Pharmaceutical Dose Form
Definition and Purpose
The pharmaceutical dose form is used to describe the manufactured item (i.e. the item as presented in the packaging by the manufacturer) or the pharmaceutical product (i.e. the item as intended to be administered to the patient, after any necessary transformation has been carried out). When used to describe the manufactured item, it may be referred to as the manufactured dose form; when describing the pharmaceutical product, it may be referred to as the administrable dose form.
The Standard Terms database does not explicitly distinguish between manufactured dose forms and administrable dose forms other than by use of the tagging system However, for a term representing a manufactured dose form such as ‘Powder for solution for injection’, the words‘for solution for injection’ indicate that a reconstitution is required, and that the resulting administrable dose form is ‘Solution for injection’.
Source: EDQM
Examples
Dispersible tablet, powder for solution for injection, prolonged-release capsule, hard
For more examples, see Pharmaceutical Dose Form Examples
and supplement (internal NOMA codes)
Pharmaceutical Dose Form Supplement Examples
Usage
Current usage: As a type of Authorised Pharmaceutical Dose Form in Profile: Medicinal Product, and as potential part of a Combined Term, Combination Pack or
Combined Pharmaceutical Dose Form.
Future usage: As the Manufacured Dose Form in the Manufactured Item and the Administrable Dose form in the Administrable Product.