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 drug given parenterally is one given by a route other than the mouth (topical dosage forms are considered separately). The route of administration is the way through which the dosage form is administered into the body for treatment of various diseases and disorders. Caking of injectable suspensions is minimized through the production of flocculated systems, comprising clusters of particles (flocs) held together in a loose, open structure. Most routes of administration for semi-solid dosage (SSD) form products are predominantly topical or by method of insertion of the drug product into an orifice of the body. Disadvantages of liquid dosage forms 4. coated tablets, sealed ampules. Drops 10.Emulsions 11.Other An ointment is a greasy, semisolid preparation that contains dissolved or dispersed drug. • s.l. The word “drug” is derived from the old French word “drogue” which means a “dry herb”; and has often been used interchangeably with “medicine”, “pharmaceutical product” and “pharmaceuticals” to refer to chemical substances intended for use in the diagnosis, prevention, treatment an… The dosage form refers to the physical characteristics of a drug product. A syrup is a concentrated aqueous solution of sugar or a sugar substitute with or without flavoring agents and a water-soluble drug. Here the drug is given from routes other than oral i.e. 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. Sheep should not be dipped (by either the plunge or shower method) until shearing wounds have healed to avoid clostridial infections or caseous lymphadenitis caused by Corynebacterium pseudotuberculosis. These include many kinds of liquid, solid, and semisolid dosage forms. 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. The micellar composition of PLO gel enhances skin penetration of the pharmaceutical agent present in the formulation. • Explain the major routes of administration and the advantages and disadvantages associated with each route of administration. Sheep lousicides include synthetic pyrethroids, organophosphates, and insect growth regulators. 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). Dose Range. Topical solutions include eye drops, ear drops, and lotions. Two common capsule types are available: hard gelatin capsules for solid-fill formulations, and soft gelatin capsules for liquid-fill or semisolid-fill formulations. Second, they affect drug dissolution within the ointment and drug partitioning from the ointment into the skin. Inhalational anesthetics are critical in management of anesthesia. Inert gases are used to displace the air in solutions and enhance product integrity of oxygen-sensitive drugs. The semisolid properties are due to a polymer imparting a continuous structure to the hydrophilic liquid. Liniments are liquid forms of drug that are applied by rubbing into the skin. The dosage form should be free from an interaction between components, with packaging materials and environmental factors (heat, humidity, oxygen, light). With all three devices, gentle pressure is exerted on the vaginal wall. 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. Ear drops are solutions of drugs such as antibiotics, insecticides, or anti-inflammatory agents. Route of administration: Oral, Parenteral, Rectal, Nasal, Vaginal, Urethral, etc. The time of onset of action for IV administration is seconds, and for IM and SC injections is minutes. The bioavailability of a drug, particularly from prolonged-release formulations, can be influenced by the location of the IM injection site. The high costs associated with plunge dipping relate principally to the costs of chemicals for charging large vats, labor, and the disposal of the hazardous wastes. Dosage Forms and Routes of Administration A dosage form is the physical form of a dose of a chemical compound used as a drug or a medication intended for administration or consumption. 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. 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. The oral route of administration is frequently used in both companion and food animals. A cream is a semisolid emulsion formulated for application to the skin or mucous membranes. List of Pharmaceutical Regulatory Agencies and Organizations around the World. Route of administration may be oral, intravenous, intramuscular, cutaneous, subcutaneous, etc. Several modified-release delivery systems have been developed that take advantage of the unique anatomy of the ruminant forestomach. The former readily rub into the skin (hence the term “vanishing” cream) and are removed by licking and washing. verify here. The hygroscopic nature of molasses in a formulation may also impact the hardness of medicated blocks and is addressed by using appropriate packaging. Pharmaceutical form: liquid, ready to use. Start studying Chapter 5 Dosage Forms, Routes of Administration and Drug Classifications, Drug Abbreviations, and Medical Terminology. The range and intensity of the effects of a substance depends on upon a number of factors. Secondary Packaging: 1) carton of 5 vials with dimensions 8.89 x 2.42 x 4.76 cm ; 2) carton of 1 vial with dimensions 3.02 x 3.02 x 6.03 cm . The hydroalcoholic character of elixirs allows, within limits, both water-soluble and alcohol-soluble medicinal substances to be maintained in solution. Presentation: 1 dose vial. The topical route of administration is used for local treatment of skin, control of external and internal parasites, and transdermal delivery of therapeutic agents. Pain not occurs because injection is not used. However, it is not a serious problem because a uniform dispersion returns upon shaking. 