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Contents
 Introduction
 Types of Materials
 Capsule Shell Filling
 Difficulties in Capsule Filling
 Remedies for Filling Capsules
 Capsule Sealing
 Packaging & Storage of Capsules
 Conclusion
 Reference
Introduction
 Capsule is the most versatile of all dosage forms. Capsules are
solid dosage forms in which one or more medicinal and inert
ingredients are enclosed in a small shell or container usually
made of gelatin.
 There are two types of capsules, “hard” and “soft”. The hard
capsule is also called “two piece” as it consists of two pieces in
the form of small cylinders closed at one end, the shorter piece
is called the “cap” which fits over the open end of the longer
piece, called the “body”. The soft gelatin capsule is also called as
“one piece”.
 Capsules are available in many sizes to provide dosing flexibility.
Unpleasant drug tastes and odors can be masked by the
tasteless gelatin shell. The administration of liquid and solid
drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.
Types of materials for filling into hard gelatin
capsules:
Dry solids – powders, pellets, granules or tablets.
Semisolids – suspensions or pastes.
Liquids – non-aqueous liquids.
Capsule shell filling:
The process of working :
 Rectification
 Separating the caps from empty capsules
 Filling the bodies
 Scraping the excess powder
 Replacing the caps
 Sealing the capsules
 Cleaning the outside of the filled capsule
Difficulties in filling capsules
Deliquescent or Hygroscopic powders – a gelatin capsule contain
water which is extracted or taken up by a hygroscopic drug and
renders the capsule very brittle which leads to cracking of the
capsule.
Eutectic mixtures – certain substances when mixed together tend to
liquefy and form a pasty mass due to the formation of a mixture
which has a lower melting point than room temperature.
Addition of inert powders – the quantity of the drug to be filled in
capsules is very small and it is not possible to fill this much small
amount in capsules .
Filling of granular powder – some powders which lack adhesiveness
and most granular powders are difficult to fill in the capsules by
punch method because they are not compressible and flow out of
the capsule as soon as they are lifted from the pile of powder into
which they are punched
Remedies for capsule filling
For deliquescent or Hygroscopic powders the addition of an adsorbent like
magnesium carbonate, heavy magnesium oxide or light magnesium oxide
overcomes this difficulty provided the capsules are packed in tightly closed
glass capsule vials.
For eutectic mixtures for filling these types of substances each troublesome
ingredient is mixed with an absorbent separately then mixed together and
filled in capsules. The absorbents used are magnesium oxide and kaolin.
Another method in dealing with such type of difficulty is that the substances
are mixed together so as to form a eutectic mixture, then an absorbent like
magnesium carbonate or kaolin is added.
For addition of inert powders inert substance or a diluent is added so as to
increase the bulk of the powder, which can be filled easily in capsules.
For filling of granular powder the non-adhesive powders should be
moistened with alcohol and the granular powders should be reduced to
powder before filling into capsules. Alternative material for Hard-shell
capsules Several materials have been examined as a substitute.
Capsule Sealing
 Aligning said cap edge to surround said body edge.
 Contacting the juncture of the cap and body edge with a sealing fluid
containing an alcohol-water solution maintained at about 40° C.
 Applying a gelatin band to gird the capsule in the area of the liquid
seal.
 The capsule surface is dried prior to the addition of the gelatin band.
 The sealing fluid is maintained at a temperature not greater than
about 60° C.
 The capsule body and cap are simultaneously spun as the sealing fluid
is applied.
Packaging & storage of capsules
 Capsules should be packed in a well-closed glass or plastic containers
and stored in a cool place. These type of containers have advantage
over cardboard boxes that they are more convenient to handle and
transport and protect the capsules from moisture and dust.
 In vials containing very hygroscopic capsules a packet-containing
desiccant like silica gel or anhydrous calcium chloride may be placed
to prevent the absorption of excessive moisture by the capsules.
 Empty gelatin capsules should be stored at room temperature at
constant humidity. High humidity may cause softening of the
capsules and low humidity may cause drying and cracking of the
capsules.
 Storage of capsules in glass containers will provide protection
not only from extreme humidity but also from dust. Storage of
filled capsules is dependent on the characteristics of the
drugs they contain.
Conclusion
Hence, the presentation on
Capsule Filling, Sealing and Packaging
was completed by accommodating
information from the sources mentioned in
the next slide.
Reference
 Pharmaceutics – The Science of Dosage form Design by M.E. Aulton,
2nd Edition.
 Remington – The Science and Practice of Pharmacy, 20th Edition,
Volume – 1.
 The Theory and Practice of Industrial Pharmacy by Leon Lachman.
 Encyclopaedia of Pharmaceutical Technology, Volume – 2.
 Textbook of Pharmaceutics by Bentley, 8th Edition.
 Modern Pharmaceutics by Gilbert S. Bankers, 4th Edition, Dekker
series.
 Website – www.capsugel.com
 Website – www.liquidcapsules.com
 Ogura T, Furuya Y, Matuura S. HPMC capsules: an alternative to
gelatin. Pharm Tech Europe. 1998; 10(11): 32-42.
