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capsule
PRESENTATION OUTLINE
1. Introduction.
2. Advantages of capsule.
3. Disadvantages of capsule.
4. Gelatin.
1. Five basic properties of gelatin.
2. Types of gelatin.
3. Manufacture of gelatin.
4. General properties of gelatin.
1. Types of capsule.
2. Hard gelatin capsule.
3. Capsule size.
4. Manufacture.
5. Soft gelatin capsule.
6. Composition of SGC.
1. Shapes and sizes of SGC.
2. Advantages of SGC.
3. Disadvantages of SGC.
4. Manufacture of SGC.
5. Rotary die machine.
6. Difference between SGC and HGC.
Capsules are a solid dosage form in
which the drug substance is enclosed in
a water soluble shell or an envelope. A
capsule shell is made from gelatin. The
capsules are available both as hard
capsule and soft capsule.
ADVANTAGES OF
CAPSULE
Odor and taste
masking possible.
Easily
swallowed.
They are
economical.
Easy to
handle and
carry.
Easily swallowed.
Easy to
handle and
carry.
Therapeutically
inert.
They are
attractive in
appearance.
Hygroscopic drugs can not be used.
Can cause irritation in stomach.
They are easily tampered.
More expensive than tablet.
DISADVANTAGES OF
CAPSULE
1
2
4
3
Gelatin is a protein substance derived from
collagen. It is a natural protein present in the
tendons, ligaments and tissues of mammals. It is
produced by boiling the connective tissues, bones
and skins of animals, usually cows and pigs. It is
the major component of capsule.
1. Non toxic.
2. Soluble in biological fluid at body temperature.
3. Good film forming material.
4. Solution of high concentration, 40% w/v are at
50◦c.
5. A solution in water changes from a sol to a gel
at temperatures only a few degrees above
ambient.
TYPES OF GELATIN
TYPE A: Derived from acid treated precursor that
exhibits an isoelectric point at pH-9.It is
manufactured mainly from pork skin.
TYPE B: Derived from alkali treated precursor
that exhibits an isoelectric point at pH-4.7.It is
manufactured mainly from animal bones.
GENERAL PROPERTIES OF GELATIN
1. Bloom value:
2. Gelling power:
3. Viscosity:
4. Foamability:
• Gelatin generally falls between 50 and 300 bloom strength.
• The gelling power varies depending on the grade of gelatin.
• The higher the bloom , the greater the viscosity.
• Pig skin grades tend to have better foaming properties.
GENERAL PROPERTIES (CONTINUED)
5. Melting point:
6. Color and odor:
7. pH:
• Lower melting point gelatin dissolve faster in the mouth.
• Lower bloom grade tend to have lower melting point.
• The gelatin should be clear and without odor.
• pH is a measured using a pH meter on a 1% solution are
typically for gelatin solutions falls between pH 4.5 and 6.5.
Capsules are generally 2 types:
1 Hard gelatin capsule
2 Soft gelatin capsule
HARD GELATIN CAPSULE
The hard gelatin capsule consist of a base or body and a
shorter cap. It contains:
12 -16% moisture
Dry solids
Powders
Granules
Tablets
Colorant
Preservatives
1
2
3
4
5
6
7
CAPSULE SIZE
For human use generally 8 sizes of capsule available:
size volume(ml)
000 1.37
00 0.95
0 0.68
1 0.5
2 0.37
3 0.3
4 0.21
5 0.13
MANUFACTURE OF EMPTY GELATIN CAPSULE
Dipping Spinning Drying Stripping
Trimming
and
joining
Polishing
Spinning
Dipping
Drying
Stripping
Cutting
Joining
SOFT GELATIN CAPSULE
Soft gelatin capsules are one piece , hermetically sealed, soft
gelatin shells containing a liquid, a suspension or a semisolid.
Added glycerol or polyhydric alcohol.
COMPOSITION OF SGC
Gelatin: 35-45%
Plasticizer: 15-25%
Water: 40%
Dye: As needed.
Opacifier: As needed.
Other: As needed.
SHAPES AND SIZES OF SOFT GELATIN CAPSULE
OBLONG ROUND
OVAL
SUPPOSITORIES
SPECIAL SHAPES
ADVANTAGES OF SOFT GELATIN CAPSULE
1 Easy to administer
2 Easy to manufacture
5 Small to large sizes possible
3 Elegance
4 Portability
6 Odor and taste masking possible
DISADVANTAGES OF SOFT GELATIN CAPSULE
1 High cost
4 Chance of interaction
2 preparation
Fill material3
5 Some liquid can not be used
MANUFACTURE OF SOFT GELATIN CAPSULE
The two most important process for manufacturing
softgels are:
1 Rotary die process
Plate process2
ROTARY DIE MACHINE
DIFFERENCE BETWEEN SGC AND HGC
Criterion
Shell
Content
Manufacture
Sizes and shapes
formulation
technology
Fill accuracy
Soft gelatin capsule Hard gelatin capsule
Plasticized Not plasticized
Usually in liquid form Usually in dry solids
Formed and filled in
one operation
Shells made in one operation
and filled in a separate process
Many Limited
Liquids Solids
More Less
Capsule
Capsule

