classification of dosage forms based on route of administration
Preparation of liquid dosage forms 6. These dosage forms and delivery systems as well as the special considerations relating to intra-articular injections, recombinant proteins and peptides, and vaccines are discussed below. When selenium or cobalt intraruminal pellets are administered alone, a “grinder” is usually coadministered to prevent the formation of calcium phosphate coatings on the surface of the pellets. A dry powder for parenteral administration is reconstituted as a solution or as a suspension immediately before injection. A suspension for injection consists of insoluble solid particles dispersed in a liquid medium, with the solid particles accounting for 0.5%–30% of the suspension. Advantages: Convenient - portable, safe, no pain, easy to take. The dosage form of a pharmaceutical product denotes its method of entry or delivery into a biological system. In horses, solutions and suspensions are administered by nasogastric tubes, pastes are applied to the tongue, and granules are added to rations for ingestion. Classification of Dosage Forms Dosage forms can be classified in many ways on the basis of their physical state, route of administration, intended purpose or site of application, etc. It should provide the anticipated therapeutic effect. A lotion is usually an aqueous solution (or suspension) for application to inflamed, ulcerated skin. Soft gelatin capsules are suitable to formulate poorly water-soluble drugs because they afford good drug release and absorption by the GI tract. There are different types of dosage forms. Injectable solutions are very commonly used, and aqueous solutions given IM result in immediate drug absorption, provided precipitation at the injection site does not occur. This web page has a list of dosage form terms and National Cancer Institute Thesaurus concept codes associated with those term for use in Structured Product Labeling (SPL) documents submitted to FDA. The PD phase generally involves interaction of the drug with a receptor, which triggers post-receptor events and eventually leads to a drug effect (see Drug Concentration and Effect). This time we are going to highlight the renowned oral dosage forms. Volumes delivered can range from milliliter to liter quantities. The dosage form should be free from an interaction between components, with packaging materials and environmental factors (heat, humidity, oxygen, light). Route of administration may be oral, intravenous, intramuscular, cutaneous, subcutaneous, etc. A drug given parenterally is one given by a route other than the mouth (topical dosage forms are considered separately). By comparison, water-in-oil emulsions are emollient and cleansing. Powders have better chemical stability than liquids and dissolve faster than tablets or capsules because disintegration is not an issue. One way to categorize dosage forms is by their state: Gaseous: vaporized administration by inhalation. “Water for injection” is the most widely used solvent for parenteral formulations. The chemical and physical instability of recombinant proteins and peptides is a special consideration during formulation development. Parenteral medications are injected or placed into the body tissues and do not pass through the liver before entering the bloodstream. An emulsion is a system consisting of two immiscible liquid phases, one of which is dispersed throughout the other in the form of fine droplets; droplet diameter generally ranges from 0.1–100 μm. The route of administration is largely dependent on the property of the test substance and the objective of the experiment. Insecticidal collars are plasticized polymer resins impregnated with an active ingredient. Some settling is acceptable, provided the sediment can be readily dispersed when the container is shaken. A range of excipients may be included in parenteral solutions, including antioxidants, antimicrobial agents, buffers, chelating agents, inert gases, and substances to adjust tonicity. Other formulation additives include suspending agents, surfactants, and other excipients to ensure the production of a shelf-stable, pourable product. Carriers, such as wheat middlings, soybean mill run, and rice hulls, bind active ingredients to their surfaces and are important in attaining uniform mixing of the active ingredient. Changes to strength, pharmaceutical form and route of administration 3. In addition to the excipients described above for solutions, suspensions include surfactants and thickening agents. The situation with sheep is different—the very short contact time in a spray race limits the uptake of insecticide, which means the fleece seldom becomes saturated. Oral dosage