MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
Supersedes the XI Monograph of the State Pharmacopoeia
Emulsions are liquid dosage forms, which are a heterogeneous two-phase disperse system with a liquid disperse phase and a liquid dispersion medium.
Emulsions can be of the oil/water and water/oil type.
Emulsions are intended for oral administration, inhalation, topical, external and parenteral administration.
Emulsions can stratify, but they should be easily restored when shaken. Emulsifiers are added in the composition of emulsions to ensure stability.
The type of emulsion formed is determined by the properties of the emulsifier (its hydrophilic-lipophilic balance).
Emulsifiers by type of emulsions formed are divided into hydrophilic (proteins, mucus, starch, dextrin, saponins, tannin, herbal extracts, bile salts, alkaline soaps, lecithin, polysorbates, etc.) forming emulsions of the oil/water type, and lipophilic (soaps of divalent and trivalent metals, sterols, resin soaps, fatty acid amides, high-molecular monohydric alcohols, etc.) forming emulsions of the water/oil type.
Emulsions can be metered-dose and not metered-dose.
When producing emulsions, almond, peach, olive, sunflower, castor, essential oils and liquid paraffin, as well as cod liver oil and other water-immiscible liquids are used.
The selection of emulsifier and its amount depends on the nature and properties of the emulsifier and oil.
Emulsions are produced by dispersing an emulsifier with an emulsifiable liquid and a dispersion medium. Active ingredients are included into emulsions taking into account their physical and chemical properties: lipophilic substances are dissolved in oils, water-soluble substances are dissolved in water, insoluble substances are dispersed and introduced into the base of emulsion.
Emulsions for parenteral administration should comply with the requirements of the GM «Parenteral dosage forms». Emulsions for inhalation should comply with the requirements of the GM «Dosage forms for inhalation». Emulsions in the form of eye drops should comply with the requirements of the GM «Ophthalmic dosage forms».
Description. Emulsion should be a homogeneous liquid in which stratification that disappears after shaking can be observed. The color and, if necessary, odor, are specified.
pH. It is determined if specified in the monograph or regulatory documentation. The test is carried out by a potentiometric method according to the GM «Ionometry».
Viscosity. The determination is carried out in accordance with the requirements of the GM «Viscosity» for emulsions in the form of eye drops if they contain ingredients that increase viscosity; for emulsions for parenteral administration and emulsions for inhalations. Standards are specified in monographs or regulatory documentation.
Particle size. It is determined if specified in the monograph or regulatory documentation. For emulsions for intravascular administration the control according to the «Particle size» parameter is mandatory (the GM «Parenteral dosage forms»).
In accordance with the requirements of the GM «Dosage forms». Emulsions are available both in multi-dose and unit-dose containers, with a device, if necessary, to ensure the convenience of use and dosage of a medicinal product.
As a means for measuring a prescribed dose, a dosing spoon or a cup, a dropper, etc. may be provided in a package.
Emulsions for parenteral administration, emulsions in the form of eye drops and emulsions for application to damaged skin are available in sterile airtight containers.
In accordance with the requirements of the GM «Dosage forms». The cautionary warning «Shake before use» should be provided on the label.
In accordance with the requirements of the GM «Storage of medicinal products». In a package that provides stability during the indicated shelf life of the medicinal product, in a dark place at a temperature of 8 to 15 °C, unless otherwise specified in the monograph or regulatory documentation. Freezing is not allowed.