Rebaz H. Ali, Ph.D....• Gelatin capsule shells may be hard or soft, depending on their composition. • Two-piece capsules are commonly referred to as hard-shell capsules, and one-piece

University of Sulaimani School of Pharmacy3rd level

Rebaz H. Ali, Ph.D.

5/7/2017 Pharmaceutical Compounding 2

Outlines

• Introduction

• Raw materials

• Hard gelatin capsules

• Soft gelatin capsule


Introduction

• The word ‘capsule’ is derived from the Latin capsula, meaning a small box.

• In pharmacy, the word is used to describe an edible package made from gelatin or

other suitable material which is filled with medicines to produce a unit dosage,

mainly for oral use.

• Gelatin capsule shells may be hard or soft, depending on their composition.

• Two-piece capsules are commonly referred to as hard-shell capsules, and one-

piece capsules are often referred to as soft-shell capsules.


Advantages

• It is a convenient dosage form to the patient.

• Tasteless

• Identification is easy (shape and color)

• Capsules are packaged and shipped by manufacturers at lower cost.

• They are more stable than liquid dosage forms.

• Uses empty hard gelatin capsules for extemporaneous compounding of prescriptions


Outlines

• Introduction

• Raw materials




Raw materials

Raw materials

Main material

Gelatin, water, colorant's.

Optional materials

Process aids and preservatives

Plasticizers

Glycerin and sorbitol.


Gelatin

• Is the major component used for capsules.

• Animal skins and bones are the raw materials used for the manufacture.

Gelatin

Type B

Produce by base hydrolysis

10 times longer

Bovine bones

Type A

Produce by acid hydrolysis

Take about 5-7 days

Mainly porcine skin


Gelatin

• The properties of gelatin that are most important to capsule manufacturers are the

Bloom strength and viscosity.

• The Bloom strength is a measure of gel rigidity, which defined as the load in

grams required to push a standard plunger 4 mm into the gel.

• A standard gel (6.66% w/ v) and maturing it at 10 °C.

• The gelatin used in hard capsule manufacture is of a higher Bloom strength

(200–250 g)

• For soft capsules (150 g)

• It is readily soluble in biological fluids at body temperature.

4 mm


Outlines

• Introduction

• Raw materials


• Formulation

• Capsule size

• Filling

• Materials for filling and excipients



Hard gelatin capsule

• The empty capsule shells are made of gelatin, sugar, and water.

• They can be clear, colorless, and essentially tasteless.

• Titanium dioxide could be added to make the shell opaque.

• Normally, hard gelatin capsules contain 13% to 16% of moisture.

• The standard moisture content for hypromellose capsules is 3% to 6% and

when they lose moisture they do not become brittle.

• Many capsules are packaged along with a small packet of a desiccant material.

• Gelatin capsules are unsuitable for aqueous.


Formulation cont.

• The Snap-fit construction enables the two halves of the capsule shells to be

positively joined through locking grooves in the shell walls.


Capsule sizes

• Empty gelatin capsules are manufactured in various lengths, diameters, and

capacities.


Filling of hard gelatin capsules

• Care in blending is especially important for low-dose drugs.

• Diluent could be added like lactose, MCC or starch.

• To achieve uniform drug distribution, it is advantageous if the density and

particle size of the drug and nondrug components are similar.

• free-flowing powder

• Lubricant and glidant could be use (up to 1%).


Materials for filling and excipients

Types of material for filling into hard gelatin capsules

Types of excipient used in powder-filled capsules

Dry solids, Powders, Pellets,

Granules, Tablets

Diluents, which give plug-forming properties.

Lubricants, which reduce powder-to-metal

adhesion.

Glidants, which improve powder flow.

Wetting agents, which improve water penetration.

Semi-solids

Thermo-softening mixtures

Pastes

Non-aqueous liquids


Outlines

• Introduction

• Raw materials




Soft gelatin capsule

• Soft gelatin capsules are made of gelatin to which glycerin or sorbitol has been

added.

• They are elegant and are easily swallowed and could be oblong, oval, or round.

• Preservative like as methylparaben and/or propylparaben, is used.

• They are used to encapsulate and hermetically seal liquids, suspensions, pasty

materials, dry powders, and tablets.

• They are not suitable for:

• Volatile organic compounds such as alcohols, ketones, acids, amines, and esters.


Softgels for different drug delivery

Drug solution in hydrophilic matrixDrug solution in hydrophobic matrix

Enteric coated

Suspension Suspension


Softgels for different drug delivery cont.

Twist-off softgels Meltable softgelsOrally administered softgels Chewable softgels


Reasons for softgel

Increased rate of absorption

• For poorly water-soluble drugs, ideally the dosage form would present the

drug to the gastrointestinal tract in solution form.

Patient compliance

• Easy to swallow. Absence of poor taste or other sensory problem.

Safety (cytotoxic drugs)

• Avoids dust-handling problems during dosage form manufacture

Oils and low melting point drugs

• Overcomes problems with manufacture as compressed tablet or hard-shell

capsules


Formulation of softgels

• Gelatin (40%)

• Plasticizer (20-30 %), to make the it elastic and pliable.

• Water (30-40%)


Thank you

Documents

Rebaz H. Ali, Ph.D....• Gelatin capsule shells may be hard or soft, depending on their composition. • Two-piece capsules are commonly referred to as hard-shell capsules, and one-piece