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II. HYDROXYPROPYL METHYLCELLULOSE (METHOCEL, HPMC) AQUEOUS COATINGS

II. HYDROXYPROPYL METHYLCELLULOSE (METHOCEL, HPMC) AQUEOUS COATINGS

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Appendix: Coating Solutions



311



D. Gloss

Scale (%, w/v)

3.33

1.66

QS



Item

1

2

3



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose 2910 (15 cps)

PEG-400 (low color), NF

Deionized purified water, USP



Quantity/L

33.33 g

16.66 g

QS to 1 L



E. Red

Scale (%, w/v)

6.00

2.00

2.00

2.50

0.50

QS



F.



Bill of Materials

Item Material Name

Quantity/L

1

Hydroxypropyl methyl cellulose 2910 (15 cps)

60.00 g

2

PEG-400 (low color), NF

20.00 g

3

PEG-8000

20.00 g

4

FD&C Red Dye No. 3 lake

25.00 g

5

Titanium dioxide

5.00 g

6

Deionized purified water, USP

QS to 1 L



Moderate Red

Scale (%, w/v)

6.00

2.00

2.00

0.50

2.50

1.00

QS



© 2004 by CRC Press LLC



Bill of Materials

Item Material Name

1

Hydroxypropyl methyl cellulose 2910 (15 cps)

2

PEG-400 (low color), NF

3

PEG-8000

4

FD&C Yellow Dye No. 3 aluminum lake

5

Ponceau Red Dye 4R lake

6

Titanium dioxide (special coating grade), USP

7

Deionized purified water, USP



Quantity/L

60.00 g

20.00 g

20.00 g

5.00 g

25.00 g

10.00 g

QS to 1 L



312



Handbook of Pharmaceutical Manufacturing Formulations: Over the Counter Drugs



G. Clear

Scale (%, w/v)

6.00

0.10

2.00

2.00

2.00

QS

a



Bill of Materials

Item Material Name

1

Hydroxypropyl methyl cellulose 2910 (15 cps)

2

Sorbic acid

3

Alcohol (200 proof), SD 3A

4

PEG-400 (low color)a

5

PEG-8000 (optional)

6

Deionized purified water



Quantity/L

60.00 g

1.00 g

20.00 mL

20.00 g

20.00 g

QS to 1 L



Increase amount to 6.00 if item 5 is not used.



MANUFACTURING DIRECTIONS

Charge approximately 500 mL of water into a suitable

vessel. Heat water to 65 to 70˚C. Add the PEG-8000 to

the hot water and dissolve (if used). While maintaining

gentle agitation, sprinkle the hydroxypropyl methyl cellulose onto the surface of the hot water solution. Position

stirring head to avoid excessive entrainment of air. When

the cellulose has been dispersed, add the PEG-400. Continue to stir until dispersion is homogeneous, although



solution of cellulose may not be complete. Stop stirring,

and allow solution to stand until entrained air is removed.

Dissolve sorbic acid in alcohol, and ensure that the solution is complete. When the solution from the step above

is clear, add 250 mL of cold water, mix well, and add

sorbic acid solution. Mix, then bring up to volume with

cold water. Store coating solution in well-filled, wellsealed containers. Use within 3 months.



H. Green

Scale (%, w/v)

6.00

0.10

2.00 v/v

2.00

2.00

1.00

0.01

0.0032

QS



Item

1

2

3

4

5

6

7

8

9



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose 2910 (15 cps)

Sorbic acid

Alcohol (200 proof), SD 3A

PEG-400 (low color)

PEG-8000

Titanium dioxide (coating grade)

Dye Yellow E104 aluminum lake

FD&C Blue Dye No. 1 lake (11 – 13%)

Deionized purified water



Quantity/L

60.00 g

1.00 g

20.00 mL

20.00 g

20.00 g

10.00 g

0.10 g

0.032 g

QS to 1 L



Item

1

2

3

4

5

6

7

8

9



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose 2910 (15 cps)

