Parteck® Delta M

PARTECK ®
Functional Particle Engineering
...For Optimal Performance
Parteck® Delta M
Advancing Your Life Sciences –
From Discovery to Launch

Mannitol
· Non hygroscopic
· Non reactive
· Compatible with amines
· Taste masking properties
· Insensitive to stearates
· Vegetable derived
· No BSE/TSE risk
· From fast renewable resources
Parteck® Delta M
· Unique Mannitol crystals
· 90 % delta-polymorphic
· Large surface area after granulation
· Excellent binding properties
· Accelerated disintegration
· DMF available
· Merck KGaA quality
Parteck® is the trade name for a range of products under our
Functional Particle Engineering® concept, which allows us to
design and control particle size distribution, modify the physical
properties of particles and process excipients together.
Parteck® Delta M, a unique Mannitol in delta-polymorphic
crystals, enables the user to develop challenging formulations by
wet granulation.

Surface in m 2 /g
Parteck® Delta M
Unique delta-polymorphic crystals
Parteck® Delta M is the only commercially available Mannitol in a delta-polymorph. Mannitol
occurs predominantly in three polymorphic forms: alpha-, beta- and delta-Mannitol.
Mannitol is known to be the excipient of choice for advanced, highly active APIs due to its nonhygroscopicity
and unreactivity. However, standard Mannitol in beta-form quality often lacks
sufficient binding and compaction properties. Parteck® Delta M combines both, the unreactivity of
Mannitol and excellent binding properties.
before wet granulation after wet granulation
Large surface area after granulation
Parteck® Delta M undergoes during contact to water in wet granulation a conversion from the delta to
the beta polymorph. This conversion is accompanied by a 10 fold increase of the surface area of the
Mannitol. The resulting granulate in beta-polymoph is highly porous and has excellent binding and
tabletting properties. The maximal increase of the surface area could be achieved by granulation of
Parteck® Delta M with about 10-20% water, whereas during the granulation of beta-Mannitol no
increase of the surface area of beta-mannitol was observed.
BET Surface – granules of delta vs. beta-Mannitol produced by wet granulation
2,5
2
1,5
1
0,5
0
Parteck® Delta M
beta-Mannitol
raw materials 5 % water 10 % water 15 % water 20 % water 25 % water 30 % water
Mannitol was granulated
with water and dried in
a fluidized bed.
Granules larger than
1000 µm were removed
by sieving and BET
surface measured.

160
140
120
100
80
60
40
20
0
Parteck® Delta M
beta-Mannitol
0
5 10 15 20 25 30 35
Compression Force [kN]
Tablet Hardness [N] Compression Profiles Parteck® Delta M and beta-Mannitol
Disintegration
Excellent binding properties
The enormous increase in surface area of Parteck® Delta M after granulation leads to significant
higher tablet hardness compared to standard beta-Mannitol.
A comparison of the two Mannitol polymorphs demonstrates that at a compression force of 10 kN
the hardness of tablets made from water-granulated Parteck® Delta M (83 N) is around 100% higher
than the hardness of tablets made from granulated beta-Mannitol (40 N).
This enables the formulator to compress at lower forces and thus the wear of the tabletting equipment
can be reduced. Furthermore, challenging formulations with poorly compressible actives can be
compressed successfully.
Accelerated Disintegration
Parteck® Delta M
4 min 17.5 min
beta-Mannitol
Material (granulated with 15 %
water) was mixed for 5 minutes
with 1.5 % Magnesium stearate
and compressed on a single punch
press at different compression
forces (Korsch EK0 DMS); punch:
11 mm, flat, facetted;
tablet weight: 400 mg
The highly porous structure of granulated Parteck® Delta M also results in rapidly disintegrating tablets:
Mannitol placebo tablets compressed to a same hardnesses exhibit strikingly different disintegration
times. Tablets made of granulated Parteck® Delta M with 40 N hardness disintegrate within 4
minutes, whereas tablets made from granulated beta-Mannitol need 17.5 min to disintegrate.
This property of Parteck® Delta M makes it an ideal choice for any challenging solid formulation,
where unreactivity, non-hygroscopicity, excellent binding properties and, simultaneously, a fast
disintegration is required.
Placebo tablets with hardnesses of
around 40 N were compressed from
a 15 % water granulation and mixed
with 1.5 % Magnesium stearate.
Disintegration test was performed
according to Ph Eur Method.

Merck KGaA quality
The basis for this is the long tradition of “Merck Quality”; this is in turn based
on comprehensive and stringent product analysis that certifies “Merck Quality”
and hence the quality of the customers product.
The production process of Parteck® Delta M has been filed in form of a DMF,
stability studies, special packaging, regulatory assistance and technical support
are available for the users of Parteck® Delta M.
Parteck® Delta M corresponds to USP, Ph Eur and JP
“Merck Quality” has been known for more than a century. We strive daily to
further advance your life sciences – from discovery to launch.
Ordering information
1.12635 Parteck® Delta M
1.05980 beta-Mannitol
1.05988 beta-Mannitol fine powder
We provide information and advice to our customers on application technologies and regulatory
matters to the best of our knowledge and ability, but without obligation or liability. Existing laws
and regulations are to be observed in all cases by our customers. This also applies in respect to
any rights of third parties. Our information and advice do not relieve our customers of their own
responsibility for checking the suitability of our products for the envisaged purpose.

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