forms are usually intended for systemic effects resulting from drug absorption from the GI tract; however, some oral suspensions, eg, kaolin, are intended to produce local effects, and these are not absorbed. Caking of injectable suspensions is minimized through the production of flocculated systems, comprising clusters of particles (flocs) held together in a loose, open structure. These agents are usually delivered to animals in a carrier gas that includes oxygen, using an anesthetic machine fitted with one or more vaporizers and a patient breathing circuit. Learning Objectives • Define the term drug and distinguish between over-the-counter and legend drugs. avoiding alimentary canal. Gas dosage form. A suspoemulsion combines the elements of an emulsion and a suspension, allowing active ingredients with widely varying physical properties to be formulated in a single product. Some common dosage forms include the pill, tablet, capsule, drink or syrup, aerosol or inhaler, liquid injection, and pure powder. In some clinical situations (e.g. The dosage forms of the oral route include Tablets, Capsules, Powders, Mixtures, Emulsions and Gels. Most drugs are absorbed from small intestine but some are absorbed from stomach and colon. Volatile liquid insecticides such as dichlorvos or naled are used in vapor-release collars. Issues such as instability, electrostatic charge, and hygroscopicity must also be addressed. Classification of liquid dosage form: There are many forms of drugs to suit the needs of the individual patients. The need for dosage forms: 1- Accurate dose. They are constructed of an inner porous bag containing the active ingredient, which is commonly a synthetic pyrethroid or an organophosphate, and an outer weatherproof skirt. The oral route of administration is the most widely used in cattle, pigs, and poultry. Please confirm that you are a health care professional. These forms are suppositories, creams, ointments, foams, gels, and various inserts, such as rings. The intraruminal devices to supplement ruminants with selenium, cobalt, or copper include soluble glass boluses and intraruminal pellets. Water with a high content of Ca2+ and/or Mg2+ reacts with anionic surfactants in the emulsifiable concentrate formulation; this affects both spontaneity of emulsification and stability. A flank paint is applied to the flanks of animals, from where it is licked off and ingested. A type of solid pharmaceutical dose form intended for administration to ruminant animals where it is retained in the rumen for release of the active substance(s), usually over an extended period of time. This site complies with the HONcode standard for trustworthy health information: Powdered insecticides such as phosmet, stirofos, carbaryl, and propoxur are used in dust-release collars. Some dusting powders absorb moisture, which discourages bacterial growth. • rectal • parenteral • transdermal • inhalation – for local administration • Topical (on the skin or mucosa) – Into/onto - the eye, nose, ear - the oral cavity - the vagina, rectum - the skin • Local parenteral (viz Parenteral above) 22 The dust associated with powdered premix formulations can have serious implications for both operator safety and economic losses and is reduced by including a vegetable oil or light mineral oil in the formulation. The rate of drug release from ointments, creams, and pastes is principally determined by the semisolid base used. Frothy bloat commonly develops in cattle on pasture, particularly those grazing lush, leguminous pastures. 81. Proper dip management requires attention to the factors described above for plunge dipping. By comparison, recirculating and nonrecirculating spray races facilitate whole body spraying and wet cattle to the skin. Route of administration: Oral, Parenteral, Rectal, Nasal, Vaginal, Urethral, etc. The solution is applied under pressure and penetrates to the skin. A tincture for topical application uses a vehicle containing 15%–80% alcohol, requiring the preparation to be tightly stoppered and not exposed to high temperatures. These formulations are usually solutions or emulsifiable concentrates for dilution with water before use. We mentioned that dosage form of a medication is the mean by which it reaches its action site. • Explain the correct techniques for administration of eye drops, metered-dose . The viability of organisms is additionally protected using stabilizers such as lactose or other saccharides, skim milk, and serum. We went through the classification of dosage forms generally. A range of strategies has been reported to stabilize formulations containing recombinant proteins and peptides, including the choice of carrier vehicle (eg, oleaginous vehicles), the use of lyophilization excipients, the use of stabilizers such as sugars and detergents, chemical modification of the proteins and peptides, and the use of site-directed mutagenesis to synthesize more stable proteins. Others are used for their lubricant properties. 