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IX. CELLULOSE ACETATE PHTHALATE AND CARBOWAX COATINGS

IX. CELLULOSE ACETATE PHTHALATE AND CARBOWAX COATINGS

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Appendix: Coating Solutions



325



X. SUGAR COATINGS



A. Basic

Scale(%, w/w)

4.00

16.00

2.40

1.20

3.20

4.00

QS



Bill

Item

1

2

3

4

5

6

7



of Materials

Material Name

Kollidon® VA 64

Sucrose

Titanium dioxide

Color lake

Lutrol E 4000

Talc

Purified water



Quantity/kg

40.00 g

160.00 g

24.00 g

12.00 g

32.00 g

40.00 g

QS to 1 kg



MANUFACTURING DIRECTIONS

Dissolve the sucrose, Kollidon, and Lutrol in the water,

and suspend the other components. Pass through a colloid

mill. Use the following conditions for use in Accela-Cota.

Tablet core loading

Amount of coating suspension

Inlet air temperature

Outlet air temperature

Nozzle

Rotation speed of the pan

Spraying pressure

Spraying time (continuously)

Quantity of film-former applied



© 2004 by CRC Press LLC



5.00 kg

1.20 kg

45˚C

35˚C

0.80 mm

15 rpm

2.0 bar

50 minutes

4.00 mg/cm2



326



Handbook of Pharmaceutical Manufacturing Formulations: Over the Counter Drugs



B. Automatic

Scale(%, w/w)

4.00

38.00

4.50

QS

4.50

14.50

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Kollidon® 30

Sucrose

Titanium dioxide

Color lake

Calcium carbonate

Talc

Purified water



Quantity, g/Kg

40.00

380.00

45.00

QS

45.00

145.00

QS to 1 kg



MANUFACTURING DIRECTIONS

Dissolve the sucrose in the hot water, then mix with glycerol. Dissolve Kollidon and suspend the other components.

Coating Procedure

Coat 4 kg of tablet cores with a weight of 420 mg each

by spraying with 2.5 kg of the above suspension in a

conventional coating pan under the following conditions:

Spray phase

Interval

Drying phase (warm air)

Total coating time



5 seconds

10 minutes

10 minutes

16 hours



C. Manual, White

Scale(%, w/w)

0.33

0.29

0.21

QS

1.62

0.10

1.40

62.70

33.40



Item

1

2

3

4

5

6

7

8

9



Bill of Materials

Material Name

Kollidon® 30

Carmellose sodium

Aerosil® 200

Color lake (white)

Talc

Polysorbate or Cremophor RH40

Titanium dioxide

Sucrose

Purified water



Quantity/kg(g)

3.36

2.92

2.14

QS

16.20

1.00

14.00

627.00

334.00



MANUFACTURING DIRECTIONS

Dissolve Kollidon, polysorbate or Cremophor and sucrose

in the water, and suspend the other components in this

solution. Mix in a colloid mill. Start with formulation



© 2004 by CRC Press LLC



without the color and then apply the color coat. The polishing can be done by means of a solution of beeswax or

PEG-6000.



Appendix: Coating Solutions



327



XI. ENTERIC COATINGS



A. Kollicoat® and Kollidon® Enteric Film Coating

Scale(%, w/w)

0.50

2.00

0.50

0.50

50.00

1.50

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Titanium dioxide

Talc

Iron oxide

Kollidon® 25 or Kollidon® 30

Kollicoat® MAE 30 DP (methacrylic acid/ethyl acrylate copolymer, 1:1)

Triethyl citrate

Purified water



Quantity/kg

5.00 g

20.00 g

5.00 g

5.00 g

500.00 g

15.00 g

QS to 1 kg



MANUFACTURING DIRECTIONS/CONDITIONS

Tablet core loading

Core size

Quantity of suspension applied

Quantity of solids/cm2

Quantity of film-forming agent/cm2

Speed of the coating pan

Spray nozzle

Spraying pressure

Type of spraying

Inlet air temperature

Outlet air temperature

Spraying time

Spraying rate



© 2004 by CRC Press LLC



5 kg

9-mm biconvex

1890 g

9 mg

6 mg

12 rpm

0.8 mm

2.0 bar

Continuous

50˚C

~30˚C

~60 minutes

~30 g/minutes



328



Handbook of Pharmaceutical Manufacturing Formulations: Over the Counter Drugs



XII. EUDRAGIT® ENTERIC AQUEOUS



A. Brick Red

Scale(%, w/w)

46.667

1.519

0.798

1.55

0.426

0.015

47.60

1.426



Item

1

2

3

4

5

6

7

8



Bill of Materials

Material Name

Distilled purified water

Talc (powder)

Titanium dioxide (special coating grade)

Iron oxide, red

Polysorbate 80

Dimethyl polysiloxane emulsion (30%)

Eudragit®; use Eudragit® L 30D-55

Triethyl citrate (Eudraflex®)



Quantity/kg (g)

466.667

15.198

7.983

15.50

4.262

0.155

476.00

14.259



MANUFACTURING DIRECTIONS

Weigh the quantity of water needed. Put approximately

21.5% of the total quantity of water in a suitable mixing

container. Add the talc powder, and stir vigorously until

well suspended (approximately 20 minutes). Add the following to this suspension, and mix thoroughly: titanium

dioxide, iron oxide, Tween 80, dimethyl polysiloxane

emulsion (30%). (Note: The pigments may require



homogenizing with colloid, corrundum disc mill, or ball

mill.) Put the Eudragit in a suitable mixing vessel, and

add the following with continuous mixing: homogenized

pigment mixture, Eudraflex (i.e., triethyl citrate), and

remaining quantity of water. (Note: When PEG-8000 is

used as a plastisizer, it should be incorporated as a 10%

aqueous solution.)



B. Yellow

Scale(%, w/w)

46.66

1.25

0.77

1.83

0.42

0.01

47.6

1.42



Item

1

2

3

4

5

6

7

8



Bill of Materials

Material Name

Quantity/kg(g)

Distilled purified water

466.66

Talc (powder)

12.57

Titanium dioxide (special coating grade)

7.79

FD&C Yellow Dye No. 10 aluminum lake (14 to 17%)

18.36

Polysorbate 80

4.27

Dimethyl polysiloxane emulsion (30%)

0.12

476.00

Eudragit®; use methacrylic acid copolymer, NF (Eudragitđ L 30D-55)

14.21

Triethyl citrate (Eudraflexđ)



C. Brown

Scale(%, w/w)

46.66

0.47

0.85

2.26

0.25

0.42

0.01

47.63

1.42



â 2004 by CRC Press LLC



Item

1

2

3

4

5

6

7

8

9



Bill of Materials

Material Name

Distilled purified water

Titanium dioxide (special grade coating), USP

Iron oxide, black

Iron oxide, red

Iron oxide, yellow

Polysorbate 80

Dimethyl polysiloxane emulsion

Eudragit®; use Eudragit® L 30D-55

Triethyl citrate (Eudraflex®)



Quantity/kg(g)

466.66

4.76

8.53

22.61

2.57

4.26

0.09

476.33

14.28



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IX. CELLULOSE ACETATE PHTHALATE AND CARBOWAX COATINGS

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