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