Sorbic acid

Alcohol (200 proof), SD 3A

PEG-400 (low color)

PEG-8000

Titanium dioxide (coating grade)

FD&C Red Dye No. 40 lake (29%)

FD&C Blue Dye No. 3 lake

Deionized purified water



Quantity/L

60.00 g

1.00 g

20.00 mL

20.00 g

20.00 g

10.00 g

15.00 g

5.00 g

QS to 1 L



I. Holberry Red

Scale (%, w/v)

6.00

0.10

2.00 v/v

2.00

2.00

1.00

1.50

0.50

QS



© 2004 by CRC Press LLC



Appendix: Coating Solutions



313



J. Sun Orange

Scale (%, w/v)

6.00

0.17

2.00 v/v

2.00

2.00

2.38

2.47

0.16

QS



Item

1

2

3

4

5

6

7

8

9



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose 2910 (15 cps)

Sorbic acid, NF

Alcohol (200 proof), SD 3A

PEG-400 (low color), NF

PEG-8000

Titanium dioxide (coating grade), USP

FD&C Yellow Dye No. 5

FD&C Yellow Dye No. 6

Deionized purified water, USP



Quantity/L

60.00 g

1.70 g

20.00 mL

20.00 g

20.00 g

23.80 g

24.70 g

1.60 g

QS to 1 L



K. Opadry Yellow

Scale (mg/caplet)

10.00

4.00

1.60

1.20

0.30

0.50

0.75

QS



Item

1

2

3

4

5

6

7

8



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose (hypromellose)

Talc (fine powder)

PEG-4000

Titanium dioxide

FD&C Blue Dye No. 1 lake

FD&C Blue Dye No. 2 (dispersed)

Opadry-OY-S 29019 (clear)

Purified water



Quantity/1000 Caplets (g)

10.00

4.00

1.60

1.20

0.30

0.50

0.75

225.00



MANUFACTURING DIRECTIONS

The formula for this coating solution is prepared to obtain

a weight gain of 10 mg per caplet (around 600 mg in

weight). Disperse item 1 in 175 g of purified water (70 to

80˚C) while stirring. Hold overnight for complete dispersion. Disperse items 2 and 3 in 25 g of purified water (25

to 30˚C). Hold overnight for complete hydration. Add

mixture from previous step. Homogenize using a homogenizer (gap setting, 1.5 mm). Homogenize items 4, 5, and



6 in 50 g of hypromellose dispersion from step above

twice, using a homogenizer (gap setting, 1.5 mm). Pass

the dispersion twice through a 90-µm sieve. (Note: This

is a critical step; follow instructions closely to prevent

foreign particles and spots.) Preparation of polishing solution: Disperse item 7 in 25 g of purified water with slow

stirring. Make a vortex by slow stirring and add the powder

in such a way as to avoid foam formation.



L. Opadry Yellow

Scale (mg/tablet)

10.00

4.00

1.60

1.34

0.046

1.34

0.75

QS



© 2004 by CRC Press LLC



Item

1

2

3

4

5

6

7

8



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose (hypromellose)

Talc (fine powder)

PEG-4000

Titanium dioxide

Sunset Yellow E110, FCF

FD&C Yellow Dye No. 10 lake

Opadry-OY-S 29019 (clear)

Purified water



Quantity/1000 Tablets (g)

10.00

4.00

1.60

1.34

0.046

1.34

0.75

225.00



314



Handbook of Pharmaceutical Manufacturing Formulations: Over the Counter Drugs



M. Opadry Red

Scale (mg/caplet)

10.00

4.00

1.60

1.34

0.15

0.75

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose (hypromellose)

Talc (fine powder)

PEG-4000

Titanium dioxide

Iron oxide red

Opadry-OY-S (clear)

Purified water



Quantity/1000 Caplets (g)

10.00

4.00

1.60

1.34

0.15

0.75

225.00



Item

1

2

3

4

5

6

7

8



Bill of Materials

Material Name

Hydroxypropyl methyl cellulose (hypromellose)

