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galenIQ 981 Sugar(-free) coatingsisomalt (Ph.Eur./BP/USP-NF)

SEM photograph of galenIQ 981, magnification 59 x

Description

galenIQ

981 is a special type of pharmaceutical graded isomaltwhich is used for sugar(free) coating of a variety of pharmaceuti-

cal centers such as tablets, pellets or compressed chewing gum.

Properties

Acts as coating agent in sugar(-free) coatings

Solubility 42g/100g solution at 20 C in water

Very low hygroscopicity

Low coating process temperatures

Narrow particle size distribution

Moderate coating times

Very smooth and shiny surface, brilliant color

appearance

High chemical and temperature stability

Good dissolution properties

Provides pleasant sweet taste

Cariostatic and low glycemic/insulinemic

Non-animal origin and GMO free

Sugar-free/lactose-free

I. Basic formulation

II. Preparation of suspension

Dissolve galenIQ981 until crystal free in water whilst stirring

and heating (70 80C)

Stop heating

Add gum arabic solution and color

Adjust and keep temperature during processing at 50 C

(see Figure 1)

Remarks

The viscosity of aqueous galenIQ 981 solutions in a temperature

range between 40 and 90 C does not differ significantly from thatof 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.

Ingredient

galenIQ 981

%

Water 33,40

61,70

Gum arabic (50 % solution) 4,60

Color (as required) 0,30

Solubility

ing

/100

gs

olution

30

50

60

80

30 60 80 T (C)70 905040

70

40

Working temperature

of galenIQ 981 solution

Figure 1: Solubility and coating temperature of galenIQ 981

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For more information please contact:

BENEO-Palatinit GmbH

Gottlieb-Daimler-Strasse 12

68165 Mannheim

Germany

Phone +49 621 421-150

Fax +49 621 421-160

galenIQ@beneo-palatinit.com

www.galenIQ.com

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.

galenIQ 981 Sugar(-free) coatings

0

Waterabsorption(%)

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

10

8

6

4

2

galenIQ 981

Sucrose

Figure 3: Reduced tendency to absorb moisture

Dense coating and smooth surface

The pronounced tendency of galenIQ 981 to crystallize from over-

saturated solutions is connected with its solubility. The resulting

coating provides an even and dense surface, which is important

to protect the API-containing center.

Highly stable against humidity

At a storage temperature of 25 C and a relative humidity of up to

80 %, galenIQ 981 coatings do not absorb noticeable moisture

a desired property for pharmaceutical coatings.

Even at higher temperatures, galenIQ 981 coatings show a lower

tendency to absorb moisture compared to e.g. sucrose based

coatings.

SoftcentregalenIQ 981

coating

Figure 2: Dense coating and even surface

III. Coating process

Pharmaceutical sugar(-free) coatings with galenIQ 981 can be

easily applied with traditional sugar coating techniques and

permits the use of open as well as all closed automated coating

systems.

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.

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

(9 13 g/kg centers).

7. Continue panning without powder addition until required

final weight is achieved. The required coating time

depends on the nature of the centers and desired thickness

of the coating.

8. To achieve smooth surfaces with galenIQ981, it is

recommended to decrease the dosage of syrup per wetting

and to increase distribution time before drying with air

during the finishing phases.

9. Coloring and polishing agents (e.g. carnauba wax) can be

used as usually known in sugar coating.

Remark

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