IPS1 - [Capsules] - Soft Gelatin Capsules; Packaging And Storage Of Capsules

Proverbs 16:3

Soft Gelatin Capsule

This type of capsule is in ONE-PIECE shell.

Soft Gelatin Capsule

This type of capsule is also known as SOFT ELASTIC CAPSULE

Soft Elastic capsule

Soft Gelatin Capsule is also known as ___

TRUE

TRUE OR FALSE:

Soft Gelatin Capsules are made of THICKER and SOFTER gelatin compared to hard gelatin capsules.

● Gelatin (35-45%)

● Sugar

● Water (40%)

● Plasticizer (15-25%)

● Preservatives (e.g., parabens)

● Colorants (dyes/pigments)

● Opacifier (e.g., titanium dioxide)

● Flavor

Composition of SOFT gelatin capsules:

35% - 45%

SOFT gelatin capsules contain ____ % GELATIN

40%

SOFT gelatin capsules contain ____ % WATER

15% - 25%

SOFT gelatin capsules contain ____ % PLASTICIZER

1 drug: 0.08 plasticizer

RATIO of DRUG to PLASTICIZER in soft gelatin capsules

● Glycerin

● Polyhydric alcohol such as sorbitol

PLATICIZERS used in SOFT gelatin capsules to render it elastic or plastic like.

Parabens

PRESERVATIVES used in SOFT gelatin capsules to prevent FUNGAL growth.

Dyes/Pigments

COLORANTS used in SOFT gelatin capsules which can be SINGLE or TWO-toned.

● Colorant

● Opacifier

● Flavor

● Sugar

These components of SOFT gelatin capsules are OPTIONAL/ AS NEEDED.

6% to 10%

MOISTURE CONTENT required for SOFT gelatin capsules.

● Liquids

● Suspensions

● Pasty materials

● Dry powders

● Preformed tablet

SOFT gelatin capsules should HERMETICALLY seal and encapsulate the following filling materials:

● Plate process

● Rotary die process

● Reciprocating die process

Methods of preparation for SOFT gelatin capsules

Plate Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

This is the OLDEST commercial process that uses set of MOLDS to form capsules.

Plate Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

This method is used for SMALL scale preparation of soft gelatin capsules and capsules formed generally, had ONE flat side.

Plate Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

Steps in this method are:

● A warmed sheet of plasticized gelatin is placed over a die plate with numerous molds (wells).

● Each mold is filled with the liquid medication.

● A second sheet of gelatin is placed on top.

● The top plate is pressed down to seal and form the capsules.

Plate Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

This method is NO LONGER AVAILABLE.

Rotary Die Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

Most common and modern industrial method.

Rotary Die Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

In this method, two plasticized gelatin ribbons are CONTINUOUSLY and SIMULTANEOUSLY fed with LIQUID or PASTE fill between the rollers of the rotary die mechanism.

Reciprocating Die Process

[METHODS OF PREPARATION FOR SOFT GELATIN CAPSULES]

In this method, the gelatin ribbons are fed between a set of VERTICAL dies that continually OPEN and CLOSE to form rows of packets in gelatin ribbons.

● Tight

● Well-closed

● Light-resistant

[PACKAGING OF CAPSULES]

Capsules should be packed in containers that are ____, depending on the item.

● Tight, well-closed, light-resistant bottles

● Strip pack

● Blister pack

[PACKAGING OF CAPSULES]

Common packaging types used in capsules

TRUE

[STORAGE OF CAPSULES]

TRUE OR FALSE:

Capsules should be stored in COOL and LOW humidity.

Capsules become DISTORTED and LOST their RIGID shape.

[STORAGE OF CAPSULES]

What will happen if capsules are stored in HIGH HUMIDITY?

Capsules become BRITTLE and will CRUMBLE.

[STORAGE OF CAPSULES]

What will happen if capsules are stored in EXTREME DRYNESS?

Desiccant materials

[STORAGE OF CAPSULES]

These are used to protect capsules from moisture.

These substances absorb excess humidity and help maintain the capsule's proper moisture balance.

● Dried silica gel

● Clay

● Activated charcoal

[STORAGE OF CAPSULES]

Common DESICCANTS used in capsules.