Solid Dosage Forms(Capsules)

Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D

Department of PharmaceuticsFaculty of Pharmacy

Omer Al-Mukhtar UniversityTobruk, Libya.

E-Mail: nanjwadebk@gmail.com

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Content• Definition• Advantages and disadvantages• Types of capsules• Methods of filling the hard gelatin capsules• Method of filling of soft gelatin capsules• Different between hard gelatin and soft gelatin capsules• Evaluation of capules• Special Applications of Capsules• Packing and Storage of Capsules

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Definition• 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.

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Advantages of capsules1. The drugs having unpleasant odour and taste can be

administered by enclosing them in a tasteless shell.2. They are smooth, become very slippery when moist and can

be easily swallowed.3. They are economical.4. They are easy to handle and carry.5. The capsules release the medicament as and when desired in

gastro-intestinal tract.6. Capsules are made from gelatin and hence they are

therapeutically inert.7. They are attractive in appearance.

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Disadvantages of capsules

1. The hygroscopic drugs cannot be filled in capsules. They absorb water present in the capsule shell and hence make it very brittle, which ultimately breaks into pieces.

2. The concentrated preparations which need previous dilution are unsuitable for capsules because it may lead to irritation in stomach if administered as such.

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Types of Capsules• Capsules are available in two types:1. Hard gelatin capsules2. Soft gelatin capsules

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1. Hard Gelatin Capsules• These are used for administration of solid medicaments.• The capsule shell is prepared from gelatin, color and

titanium dioxide to make it opaque.• It consists of two parts i.e. body and cap. • The powdered material is filled into the cylindrical body

of the capsule and then the cap is placed over it. • The empty capsules are available in various sizes. • They are numbered according to the capacity of the

capsules. • The number starts from 000 and goes up to 5.

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1. Hard Gelatin CapsulesCapsule number Approximate capacity in mg

000 95000 6500 4501 3002 2503 2004 1505 100

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2. Soft Gelatin Capsules• These are used for administration of liquid medicaments. • Soft gelatin capsules are available in round, oval and tube

like shapes. • They are made from gelatin. • The gelatin is plasticized by the addition of glycerin and

sorbitol etc. • The soft gelatin shell may contain a preservative to

prevent the growth of fungi. • They are used to enclose liquid medicaments-oils,

suspensions, food concentrates and ophthalmic products.

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Excipients used in the filling of capsules

• While filling solid medicaments in a powder form into the body of hard gelatin capsule, the following additives, too are included in the formulation:

1. Diluents2. Absorbents3. Glidants4. Antidusting compounds

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Methods of filling the hard gelatin capsules

• The capsules can be filled either by hand or by a semi-automatic device or by an automatic filling machine.

• Capsule filling machine (Hand operated) It consists of:-1. A bed having 200-300 holes2. A loading tray having 200-300 holes3. A powder tray4. A pin plate having 200-300 pins5. A sealing plate having a rubber top6. A lever7. A cam handle

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Capsule filling machine (Hand operated)

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Method of filling of soft gelatin capsules

• Soft gelatin capsules are generally filled mechanically.• The manufacturing of the capsule shell and the filling of the

medicament take place simultaneously. • Nowadays, a rotary machine is used for this purpose.• In a rotary die machine, the soft gelatin capsules are prepared

and then filled immediately with the liquid medicaments. • The machine consists of two hoppers. • Liquid gelatin mixture is placed in one hopper and the liquid

medicament in the other hopper. • There are two rotating dies which rotate in opposite directions.

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Rotary machine

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Difference between Hard Gelatin and Soft Gelatin Capsules

Sl. No. Hard gelatin capsules Soft gelatin capsules

01 The hard gelatin capsule shell consists of two parts: (a) Body; (b) Cap.

The soft gelatin capsule shell becomes a single unit after sealing the two halves of the capsules.

02 They are cylindrical in shape. They are available in round, oval and tube like shapes.

03 The contents of a hard gelatin capsule usually consists of the medicaments or mixture of medicaments in the form of powder, beads or granules.

The contents of soft gelatin capsules usually consists of liquids or solids dissolved or dispersed in suitable excipients to give a paste-like consistency.

04 These are prepared from gelatin, titanium dioxide, coloring agent and plasticizer.

These are prepared from gelatin, plasticizer (Glycerin or Sorbitol) and a preservative.

05 Capsules are sealed after they are filled to ensure that the medicaments may not come out of the capsule due to rough handling.

Filling and sealing of soft gelatin capsules are done in a combined operation on machines.

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Evaluation of Capsules• The following tests should be carried out for

evaluation of the capsules:

1. Uniformity of weight2. Content of the active ingredients in the capsules3. Disintegration test4. Dissolution test

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Special Applications of Capsules

1. Enteric-coated capsules2. Sustained release capsules3. Rectal capsules4. Capsules containing ophthalmic ointments

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Packing and Storage of Capsules

• Capsules should be packed in well-closed glass or plastic containers and stored at a temperature not exceeding 30 0C.

• They should comply with such additional storage requirements as are specified in the individual monographs given in the pharmacopoeia of India.

• Capsules can be individually protected by enclosing them in a strip or blister packs.

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• In strip packing, the capsule is hermetically sealed within the strips of an aluminium foil and/or plastic film.

• The contents are removed from the strip packs by tearing or cutting to separate the capsules.

• In case of blister packs, a press on the blister forces the capsule through the backing strip.

• Generally, capsules have a longer shelf life in unopened glass bottles than in strip-packs but this is reversed, once a bottle has been opened.

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Packing and Storage of Capsules

THANK YOUe-mail nanjwadebk@gmail.com

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