Excipients

By testing the powder at each step, you can be sure that the chosen
excipient will improve the following attributes of solid dosage forms:
Stability | Content uniformity | Resistance to defects | Dissolution rate | Bioavailability

Density, particle size,
compressibility, andflowability can beused to define thegranule strength anduniformity, as well as
the water loss afterdrying.

Granule moisture canbe investigated bylooking at the porosity,
density, particle size,and cohesiveness.

WET
GRANULATIONINPUT
MATERIALS

DRYINGSOLIDDOSAGE FORMBLENDING

Active Pharmaceutical Ingredients(API) + excipientsDRYGRANULATIONFirst of all, thefollowing propertiesof the incoming
materials have to bechecked:Particle properties- size- density- porosity- surface area
Bulk properties- powder flow
- moisture- adsorption- bulk density- tapped density- compressibility- crystal structure- phase purity

The particle size,
surface area, density,
flowability andcohesion strength ofthe powder mix affectcontent uniformity andcan be monitored toprevent segregation.

Granule surface
area, porosity, size,
crystal structure, andflowability will impact
further processing
steps such astableting and capsulefilling.

The unbeatable team for excipients characterization

Autotap | Ultrapyc | Nova series | VSTARMCR powder rheology

PSA particle size analyzers

Surface area plays a major role in the purification, processing, blending and tableting, of pharmaceutical powders, ingredients,APIs, and excipients. Surface area also impacts shelf life, dissolution rate, and bioavailability and can be measured using
Anton Paar's Nova series gas sorption analyzers. Water sorption measurements on VSTAR allow you to correlate water vapor
sorption uptake with important information regarding the shelf life, water sorption rates, and hydrophilicity of your compounds.
The Autotap solid density analyzer supplies a definitive measure of powder compressibility to help you make intelligent decisions
regarding densification and tableting. Measuring the true density with Ultrapyc 5000 provides essential data about the texturalproperties and gives you confidence that you are delivering compounds in the correct crystalline state.

Solid dosage forms in pharmaceutics consist of a mixtureof active pharmaceutical ingredients and excipients.
With MCR Evolution rheometers excipients can becharacterized in all phases of the production and theimpact of processing parameters can be investigated.
Flowability and compressibility are parameters that canbe easily determined by an MCR Evolution rheometerequipped with a powder flow cell and a powder shear
cell. Tests at different temperatures and humidities leadto a better understanding of the powder behavior during
handling and processing. The change in flowability due tomoisture uptake helps predict the suitability of the powderfor granulation or direct compression. Determination ofcompressibility and cohesion makes it possible to improvethe manufacturability and stability of tableting and capsulefilling processes. In this way common manufacturing
defects can be avoided.

PSA by Anton Paar helps reduce the costs and timerequired by a multiple-step process such as tableting.
The behavior of excipients can be investigated directly at
the production line under defined processing conditions.
The particle size measurement allows you to define theimpact on flowability and compressibility. Fine excipientstend to reduce the powder flow because they provide agreater surface area for surface cohesive forces to interact
with, resulting in more cohesive flow. The granulation step
helps increase flowability. Therefore, the compaction isimproved due to the reduced stickiness of the powder tothe pressing punch and higher filling capacity of the dieduring tableting. The right particle size results in tabletsand capsules that are more resistant to handling failure
and packaging problems.

Main features of an MCR Evolution rheometer with apowder flow cell and a powder shear cell

Main features of the PSA series- Compliant with QM requirements likeGMP or 21 CFR Part 11- Measures excipients in dry form or dispersed in any
suitable liquid – both with just one setup- Easy, safe, and clean sample handling and preparation- Accurate and repeatable particle size distribution- Precise temperature and humidity control- Stability for a lifetime- Modular rheometer concept for fluidized andconsolidated powders, as well as for suspensions
and solids (with other MCR accessories)- Compliant with QM requirements like
GMP or 21 CFR Part 11

Measure surface area, solid density, and water vapor sorption

Main features of Autotap

Main features of the Nova series- Simple and easy to use, incorporating a high degreeof automation- Fully suited for surface area and mesopore analysis,
conforms to USP <846>- Compliant with most internationally recognized
standard methods, including USP <616>- Measures up to four samples simultaneously, and inparallel prepares up to four more samples- User-selectable, lockable number of taps provides
reproducible test method parameters- Proprietary small cold-zone technology for improved
sensitivity

Main features of Ultrapyc- Integrated touchscreen displays real-time data andsimplifies user experience- TruPyc technology for accurate results over thewidest available sample range- TruLock lid delivers unmatched repeatability- Peltier temperature control provides stability of better
than ±0.05 °C- PowderProtect mode for safely measuring finepowders- Conforms to USP <699>

Main features of VSTAR- Dosing manifold and vapor source in a single
thermostatically controlled chamber- Superior manifold temperature control from the vapor
source to the sample eliminates the possibility oflocal condensation of the adsorptive and ensures thehighest accuracy- Ability to analyze up to four samples simultaneously
provides unprecedented throughput

Measure powder flow properties

Measure particle size

- Multiple-laser technology for a wide range of particle sizes

The unbeatable team for excipients characterization
We’re conﬁdent in the high quality of
our instruments. That’s why we provide
a full warranty for three years.
All new instruments* include repair for three years. You avoid unforeseen costs
and can always rely on your instrument. Alongside the warranty, we offer a wide range ofadditional services and maintenance options.
*Due to the technology they use, some instruments require maintenance according to a maintenance schedule.
Complying with the maintenance schedule is a prerequisite for the three-year warranty.

XRDynamic 500 powder X-ray diffractometer
Measure crystal structure, phase purity, and crystallite size

Service and support directly from the manufacturer
Our comprehensive service provides you with the best individual coverage foryour investment so that maximum uptime is ensured.

Crystal structure, crystallite size, and phase purity play a crucial role in determining the physical properties of pharmaceuticalpowders such as APIs and excipients. X-ray diffraction (XRD) measurements with Anton Paar’s XRDynamic 500 can be used
to study all of these properties and much more. Pharmaceutical powder materials can be investigated at every stage of thedevelopment and manufacturing process, across assessment of the quality of raw materials, blended ingredients, and finalproducts. In addition to standard measurements under ambient conditions, non-ambient XRD studies can also be used toexamine possible structural changes when the samples are exposed to high/low temperatures or dry/humid atmospheres andenvironments, for a complete understanding of the behavior of pharmaceutical powders under all conditions.

Safeguarding your investment
Regardless of how intensively you use your instrument, wehelp you keep your device in good shape and safeguard yourinvestment – including a three-year warranty.

XRDynamic 500- Right out of the box: Best-in-class resolution / signal-to-noise ratio- TruBeam™ concept: Larger goniometer radius and evacuated beam path

24The shortest response time
We know that sometimes it’s urgent. That’s why we provide
a response to your inquiry within 24 hours. We give you
straightforward help from real people, not from bots.

- Full automation: X-ray optics and beam geometry change- Self-alignment: Instrument and sample, for maximum convenience- Compliant with most internationally recognized standard methods, including USP <941>

Certiﬁed service engineers
The seamless and thorough training of our technical experts isthe foundation of our excellent service provision. Training andcertiﬁcation are carried out at our own facilities.

Our service is global
Our large service network for customers spans 86 locations witha total of 350 certiﬁed service engineers. Wherever you’re located,
there’s always an Anton Paar service engineer nearby.

www.anton-paar.com© 2022 Anton Paar GmbH | All rights reserved.
Specifications subject to change without notice.
document
numberXPAIP115EN-D