Tuesday, July 14, 2009

Powders for oral solutions, oral suspensions or oral drops

Presentations of powder (usually single-dose presentations, for example, a small sachet) that are
intended to be issued to the patient as a powder, to be taken in or with water or another suitable
liquid, are outside the scope of this general monograph. Such preparations are controlled by the
monograph for Oral powders.
Powders for oral solutions, suspensions or drops are multidose preparations consisting of solid,
loose, dry particles of varying degrees of fineness. They contain one or more active ingredients,
with or without excipients and, if necessary, authorized colouring matter and flavouring substances.
They may contain antimicrobial preservatives and other excipients in particular to facilitate
dispersion or dissolution and to prevent caking.

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After dissolution or suspension in the prescribed liquid, they comply with the requirements for Oral
solutions, Oral suspensions or Oral drops, as appropriate.
In the manufacture of powders for oral solutions, suspensions or drops, the components of the
powder mixture are passed through a sieve to remove lumps and particle aggregates. The weighed
masses of the sieved components, preferably of a narrow particle size distribution, are then
transferred to a suitable mixer. The greatest risk of segregation of the powder mixture usually
occurs when emptying the mixer container and when the powder mixture is dosed into the
containers. Ensuring the suitability of the mixing equipment and the dosing devices is, therefore,
Visual inspection
Inspect the powder. Evidence of physical instability is demonstrated by noticeable changes in
physical appearance, including texture (for example, clumping). A change in colour may indicate
chemical degradation or microbial contamination.

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