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Capsule

  • 1.
  • 3. PRESENTATION OUTLINE 1. Introduction. 2. Advantages of capsule. 3. Disadvantages of capsule. 4. Gelatin. 1. Five basic properties of gelatin. 2. Types of gelatin. 3. Manufacture of gelatin. 4. General properties of gelatin. 1. Types of capsule. 2. Hard gelatin capsule. 3. Capsule size. 4. Manufacture. 5. Soft gelatin capsule. 6. Composition of SGC. 1. Shapes and sizes of SGC. 2. Advantages of SGC. 3. Disadvantages of SGC. 4. Manufacture of SGC. 5. Rotary die machine. 6. Difference between SGC and HGC.
  • 4. Capsules are a solid dosage form in which the drug substance is enclosed in a water soluble shell or an envelope. A capsule shell is made from gelatin. The capsules are available both as hard capsule and soft capsule.
  • 5. ADVANTAGES OF CAPSULE Odor and taste masking possible. Easily swallowed. They are economical. Easy to handle and carry. Easily swallowed. Easy to handle and carry. Therapeutically inert. They are attractive in appearance.
  • 6. Hygroscopic drugs can not be used. Can cause irritation in stomach. They are easily tampered. More expensive than tablet. DISADVANTAGES OF CAPSULE 1 2 4 3
  • 7. Gelatin is a protein substance derived from collagen. It is a natural protein present in the tendons, ligaments and tissues of mammals. It is produced by boiling the connective tissues, bones and skins of animals, usually cows and pigs. It is the major component of capsule.
  • 8. 1. Non toxic. 2. Soluble in biological fluid at body temperature. 3. Good film forming material. 4. Solution of high concentration, 40% w/v are at 50◦c. 5. A solution in water changes from a sol to a gel at temperatures only a few degrees above ambient.
  • 9. TYPES OF GELATIN TYPE A: Derived from acid treated precursor that exhibits an isoelectric point at pH-9.It is manufactured mainly from pork skin. TYPE B: Derived from alkali treated precursor that exhibits an isoelectric point at pH-4.7.It is manufactured mainly from animal bones.
  • 10.
  • 11. GENERAL PROPERTIES OF GELATIN 1. Bloom value: 2. Gelling power: 3. Viscosity: 4. Foamability: • Gelatin generally falls between 50 and 300 bloom strength. • The gelling power varies depending on the grade of gelatin. • The higher the bloom , the greater the viscosity. • Pig skin grades tend to have better foaming properties.
  • 12. GENERAL PROPERTIES (CONTINUED) 5. Melting point: 6. Color and odor: 7. pH: • Lower melting point gelatin dissolve faster in the mouth. • Lower bloom grade tend to have lower melting point. • The gelatin should be clear and without odor. • pH is a measured using a pH meter on a 1% solution are typically for gelatin solutions falls between pH 4.5 and 6.5.
  • 13. Capsules are generally 2 types: 1 Hard gelatin capsule 2 Soft gelatin capsule
  • 14. HARD GELATIN CAPSULE The hard gelatin capsule consist of a base or body and a shorter cap. It contains: 12 -16% moisture Dry solids Powders Granules Tablets Colorant Preservatives 1 2 3 4 5 6 7
  • 15. CAPSULE SIZE For human use generally 8 sizes of capsule available: size volume(ml) 000 1.37 00 0.95 0 0.68 1 0.5 2 0.37 3 0.3 4 0.21 5 0.13
  • 16. MANUFACTURE OF EMPTY GELATIN CAPSULE Dipping Spinning Drying Stripping Trimming and joining Polishing Spinning Dipping Drying Stripping Cutting Joining
  • 17. SOFT GELATIN CAPSULE Soft gelatin capsules are one piece , hermetically sealed, soft gelatin shells containing a liquid, a suspension or a semisolid. Added glycerol or polyhydric alcohol.
  • 18. COMPOSITION OF SGC Gelatin: 35-45% Plasticizer: 15-25% Water: 40% Dye: As needed. Opacifier: As needed. Other: As needed.
  • 19. SHAPES AND SIZES OF SOFT GELATIN CAPSULE OBLONG ROUND OVAL SUPPOSITORIES SPECIAL SHAPES
  • 20. ADVANTAGES OF SOFT GELATIN CAPSULE 1 Easy to administer 2 Easy to manufacture 5 Small to large sizes possible 3 Elegance 4 Portability 6 Odor and taste masking possible
  • 21. DISADVANTAGES OF SOFT GELATIN CAPSULE 1 High cost 4 Chance of interaction 2 preparation Fill material3 5 Some liquid can not be used
  • 22. MANUFACTURE OF SOFT GELATIN CAPSULE The two most important process for manufacturing softgels are: 1 Rotary die process Plate process2
  • 24. DIFFERENCE BETWEEN SGC AND HGC Criterion Shell Content Manufacture Sizes and shapes formulation technology Fill accuracy Soft gelatin capsule Hard gelatin capsule Plasticized Not plasticized Usually in liquid form Usually in dry solids Formed and filled in one operation Shells made in one operation and filled in a separate process Many Limited Liquids Solids More Less

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