Mannitol Parteck M - EMD Chemicals

PARTECK
Parteck M
Directly Compressible Mannitol

Parteck M
Directly Compressible
Mannitol
Main applications
Mannitol
Mannitol is the excipient of choice for a wide variety of
pharmaceutical tabletting applications since Mannitol is:
· Non hygroscopic
· Non reactive
· Compatible with amines
· The best choice for taste masking properties
· Insensitive to stearates

Method: Formulation: 99% test
material + 1% magnesium
stearate; 5 min. mixing;
compression: single punch press
(Korsch EK0 DMS, rpm: 54, punch:
11mm, flat, facetted); Tablet
weight: 500 mg (rel. S.D.: 0.5);
Mannitol A and B are commercially
available mannitol grades for
direct compression.
Tablet Hardness [N] Parteck M – Compression profile
Parteck M
· Directly compressible Mannitol
· Unique particle properties
· High compactibility at low compression forces
· Rapid disintegration and dissolution
· High dilution potential
· Excellent flow
· Available in two different particle size distributions
Parteck brand products are manufactured by Merck KGaA, Darmstadt,
Germany, under the Functional Particle Engineering concept which allows
the design and control of particle size distribution, modification of the
physical properties of particles, and the processing of excipients together.
Parteck M, a superior directly compressible Mannitol, is the first product
available in the Parteck range. EMD Chemicals is offering Parteck M in
two different particle size distributions: Parteck M 200 and Parteck M
300.
High compactability at low compression forces
Parteck M is produced using a unique technology which offers
distinct advantages in direct compression . Compression with Parteck
M minimizes the wear and tear on tabletting equipment, this is due to
the open filamentous particle structure of Parteck M, which allows the
use of relatively low compression forces. Parteck M is free flowing,
which enables it to be used in a variety of dosage forms.
450
400
350
300
250
200
150
100
50
0
Parteck M 200
Mannitol A
Mannitol B
0 5 10 15 20 25 30 35
Compression Force [kN]

Tablet Hardness [N] Vitamin C tablets with Parteck M
250
200
150
100
50
Parteck M 200
Mannitol A
Mannitol B
0
Compression Force [kN]
Content uniformity and homogeneity
Parteck M has a large surface area and a unique particle structure which allows strong adsorbtion of
active ingredients and prevents segregation during the process. Parteck M can be used as a diluent for
low dose formulations where the dose uniformity and the mix of the homogeneity is of the utmost
importance.
Parteck M’s improved slow properties and chemical stability increase the ease of handling during
development and production.
Parteck M 200 Parteck M 300
Loose density | 0.45 g/ml | 0.49 g/ml
Tapped density | 0.57 g/ml | 0.61 g/ml
Hauner Index | 1.27 | 1.25
Angle of repose | 25° | 26°
Rapid disintegration and dissolution
15 25
Parteck M’s unique particle structure and greatly increased surface area facilitates the fast disintegration
of even very hard tablets. Tablets compressed using Parteck M disintegrate much faster than
those containing pre-granulated Mannitol. Tablets produced with hardness in excess of 405 N disintegrate
within 8 minutes (compressed on rotary press Korsch PH 230/14; 1.5% Magnesium stearate, 20 kN
compression force).
Parteck M 200 Granulated Mannitol
Tablet hardness | 85 N | 85 N
Disintegration | 0.5 min | 13.5 min
Dissolution (Q = 80%) | 10 min | 30 min
Method: Formulation: 25%
Ascorbic acid, 74% test material,
1% Mg stearate, tablet press:
Kilian LX 28A, punch: 9/16''
diameter concave, bevel edge,
tablet weight: 1000mg. Mannitol
A and B are commercially
available mannitol grades for
direct compression
Method: Formulation: 50% Ascorbic acid, 49% test material, 1% Mg stearate, tablet press: Kilian LX 28A, punch: 9/16''
diameter concave, bevel edge, tablet weight: 1000 mg. Disintegration & Dissolution : USP method (paddle)

percentage of particles [%]
When Parteck M is used as a tabletting diluent there is a substantial improvement in the dissolution
time of the active ingredient, hence availability for absorption, is improved. For the tablets containing
either ascorbic acid and Parteck M (50/50) or ascorbic acid and granular mannitol (50/50), compressed
to a similar hardness, the 80% of ascorbic acid is dissolved respectively in 10 minutes and 30 minutes.
The choice is yours
High dilution potential
Parteck M has been specifically designed as a diluent for the tabletting
of poorly compressible actives. Tablets containing 25% ascorbic acid and
diluted with Parteck M 200 do not show any significant loss in
hardness. As a result of its excellent compressibility, Parteck M 200
allows the inclusion of a relatively high level of non-directly compressible
actives in the formulation without compromising the quality of the
tablet.
Parteck M is available in two different size distributions: M 200 has a narrow particle size distribution
and is ideal for smaller tablets or where mouthfeel is important. For formulations with coarser actives,
larger tablets or effervescent formulations, the M 300 quality is recommended.
Parteck M – Typical Particle Size Distribution
60
50
40
30
20
10
0
Merck KGaA, Darmstadt, Germany quality
Parteck M 200
Parteck M 300
0 - 100 100 - 200 200 - 300 300 - 400 < 500
particle size range [µm]
The consistently high quality of both types of Parteck M is ensured by extensive and detailed
investigations in our analytical laboratories to check that every single batch and every single parameter
meets the stringent specifications.
Parteck M complies with the Mannitol monographs of Ph Eur, BP, JP, USP
Product # Product Name Size
1.00419.1000 Parteck M 200 Mannitol, Ph Eur, BP, JP, USP, E421 1kg
1.00419.9050 Parteck M 200 Mannitol, Ph Eur, BP, JP, USP, E421 50kg
1.00493.1000 Parteck M 300 Mannitol, Ph Eur, BP, JP, USP, E421 1kg
1.00493.9050 Parteck M 300 Mannitol, Ph Eur, BP, JP, USP, E421 50kg

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