Gelatin Capsule Shells

Session 11: Gelatin Capsule Shells

Total Session Time: 120 minutes

Pre-requisites

Learning Tasks

By the end of this session students are expected to be able to:

Resources Needed:

SESSION OVERVIEW

|Step |Time |Activity/ |Content |

| | |Method | |

|1 |05 minutes |Presentation |Introduction, Learning Tasks |

|2 |15 minutes |Presentation |Definitions |

|3 |30 minutes |Presentation |Composition of Hard Gelatin Capsule |

| | | |Shells |

|4 |30 minutes |Presentation |Production of Hard Gelatin Capsule |

| | | |Shells |

|5 |30 minutes |Presentation |Size and Specification of Hard Shell |

| | | |Capsules |

|6 |05 minutes |Presentation |Key Points |

|7 |05 minutes |Presentation |Evaluation |

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definitions (15 minutes)

for encapsulation of drug materials in solid form

reasons;

➢ It is non toxic

➢ Readily soluble in biological fluids at body temperature

➢ It is a good film forming material

them hard

o The capsule body, which is longer and in which the contents are filled

o The capsule cap, which is shorter and fits tightly over the open end

of the capsule body

STEP 3: Composition of Hard Gelatin Capsule Shells (30 minutes)

soft gelatine capsules

make them soft)

sugar and water

o They are essentially tasteless

o Gelatine is heterogeneous product derived by hydrolytic extraction of

animal collagen

o According to the USP NF, gelatin is a product obtained by hydrolysis

of collagen derived from the skin, white connective tissue and bones

of animals

o The hydrolysis may be catalyzed by addition of strong acid or base

o Gelatin derived from acid-catalyzed hydrolysis is known as Type A

gelatin and gelatine obtained by hydrolysis catalyzed by bases is

known as Type B gelatin

o It is the main component for both hard and soft shell capsules

o Bloom Strength

gelatin to set up in water under controlled conditions and is a

function of the molecular weight of the gelatin molecules, the

concentration of the gelatin in the gel, and the pH of the gel

and is reported in bloom-grams or simply grams

gel increases, when the average molecular weight of the gelatin

increases, and when the pH of the gel approaches neutrality (from

either direction)

of the liquid-filled capsules

most gelatin used in the manufacture of liquid-filled capsules have

bloom strength of approximately 150–200 for soft gels and 220–280

for hard gels

strength

specifications;

➢ Gel strength of 200-300 Bloom depending on the gelatin type (A or B)

➢ Viscosity (at 60 ͦC at 6-23 % w/w) of 44-60 mPa depending on the

gelatin type

➢ pH of 4.5-6.5

➢ Aerobic Plate Count <1000/grams

o These are materials that make the walls of the shell softer and

flexible

o Are added to improve appearance of the capsule shells

o Soluble dyes and insoluble pigments are commonly used

o Opaquants are materials used to make the capsule opaque e.g. to

protect against light

o Preservatives are added to prevent microbial growth as gelatin is

susceptible to microbial attack

o Solvent (moisture content is controlled)

STEP 4: Production of Hard Gelatin Capsule Shells (35 minutes)

Production of hard shell gelatine capsules involves the following

processes;

o Pairs of stainless steel pins (metal moulds) with different diameters

at room temperature are dipped into hot gelatin solution to

simultaneously form the caps and bodies

o The hot gelatin solution gels to form a film around the metal moulds

o The dipping solution is maintained at a temperature of about 50 ͦ C in

a heated, jacketed dipping pan

o The pins are then rotated to distribute the gelatin over the pins

uniformly and avoid the formation of a bead at the capsule ends

o The gelatin film is dried by a blast of cool air to form a hard shell

o The pins are moved through a series of air drying kilns to remove

water

o A series of bronze jaws strip the cap and body portions of the

capsules from the pins

o The stripped cap and body portions are trimmed to the required length

by stationary knives and removed from the moulds

o The cap and body portions are finally joined together to form the

capsule shell

o The finished product (joined capsule shells) are dusted and polished

to acquire the final elegancy

o The finished hard shells may be imprinted with a logo or letters e.g.

monograms of manufacturers, which enhances identification of the

product

STEP 5: Size and Specification of Hard Shell Capsules (30 minutes)

o Hard gelatin capsule shells are available in various sizes for both

human and veterinary uses

o For human use the hard gelatin capsule shell sizes are from the

largest to the smallest;

products

o Generally hard gelatin capsule shells are used to encapsulate between

o Capsule shell produced by one company may differ from shells produced

by another company by altering the shape of the capsule end (which is

usually round)

a tapered end and the round shaped cap

o In order to protect the capsule from accidental opening or tempering,

reliable closing of the filled capsules can be achieve by producing

capsule shells with locking grooves or indentations

o The grooves fit into each other for tight closing and prevent

accidental separation (or splitting) of the capsules or tempering

o Some capsules are made tamper-proof and leak proof by sealing the

joint between the two capsule parts with a gelatin or polymer band

o Other capsule shells are made temper evident by wetting the contact

area between the body and the cap with a mixture of water and ethanol

and then thermally bonded at 40–45 °C

STEP 6: Key Points (5 minutes)

collagen derived from the skin, white connective tissue and bones of

animals

readily soluble in biological fluids at body temperature and it is a good

film forming material

which tightly fits over the body

colouring agents and water

stripping, trimming, joining and polishing. Finished shells may also be

imprinted for enhanced identification

filled capsules from accidental opening or tempering

STEP 7: Evaluation (5 minutes)

opening or tempering

References

Aulton M.E & Kevin M.G, (Eds): (2013) Pharmaceutics: The design and

manufacture of medicines, 4th (ed.) Churchill Livingstone

Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.), Willey-

Blackwel publications

Gennaro, R. A, et al. (Eds) (1995) Remington: The Science and Practice of

Pharmacy, Volume I & II, (19th ed.) Mack Publishing Company, Easton,

Pennsylvania 18042

Liebsch, B et al (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam

University Press.

Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice

of Pharmaceutics (12th ed.): The Pharmaceutical Press, London

Polderman, J (1990) Introduction to Pharmaceutical Production: Novib, The

Hague

Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, 8th Ed.

Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)

Manual for Decentralized Infusion Production, Infusion Unit Project

Tanzania

Schmidt, O. (Eds) 2000 Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

USP 31–NF 26. Rockville, MD: US Pharmacopeial Convention; 2008:1139

Watson, D. G (1999) Pharmaceutical Analysis: A Textbook for Pharmacy

Students and Pharmaceutical Chemists: Churchill Livingstone,

Edinburgh.

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