EXPERIMENT 3-4

Capsules

are solid dosage form in which the drug is enclosed within either a hard or soft soluble container or SHELL

• They are usually formed from gelatin; however, they also may be made from starch or other suitable substances.

• Plate process

• Rotary die process

• Reciprocating die process

METHODS IN FILLING CAPSULES

• SGC

• Punch method

• Capsule filler method

METHODS IN FILLING CAPSULES

• HGC

Pin Method

• dipping

• spinning

• drying

• stripping

• trimming

• joining

METHODS OF PRODUCTION OF HGCs

• 000

• 5

Hard Shell Capsules

• largest

• smallest

Larger bolus capsule

: Veterinary use in large animals

00

is usually the largest capsule size used orally for humans

000

size for suppositroy

PEARLS

SGC

• AKA

000

are sometimes used to encapsulate the medication for rectal or vaginal use.

1. RECTIFICATION 2. SEPARATION 3. FILLING 4. JOINING / CLOSING 5. EJECTION 6. FINISHING

STEPS IN FILLING HGCs

1. Lilly and Parke Davis Machines

2. The Model mG2 Machine Automatiche

3. Zanasi

4. Hofliger and Karg

4 CAPSULE FILLING EQUIPMENT

• SALTING

  • NaCL

• PAN

  • PolyERETHANE/CHEESE CLOTH

• COTH DUSTING

• BRASHING

FINISHING 4 TYPE AND THEY USES

TITANIUM DI OXIDE

Opaquant of capsule shells

12-16% or 10-15%

Usually —- water must be present

SOFT GELATIN CAP

• SORBITOL

- Are made of gelatin to which glycerine or a polyhydric alcohol such as ___________ has been added

METHYL PARABEN

PROPYL PARABEN

SOFT GELATIN CAP

• May have a preservative like

ROBERT SHERER

• 1933

  • 1949

Rotary die process

• WHO AND YEAR

Reciprocating die process

• YEAR

Disintegration test

Dissolution test

CAPSULE STANDARD

USP Tests for Capsules

Weight Variation

Content Uniformity

DOSAGE UNIT UNIFORMITY

Ferrous sulfate (20% elemental iron): active ingredient/prevention of IDA

Talc: Diluent

MO#3 Ferrous sulfate capsule

• API

• DILUENT

3.75 g

4.25 g

According to USP: Ferrous sulfate per 100 mL should contain

• NLT

• NMT

• NLT 0.75 g

• NMT 0.85 g

As elemental Iron: should contain

• NLT

• NMT

(11.6%),

300 mg of Ferrous gluconate contains 35 mg of elemental iron

(20%).

300 mg of ferrous sulfate contains 60 mg of elemental iron

(33%),

300 mg of ferrous fumarate contains 100 mg of elemental iron

Feosol® • Feosol® Caplets • Fergon® • Slow FE

Brand names OF Ferrous sulfate capsule

Amoxicillin: API/Antibiotic

Cornstarch: Diluent •

Mg Stearate: Lubricant/ antiadherent/ glidant

MO#4 Amoxicillin Capsule Raw Materials: •

API/Antibiotic •

Diluent •

Lubricant/ antiadherent/ glidant

Amoxicillin

is a broad-spectrum antibiotic that belongs to the aminopenicillin class of drugs. It is used to treat a wide range of bacterial infection

C16

H19

N3

O5

S

Amoxicillin

• FORMULA

PENICILLIN BINDING PROTEIN

Amoxicillin INHIBIT WHAT

20 - 25*c

STORAGE

Amoxicillin

AMOXIL

Amoxicillin

• BRAND NAME