Creams

Creams are homogeneous, semi-solid or viscous preparations

that possess a relatively fluid consistency and are intended
for external application to the skin or certain mucous
membranes for protective, therapeutic or prophylactic
purposes especially where an occlusive effect is not necessary.
They are semisolids usually consisting of solutions or
dispersions of one or more medicaments in suitable bases*.
They are formulated using hydrophilic or hydrophobic bases
to provide preparations that are essentially miscible with the
skin secretion.
In recent times the term cream has been restricted to products
consisting of oil-in-water emulsions or aqueous
microcrystalline dispersions of long-chain fatty acids or
alcohols that are water-washable and more cosmetically and
aesthetically acceptable. Creams can be used for administering
drugs via the vaginal route.
The base should not produce irritation or sensitisation of the
skin, nor should it retard wound healing; it should be smooth,
inert, odourless or almost odourless, physically and chemically
stable and compatible with the skin and with incorporated
medicaments.
Creams may contain suitable antimicrobial preservatives unless
the active ingredients or the bases themselves have sufficient
bactericidal or fungicidal activity. They may contain other
suitable auxiliary substances such as antioxidants, stabilisers,
thickeners and emulsifiers.
If a cream is specifically intended for use on large open wounds
or on severely injured skin it should be sterile.
Creams should not normally be diluted; should dilution be
necessary care should be taken to prevent instability and, in
particular, microbial contamination.
Production
Creams should be packed in well-closed containers fitted with
closures that minimise contamination with micro-organisms.
When practicable, creams should be packed in collapsible
tubes of suitable metal or plastic.
During manufacture, packaging, storage and distribution of
creams, suitable means shall be taken to ensure their microbial
quality; acceptance criteria for microbial quality are given in
Chapter 5.9.
Tests
Creams comply with the requirements of tests stated under
the individual monographs and with the following
requirements.
Uniformity of weight. Comply with the test for contents of
packaged dosage forms (2.5.6).
Sterility. When the cream is labelled as sterile, it complies
with the test for sterility (2.2.11).
Storage. Store at temperatures below 25º unless otherwise
directed. Do not freeze.
Labelling. The label states (1) that the cream is sterile, where
necessary; (2) the name and concentration of any added
antimicrobial preservative; (3) the storage conditions.
* The term basis as a synonym for base in some of the monographs
means a carrier, composed of one or more excipients, for the active
pharmaceutical ingredient(s) in semi-solid and solid preparations.