
creation of  fit-for-purpose droplets, observation of multi-phase systems, and
scale-up.


 * White Paper: PAT For Emulsions


INLINE PROCESS ANALYTICAL TECHNOLOGY


MEASURE PARTICLE SIZE IN REAL TIME

ParticleTrack and ParticleView are probe-based tools that measure changes to
particle size, shape, and count in real time. By applying inline analysis to
formulation development, scientists can obtain comprehensive process
understanding, avoid the errors and time delay associated with offline and
ultimately develop formulations with desired attributes in the shortest possible
time.   Click Request More Information below to gain technical expertise or to
assess the fit of your application with ParticleTrack and ParticleView
technology.

Request More Information


FOCUSED BEAM REFLECTANCE MEASUREMENT


INLINE PARTICLE SIZE, COUNT, AND SHAPE

A ParticleTrack probe with FBRM technology is immersed into a flowing slurry or
droplet system with no dilution necessary. A focused laser scans the surface of
the probe window and tracks individual chord lengths - measurements of particle
size, shape, and count. This real-time measurement is presented as a
distribution and statistics (eg. mean, counts) are trended over time.


APPLICATIONS


APPLICATIONS RELATED TO SOLID AND LIQUID FORMULATIONS


Tablet Disintegration and Dissolution
Solid Oral Dosage Form Development




Liquid Suspensions and Emulsions
Particle or droplet size and stability are critical in liquid formulations of
suspensions or emulsions




Tablet Disintegration and Dissolution



See details
Request Info
 * Overview
 * Related Products

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Liquid Suspensions and Emulsions



See details
Request Info
 * Overview
 * Applications
 * Publications

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PUBLICATIONS


PUBLICATIONS ON SOLID AND LIQUID FORMULATIONS




WHITE PAPERS

PAT For Emulsions
Use PAT for emulsions and suspension characterization without the need for
sampling or sample prep.
Monitor Tablet & Granule Disintegration
The role of in-process particle measurement to complement traditional API
dissolution studies is presented. The use of particle size and count measure...
Particle Size Analysis for Process Optimization
This white paper introduces some of the most common particle size analysis
approaches and how they can be deployed for the effective delivery of high...




ON-DEMAND WEBINARS

Emulsion Formulation in Consumer Products
This webinar discusses how to optimize the emulsion formulation process in
consumer products. Inline particle size measurement is used to improve the...
Online Monitoring of MicroEncapsulation
The effect that product and process variability has on microparticle is
essential for successful development, optimization, and scale-up of an
encapsu...
De-Emulsification and Emulsification of Petroleum-Water
In Petroleum, emulsions are often necessary in upstream transfer of crude oil
and in downstream separation of oil and water in the crude oil process....
Improve Emulsion Stability
Particle or droplet size is critical to improve the stability of emulsions and
liquid formulations. Ideally, scientists and engineers accelerate their...




RELATED PRODUCTS


PARTICLE SIZE MEASUREMENT TECHNOLOGY FOR FORMULATIONS




PARTICLE SIZE ANALYZERS

Understand, Optimize & Control Particle & Droplets With Real-Time In Situ
Particle Size Analyzers

Webinars
On Demand Webinar
 * De-Emulsification and Emulsification of Petroleum-Water

 * Online Monitoring of MicroEncapsulation

 * Emulsion Formulation in Consumer Products

 * Improve Emulsion Stability








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