Talc (fine powder)

PEG-4000

Titanium dioxide

FD&C Blue Dye No. 1 lake

FD&C Yellow Dye No. 10 lake

Opadry-OY-S (clear)

Purified water



Quantity/1000 Caplets(g)

10.00

4.00

1.60

2.125

0.053

0.15

0.75

225.00



N. Opadry Green

Scale (mg/caplet)

10.00

4.00

1.60

2.125

0.053

0.15

0.75

QS



MANUFACTURING DIRECTIONS

Disperse item 1 in 175 g of purified water (70 to 80˚C)

while stirring. Keep overnight for complete dispersion.

Disperse items 2 and 3 in 25 g of purified water (25 to

30˚C). Keep overnight for complete hydration. Add

together and homogenize using homogenizer (gap setting,

1.5 mm). Homogenize items 4, 5, and 6 in 50 g of

hypromellose dispersion twice, using homogenizer (gap

Caplet load

Pan speed

Drying air temperature

Exhaust temperature

Fluid pressure

Valve on spray gun

Atomizing pressure

Nozzle orifice

Nozzle distance to bed

Difference of air pressure

Spray rate

Coating time



Stir the dispersion at slow speed (6 to 10 rpm) continuously. Spray the polishing solution under the same conditions as above, adjusting the spray rate to 180 g/min.

Check the caplet surface every 5 minutes for sticking. If

sticking tends to appear, stop the coating immediately.

When the spraying is over, roll the tablets in a pan for 10



© 2004 by CRC Press LLC



setting, 1.5 mm). Pass the dispersion twice through a 90µm sieve. (Note: This is a critical step; follow instructions

closely to prevent foreign particles and spots.) Disperse

item 7 in 25 g of purified water while stirring slowly. Make

a vortex by slow stirring and add the powder in such a

way as to avoid foam formation. Follow the parameters

for coating in Accela Cota:

620 g

4 rpm

70 – 75˚C

50 – 55˚C

15 – 20 psi

One revolution open

55 psi

1 mm

250 – 280 mm

–1.0 to –1.5 cm

200 – 225 g/min

3.0 – 3.5 hours



minutes with cold air blowing onto the caplets. Unload

the film-coated caplets into stainless steel containers lined

with polyethylene bags. Appearance is a light green, filmcoated caplet that is smooth, with no sticking or chipping

on the caplet surface. Weight gain per caplet is NLT 10

mg/tablet.



Appendix: Coating Solutions



315



O. White Coating

Scale(mg/tablet)

22.75

4.54

12.50

10.00

1.30







Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Hyperomellose

Polyethylene glycol

Talc (fine powder)

Titanium dioxide

FD&C Yellow No. 10 lake

Purified water

Ethanol (95%)



Quantity/1000 Tablets(g)

22.75

4.54

12.50

10.00

1.30

~24.00

~21.00



III. HYDROXYPROPYL METHYLCELLULOSE

OPAQUE ORGANIC COATING



A. Brite Green

Scale(%, w/v)

1.00

50.00 v/v

1.69

0.02

0.0068

4.00

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Titanium dioxide

Alcohol (200 proof), SD 3A

PEG-400 (low color), NF

FD&C Yellow Dye No. 5

FD&C Blue Dye No. 1

Hydroxypropyl methyl cellulose 2910 (15 cps)

Methylene chloride



MANUFACTURING DIRECTIONS

Charge titanium dioxide and QS with alcohol into a Ball

mill. Mill the material for 16 hours. Charge 465 mL alcohol

into a suitable mixing tank. Start agitation. Slowly add

PEG-400 to mixing tank. Mix for 5 minutes. Add FD&C

Yellow Dye to the mixing tank with continued agitation.

