Module 3 - Strategic case studies in practice

3.2.P.1 Description and Composition of the Drug Product

3.2.P.1. Description and Composition of the Drug Product Composition of the dosage form

mg / capsule Function

Reference Standard

Name

ACTIVE INGREDIENT Paracetamol

300

Analgesic/antipyretic

Ph.Eur

Caffeine Anhydrous

25

Analgesic adjuvant

Ph.Eur

Phenylephrine Hydrochloride

5

Decongestant

Ph.Eur

EXCIPIENTS Starch

Binder/ Disintegrating Agent Diluent/ Disintegrating Agent

6.5

Ph.Eur

Croscarmellose sodium

5

Ph.Eur

Sodium laurilsulfate Magnesium Stearate

2

Wetting Agent

Ph.Eur Ph.Eur

4.2

Lubricant

TOTAL CAPSULE FILL

347.7

CAPSULE SHELL Gelatin

73

Capsule

Ph.Eur

Comply with 78/25/EEC Comply with 78/25/EEC Comply with 78/25/EEC Comply with 78/25/EEC

Iron oxide yellow (E172)

0.9

Capsule Colorant

Titanium dioxide (E171)

1.5

Capsule Colorant

Quinoline yellow (E104)

0.5

Capsule Colorant

Patent blue V (E131)

0.1

Capsule Colorant

TOTAL CAPSULE SHELL

76.0

GRAND TOTAL

423.7

Key: Ph.Eur - European Pharmacopoeia

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