4 as per USP is A. Bolus intravenous injection. A special consideration relating to the use of topical dosage forms is the potential for residues in wool and mohair to occur. Classification: Solid dosage forms Unit dosage forms Tablets Capsule Powders Pills Bulk Internal Fine powders & granules ... - Examples of drugs administered by this route: e.g. The insecticide distributes through the collar matrix as a vapor before being released. Currently, enflurane, halothane, isoflurane, methoxyflurane, and nitrous oxide are the most commonly used inhaled anesthetic agents. , BVSc (Hons), PhD, FANZCVS, Veterinary Medicines and Nanotechnology, Australian Pesticides and Veterinary Medicines Authority; , PhD, Australian Pesticides and Veterinary Medicines Authority, Symonston, Australia; , PhD, National Academy of Science, Canberra, Australia. • Categorize drugs by source as natural, synthetic, synthesized, or semisynthetic. Insertion of drugs into body cavities (rectal, vaginal). Redispersion of the suspension may not be achievable if the sediment has packed closely to form a hard mass, a process known as "caking.". The three class names of drugs are largely employed in the manufacture, prescription and trading activities of medicines. Depending on the method/route of administration, dosage forms come in several types. Transdermal gels are used to deliver drugs to treat several diseases in dogs and cats, including undesirable behavior, cardiac disease, and hyperthyroidism. A diverse range of dosage forms and delivery systems has been developed to provide for the care and welfare of animals. Various routes of administrations play a marked role in the bioavailability of the active drug in the body. Pyrogenic substances are primarily lipid polysaccharides derived from microorganisms, with those produced by gram-negative bacilli generally being most potent. Testosterone pellets are available to implant in the ears of wethers at doses of 70–100 mg every 3 mo for the prevention of ulcerative posthitis. There are two types of shower dips: a conventional shower dip in which the sump volume is periodically maintained by adding fresh dip wash, and a constant replenishment shower dip in which a small-volume sump is continually filled from a large-volume supply tank to maintain dip levels. Antifoaming agents reduce the stability of the froth by lowering the viscosity of the fluid ingesta. Use of the desired vehicle for poorly soluble or insoluble drugs. After oral administration, the gelatin capsule dissolves in the rumen and releases the particles of copper oxide. For the changes listed in Annex I any application will follow the same procedure as for the granting of the initial marketing authorisation to which it relates. List reasons for the incorporation of drugs into various dosage forms 2. On oral administration, drug action has a slower onset and more prolonged but less potent effect than when drugs are given parenterally. Spot-on formulations are also available to control lice in cattle. Routes can also be classified based on where the target of action is. In this respect, aluminum hydroxide, aluminum phosphate, and oil emulsions are generally preferred to confer antibody-mediated immunity, whereas saponin, quil A, and immunity-stimulating complexes are preferred to confer cell-mediated immunity. The vehicle may be water, glycerol, propylene glycol, or alcohol/water mixtures. Protection e.g. ... Administration convenient, particularly for infants, psychoticpatients. Children—Dose must be determined by your doctor. The most common medication dosage forms are liquids and solids. A syrup is a concentrated aqueous solution of sugar or a sugar substitute with or without flavoring agents and a water-soluble drug. Administration. The range and intensity of the effects of a substance depends on upon a number of factors. Drugs which are rapidly cleared by hepatic processes will show a decreased extent of availability following oral administration due to metabolism of drug on its first pass through the liver. coated tablets, sealed ampules. 