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. To be delivered into the airways, a drug must be presented as an aerosol, either as solid particles or liquid droplets in air. The thickening agent may be a naturally occurring material such as acacia or tragacanth, or a synthetic or chemically modified derivative such as xanthum gum or hydroxypropylmethyl cellulose. A range of ointment bases is used, including hydrocarbons, vegetable oils, silicones, absorption bases consisting of a mixture of hydrocarbons and lanolin, emulsifying bases consisting of a mixture of hydrocarbons and an emulsifying agent, and water-soluble bases. Formulation options for injectable emulsions are also severely restricted, because suitable stabilizers and emulsifiers are very limited. Solid dosage form, 2. 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. Some dusting powders absorb moisture, which discourages bacterial growth. Adjuvants enhance the immunogenicity of antigens by stimulating the immune system and prolonging antigen release. 1. of absorption. Particle or droplet size largely determines the extent to which the drug penetrates the alveoli. Following agents are used with the drug in the suitable dosage form. Additionally, the incorporation of a binder such as lignin sulfonate in blocks manufactured by compression, or magnesium oxide in blocks manufactured by chemical reaction, increases hardness. Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest: Route of. Apparatus No. Recombinant proteins and peptides have been formulated as solutions, lyophilized powders, implants, and microparticles. Issues such as instability, electrostatic charge, and hygroscopicity must also be addressed. Solid: powder, tablet, capsule, transdermal patches. Suspensions are useful to administer insoluble or poorly soluble drugs or when the presence of a finely divided form of the material in the GI tract is required. 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. Parenteral administration is a route of drug administration devoid of oral route. 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. Failing to adjust the tonicity of the solution can result in the hemolysis or crenation of erythrocytes when hypotonic or hypertonic solutions, respectively, are given IV in quantities >100 mL. In dogs and cats, an extensive range of topical formulations is used in the control of fleas, lice, mites, and ticks. Retention of the device is >95%. Two types of insecticide-releasing ear tags to control flies on cattle are available. 3. Froth obstructs the cardia of the stomach, preventing the eructation of excessive gas produced in the rumen. The chemical and physical instability of recombinant proteins and peptides is a special consideration during formulation development. Back rubbers are charged by soaking thoroughly in oil-containing pesticide, typically a synthetic pyrethroid, an organophosphate, or a combination of the two. Compared with solid dosage forms, solutions are absorbed faster and generally cause less irritation of the GI mucosa. Depot injectable preparations achieve prolonged release and maintain therapeutic concentrations of drug throughout 2–5 days. PLO gel is generally well tolerated and is nontoxic if ingested. The pesticides used include rotenone, synthetic pyrethroids, organophosphates, insect growth regulators, and macrocyclic lactones. The three main parenteral routes of drug administration are IV, IM, and SC, and in all cases administration is usually via a hollow needle. 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. These properties result in lower concentrations of drug residues in the milk. 1. In food animals, a diverse range of topical dosage forms and delivery systems are used to control external parasites. For example, most pour-on formulations, plunge and shower dip concentrates, and jetting fluids are suspension concentrates or emulsifiable concentrates. Classification of Liquid dosage forms 2. Preparation of Dilution. For better patient compliance, it should not disturb his routine life cycle as for as possible and should be acceptable aesthetically, organoleptically, therapeutically, and from an economic standpoint. 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. The legacy of this great resource continues as the Merck Veterinary Manual in the US and Canada and the MSD Manual outside of North America. Start studying chapter 5: dosage forms, abbreviations and route of administration. 