sorbitol, Parteck™ SI - EMD Chemicals
sorbitol, Parteck™ SI - EMD Chemicals
sorbitol, Parteck™ SI - EMD Chemicals
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PARTECK <br />
Parteck <strong>SI</strong><br />
Directly Compressible Sorbitol
Parteck <strong>SI</strong><br />
Directly Compressible<br />
Sorbitol<br />
Main applications<br />
Superior direct compression characteristics,<br />
excellent mouthfeel, pleasant taste, good flow and<br />
high solubility make Parteck <strong>SI</strong> the excipient of<br />
choice for sugar free chewables, effervescent<br />
tablets and lozenges. Parteck <strong>SI</strong> is particularly<br />
suitable for formulations where low dose active<br />
preparations are required. This includes sublingual<br />
and buccal tablets where mouthfeel is important.<br />
In addition, the unique ability of Parteck <strong>SI</strong><br />
particles to form stable ordered mixtures has been<br />
widely studied and applied extensively in the area<br />
of reconstitution syrups and suspensions.
General Characteristics<br />
of Sorbitol<br />
· Non cariogenic<br />
· Chemically stable<br />
· Pleasant tasting<br />
· High solubility<br />
Method: 99% test material and 1%<br />
magnesium stearate were mixed<br />
and compressed on an Korsch EK0<br />
DMS (rpm:54, punch: flat, facetted,<br />
11mm; tablet weight 500mg).<br />
Parteck <strong>SI</strong> is spray-dried <strong>sorbitol</strong>,<br />
cryst. <strong>sorbitol</strong> A is commercially<br />
available as crystalline <strong>sorbitol</strong>.<br />
Tablet Hardness [N]<br />
Parteck <strong>SI</strong><br />
· Unique, functional Sorbitol particles<br />
· Excellent compressibility<br />
· High adsorption capacity<br />
· High dilution potential<br />
· Low hygroscopicity of Parteck <strong>SI</strong> tablets<br />
· Free flowing<br />
· Variety of types available<br />
Parteck brand of products are manufactured by Merck KGaA,<br />
Darmstadt, Germany under the Functional Particle Engineering<br />
concept, which allows the design and control of particle size distribution,<br />
modification of the physical properties of particles and the<br />
processing of excipients together.<br />
Parteck <strong>SI</strong>, a superior, directly compressible Sorbitol (<strong>SI</strong>=Sorbitol<br />
Instant), is offered in a variety of particle size distributions and qualities<br />
designed to meet requirements of the pharmaceutical industry.<br />
Parteck <strong>SI</strong>: A Unique Particle Structure<br />
The particle structure of Parteck <strong>SI</strong> consists of very loosely packed,<br />
randomly orientated, interwoven filamentary crystals. These needle-like<br />
crystals, unique to Parteck <strong>SI</strong>, give rise to its distinctive physical<br />
properties. As a truly directly compressible material, Parteck <strong>SI</strong> offers<br />
a number of benefits to the pharmaceutical formulator.<br />
Parteck <strong>SI</strong> Compression profile<br />
450<br />
400<br />
350<br />
300<br />
250<br />
200<br />
150<br />
100<br />
50<br />
0<br />
Parteck <strong>SI</strong> 400<br />
Parteck <strong>SI</strong> 150<br />
cryst. <strong>sorbitol</strong> A<br />
0 5 10 15 20 25 30 35<br />
Compression Force [kN]<br />
Excellent compressibility<br />
For lozenges and chewable tablets the high compressibility of diluent is<br />
of the utmost importance. When compared to standard, commercially<br />
available crystalline <strong>sorbitol</strong>, Parteck <strong>SI</strong> exhibits superior compression<br />
properties. This excellent compressibility profile reduces the stress on<br />
tabletting machines and other processing tools by operating at lower<br />
pressures for a given tablet hardness.
