Soft Gelatin Capsules

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Soft Gelatin Capsules

• Miss Surabhi R Singh,
• B. Pharm
• SGSPS Institute of Pharmacy,
• Kaulkhed, Akola.

Guide Dr. Suresh G. Sudke
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CAPSULES

• Defination
• Unit solid dosage form in which drug(s) are
  enclosed in a water soluble shell mainly of
  gelatin.

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CLASSIFICATION OF CAPSULES
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SOFT GELATIN CAPSULES

• Defination
  
  Capsules which contain drug(s) in a
  liquid or at least dissolved, solubilised or
  dispersed form by encapsulation process.

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ADVANTAGES

• Reproducibility
• Homogenisity
• Rapid dissolution
• Enhanced bioavailability
• Higher mean plasma levels
• Less amount of exicipients
• Elegency
• Masking of taste and odor of drugs

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DISADVANTAGES

• Expensive
• Incompatability
• Loss of drug
• Softening

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SHELL COMPOSITION

• Gelatin
• Plasticizer
• Preservation
• Colours
• Opacifier
• Flavours

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GELATIN

• Gelatin is heterogeneous product derived from
  the partial, irreversible, hydrolytic extraction
  of the treated animal collagens obtained from
• Animals bones
• Hide portions
• Frozen pork skin
• Connective tissues

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GELATIN (Cont)

• This long polypeptide chain yields on hydrolysis
  18 amino acid, the most prevalent of which are
  glycine and alanine.
• Gelatin can vary in its chemical and physical
  properties depending on the manner of extraction.
  
• There are two basic types of gelatin
• Types A
• Types B

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Alkaline hydrolysis
Pharmagel B
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GELATIN (Cont)

• Physicochemical properties of gelatin
• Bloom strength
• Viscosity
• Iron content

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PLASTICIZER

• Exact proportion of gelatin and Plasticizer has
  to be determined on the basis of use of capsule
  and their storage conditions.
• The ratio of dry Plasticizer to the dry gelatin
  determines the hardness of shell and can vary.
• In SGC the ratio of Plasticizer Gelatin is 0.81
  .
• Example Sorbitol, Glycerin, Propylene glycol.

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COLOURS

• Identification of product
• Improving patient compliance
• Selected based on their use
• Certified lakes, pigments, vegetables colour,
  water soluble dye.

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COLOUR DISEASE
White Analgesic
Lavender Hallucination
Orange Stimulants
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PRESERVATIVES

• Methyl paraben Propyl paraben (41) 0.2 .
• Paraben are often selected.
• FLAVOURS
• Ethyl vallinin, Essential oil, etc.
• Not more than 2 is use.

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OPACIFIER

• Opaque capsules may be employed
• To provide protection against light
• To control conceal the contents
• Example Titanium dioxide ( 0.2-1.2 ).
• Titanium dioxide may be included to render the
  shell opaque.

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FORMULATION

• Formulation of SGCs involves liquid rather than
  powder technology.
• Material are formulated to produce the smallest
  possible capsule consistent with maximum
  stability , therapeutic effectiveness and
  manufacture efficiency.
• Soft gelatin capsules contain single liquid, a
  combination of miscible liquids, a solution of
  drug in a liquids or a suspension of drug in
  liquids.

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.

• Liquid is limited to those that do not have a
  adverse effect on the gelatin walls.
• pH of liquid should be between 2.5-7.5.
• Liquid with more acid pH can cause leakage by
  hydrolysis of gelatin.
• Emulsion can not be filled because inevitably
  water will be released that will affect the
  shell.

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.

• Bauer and Dortune have proposed non aq. emulsion
  for SGCs. Emulsion were composed of a
  hydrophilic liquid such as polyethylene glycol
  400 and a triglyceride oil as the lipophillic
  liquid.
• Two types of solvent
• Water immiscible,
• Water miscible .

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METHOD OF MANUFACTURE

• There are four types of process for
  manufacturing the SGCs.
• 1) Plate method
• 2) Rotary method
• 3) Acogel method
• 4) Bubble method

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PLATE METHOD

• The oldest commercial semiautomatic process.
• In general, the process involved
• A) Placing the upper half of a plasticized
  gelatin sheet over a die plate containing
  numerous die pockets.
• B) Application of vaccum to draw the sheet
  into the die pockets.

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.

• C) Filling the pockets with liquor or paste.
• D) Folding the lower half of the gelatin sheet
  back over the filled pockets.
• E) Inserting the sandwich under a die press
  where the capsules are formed and cut out.

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ROTARY DIE PROCESS

• The first continuous process is the rotary die
  process, that was invented in 1933 by R. P.
  Scherer.
• A side from this continous process, the rotary
  die process reduced manufacturing losses to a
  negligible level and content variation to 1-3
  range, both major problems with earlier
  processes.

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.

• .

Fig. Rotary die process
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ACOGEL PROCESS

• A continous process for the manufacture of SGCs
  filled with powder or granules was developed by
  Lederle lab. in 1949.
• In general, this is another rotary process
  involving
• a measuring roll
• a die rolls
• a sealing roll.

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.

• .

Fig. Acogel Method
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BUBBLE METHOD

• A concentric tube dispenser simultaniously
  discharge the molten gelatin from the outer
  annulus of the liquid content from the inner
  tube.
• The Globex mark II capsulator produced truly
  seamless, one piece soft gelatin capsules by a
  Bubble method.

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Fig. Bubble method
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QUALITY CONTROL TESTS

• Uniformity of weight
• Uniformity of content
• Disintegration.

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