Tests that are universally applied to ensure safety, efficacy, strength, quality, and purity include description, identification, assay, and impurities. Labeling statements: Some dosage forms or articles have mandatory labeling statements that are given in the Code of Federal Regulations (e. g., 21 CFR 201. Though aggregation and creaming are usually unavoidable, the preparation should be formulated so that the internal phase readily redisperses to give a uniform emulsion when the preparation is shaken. Typically the impregnated drug substance is present in the dry state. Water-removable bases ( oil in water). Ocular systems are intended for placement in the lower conjunctival fornix from which the drug diffuses through a mambrane at a constant rate. A levigating agent is often added to facilitate the incorporation of the medicament into the ointment base by the direct incorporation procedure. Advantages of semi-solid dosage form: - It is used externally. The blend is then processed through a conventional tablet press and tableted into desired shapes. Poultices, or cataplasms, are an SSD form that is meant for topical use only. Soaps used as dosage forms may contain a drug substance intended for topical application to the skin. The design of the delivery system is intended to release measured mass and appropriate quality of the active substance with each actuation.
Gum: A dosage form in which the base consists of a pliable material that, when chewed, releases the drug substance into the oral cavity. See 795 for general procedures. Excipients are selected on the basis of their ability to produce a mass that is firm and plastic. Jellies are used to treat conditions like vaginal dryness. Tablet triturates traditionally were used as dispensing tablets in order to provide a convenient, measured quantity of a potent drug substance for compounding purposes, but they are rarely used today. The typical therapeutic categories of drug substances delivered in lozenges are antiseptics, analgesics, decongestants, antitussives, and antibiotics. The procedure to assure sterility should be validated by media fills.
Emulsion: A dosage form consisting of a two-phase system composed of at least two immiscible liquids, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. Tablet presses use steel punches and dies to prepare compacted tablets by the application of high pressures to powder blends or granulations. Lotion dosage form) A semi-solid composed of an oil in water emulsion, with lower viscosity than cream or ThesaurusU. For tablets, capsules, oral suspensions, and implants, in vitro release test procedures such as dissolution and disintegration provide a measure of continuing consistency in performance over time (see Dissolution 711, Disintegration 701, and Drug Release 724). This permits the prescriber the choice of selecting either a single drug substance or a combination of drug substances at the exact dose level considered best for an individual patient. Pastes have a thicker consistency than ointments, as they are a mixture of powder and ointment.
Coatings are applied for functional or aesthetic purposes such as taste masking, stability, modifying release characteristics, product identification, and appearance. Antimicrobial preservative content: Acceptance criteria for preservative content in multidose products should be established. Gas: One of the states of matter having no definite shape or volume and occupying the entire container when confined. When the preparation is supplied as a multidose container, the addition of a suitable antimicrobial preservative may be necessary. All other things being equal, the phase that is present in the greater concentration tends to be the external phase, but an emulsifying agent that strongly favors a particular emulsion type and that forms a good barrier at the interface can overcome an unfavorable phase ratio. Many factors can contribute to small droplets. Any SSD form that contains water must also contain a preservative, which needs to be carefully chosen. Gels are semisolids consisting either of suspensions of small inorganic particles or of organic molecules interpenetrated by a liquid. From the skin surface. Gas bubbles are distributed in a liquid, which contains the active pharmaceutical ingredient (API) and excipients. More stable than a liquid dosage form. Preparation of Semi-Solids |. In an attempt to be comprehensive, this glossary was compiled without the limits imposed by current preferred nomenclature conventions. The temperature of the mixture increases to Assuming that the specific heat capacity of the solution is 6.
