Colouring Agents, Antimicrobial Preservatives, Sweetening Agents

Colouring Agents, Antimicrobial Preservatives, Sweetening Agents

5.4 Colouring Agents:

The use of colouring agents in paediatric medicines is generally discouraged, in particular in medicines for infants and young children. Their use may, however, be justified in certain cases, e.g. to avoid accidental dosing errors in connection with medicines produced in several strengths. In this case, a solid dosage form
of the types mentioned in section 3 may be preferred because size, shape and embossing can facilitate identification of different strengths of the preparation.

Some colouring agents used in paediatric medicines have been associated with hypersensitivity (25). The number of colouring agents that are acceptable for use in medicines is limited. Azo-dyes should be avoided in children’s medicines and attention should be paid to the risk of allergic reactions associated with natural colourants (26). 

5.5 Antimicrobial Preservatives:

FPPs may require antimicrobial preservatives to avoid microbial proliferation during storage, in particular under in-use conditions. Preservatives are needed in particular for aqueous multidose preparations and semi-solid preparations and may also be needed for other aqueous preparations. Usually solid dosage forms do not require preservatives.

Preservatives may have a potential to cause adverse reactions, in particular in infants and neonates, and should be avoided where possible. Furthermore, complex preservative systems should be avoided.

Ophthalmic preparations without preservatives are strongly recommended for use in children, especially neonates. Therefore, preparations without preservatives should be developed wherever possible in order to cater for the diversity of patients’ needs. When preservatives are required, their concentration should be the minimum level consistent with satisfactory antimicrobial function in each individual preparation and a thorough justification for the choice of the preservative should be established. Ophthalmic preparations without any mercury-containing preservatives, e.g. thiomersal, should also be considered. Further details on this topic are provided in a public statement (27) published on the EMA web site.

5.6 Sweetening Agents:

Oral paediatric medicines often use sweetening agents to make them palatable. These may be either cariogenic or non-cariogenic sweeteners. In addition to the considerations listed in section 4.3, attention should be paid to:

■ Safety of the sweetening agent in relation to specific conditions of the child, e.g. diabetes, fructose intolerance, and avoiding use ofaspartame in patients with phenylketonurea;

■ The laxative effect of poorly absorbed or non-digestible sweeteners inhigh concentrations;

■ The severity of the condition to be treated, i.e. are potential adverse reactions of the sweetening agent secondary to patient adherence?

Development of Paediatric Medicines: points to consider in formulation, 
(Annex 5, WHO Technical Report Series 970, 2012)

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