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Can absorb water, but not as much as anhydrous. Additionally, dosage forms intended for the inhalation route of administration must be monitored for particle size and spray pattern (for a metered-dose inhaler or dry powder inhaler) and droplet size (for nasal sprays). Medicated soap and shampoo formulations frequently contain suitable antimicrobial agents to protect against bacteria, yeast, and mold contamination.
Substances in solutions are more susceptible to chemical instability than they are in the solid state and, dose-for-dose, are generally heavier and more bulky than solid dosage forms. Near-infrared (NIR) or Raman spectrophotometric methods could also be acceptable as the sole identification method of the drug product formulation (see Near-Infrared Spectroscopy 1119 and Raman Spectroscopy 1120). In compounding suppositories, avoid caustic or irritating ingredients, carefully select a base that will allow the drug substance to provide the intended effect, and in order to minimize abrasion of the rectal membranes, reduce solid ingredients to the smallest reasonable particle size. Powders for internal use can be applied to accessible mucous membranes with suitable applicators or are entrained in air streams for application to the nose or lungs. One-piece or soft-shell capsules: One-piece capsules typically are used to deliver a drug substance as a solution or suspension. As a consequence, pastes are more often used for protective action than are ointments. Excess volume in injections: Each container of an injection is filled with a volume in slight excess of the labeled size or the volume that is to be withdrawn. Antioxidant content: If antioxidants are present in the drug product, tests of their content should be performed to maintain the product's quality at all stages throughout its proposed usage and shelf life. Water-soluble bases (polyethylene glycol). For a more complete discussion of Stokes' Law, see section III. It should be noted that general terms, such as lotion, liniment, and liquid, have been used to name topical liquids, which could be solutions, suspensions, or emulsions.
The mass is formed by kneading. Pellet formulations are sometimes used to minimize variability associated with gastric retention of larger dosage forms. The pharmaceutical industry has specialized equipment for this task. Nasal: Route of administration (mucosal) characterized by administration to the nose or by way of the nose for local or systemic effect. 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. Large quantities of gases such as oxygen or nitrogen can be stored in the liquid state in a cryogenic container and converted into a gas, as needed, by evaporation. Avoid stratification and settling. Dental pastes are applied to the teeth. Lime water should be freshly prepared. Prolonged-release (not preferred; see Extended-release). The term patch has sometimes been used but is not preferred for use in drug product monograph nomenclature when referring to a system. Description: The Definition section (see General Notices and Requirements 4.
The ratio of the plasticizer to the gelatin can be varied to change the flexibility of the shell depending on the nature of the fill material, its intended usage, or environmental conditions. Although nonionized drug substances partition more readily out of water-miscible bases such as glycerinated gelatin and polyethylene glycol, the bases themselves tend to dissolve very slowly, which slows drug substance release. C. 2. in Chapter 27, Solutions. The polymer solvent can be water or an organic solvent. The term is synonymous with prolonged- or sustained-release. Powders can be intended for internal or external use. Various routes of administration are possible, so the route must always be indicated in the compendial name when a specific location for application is essential for proper use (e. g., intrauterine, ocular, or periodontal as the route of administration). Ointments are typically prepared by either direct incorporation into a previously prepared ointment base or by fusion (heating during the preparation of the ointment). 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. Jellies are a type of gel that typically have a higher water content. The preparation of medicated soaps and shampoos follows techniques frequently used for the preparation of emulsified systems. Gels are semi-solid dosage forms that can be either topical or transdermal.
Irrigation: A sterile solution or liquid intended to bathe or flush open wounds or body cavities. Less irritating, while gels are irritating. It displays Newtonian or pseudoplastic flow behavior. The text of 21 CFR should be consulted to determine the current recommendations. External use also means there is a lower risk of gastrointestinal difficulties from taking a medication orally. Modified-release: A descriptive term for a dosage form with a drug substance release pattern that has been deliberately changed from that observed for the immediate-release dosage form of the same drug substance.
Extended-release injectable suspension: Liquid preparations of solids suspended in a suitable vehicle and formulated to allow the drug substance to be available over an extended period of time. See also CDER Guidance for Industry, Orally Disintegrating Tablets. Unless studies confirm that the formulation will not support microbial growth, suspension preparations packaged to provide multiple doses should contain suitable antimicrobial agents to protect against bacterial, yeast, and mold contamination (see 51) or other appropriate measures should be taken to avoid microbial contamination. Procedures such as those found in Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers 601 and Particle Size Distribution Estimation by Analytical Sieving 786 could be used.
Some medicated gums are coated with magnesium stearate to reduce tackiness and improve handling during packaging. You know this has occurred when the system changes from a translucent, oily-appearing liquid into a thick, white liquid. Emulsions intended for parenteral administration can be formulated using the same principles as creams and lotions. Sugar coating is an alternative, less common approach. Choose an appropraite solvent based on solubility of API.
Emulsions can also undergo creaming, where one of the phases migrates to the top (or the bottom, depending on the relative densities of the two phases) of the emulsion. The resultant coating is a polymeric matrix that controls the extended release of the drug substance. Specific quality tests for TDSs are found in 3. Disadvantages of semi-solid dosage form: - The accuracy can't be measured, for the semisolid dosage form. Films are used in various routes of administration including as a means of oral administration of material in a rapidly dissolving form. The powder is used with a device that aerosolizes and delivers an accurately metered amount. From the skin surface. Dry powder coating or layering processes are often performed in specialized rotor granulation equipment. The surface-active properties of the vehicle facilitate contact of the drug substance with the skin or scalp.
Molded tablet: A tablet that has been formed by dampening the ingredients and pressing into a mold, then removing and drying the resulting solid mass. Release of the drug substance from the microparticles begins after physiological fluid enters the polymer matrix, dissolving some of the drug substance that is then released by a diffusion-controlled process. Care is taken to avoid excessive moisture during storage to prevent crystallization of the sugar base. Some emulsifying agents also increase the viscosity of the system, slowing aggregation of the droplets and decreasing the rate of creaming. They are administered by the parenteral route. In most cases, one-piece capsules are filled with liquids. Coalescence is another form of instabilitysmall droplets within the media continuously combine to form progressively larger droplets.