galenIQ™ 981 Sugar(-free) coatings

isomalt (Ph.Eur./BP/USP-NF)

SEM photograph of galenIQ™ 981, magnification 59 x

I. Basic formulation
Description Ingredient %
galenIQ™ 981 61,70

galenIQ™ 981 is a special type of pharmaceutical graded isomalt Water 33,40

which is used for sugar(free) coating of a variety of pharmaceuti- Gum arabic (50 % solution) 4,60

cal centers such as tablets, pellets or compressed chewing gum. Color (as required) 0,30

Properties II. Preparation of suspension

• Dissolve galenIQ™ 981 until crystal free in water whilst stirring
• Acts as coating agent in sugar(-free) coatings and heating (70 – 80˚C)
• Solubility 42 g/100 g solution at 20 °C in water • Stop heating
• Add gum arabic solution and color
• Very low hygroscopicity • Adjust and keep temperature during processing at 50 ˚C
• Low coating process temperatures (see Figure 1)

• Narrow particle size distribution 80

Solubility in g/100 g solution

70
• Moderate coating times
• Very smooth and shiny surface, brilliant color 60

appearance 50
Working temperature
• High chemical and temperature stability of galenIQ™ 981 solution
40

• Good dissolution properties 30

30 40 50 60 70 80 90 T (°C)
• Provides pleasant sweet taste
Figure 1: Solubility and coating temperature of galenIQ™ 981
• Cariostatic and low glycemic/insulinemic
• Non-animal origin and GMO free Remarks
• The viscosity of aqueous galenIQ™ 981 solutions in a temperature
• Sugar-free /lactose-free
range between 40 and 90 °C does not differ significantly from that
of corresponding sucrose solutions.
• Alternatively to gum arabic, other film formers such as HPMC,
gelantine or polysorbate can be used.
• Up to 1,5 % talcum can be dispersed to reduce possible stickiness
during coating process.
• For very white products, add up to 1 % titanium dioxide.
• Flavors and/or high intense sweeteners can be added according
to suppliers’ recommendations.
galenIQ™ 981 Sugar(-free) coatings

III. Coating process Dense coating and smooth surface

Pharmaceutical sugar(-free) coatings with galenIQ™ 981 can be The pronounced tendency of galenIQ™ 981 to crystallize from over-
easily applied with traditional sugar coating techniques and saturated solutions is connected with its solubility. The resulting
permits the use of open as well as all closed automated coating coating provides an even and dense surface, which is important
systems. to protect the API-containing center.

1. Seal the centers if necessary.

2. Spray the amount of suspension necessary to wet the
centers completely (approx. 10 – 12 ml/kg center).
3. Distribute sufficiently. galenIQ™ 981
™ coating Softcentre
4. Dust with sieved galenIQ 810 if necessary
(approx. 10 – 15 g/kg centers) and distribute well.
5. Dry with inlet air (max. 40 % r.h.; 20 – 40 °C).
6. Repeat steps 2 – 5 by stepwise decrease of suspension
(approx. 7 – 10 ml/kg centers) and powder dosage Figure 2: Dense coating and even surface
(9 – 13 g/kg centers).
7. Continue panning without powder addition until required
final weight is achieved. The required coating time Highly stable against humidity
depends on the nature of the centers and desired thickness
of the coating. At a storage temperature of 25 °C and a relative humidity of up to
8. To achieve smooth surfaces with galenIQ™ 981, it is 80 %, galenIQ™ 981 coatings do not absorb noticeable moisture –
recommended to decrease the dosage of syrup per wetting a desired property for pharmaceutical coatings.
and to increase distribution time before drying with air Even at higher temperatures, galenIQ™ 981 coatings show a lower
during the finishing phases. tendency to absorb moisture compared to e.g. sucrose based
9. Coloring and polishing agents (e.g. carnauba wax) can be coatings.
used as usually known in sugar coating. 10
Sucrose
8
Water absorption (%)

galenIQ™ 981
6

Remark 4

Ideally, the centers should be round, convex with small or no shaft.

2

0
Gum centers 36% galenIQ™ 981 resp. sucrose coating with 5,5% gum arabic
Open storage at 37°C, 80% rh., 48 h, changes in weight based on initial weight of product

Figure 3: Reduced tendency to absorb moisture

This information on average values is presented in good faith, but warranty to accuracy
of results is not given. It is offered solely for your consideration, investigation and
verification. Typical analysis data fall within the range of specification of galenIQ™.

For more information please contact:

BENEO-Palatinit GmbH Phone +49 621 421-150
Gottlieb-Daimler-Strasse 12 Fax +49 621 421-160
68165 Mannheim galenIQ@beneo-palatinit.com
Germany www.galenIQ.com