Rinse bottle with alcohol tapped from mixing tank. Return

rinse to mixing tank. Add FD&C Blue Dye to the mixing

tank, and rinse. Mix for 2 hours. Tap approximately 10 mL

of solution from mixing tank after 1/2, 1, and 1-1/2 hours

of mixing. Put solution back into mixing tank. (Note: Tapping solution ensures that dye is not tapped into lower valve

and/or pipeline.) Rinse the Ball mill with two rinses of 11.6

mL alcohol. Reseal the Ball mill, and allow it to run 2 to

5 minutes between rinses. Empty content of the Ball mill

and rinses into mixing tank. Slow sprinkle hydroxypropyl

methyl cellulose into mixing tank with constant agitation.

Agitate for an additional 15 minutes. (Note: Prevent the



© 2004 by CRC Press LLC



Quantity/L(g)

10.00

~397.00

16.90

0.20

0.068

40.00

~625.00



development of lumps by slowly sprinkling hydroxypropyl

methyl cellulose into the alcohol.) After mixing 10 minutes,

tap approximately 10 mL from the mixing tank and put

back into tank to recirculate. Add sufficient methylene chloride (~474 mL) to bring up to volume. Continue agitation

for 2 hours. After 1/2, 1, and 1-1/2 hours, tap approximately

10 mL of solution from mixing tank and put back into

mixing tank to recirculate. (Note: No residue should be

present in the solution when tapped at 1-1/2 hours; if some

is present, then continue agitation and tap every 15 minutes

until no residue is observed.) (Caution: Avoid contact with

methylene chloride and vapors; they may have toxic effects

when swallowed or inhaled.) (Note: Nitrogen pressure may

be used to assist bottle filling.) Strain mixing tank contents

through two-ply cheesecloth, or similar, into suitable

approved containers (one half the total number of bottles).

(Note: Lumps may obstruct spray nozzle.)



316



Handbook of Pharmaceutical Manufacturing Formulations: Over the Counter Drugs



B. Red Mahogany

Scale(%, w/v)

0.40

45.00 v/v

0.40

1.00

1.50

1.00

4.00

QS



Bill of Materials

Material Name

Titanium dioxide

Alcohol (200 proof), SD 3A

Vanillin (crystals)

Propylene glycol

FD&C Red Dye No. 40 lake (29%)

Dye Brown lake blend

Hydroxypropyl methyl cellulose 2910 (15 cps)

Methylene chloride



Item

1

2

3

4

5

6

7

8



Quantity/L(g)

4.00

~375.30

4.00

10.00

15.00

10.00

40.00

~530.40



C. Sun Orange

Scale(%)

3.00 (w/v)

50.00 (v/v)

2.11 (w/v)

3.11 (w/v)

0.20 (w/v)

4.00 (w/v)

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Titanium dioxide

Alcohol (200 proof), SD 3A

Propylene glycol

FD&C Yellow Dye No. 5

FD&C Yellow Dye No. 6

Hydroxypropyl methyl cellulose 2910 (15 cps)

Methylene chloride



Quantity/L(g)

30.00

~397.00

21.10

31.10

2.00

40.00

~625.00



D. Dark Red

Scale(%, w/v)

1.00

20.00 v/v

2.00

0.02

0.0068

2.95

QS



Item

1

2

3

4

5

6

7



Bill of Materials

Material Name

Titanium dioxide

Alcohol (200 proof), SD 3A

PEG-400 (low color)

Ponceau 4R dye (red)

FD&C Blue Dye No. 1

Hydroxypropyl methyl cellulose 2910 (15 cps)

Methylene chloride



Quantity/L(g)

10.00

~200.00 mL

20.00

20.00

0.068

29.50

QS to 1 L



E. Deep Yellow

Scale(%, w/v)

2.00

50.00

2.00

2.00

2.95

QS



© 2004 by CRC Press LLC



Item

1

2

3

4

5

6



Bill of Materials

Material Name

Titanium dioxide

Alcohol (200 proof), SD 3A

PEG-400 (low color)

FD&C Yellow Dye No. 5 lake

Hydroxypropyl methyl cellulose 2910 (15 cps)

Methylene chloride



Quantity/L

20.00 g

~397.00 g

20.00 g

20.00 g

29.50 g

QS to 1 L



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