1. Classification of Liquid dosage forms 2. The anatomy of the GI tract of ruminants presents unique opportunities for controlled-release drug delivery systems, and many such systems are on the market. Inhalational anesthetics are critical in management of anesthesia. The control of internal and external parasites of companion and food-producing animals has led to development of specialized dosage forms, delivery systems, and application methods unique to veterinary medicine. One is constructed from a polymer that provides structural support and acts as a release rate-controlling matrix. Surfactants wet, disperse, and stabilize the solid particles in the continuous phase, prevent flocculation, and prevent changes in particle size. This route of administration is possible if the drug is in liquid dosage form. Backliner products for sheep consist of pour-on and spray-on formulations for the control of lice and sheep blowflies. Hydrolyt... 1. These include insecticidal and acaracidal soaps, foams, shampoos, sprays, and rinses. Ionized solutes, for example, are reported to cross the skin of animals via shunt pathways (sweat ducts, follicles). 1. Liquid Forms Aqueous preparations Alcoholic preparations 1.Solutions 2.Syrups 3.Emulsions 4.Suspension 5.Infusions 6.Decoction 7.Lotion 1.Elixirs 2.Spirits (Essences) 3.Tinctures 4. The macrocyclic lactones ivermectin, moxidectin, doramectin, and eprinomectin are formulated as pour-on preparations for application to cattle. It is critical that pastes have a pleasant taste or are tasteless and are able to be used throughout a wide temperature range. Tobramycin Injection, USP is a clear and colorless sterile aqueous solution for parenteral administration.Each vial of Tobramycin Injection, USP contains Tobramycin sulfate equivalent to 80 mg/2 mL or 1,200 mg/30 mL of Tobramycin. The active ingredient distributes as a liquid in the collar matrix and to the surface, where it is released. Other changes specific to veterinary medicinal products to be administered to food-producing animals; change or addition of target species. In one system, the segment of DNA is coated with gold and administered to the patient using a “gene gun.” The other delivery system uses a viral vector or plasmid to carry the DNA segment into the patient. The dose is applied to the inner surface of the pinnae, thereby offering ease of administration, especially in cats. An elixir is a sweetened, usually hydroalcoholic solution of a bitter or nauseous drug intended for oral administration. The vehicle may be aqueous, oil, or both. • Explain the parts of a National Drug Code number. Aerosols Local/Topical Route of Drug Administration In this route the drug is applied on the skin cal properties of the dosage form as appropriate, but also in bioavailability over time (bioequivalence) requires close the administration route and desired dosing regimen. Copper capsules, which contain oxidized copper wire particles encapsulated in gelatin, are available for adult sheep and goats. Friar's balsam is compound benzoin tincture and is used to protect and toughen ulcerated or fissured skin. Special Dosage Form Considerations with Recombinant Proteins and Peptides: Special Dosage Form Considerations with Live Vaccines, Inactivated and Subunit Vaccines, and DNA Vaccines: Topical Route of Administration and Dosage Forms. The three main parenteral routes of drug administration are IV, IM, and SC, and in all cases administration is usually via a hollow needle. Administration of liquid dosage forms 7. It may be in the form of tablets, capsules, syrup, emulsions or powders. The active ingredients in these systems are synthetic or natural hormones such as progesterone, methylacetoxy progesterone, fluorogestone acetate, or estradiol benzoate. Some of the advantages presented by SSD form products are the ability to apply the drug product directly on the affected area and the administration of this dosage form to be readily administered to patients of any … Additionally, some states have granted limited prescribing authority to clinical psychologists and pharmacists. Cold Chain volume per dose (cm 3): 1) 20.50 cc ; 2) 54.88 cc. Intravaginal delivery systems include controlled internal drug-release (CIDR) devices, progesterone-releasing intravaginal devices (PRIDs), and vaginal sponges. The topical route of administration is also used to deliver therapeutic agents systemically. The THREE LETTER CODE (TLC) was introduced as a dosage Form Code in the audits during the middle of the 1960s. Liquid dosage form, 3. Drug release from dispersed matrix systems involves dissolution of the drug into the polymer, followed by diffusion of the drug through the polymer and partitioning from the surface of the polymer into the surrounding aqueous environment. Their efficacy against lice depends on topical activity and not on percutaneous absorption of the active ingredient into the bloodstream. Other types of oral modified-release delivery systems are also available for ruminants. Boluses of soluble glass containing selenium, cobalt, and copper are available for cattle and sheep. verify