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. We mentioned that dosage form of a medication is the mean by which it reaches its action site. 2- Protection e.g. Currently, enflurane, halothane, isoflurane, methoxyflurane, and nitrous oxide are the most commonly used inhaled anesthetic agents. This requires that the race leading to the vat is constructed of concrete or slats to remove dirt from the animals’ feet and that animals be held in a yard overnight before dipping, during which time they are offered water but no feed. Coarse powders often have a gritty feel, whereas powders containing particles that are <20 μm in all dimensions have a smooth feel. Emulsions for oral administration are usually oil (the active ingredient) in water, and they facilitate the administration of oily substances such as castor oil or liquid paraffin in a more palatable form. A medicated block is a compressed feed material that contains an active ingredient, such as a drug, anthelmintic, surfactant (for bloat prevention), or a nutritional supplement, and is commonly packaged in a cardboard box to feed to livestock. Semi-solid dosage form, 4. Drug powders are principally used prophylactically in feed or formulated as a soluble powder for addition to drinking water or milk replacer. For example, particle size is rarely altered during capsule manufacture, and capsules mask the taste and odor of the active ingredient and protect photolabile ingredients. Use of the desired vehicle for poorly soluble or insoluble drugs. Emulsions are inherently unstable and are stabilized through the use of an emulsifying agent, which prevents coalescence of the dispersed droplets. Drugs are usually injected into the muscle of the upper arm, thigh, or buttock. The liquid form of a drug dose for administration or consumption. the dose forms and delivery systems of the many pharmaceuticals scientists have created. 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. Keep accurate record of drugs given, dosage, routes of administration and the data on patient. Solid: powder, tablet, capsule, transdermal patches. 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. 2. In horses, solutions and suspensions are administered by nasogastric tubes, pastes are applied to the tongue, and granules are added to rations for ingestion. Parenteral dosage forms and delivery systems include injectables (ie, solutions, suspensions, emulsions, and dry powders for reconstitution), intramammary infusions, intravaginal delivery systems, and implants. Collars for the control of ticks and fleas on dogs and cats release the active ingredient as a vapor, a dust, or a liquid, depending on the physicochemical properties of the chemical. After dilution, an emulsifiable concentrate for topical use produces a two-phase system involving two immiscible liquids, a dispersed phase, consisting of fine oil droplets ranging in size from 0.5 μm to several hundred microns, and a continuous phase. Administration. Ointment bases influence topical drug bioavailability via two mechanisms. The dose is applied to the inner surface of the pinnae, thereby offering ease of administration, especially in cats. Drugs are given in different forms. Intraruminal pellets containing selenium or cobalt are available for sheep. If the active ingredient is sensitive to moisture, it may be formulated as a flavored powder or granulation and reconstituted in water immediately before oral administration. Dosage Form Design: Pharmaceutical and Formulation Considerations 4 SECTION II DRUG DOSAGE FORM AND DRUG DELIVERY SYSTEM DESIGN After reading this chapter, the student will be able to: 1. 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. The particle size of the active ingredient in pastes can be as large as 100 μm. Semi-solid dosage form, 4. 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. , 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. It is critical that pastes have a pleasant taste or are tasteless and are able to be used throughout a wide temperature range. This route is risky but has many advantages than the oral route of drug administration. Some common dosage forms include the pill, tablet, capsule, drink or syrup, aerosol or inhaler, liquid injection, and pure powder. The reagent is not used to detect alkaloids A. Mayer’... Posology The word “posology” is derived from the Greek words “posos” , meaning ‘how much’ and “logos” , meaning ‘science’ . 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. 4- Masking taste and odour. This route of administration is possible if the drug is in liquid dosage form. 5- Placement of drugs within body tissues. The dosage form of a pharmaceutical product denotes its method of entry or delivery into a biological system. By comparison, recirculating and nonrecirculating spray races facilitate whole body spraying and wet cattle to the skin. Physical state: Solid, Semisolid, Liquid, Gaseous. After oral administration, the gelatin capsule dissolves in the rumen and releases the particles of copper oxide. The main classification is according to the route of administration, or physical form. Surfactants wet the suspended powders and provide acceptable syringeability while suspending agents modify the viscosity of the formulation. Creaming is, nonetheless, undesirable because it is associated with an increased likelihood of the droplets coalescing and the emulsion “breaking.” Other additives include buffers, antioxidants, and preservatives. A suspension is a coarse dispersion of insoluble drug particles, generally with