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III. HYDROXYPROPYL METHYLCELLULOSE OPAQUE ORGANIC COATING

III. HYDROXYPROPYL METHYLCELLULOSE OPAQUE ORGANIC COATING

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274



Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products



MANUFACTURING DIRECTIONS

Charge titanium dioxide and QS with alcohol into the Ball

mill. Mill the material for 16 h. Charge 465 ml of alcohol

into a suitable mixing tank. Start agitation. Slowly add

polyethylene glycol 400 to the mixing tank. Mix for 5

min. Add dye yellow to the mixing tank with continued

agitation. Rinse the bottle with alcohol tapped from the

mixing tank. Return the rinse to the mixing tank. Add dye

blue to the mixing tank, and rinse. Mix for 2 h. Tap

approximately 10 ml of the solution from the mixing tank

after 1/2, 1, and 1 1/2 h of mixing. Put the solution back

into the mixing tank. Note: The trapping solution assures

that dye is not trapped in a lower valve or pipeline. Rinse

the Ball mill into two rinses with 11.6 ml alcohol each

time. Reseal the Ball mill, and allow it to run 2 to 5 min

between rinses. Empty the content of the Ball mill and

rinses into the mixing tank. Slowly sprinkle hydroxypropyl methylcellulose into the mixing tank with constant

agitation. Agitate for an additional 15 min. (Note: Prevent



B.



the development of lumps by slowly sprinkling hydroxypropyl methylcellulose into the alcohol.) After mixing 10

min, tap approximately 10 ml from the mixing tank, and

put it back into the tank to recirculate. Add a sufficient

amount of methylene chloride (approximately 474 ml) to

bring up to volume. Continue agitation for 2 h. After

1/2, 1, and 1 1/2 h, tap approximately 10 ml of the solution

from the mixing tank, and put it back into the mixing tank

to recirculate. (Note: There should be no residue in the

solution when tapped at 1 1/2 h. If there is, continue

agitation, and tap every 15 min until no residue is present.

Nitrogen pressure may be used to assist bottle filling.

CAUTION: Avoid contact with methylene chloride and

vapors. They may have toxic effects when swallowed or

inhaled.

Strain the mixing tank contents through two-ply cheesecloth, or a similar material, into suitably approved containers (1/2 the total number of the bottles). Note: Lumps

may obstruct spray nozzle.



RED MAHOGANY

Bill of Materials

Scale(%w/v)

0.40

45.00 v/v

0.40

1.00

1.50

1.00

4.00

QS



Item

1

2

3

4

5

6

7

8



Material Name

Titanium dioxide

Alcohol SD 3A 200 proof, ca

Vanillin crystals

Propylene glycol

Dye Red FD&C No. 40 Lake 29%

Dye brown lake

Hydroxypropyl methylcellulose 2910 15 cps

Methylene chloride, ca



Quantity (g/l)

2.50

1.50

QS



4. Dry granules at 60°C for 12 h to an LOD of

not more than 2%.

5. Pass the granules through #16 mesh into the

blending vessel.

6. Pass croscarmellose sodium and magnesium

stearate through a 250-mm sieve, and add to

Step 5. Blend for 3 min.

7. Compress 400 mg in a suitable punch.



Terfenadine Tablets (60 mg)

Bill of Materials

Scale (mg/tablet)

60.00

235.00

6.00

1.00



Item

1

2

3

4



Material Name

Terfenadine

Ludipress

Kollidon CL

Magnesium stearate



MANUFACTURING DIRECTIONS

1. Mix all components, pass through a 0.8-mm

sieve, and press with very low-compressive

force.

2. Compress 301 mg in 8-mm biplanar punches.



© 2004 by CRC Press LLC



Quantity/1000 Tablets (g)

60.00

235.00

6.00

1.00



Compressed Solid Formulations



253



Tetracycline Tablets (125 mg)

Bill of Materials

Scale (mg/tablet)

125.00

100.00

42.00

3.00



Item

1

2

3

4



Material Name

Tetracycline hydrochloride

Ludipress

Microcrystalline cellulose (Avicel PH 101)

Magnesium stearate



Quantity/1000 Tablets (g)

125.00

100.00

42.00

3.00



MANUFACTURING DIRECTIONS

1. Mix all components, pass through a 0.8-mm

sieve, and press to tablets with very low-compression force.