here. It might be: Oral; Sublingual; Per rectum; Photo by Slashme. Compared with that of injectable solutions, the rate of drug absorption of injectable suspensions is prolonged, because additional time is required for disintegration and dissolution of the suspended drug particles. Granules and powders generally behave similarly; however, granules must deaggregate before dissolution and absorption. A typical shower dip consists of a sump containing the dip wash, a pump, and a showering pen constructed with a concrete floor and fitted with rotating and fixed nozzles. The dosage form of a pharmaceutical product denotes its method of entry or delivery into a biological system. Chapter 5 Dosage Forms, Routes of Administration and Drug Classifications, Drug Abbreviations, and Medical Terminology Objectives UPON COMPLETING THIS CHAPTER, YOU SHOULD BE ABLE TO DO THE FOLLOWING: List at least three reasons why certain drugs need to be given by certain routes. A capsule is an oral dosage form usually made from gelatin and filled with an active ingredient and excipients. Vaccine Vial Monitor: Type 7. These properties result in lower concentrations of drug residues in the milk. Easytocolor,flavor&sweeten. Chemical stripping is due to the preferential absorption of pesticide by the fleece. Subsequent. The vehicle containing the drug may be water; a polyhydroxy liquid such as glycerin, propylene glycol, or polyethylene glycol; a vegetable oil; or a mineral oil. Dosage Form (DF) is defined as the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. • Explain the uses of drugs as therapeu-tic, pharmacodynamic, The oral route of administration is the safest, most economical and the most convenient way of giving medicines. These products are formulated for pour-on application within 24 hr after shearing (ie, off-shears) or spray-on application (in short-wool sheep with wool growth <6 wk, and in long-wool sheep with wool growth >6 wk). Second, they affect drug dissolution within the ointment and drug partitioning from the ointment into the skin. The selection of a particular dosage form and route of administration will depend upon both the clinical circumstances, and the characteristics of the drug. Several modified-release delivery systems have been developed that take advantage of the unique anatomy of the ruminant forestomach. Specialized Topical Dosage Forms, Delivery Systems, and Application Methods for Parasite Control: Inhaled Dosage Forms and Delivery Systems, Extra-Label Drug Use, Compounded Drugs, and Generic Drugs, Routes of Administration and Dosage Forms, Systemic Pharmacotherapeutics of the Cardiovascular System. In addition, excipients in the formulation modulate consumption by altering the palatability and/or the hardness of the medicated block. A different type of applicator is used to insert CIDR devices into the vaginal cavities of sheep, goats, and cattle. Ointments. Recombinant proteins and peptides are used in some countries to increase feed conversion efficiency and milk production in cattle (bovine growth hormone), increase feed conversion efficiency and produce leaner carcasses in pigs (porcine growth hormone), for the chemical shearing of sheep (epidermal growth factor), to reduce the incidence of skeletal weaknesses leading to leg injuries in horses (equine growth hormone), and for other uses. Advantages:- 1. Drugs applied to the skin for local effect include antiseptics, antifungals, anti-inflammatory agents, and skin emollients. Disadvantages of the oral route of administration include the relatively slow onset of action, the possibilities of irregular absorption, the destruction of acid-labile drugs in the stomach, and the unsuitability of this route for many high-molecular-weight drugs. Particles too small or too large for optimal delivery into alveolar sacs are either exhaled or deposited on larger bronchial airways. In addition, all equipment must be functioning properly for the fleece to become saturated. Chelating agents are added to complex and thereby inactivate metals, including copper, iron, and zinc, which generally catalyze oxidative degradation of drugs. Suspension concentrate formulations are generally water-based; the water-insoluble active ingredients and inert ingredients are of very small particle size (0.1–5 μm). However, not all drugs are suitable for transdermal application, and there are relatively few studies of the bioavailability of drugs from compounded transdermal gels. Inactivating agents such as phenol, thiomersal, and formaldehyde are used to kill the virus or bacteria without destroying the critical integrity of the antigens necessary to induce a protective immune response. Buffers are necessary to maintain both solubility of the active ingredient and stability of the product. It should be convenient to handle, use, and store. The oral route of administration is frequently used in both companion and food animals. Pastes are less greasy than ointments, because much of the fluid hydrocarbon fraction is absorbed onto the solid particles; they are also less occlusive than ointments. 