NTA Level 6 • Semester 1 • PST06103

Introduction to Capsules

Pharmaceutical Production • Source Session/Topic 10

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Session 10: Introduction to Capsules

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

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

• Define capsules

• Classify capsules

• Explain modified release capsules

• List advantages and disadvantages of capsules

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

SESSION OVERVIEW

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)

• Capsules are solid unit dosage forms with hard or soft shells of various

shapes and capacities containing a single dose of a drug substance

• The term capsule is derived from the Latin word “capsula”, meaning a

small container.

• The first capsule prepared from gelatin was a one-piece capsule patented

in France by Mothes and Du Blanc in 1834

• Capsules are intended to be swallowed whole; however, some soft gelatin

capsules are intended for rectal or vaginal insertion as suppositories.

• Capsules consists of two main parts, the shell (commonly but exclusively

made up of gelatin) and the fill material (the Active pharmaceutical

ingredient(s) and the excipients)

o The capsule shell may also be made up of plant materials e.g. vegicaps

• Capsules are a common form of dosage for oral administration of

pharmaceutical and nutraceutical products

• Branding and dosage information may be printed on the outer surface of

the capsule

• Medication or ingredients inside the capsule (the fill content) may be

in form of solid, liquid or paste depending on the active pharmaceutical

ingredient (API) or, in the case of nutraceutical, on the form of the

main nutrient (e.g. liquid fish oil)

STEP 3: Classification of Capsules (25 minutes)

• Capsules are classified as either hard or soft, depending on the nature

of the shell

o Hard shell capsules

▪ Hard gelatine capsules consist of a hard gelatine capsule shell

encasing solid fill material

▪ Hard gelatin capsules are also known as dry-filled capsules or

two pieces capsules

▪ Hard gelatin capsules consist of two parts known as capsule body

(longer part) and the capsule cap (the shorter part)

▪ The drug substance placed in the body and the caps are slided

over it, hence enclosing the drug substance

▪ The caps and body pieces of the capsule shell are supplied

unlocked to be filled with the appropriate drug or nutraceutical

ingredients

o Soft shell gelatine capsules

▪ Soft gelatin capsules, also called soft gels, are thicker than

hard shell gelatin capsules

▪ They are softer and hence easier to swallow

▪ They are made up of one piece and hemetically sealed

▪ They are softer due to addition of plasticizers (glycerin or

sorbitol) in the gelatin

▪ The shell is usually made up of gelatin like in the hard shell

gelatin capsule but softer and contain more water (generally

between 6% and 13% by weight) and preservatives

▪ Soft gels can be filled with liquid (solution, suspension etc),

semi solid or rarely solid materials which can be dissolved or

suspended in water to form a paste mixture

▪ In other case the capsule may simply be filled with granules or

powder

▪ Instead of gelatine, seaweed extract and gluten free starch are

used in making up the soft shell (providing animal free product,

suitable for strict vegetarians)

▪ The shell can be clear or coloured and there is a wide range

of shapes, sizes and colours available

▪ They are suitable for vegetarians or people who do not prefer

animal products

▪ They have low shell odour

STEP 4: Modified Release Capsules (30 minutes)

• Both hard or soft gel capsules can be chemically modified to control the

release of the active pharmaceutical ingredient (s)

• Delivery of the active ingredient from the capsule shell is usually

effected by disintegration of the shell and disintegration of the fill

content upon opening of the shell

• The release of the active pharmaceutical ingredient(s) may be modified by

various methods including;

o Coating the capsule shell with a material through which the drug

diffuses

o Coating the capsule shell with a slowly dissolving coat that slowly

releases the drug over time

o Employing a system utilizing a semipermeable membrane that blocks the

drug from diffusing out through the membrane, but where the water on

the exterior of the membrane can diffuse into the formulation,

allowing the drug to be released through channels within the membrane

o Designing the capsule shell to resist disintegration by the stomach

acid until it reaches the intestinal fluid where at a higher pH it

breaks down and releases the active ingredients i.e. enterically

coated capsules

STEP 5: Advantages and Disadvantages of Gelatin Capsules (35 minutes)

|Activity: Small Group Discussion (10 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are the advantages and disadvantages of capsule dosage forms? |

| |

|ALLOW students to discuss for 10 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Advantages of Capsules;

o They are quickly and conveniently filled

o They mask odour and taste of drug substances with objectionable odour

and taste

o They are attractive in appearance

o It is easy to change and dose and combination of drug according to

patient requirement

o They are economical

o They are easy to handle and carry

o They are easy to identify

o Easy to administer

o Easy to package and ship at lower

o Do not break easily

o Shells can be opacified with titanium dioxide or coloured to protect

from light

o Shells are physiologically inert

• Disadvantages of capsules

o Hygroscopic drugs are not suitable for filling into capsules

▪ They absorb water moisture present in capsule shell and make the

shells very brittle ultimately leading to crumbling of the capsules

into pieces

o Concentrated solution requiring previous dilution are unsuitable for

capsules because if administered as such, they will lead to irritation

in the gastrointestinal tract (stomach)

o Gelatin is susceptible to microbial degradation

▪ They require care to be observe during the manufacturing,

packaging, storing and distribution of capsules

o Shell odour especially gelatin capsules

STEP 6: Key Points (5 minutes)

• Capsules are solid unit dosage forms with hard or soft shells of various

shapes ad capacities containing a single dose of a drug substance

• The fill contents for capsule may be liquid, semisolid or rarely solid

• There are two main types of capsules, hard shell and soft shell capsules

• Both hard or soft gel capsules can be chemically modified to control the

release of the active pharmaceutical ingredient (s) e.g. enterically

coated capsules resist gastric acid and open after reaching the alkali

milieu of the small intestine

STEP 7: Evaluation (5 minutes)

• What is a capsule?

• What are the major types of capsule?

• What is the difference between capsule shell and capsule fill content?

• What is the major component of capsule shell?

• What are factors affecting release of medicament(s) from capsule shell?

References

Aulton M.E and 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. (Ed) 2000 Pharmaceutical Quality systems, Interpharm Press,

Colorado.

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

and processes, John Wiley & Sons

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

Students and Pharmaceutical Chemists: Churchill Livingstone,

Edinburgh.

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