2. Compress 278 mg in 8-mm biplanar punches.



Tetracycline Tablets (250 mg)

Bill of Materials

Scale (mg/tablet)

250.00

175.00

15.00

25.00

28.00

3.50

3.50



Item

1

2

3

4

5

6

7



Material Name

Tetracycline hydrochloride

Lactose monohydrate

Kollidon 30

Kollidon CL

Talc

Aerosil 200

Calcium arachinate



MANUFACTURING DIRECTIONS

1. Pass Items 1 to 4 through a 0.5-mm sieve, add

the mixture of Items 6 and 7, and press with

low-compression force.

2. Compress 505 mg in 12-mm biplanar punches.



© 2004 by CRC Press LLC



Quantity/1000 Tablets (g)

250.00

175.00

15.00

25.00

28.00

3.50

3.50



254



Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products



Tetrazepam Tablets (50 mg)

Bill of Materials

Scale (mg/tablet)

50.00

113.00

30.00

5.00

2.00



Item

1

2

3

4

5



Material Name

Tetrazepam

Microcrystalline cellulose (Avicel PH 101)

Starch 1500 (Colorcon)

Kollidon VA 64

Magnesium stearate



Quantity/1000 Tablets (g)

50.00

113.00

30.00

5.00

2.00



MANUFACTURING DIRECTIONS

1. Pass the components through a 0.5-mm sieve,

and press with low-compression force.

2. Compress 208 mg in 8-mm biplanar punches.



Theophylline and Ephedrine Tablets (130 mg/15 mg)

Bill of Materials

Scale (mg/tablet)

130.00

15.00

150.00

2.00

2.00



Item

1

2

3

4

5



Material Name

Theophylline (0.1 to 0.4 mm)

Ephedrine hydrochloride

Ludipress

Aerosil 200

Magnesium stearate



Quantity/1000 Tablets (g)

130.00

15.00

150.00

2.00

2.00



MANUFACTURING DIRECTIONS

1. Mix all components, pass through a sieve, and

press with very low-compression force.

2. Compress 302 mg in 8-mm biplanar punches.



Theophylline Tablets (100 mg)

Bill of Materials

Scale (mg/tablet)

100.00

147.00

3.00



Item

1

2

3



Material Name

Theophylline (0.1 to 0.4 mm)

Ludipress

Magnesium stearate



MANUFACTURING DIRECTIONS

1. Mix all components, pass through a sieve, and

press with low-compression force.

2. Compress 247 mg in 8-mm biplanar punches.



© 2004 by CRC Press LLC



Quantity/1000 Tablets (g)

100.00

147.00

3.00



Compressed Solid Formulations



255



Theophylline Tablets (100 mg)

Bill of Materials

Scale (mg/tablet)

100.00

137.10

60.00

1.50

1.50



Item

1

2

3

4

5



Material Name

Theophylline

Lactose anhydrous

Carbopol® 971P

Cab-o-Sil®

Magnesium stearate



Quantity/1000 Tablets (g)

100.00

137.10

60.00

1.50

1.50



MANUFACTURING DIRECTIONS

1. Pass all items through a 250-mm mesh, and

charge Items 1 to 3 in a suitable blender. (Item

3 can be used granulated in a fluid-bed.)

2. Add Items 4 and 5, and blend for 3 min.

3. Compress 300 mg in a suitable punch.



Theophylline Tablets CR (200 mg)

Bill of Materials

Scale (mg/tablet)

200.00

2.00

2.00

35.00

3.60

1.60

148.00





Item

1

2

3

4

5

6

7

8



Material Name

Theophylline powder

Sodium lauryl sulfate

Calcium stearate

Ethyl cellulose

Cetanol

Sodium lauryl sulfate

Triethyl citrate

Water, purified



MANUFACTURING DIRECTIONS

1. Charge Items 1 to 3 in a suitable mixer, and

mix for 10 min.

2. Granulate Step 1 by passing the items through

a compactor or dry granulator.

3. Pass the compact material from Step 2 through

#16 to #32 mesh.



© 2004 by CRC Press LLC



Quantity/1000 Tablets (g)

200.00

2.00

2.00

35.00

3.60

1.60

148.00

QS



4. In a separate vessel, add Items 4 to 7, and make

a solution with Item 8 to 200 g.

5. Transfer Step 3 into a fluid-bed granulator, and

apply the solution in Step 4 to coat the granules.

6. Compress.



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