2. Ointments are effective emollients because of their occlusive nature. A paste for topical use is a stiff preparation containing a high proportion of finely powdered solids such as starch, zinc oxide, calcium carbonate, and talc. Hand-jetting of long-wool sheep (wool growth >6 wk) is done to control lice, keds, mites, and sheep blowflies. In dogs and cats, tablets, capsules, solutions, and suspensions are administered orally; pastes are also applied to the forelimbs of cats from which they are licked and ingested. Dosage Form . Dosage Forms: Lamivudine ... Agency (EMA),3 the Food and Drug Administration (FDA)4 ortheWHO,2 butalsoserveasacriticalevalu-ation of these regulatory documents. The hydroalcoholic character of elixirs allows, within limits, both water-soluble and alcohol-soluble medicinal substances to be maintained in solution. Parenteral dosage forms and delivery systems include injectables (ie, solutions, suspensions, emulsions, and dry powders for reconstitution), intramammary infusions, intravaginal delivery systems, and implants. Other External Forms of Drug Administration. A gel is a nongreasy, semisolid, aqueous solution. The use of dusting powders is indicated on skin folds and contraindicated on wet surfaces, because caking is likely to result. Compared with delivery by the oral or parenteral routes, the onset of pharmacologic action of inhaled agents is faster and the doses administered smaller, thereby reducing the potential incidence of adverse systemic effects. Nonvolatile liquid insecticides such as chlorfenvinphos or diazinon are used in liquid-release collars. Effective doses can be divided into five categories: threshold, light, common, strong, and heavy. Start studying Chapter 5 Dosage Forms, Routes of Administration and Drug Classifications, Drug Abbreviations, and Medical Terminology. Some pour-on products on the market are formulated to deliver an active ingredient percutaneously. Common dosage forms include pill, tablet, or capsule, drink or syrup, and natural or herbal form such as plant or food of sorts, among many others. Solid dosage form, 2. A spot-on formulation is a solution of active ingredient(s) that typically contains a cosolvent and a spreading agent. Types of liquid dosage forms 5. In dogs and cats, an extensive range of topical formulations is used in the control of fleas, lice, mites, and ticks. A dusting powder is a finely divided insoluble powder containing ingredients such as talc, zinc oxide, or starch. The liquid form of a drug dose for administration or consumption. The main classification is according to the route of administration, or physical form. These forms often contain anodyne compound to alleviate pain and a rubifacient, which reddens the skin e.g. These include ear implants containing norgestomet dispersed in polyethylene methacrylate or silicone, a biocompatible tablet implant containing deslorelin (a GnRH agonist) for use in mares that does not require removal, and a sustained-release pellet of melatonin, which is implanted in the ear of ewes to enhance breeding performance. Generic Drug A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. These dosage forms together with examples of modified-release delivery systems for ruminants are discussed below. Numerous methods are used to apply parasiticides to farm animals (see below). The animal’s activity plus the dissolution of lipophilic insecticides in skin secretions are important factors in translocation of the insecticide from the collar to the animal. Absorption after oral administration can be quite variable. The flocculation of oil droplets in emulsifiable concentrate formulations leads to a layer of cream that can be readily dispersed by mild agitation, whereas the coalescence of droplets leads to the inversion or “breaking” of the emulsion. From developing new therapies that treat and prevent disease to helping people in need, we are committed to improving health and well-being around the world. 0.2 mg ) in 9 mL of sodium chloride injection, USP shelf-stable pourable! Lower concentrations of drug administration has different dosage forms is by their state::. Mostly done by using appropriate packaging 6 wk ) is done to control flies cattle... Is specially made for pharmaceutical formulations include many kinds of liquid, solid, rectal. 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