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Compri made by Südzucker – Directly compressible sugars for pharmaceutical applications
Compri OCompri M3Compri SCompri Tailor-made
Introduction
Each pharmaceutical preparation has its own demands – and with its broad range of Compri products, Südzucker has the exact excipient to meet those demands for your recipes and applica-tions. Compri made by Südzucker are
the optimal binders for your actives and are characterized by excellent solubility. And for specifi c needs, we can develop a tailor-made solution for you.
Adding up many benefi ts
Compri sugars are agglomerated, directly compressible materials for manufacturing compressed products, tablets, and instant powder products. The pure, white granulated products are based on refi ned sugar (sucrose). Binders and other components such as fl avours, actives, lubricants or colours may be added for a tailored solution. Despite sucrose remaining the main constituent, the process of agglomeration yields a Compri product with entirely different physical-chemical properties and struc-ture to sugar crystals.
Based on these special properties, Compri products offer an outstanding quality and superior effi ciency in pro-cessing. They have excellent fl ow char-acteristics, so can be precisely dosed, ensuring ease of processing on modern high-speed presses. The agglomerated structure yields a high surface area and porosity, which provides optimal absorp-
tion and binding for both liquid and powdered adjuncts. Bitterness and other unpleasant notes can be masked by the sweetness of Compri sugar, providing the ideal excipient for a range of API’s. The low hygroscopicity of Compri sugars also ensures good stability for prolonged periods of time.
Typical applications of the various Compri types include tablets, lozenges, chewable tablets, effervescent tablets and instant products.
Physical and analytical properties* of Compri
* This information on average values is presented in good faith, but warranty to accuracy of results is not given.
Ingredients Sucrose Sucrose, starch Sucrose, maltodextrin
e.g. with gelatine
Preferred application Instant products, direct compression
Direct compression
Direct compression
Particle size distribution for min. 90% of the sugar (mm)
0.1–0.6 0.1–1.0 0.2–0.6 On demand
Color in solution (IE) ≤ 45 ≤ 45 ≤ 45
Humidity (%) ≤ 0.1 ≤ 0.7 ≤ 0.7
Inverted sugar (%) ≤ 0.015 ≤ 1.0 ≤ 0.05
Bulk density (g/l) 550–650 580–680 530–630
Tapped density (g/l) ca. 700 ca. 740 ca. 660
Angle of response (°) ca. 37 ca. 38 ca. 37
Flowabillity (s/100g) 41 43 45
Hausner factor 1.16 1.17 1.14
Carr index 14 15 12
Conductivity (µS/cm) ≤ 35 ≤ 35 ≤ 35
Compri O Compri S Compri M3 Compri Tailor-made
Technical properties
The following charts clearly demonstrate that the various Compri types fully meet the requirements for pharmaceutical formulations.
Pharmaceutical certifi cation
EP/PhEur (European Pharmacopeia)
The European Pharmacopeia currently do not include a monograph on “com-pressible sucrose”. If Compri sugar is to be used in pharmaceutical formulations, Südzucker will issue an EP Certifi cate for the raw materials used in its production process (sucrose plus binders/additives, if any) on request.
USP-NF (United States Pharmacopeia National Formula)
The USP NF includes a monograph on “Compressible Sugar” specifying the following requirements:• 95%–98% of sucrose• 2%–5%of starch, inverted sugar or
maltodextrin
Based on their sucrose content of more than 98%, most Compri types are not in compliance with the USP NF mono-graph on “Compressible Sugar”. There-fore only Compri M3 can be classifi ed as “Compressible Sugar” in accordance with USP NF. For all other Compri types, EP or USP certifi cates can be issued with respect to the raw materials used. Customer-specifi c certifi cates are avail-able on request.
Brea
king
load
aft
er o
ne d
ay [N
]
5 10 20 300
50
100
150
200
250
Pressing force [kN]
Chewable
Suckable
Tim
e of
dis
solv
ing
[s]
60
70
80
90
100
110
Time of dissolving (25 °C, 10 % TS)
Compri O
White crystal sugar
80
107
Compri M3
Compri S
Compri O
Brea
king
load
aft
er o
ne d
ay [N
]
5 10 20 300
50
100
150
200
250
Pressing force [kN]
Chewable
SuckableTi
me
of d
isso
lvin
g [s
]
60
70
80
90
100
110
Time of dissolving (25 °C, 10 % TS)
Compri O
White crystal sugar
80
107
Compri M3
Compri S
Compri O
Product range
Südzucker offers a wide range of differ-ent Compri products. Each one distin-guished by their ingredients (binders and other additives) and their particle size distribution.
Compri without binders
In the standard range sucrose is the only raw material used for the production of these Compri types. A range of different particle size distributions are available, making these Compri products without binders suitable for use in instant prod-ucts, such as sachets.
Compri with binders
Various binders are incorporated in order to optimize the tabletting properties of the Compri products enabling the pro-duction of hard tablets with low com-pression force. These binders are sprayed as solutions to the milled sucrose during the agglomeration process.
Compri tailor-made
In order to meet special customer de-mands, Südzucker develops tailor-made products that are precisely matched to the desired formulation in terms of composition and particle size distri-bution. The technical facilities of our research and development department are designed to allow scaling up to any level of production. Individual compres-sion trials are run on our factoryscale high-speed rotary press to optimize the tablet formulation. Also equipped with a full range of test facilities our labo-ratories can characterize these results, so optimizing the recipes and processes under real-life conditions.
Contact:
Südzucker Sales Offi ce +49 621 421-563
E-mail: compri@suedzucker.de
P.O. Box 10285568028 Mannheim
Germany
www.comprisugar.com
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