sorbitol, Parteck™ SI - EMD Chemicals

PARTECK
Parteck SI
Directly Compressible Sorbitol

Parteck SI
Directly Compressible
Sorbitol
Main applications
Superior direct compression characteristics,
excellent mouthfeel, pleasant taste, good flow and
high solubility make Parteck SI the excipient of
choice for sugar free chewables, effervescent
tablets and lozenges. Parteck SI is particularly
suitable for formulations where low dose active
preparations are required. This includes sublingual
and buccal tablets where mouthfeel is important.
In addition, the unique ability of Parteck SI
particles to form stable ordered mixtures has been
widely studied and applied extensively in the area
of reconstitution syrups and suspensions.

General Characteristics
of Sorbitol
· Non cariogenic
· Chemically stable
· Pleasant tasting
· High solubility
Method: 99% test material and 1%
magnesium stearate were mixed
and compressed on an Korsch EK0
DMS (rpm:54, punch: flat, facetted,
11mm; tablet weight 500mg).
Parteck SI is spray-dried sorbitol,
cryst. sorbitol A is commercially
available as crystalline sorbitol.
Tablet Hardness [N]
Parteck SI
· Unique, functional Sorbitol particles
· Excellent compressibility
· High adsorption capacity
· High dilution potential
· Low hygroscopicity of Parteck SI tablets
· Free flowing
· Variety of types available
Parteck brand of 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 SI, a superior, directly compressible Sorbitol (SI=Sorbitol
Instant), is offered in a variety of particle size distributions and qualities
designed to meet requirements of the pharmaceutical industry.
Parteck SI: A Unique Particle Structure
The particle structure of Parteck SI consists of very loosely packed,
randomly orientated, interwoven filamentary crystals. These needle-like
crystals, unique to Parteck SI, give rise to its distinctive physical
properties. As a truly directly compressible material, Parteck SI offers
a number of benefits to the pharmaceutical formulator.
Parteck SI Compression profile
450
400
350
300
250
200
150
100
50
0
Parteck SI 400
Parteck SI 150
cryst. sorbitol A
0 5 10 15 20 25 30 35
Compression Force [kN]
Excellent compressibility
For lozenges and chewable tablets the high compressibility of diluent is
of the utmost importance. When compared to standard, commercially
available crystalline sorbitol, Parteck SI exhibits superior compression
properties. This excellent compressibility profile reduces the stress on
tabletting machines and other processing tools by operating at lower
pressures for a given tablet hardness.

Effect of the operating pressure
of an Alpine air jet sieve on the
content of Ampicillin trihydrate
left in the mixture after sieving a
standard 20% mixture of either
Parteck SI or standard crystalline
sorbitol.
Method: 25-75% cryst. ascorbic,
1% magnesium stearate and 24-
74% test material were mixed
and compressed on an Korsch
EK0 DMS single punch tablet
press (punch: flat, facetted,
11mm; tablet weight 500mg).
Parteck SI is spray-dried
sorbitol, cryst. sorbitol A is
commercially available as
crystalline sorbitol.
drug content after sieving [%] Ampicillin mixture with Parteck SI
7,5
5
2,5
0
0
20 40 60
80
100
pressure of air jet sieve [mm H2O] High adsorption capacity
Parteck SI has the outstanding ability to form ordered mixtures with other solid
substances. The unique, rough, porous surface area available for adsorption of
Parteck SI (~ 1m 2 /g), allows the active to become entrapped within the filamentous
matrix. The high potential for Parteck SI’s electrostatic attraction improves
the overall stability of the resultant adsorbate. This phenomenon helps to increase
the homogeneity of powder blends, to avoid dust development during manufacturing
and to achieve a high level of content uniformity. Parteck SI can also be used
as an excellent diluent for low dose preparations. The adsorption capacity and
stability of resultant mixtures were tested when mixtures of Ampicillin trihydrate
(20%) with Parteck SI or crystalline sorbitol (80%) were sieved using air jet sieve
(pressure 100mm H 2 O). The sieved Ampicillin mixture with Parteck SI contained
over 6% Ampicillin, whereas the concentration of the active in the crystalline
sorbitol was below 1% reconstitution syrups and suspensions.
High dilution potential
Parteck SI’s open internal structure and high capacity to form ordered mixtures
assures the highest quality (hardness) tablet even with actives that have little or no
compressibility of their own. This feature is illustrated in the chart below showing
tablet hardness with Parteck SI when it is compressed in combination with
increasing amounts of ascorbic acid.
250
200
150
100
50
0
25
Asorbic acid concentration [%]
Parteck SI 400
Parteck SI 150
cryst. sorbitol A
50 75
Tablet Hardness [N] Vitamin C tablets made with Parteck SI
Parteck SI 400
cryst. sorbitol A

Method: tablet diameter 11mm,
weight 360mg. Tablets were
stored at room temperature at
65% relative humidity for 1, 2 and
4 weeks. Initial moisture content
of Parteck SI and cryst. sorbitol
0.5%.
Low hygroscopicity of Parteck SI tablets
Crystalline Sorbitol is known to be slightly hygroscopic which increases the
likelihood of potential problems with the production and the stability of tablets.
However, in tablets made with Parteck SI a hard and smooth film is formed on
the surface of the tablet after compression. This reduces the ability of moisture to
penetrate into the core. Parteck SI tablets stored at 65% relative humidity and
room temperature for four weeks, showed a weight increase of only 0.8%
compared with 1.3% for the tablets containing crystalline sorbitol.
Water uptake of Parteck SI tablets
The choice is yours
Parteck SI 400 is recommended for most applications. However, there are
additional specialized Parteck SI products available as well. More detailed
information on type and particle size is available upon request.
Most Parteck SI qualities comply with the Sorbitol monographs of Ph Eur,
BP and NF
Product # Product Size
1.03140.1000 Parteck SI 400, Sorbitol Instant, Ph Eur, BP, NF, E420 1kg
1.03140.9028 Parteck SI 400, Sorbitol Instant, Ph Eur, BP, NF, E420 25kg
1.03557.1000 Parteck SI 500, Sorbitol Instant Granular, NF, FCC 1kg
1.03557.9028 Parteck SI 500, Sorbitol Instant Granular, NF, FCC 25kg
1.03583.9028 Parteck SI 150, Sorbitol Powder, Ph Eur, BP, NF, E420 25kg
1.07703.1000 Parteck SI 400, Sorbitol Instant, Ph Eur, BP, NF, micro tested 1kg
1.07703.9028 Parteck SI 400, Sorbitol Instant, Ph Eur, BP, NF, micro tested 25kg
1.11597.1000 Parteck SI 400LEX, Sorbitol Instant Low Endotoxin, Ph Eur, BP, NF 1kg
1.11597.9028 Parteck SI 400LEX, Sorbitol Instant Low Endotoxin, Ph Eur, BP, NF 25kg

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