Gases used as excipients for administration of aerosol products, as an adjuvant in packaging, or produced by other dosage forms, are not included in this definition. Birth control and smoking cessation medications can also be delivered in a transdermal manner. To control the rate of creaming, you can adjust some of the parameters found in Stokes' Law. Other advantages of the water-removable bases are that they can be diluted with water and that they favor the absorption of serous discharges in dermatological conditions. Compressed lozenges are made using excipients that may include a filler, binder, sweetening agent, flavoring agent, and lubricant. Most of the sprays are generated by manually squeezing a flexible container or actuation of a pump that generates the mist by discharging the contents through a nozzle. Aerosol preparations may consist of either a two-phase (gas and liquid) or a three-phase (gas, liquid, and solid or liquid) formulation. B. Topical emulsions: Topical emulsions are more common. Reconstitution of granules must ensure complete wetting of all ingredients and sufficient time and agitation to allow the soluble components to dissolve.
Lotions are similar to creams, but have an even higher water content, making them the lightest of the semi-solid topical dosage forms. Granules manufactured for this purpose are packaged in quantities sufficient for a limited time periodusually one course of therapy that typically does not exceed 2 weeks. If packaging is plastic, manufacturers need to ensure that there is no migration through the bottle. If the medication is present as a suspension, the particle size must be controlled to promote uniform distribution of the drug substance and possibly optimize performance. Periodontal: Descriptive term for a preparation that is applied around a tooth for localized action. A footnote states that this term will be restricted to emulsions and will no longer be used for solutions or suspensions (2). Sometimes known as semi-liquid dosages, these drugs are easy to administer and can be produced in a variety of formulations. For systemic delivery they may be placed subcutaneously, or for local delivery they can be placed in a specific region in the body (e. g., in the sinus, in an artery, in the eye, in the brain, etc. Hydrocarbon aka Oleaginous bases |. Some suspensions are designed to form a mass in situ.
Stent, drug-eluting: A specialized form of implant used for extended local delivery of the drug substance to the immediate location of stent placement. Some of these dosage forms have been formulated to facilitate rapid disintegration and are manufactured by conventional means or by using lyophilization or molding processes. While appearance information to aid in identification is used in a regulatory submission (e. g., a qualitative description of size, shape, color, etc. ) Tablets for human use that include Chewable in the title must be chewed or crushed prior to swallowing to ensure reliable release of the drug substance(s) or to facilitate swallowing. Inhalation suspensions (see 5), ophthalmic suspensions, injectable suspensions, and some otic suspensions are prepared in sterile form. Coalescence is another form of instabilitysmall droplets within the media continuously combine to form progressively larger droplets. Bioavailability (see also In Vitro and In Vivo Evaluation of Dosage Forms 1088 and Assessment of Drug Product PerformanceBioavailability, Bioequivalence, and Dissolution 1090): Bioavailability is influenced by factors such as the method of manufacture or compounding, particle size, crystal form (polymorph) of the drug substance, the properties of the excipients used to formulate the dosage form, and physical changes as the drug product ages.
Coating: Attribute (coated) of a solid dosage form that involves covering with an outer solid. Care should be exercised to avoid microbial contamination. Some transdermal delivery systems provide controlled release, which means the level of a drug in the bloodstream has fewer fluctuations. Direct compression: Tablet processing involves dry blending of the drug substance(s) and excipients followed by compression. Most acne lotions are hydroalcoholic which evaporate fast; they are non-sticky and. Creams: Creams are semisolid emulsion dosage forms. Powder flow can be influenced by both particle size and shape. Soft gel capsule (not preferred; see Capsule): A specific capsule type characterized by increased levels of plasticizers producing a more pliable and thicker-walled material than hard gelatin capsules. The final product may be passed through a colloid mill or other blender or mixing device to ensure uniformity. Glidants improve powder fluidity, powder handling properties, and tablet weight control.
Manufacture: Although detailed instructions about the manufacture of any of these dosage forms are beyond the scope of this general information chapter, general manufacturing principles have been included. 3 g. Purified Water. Add the calcium hydroxide to 1, 000 mL of cool Purified Water, and agitate the mixture vigorously and repeatedly during 1 hour. Areas, skin prone to folliculitis, or hot weather conditions). Alternatively, the pellet design may combine these two approaches. Also see the information contained under Suspensions for the formulation and manufacture of gels containing inorganic components or drug substances in the solid phase.