Effect of the operating pressure<br />
of an Alpine air jet sieve on the<br />
content of Ampicillin trihydrate<br />
left in the mixture after sieving a<br />
standard 20% mixture of either<br />
Parteck <strong>SI</strong> or standard crystalline<br />
<strong>sorbitol</strong>.<br />
Method: 25-75% cryst. ascorbic,<br />
1% magnesium stearate and 24-<br />
74% test material were mixed<br />
and compressed on an Korsch<br />
EK0 DMS single punch tablet<br />
press (punch: flat, facetted,<br />
11mm; tablet weight 500mg).<br />
Parteck <strong>SI</strong> is spray-dried<br />
<strong>sorbitol</strong>, cryst. <strong>sorbitol</strong> A is<br />
commercially available as<br />
crystalline <strong>sorbitol</strong>.<br />
drug content after sieving [%] Ampicillin mixture with Parteck <strong>SI</strong><br />
7,5<br />
5<br />
2,5<br />
0<br />
0<br />
20 40 60<br />
80<br />
100<br />
pressure of air jet sieve [mm H2O] High adsorption capacity<br />
Parteck <strong>SI</strong> has the outstanding ability to form ordered mixtures with other solid<br />
substances. The unique, rough, porous surface area available for adsorption of<br />
Parteck <strong>SI</strong> (~ 1m 2 /g), allows the active to become entrapped within the filamentous<br />
matrix. The high potential for Parteck <strong>SI</strong>’s electrostatic attraction improves<br />
the overall stability of the resultant adsorbate. This phenomenon helps to increase<br />
the homogeneity of powder blends, to avoid dust development during manufacturing<br />
and to achieve a high level of content uniformity. Parteck <strong>SI</strong> can also be used<br />
as an excellent diluent for low dose preparations. The adsorption capacity and<br />
stability of resultant mixtures were tested when mixtures of Ampicillin trihydrate<br />
(20%) with Parteck <strong>SI</strong> or crystalline <strong>sorbitol</strong> (80%) were sieved using air jet sieve<br />
(pressure 100mm H 2 O). The sieved Ampicillin mixture with Parteck <strong>SI</strong> contained<br />
over 6% Ampicillin, whereas the concentration of the active in the crystalline<br />
<strong>sorbitol</strong> was below 1% reconstitution syrups and suspensions.<br />
High dilution potential<br />
Parteck <strong>SI</strong>’s open internal structure and high capacity to form ordered mixtures<br />
assures the highest quality (hardness) tablet even with actives that have little or no<br />
compressibility of their own. This feature is illustrated in the chart below showing<br />
tablet hardness with Parteck <strong>SI</strong> when it is compressed in combination with<br />
increasing amounts of ascorbic acid.<br />
250<br />
200<br />
150<br />
100<br />
50<br />
0<br />
25<br />
Asorbic acid concentration [%]<br />
Parteck <strong>SI</strong> 400<br />
Parteck <strong>SI</strong> 150<br />
cryst. <strong>sorbitol</strong> A<br />
50 75<br />
Tablet Hardness [N] Vitamin C tablets made with Parteck <strong>SI</strong><br />
Parteck <strong>SI</strong> 400<br />
cryst. <strong>sorbitol</strong> A
Method: tablet diameter 11mm,<br />
weight 360mg. Tablets were<br />
stored at room temperature at<br />
65% relative humidity for 1, 2 and<br />
4 weeks. Initial moisture content<br />
of Parteck <strong>SI</strong> and cryst. <strong>sorbitol</strong><br />
0.5%.<br />
Low hygroscopicity of Parteck <strong>SI</strong> tablets<br />
Crystalline Sorbitol is known to be slightly hygroscopic which increases the<br />
likelihood of potential problems with the production and the stability of tablets.<br />
However, in tablets made with Parteck <strong>SI</strong> a hard and smooth film is formed on<br />
the surface of the tablet after compression. This reduces the ability of moisture to<br />
penetrate into the core. Parteck <strong>SI</strong> tablets stored at 65% relative humidity and<br />
room temperature for four weeks, showed a weight increase of only 0.8%<br />
compared with 1.3% for the tablets containing crystalline <strong>sorbitol</strong>.<br />
Water uptake of Parteck <strong>SI</strong> tablets<br />
The choice is yours<br />
Parteck <strong>SI</strong> 400 is recommended for most applications. However, there are<br />
additional specialized Parteck <strong>SI</strong> products available as well. More detailed<br />
information on type and particle size is available upon request.<br />
Most Parteck <strong>SI</strong> qualities comply with the Sorbitol monographs of Ph Eur,<br />
BP and NF<br />
Product # Product Size<br />
1.03140.1000 Parteck <strong>SI</strong> 400, Sorbitol Instant, Ph Eur, BP, NF, E420 1kg<br />
1.03140.9028 Parteck <strong>SI</strong> 400, Sorbitol Instant, Ph Eur, BP, NF, E420 25kg<br />
1.03557.1000 Parteck <strong>SI</strong> 500, Sorbitol Instant Granular, NF, FCC 1kg<br />
1.03557.9028 Parteck <strong>SI</strong> 500, Sorbitol Instant Granular, NF, FCC 25kg<br />
1.03583.9028 Parteck <strong>SI</strong> 150, Sorbitol Powder, Ph Eur, BP, NF, E420 25kg<br />
1.07703.1000 Parteck <strong>SI</strong> 400, Sorbitol Instant, Ph Eur, BP, NF, micro tested 1kg<br />
1.07703.9028 Parteck <strong>SI</strong> 400, Sorbitol Instant, Ph Eur, BP, NF, micro tested 25kg<br />
1.11597.1000 Parteck <strong>SI</strong> 400LEX, Sorbitol Instant Low Endotoxin, Ph Eur, BP, NF 1kg<br />
1.11597.9028 Parteck <strong>SI</strong> 400LEX, Sorbitol Instant Low Endotoxin, Ph Eur, BP, NF 25kg
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prescribed procedure for use may adversely<br />
affect its stated specification and therefore<br />
<strong>EMD</strong> <strong>Chemicals</strong> shall not be liable in the<br />
event of any such change or modification.<br />
All <strong>EMD</strong> <strong>Chemicals</strong>’ products are sold on<br />
the condition that they be used and<br />
disposed of only within the scope of<br />
currently recognized critical standards<br />
related to human health and the physical<br />
environment. Price and specifications are<br />
subject to change without notice. We<br />
reserve the right to discontinue items<br />
without prior notice.<br />
EXCEPT FOR THE WARRANTY STATED<br />
ABOVE, <strong>EMD</strong> CHEMICALS MAKES NO<br />
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REGARD TO ITS PRODUCTS WHETHER<br />
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LT 331018 REV08/03<br />
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Gibbstown, NJ 08027<br />
Phone 800-222-0342<br />
856-423-6300<br />
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