CRED Getting the CMC Dossier Right 2024

28/08/2024

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

Description of the finished dosage form:

● The section should contain (visual) product description in line with specification in section 3.2.P.5.1, SmPC-section 3 and PIL. Differentiation between strengths.

CASE STUDY

Film-coated tablet intended for children (>5 years) and adult patients:

• 60 mg strength: Yellow, round, biconvex tablet debossed with ‘I’ on one side and plain on other side. • 120 mg strength: Yellow, octagonal, biconvex tablet debossed with ‘II’ on one side and plain on other side. • 240 mg strength: Yellow, square, biconvex tablet debossed with ‘III’ on one side and plain on other side.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

7

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

Composition per bottle?

Oral solution (300 mL)

Function

ORAL SOLUTION Ingredient

Quantity (mg/ml)

Quality standard

Oxicodone (as acetate)

2 mg/ml*

Active ingredient Sweetening agent

Ph.Eur. Ph.Eur. Ph.Eur. Ph.Eur. Ph.Eur. Ph.Eur. Ph.Eur. HSE

Saccharin sodium

3.85 mg/ml 2.0 mg/ml 24.75 mg/ml 0.135 mg/ml 35.0 mg/mL

Methyl parahydroxybenzoate

Preservative

Citric acid

Thickening agent Flavouring agent Thickening agent pH adjustment

Raspberry flavour** Hypromellose 2910

Hydrochloric acid, concentrated

-

Purified water

to 1 ml

Solvent

*API as free base (equivalent to 2.23 mg/mL of Oxicodone acetate)

**Raspberry flavour contains propylene glycol (E1520)

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

8