Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

• Composition of the dosage form Day Capsules

mg capsule

Reference Standard

Name

Function

ACTIVE INGREDIENT Paracetamol

Ph.Eur & RM/045 Ph.Eur & RM/054 Ph.Eur & RM/046

500.0

Analgesic

Phenylephrine Hydrochloride

6.1

Decongestant

Caffeine

25.0

Stimulant

EXCIPIENTS Maize Starch

Diluent/ Disintegrating Agent Diluent/ Disintegrating Agent

9.0

Ph.Eur

Croscarmellose Sodium Sodium Laurilsulfate Magnesium Stearate

29.2

Ph.Eur Ph.Eur Ph.Eur Ph.Eur

5.9 3.0 6.0

Wetting Agent

Lubricant Flow Aid

Talc

TOTAL CAPSULE FILL

584

RM 042

CAPSULE SHELL

Gelatin

91.28

Capsule Shell

Ph.Eur

Directive 95/45/EC *

0.999 †

Erythrosine (E127)

Colorant

1.77 †

Titanium Dioxide (E171)

Colorant/ Opacifier

Ph.Eur

Directive 95/45/EC * Directive 95/45/EC *

0.953 †

Quinoline Yellow (E104)

Colorant

0.0022 †

Patent Blue V (E131)

Colorant

TOTAL CAPSULE SHELL

95

GRAND TOTAL 679 * Complies with Directive 95/45/EC which lays down the criteria concerning colours for use in foodstuffs. † Due to the nature of the raw materials, their sourcing and technology improvements, the colorant composition data indicated are target values. Actual values may vary to ensure consistency of lot colour.