U.S. PHARMACOPEIA

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SUSPENSIONS
Suspensions are liquid preparations that consist of solid particles dispersed throughout a liquid phase in which the particles are not soluble. Dosage forms officially categorized as “Suspensions” are designated as such if they are not included in other more specific categories of suspensions, such as Oral Suspensions, Topical Suspensions, etc. (see these other categories). Some suspensions are prepared and ready for use, while others are prepared as solid mixtures intended for constitution just before use with an appropriate vehicle. Such products are designated “for Oral Suspension”, etc. The term “Milk” is sometimes used for suspensions in aqueous vehicles intended for oral administration (e.g., Milk of Magnesia). The term “Magma” is often used to describe suspensions of inorganic solids such as clays in water, where there is a tendency for strong hydration and aggregation of the solid, giving rise to gel-like consistency and thixotropic rheological behavior (e.g., Bentonite Magma). The term “Lotion” has been used to categorize many topical suspensions and emulsions intended for application to the skin (e.g., Calamine Lotion). Some suspensions are prepared in sterile form and are used as Injectables, as well as for ophthalmic and otic administration. These may be of two types, ready to use or intended for constitution with a prescribed amount of Water for Injection or other suitable diluent before use by the designated route. Suspensions should not be injected intravenously or intrathecally.
Suspensions intended for any route of administration should contain suitable antimicrobial agents to protect against bacteria, yeast, and mold contamination (see Emulsions for some consideration of antimicrobial preservative properties that apply also to Suspensions). By its very nature, the particular matter in a suspension may settle or sediment to the bottom of the container upon standing. Such sedimentation may also lead to caking and solidification of the sediment with a resulting difficulty in redispersing the suspension upon agitation. To prevent such problems, suitable ingredients that increase viscosity and the gel state of the suspension, such as clays, surfactants, polyols, polymers, or sugars, should be added. It is important that suspensions always be shaken well before use to ensure uniform distribution of the solid in the vehicle, thereby ensuring uniform and proper dosage. Suspensions require storage in tight containers.
Oral Suspensions
Oral Suspensions are liquid preparations containing solid particles dispersed in a liquid vehicle, with suitable flavoring agents, intended for oral administration. Some suspensions labeled as “Milks” or “Magmas” fall into this category.
Topical Suspensions
Topical Suspensions are liquid preparations containing solid particles dispersed in a liquid vehicle, intended for application to the skin. Some suspensions labeled as “Lotions” fall into this category.
Otic Suspensions
Otic Suspensions are liquid preparations containing micronized particles intended for instillation in the outer ear.
Ophthalmic Suspensions
See Ophthalmic Preparations.