![]() The other class, the fatty pastes (e.g., Zinc Oxide Paste), consists of thick, stiff ointments that do not ordinarily flow at body temperature, and therefore serve as protective coatings over the areas to which they are applied ( 1).Ī semisolid dosage form, containing a large proportion (20–50%) of solids finely dispersed in a fatty vehicle. One class is made from a single-phase aqueous gel (e.g., Carboxymethylcellulose Sodium Paste). Pastes are semisolid dosage forms that contain one or more drug substances intended for topical application. A gel may contain suspended particles ( 2). Gels (sometimes called Jellies) are semisolid systems consisting of either suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid ( 1).Ī semisolid dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion. Notice the new CDER definition applies to any semisolid emulsion, not just water-washable (o/w) types. This dosage form is generally for external application to the skin or mucous membranes ( 2). ![]() However, more recently the term 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 ( 1).Īn emulsion, semisolid dosage form, usually containing > 20% water and volatiles and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. The term has traditionally been applied to semisolids that possess a relatively fluid consistency formulated as either water-in-oil (e.g., Cold Cream) or oil-in-water (e.g., Fluocinolone Acetonide Cream) emulsions. Will these terms be changed to semisolid jar, semisolid slab, semisolid mill, etc.? Therefore, for the purposes of this chapter, the term semisolid is used interchangeably with the term ointment, which is used in its traditional general sense, encompassing all semisolid dosage forms intended for application to skin or mucous membranes.Ĭreams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base. While the proposed nomenclature clarifies the terminology, you can easily see the difficulty in making this change because the word ointment in its more general sense is part of many traditional derived terms such as ointment jar, ointment slab, and ointment mill. The CDER nomenclature, which was adopted in 2006, addresses this issue by using the general term semisolid for the type of physical system and reserves the term ointment for oleaginous semisolids as just defined in italics. When the same term is applied to more than one entity, it can lead to confusion. The problem with the first definition is that, although the word ointment has this general meaning, which applies to any semisolid dosage form for external application (e.g., oleaginous ointments, creams, gels), pharmaceutical manufacturers use this term for a specific semisolid dosage form type, oleaginous ointments. Ointments are semisolid preparations intended for external application to the skin or mucous membranes ( 1).Ī semisolid dosage form, usually containing 50% hydrocarbons, waxes, or polyols as the vehicle. The quoted definitions below that are printed in regular font are the traditional ones from USP 31/NF 26 Chapter 〈1151〉 Pharmaceutical Dosage Forms ( 1) the definitions in italic type are taken from the FDA CDER Data Standards Manual ( 2). The definitions and descriptions in this section should help in this regard. During the period when traditional terms are still used but new terms and definitions are being suggested, it is important that pharmacists and pharmacy technicians understand proposed dosage form taxonomy and nomenclature but also recognize the various traditional terms used to describe dosage forms. As was described in the beginning section of Chapter 27, the nomenclature for pharmaceutical dosage forms is in transition between use of traditional terms and definitions and a more systematic approach that has been proposed to more accurately and consistently describe drug products and preparations. ![]() DEFINITIONS AND NOMENCLATURE FOR SEMISOLIDSĪ. Definitions and Nomenclature for Semisolids
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