 Gelatin. Gelatin Manufacturer’s Institute of America.
Thank You

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Capsules

  • 1.
  • 2. Contents  Introduction  Types of Materials  Capsule Shell Filling  Difficulties in Capsule Filling  Remedies for Filling Capsules  Capsule Sealing  Packaging & Storage of Capsules  Conclusion  Reference
  • 3. Introduction  Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms in which one or more medicinal and inert ingredients are enclosed in a small shell or container usually made of gelatin.  There are two types of capsules, “hard” and “soft”. The hard capsule is also called “two piece” as it consists of two pieces in the form of small cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of the longer piece, called the “body”. The soft gelatin capsule is also called as “one piece”.  Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell. The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most frequently utilized dosage forms.
  • 4. Types of materials for filling into hard gelatin capsules: Dry solids – powders, pellets, granules or tablets. Semisolids – suspensions or pastes. Liquids – non-aqueous liquids.
  • 5. Capsule shell filling: The process of working :  Rectification  Separating the caps from empty capsules  Filling the bodies  Scraping the excess powder  Replacing the caps  Sealing the capsules  Cleaning the outside of the filled capsule
  • 6. Difficulties in filling capsules Deliquescent or Hygroscopic powders – a gelatin capsule contain water which is extracted or taken up by a hygroscopic drug and renders the capsule very brittle which leads to cracking of the capsule. Eutectic mixtures – certain substances when mixed together tend to liquefy and form a pasty mass due to the formation of a mixture which has a lower melting point than room temperature. Addition of inert powders – the quantity of the drug to be filled in capsules is very small and it is not possible to fill this much small amount in capsules . Filling of granular powder – some powders which lack adhesiveness and most granular powders are difficult to fill in the capsules by punch method because they are not compressible and flow out of the capsule as soon as they are lifted from the pile of powder into which they are punched
  • 7. Remedies for capsule filling For deliquescent or Hygroscopic powders the addition of an adsorbent like magnesium carbonate, heavy magnesium oxide or light magnesium oxide overcomes this difficulty provided the capsules are packed in tightly closed glass capsule vials. For eutectic mixtures for filling these types of substances each troublesome ingredient is mixed with an absorbent separately then mixed together and filled in capsules. The absorbents used are magnesium oxide and kaolin. Another method in dealing with such type of difficulty is that the substances are mixed together so as to form a eutectic mixture, then an absorbent like magnesium carbonate or kaolin is added. For addition of inert powders inert substance or a diluent is added so as to increase the bulk of the powder, which can be filled easily in capsules. For filling of granular powder the non-adhesive powders should be moistened with alcohol and the granular powders should be reduced to powder before filling into capsules. Alternative material for Hard-shell capsules Several materials have been examined as a substitute.
  • 8. Capsule Sealing  Aligning said cap edge to surround said body edge.  Contacting the juncture of the cap and body edge with a sealing fluid containing an alcohol-water solution maintained at about 40° C.  Applying a gelatin band to gird the capsule in the area of the liquid seal.  The capsule surface is dried prior to the addition of the gelatin band.  The sealing fluid is maintained at a temperature not greater than about 60° C.  The capsule body and cap are simultaneously spun as the sealing fluid is applied.
  • 9. Packaging & storage of capsules  Capsules should be packed in a well-closed glass or plastic containers and stored in a cool place. These type of containers have advantage over cardboard boxes that they are more convenient to handle and transport and protect the capsules from moisture and dust.  In vials containing very hygroscopic capsules a packet-containing desiccant like silica gel or anhydrous calcium chloride may be placed to prevent the absorption of excessive moisture by the capsules.  Empty gelatin capsules should be stored at room temperature at constant humidity. High humidity may cause softening of the capsules and low humidity may cause drying and cracking of the capsules.  Storage of capsules in glass containers will provide protection not only from extreme humidity but also from dust. Storage of filled capsules is dependent on the characteristics of the drugs they contain.
  • 10. Conclusion Hence, the presentation on Capsule Filling, Sealing and Packaging was completed by accommodating information from the sources mentioned in the next slide.
  • 11. Reference  Pharmaceutics – The Science of Dosage form Design by M.E. Aulton, 2nd Edition.  Remington – The Science and Practice of Pharmacy, 20th Edition, Volume – 1.  The Theory and Practice of Industrial Pharmacy by Leon Lachman.  Encyclopaedia of Pharmaceutical Technology, Volume – 2.  Textbook of Pharmaceutics by Bentley, 8th Edition.  Modern Pharmaceutics by Gilbert S. Bankers, 4th Edition, Dekker series.  Website – www.capsugel.com  Website – www.liquidcapsules.com  Ogura T, Furuya Y, Matuura S. HPMC capsules: an alternative to gelatin. Pharm Tech Europe. 1998; 10(11): 32-42.  Gelatin. Gelatin Manufacturer’s Institute of America.