a diameter >1 μm, in a liquid (usually aqueous) medium. Types of dosage forms: Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. Parenteral administration types: The administration is mostly done by using needle and is of following types. A premix is a solid dosage form in which an active ingredient, such as a coccidiostat, production enhancer, or nutritional supplement, is formulated with excipients. The nature of the disease or illness for which the drug substance is intended is essential in deciding which dosage forms of that drug should be prepared and marketed. The composition of the glass determines the solubility of the bolus, with an increase in the ratio of monovalent to divalent cations resulting in an increase in solubility. • 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 Route of administration may be oral, intravenous, intramuscular, cutaneous, subcutaneous, etc. The dosage form (e.g. Suspension concentrates are used topically as pour-ons, plunge and shower dip concentrates, and jetting fluids. A spot-on formulation is a solution of active ingredient(s) that typically contains a cosolvent and a spreading agent. For salsalate. • Tarceva is not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies ]. Numerous methods are used to apply parasiticides to farm animals (see below). Advantages of liquid dosage forms 3. 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. Other types of oral modified-release delivery systems are also available for ruminants. In addition to the excipients described above for solutions, suspensions include surfactants and thickening agents. Both dosage forms are usually administered orally, but may sometimes be … • Categorize drugs by source as natural, synthetic, synthesized, or semisynthetic. These dosage forms as well as the specialized topical dosage forms and delivery systems for transdermal drug delivery and parasite control are discussed below. The excipients present in premix formulations include carriers, liquid binders, diluents, anticaking agents, and antidust agents. 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. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Liniment. Transdermal patches, for instance, are used to deliver analgesics to the systemic circulation. The vehicle may be water, glycerol, propylene glycol, or alcohol/water mixtures. Innovative solutions have been developed to meet many of these challenges (eg, the convenient dosing option offered by topical spot-on formulations to treat external and internal parasites on dogs and cats, the microencapsulation of NSAIDs as a way to mask taste when these agents are added to the rations of horses). Active ingredients that are soluble in water-immiscible organic solvents are frequently formulated as emulsifiable concentrates. Parenteral emulsions are rare, because it is seldom necessary to achieve an emulsion for drug administration. All administration should be performed with knowledge of the chemical and physical characteris-tics of the substance. Parenteral Route of Administration and Dosage Forms. Routes of administration are generally classified by the location at which the substance is applied. Previously, we talked about dosage forms and their significance. Merck & Co., Inc., Kenilworth, NJ, USA is a global healthcare leader working to help the world be well. Oral solutions provide a convenient means of drug administration to neonates and young animals. The oral route of administration is the safest, most economical and the most convenient way of giving medicines. A lotion is usually an aqueous solution (or suspension) for application to inflamed, ulcerated skin. Examples of diluents include ground limestone, dicalcium phosphate, dextrose, and kaolin. Increasingly, a PK/PD model that describes the drug response is the basis of dose optimization. Rather, freeze-drying, or lyophilization, is used to produce a porous powder that reconstitutes readily. Pyrogenic substances are primarily lipid polysaccharides derived from microorganisms, with those produced by gram-negative bacilli generally being most potent. Examples:- 1. 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. However, this may not be the case in species in which the emulsifying properties of skin secretions and the large numbers of follicles and glands per unit surface area must be considered (eg, cattle and sheep). Shelf life: 24 months at 2 - 8 °C . Friar's balsam is compound benzoin tincture and is used to protect and toughen ulcerated or fissured skin. 4 as per USP is A. Drugs applied to the skin for local effect include antiseptics, antifungals, anti-inflammatory agents, and skin emollients. The liquid form of a drug dose for administration or consumption. Various routes of administrations play a marked role in the bioavailability of the active drug in the body. Learn vocabulary, terms, and more with flashcards, games, and other study tools. It should be economical and presentation should be elegant. The plunge dipping of sheep and cattle for external parasites requires a dipping vat, which may be a portable unit or a permanent in-ground structure shielded from direct sunlight by roofing. Glass boluses are designed to dissolve in ruminal fluids, thereby releasing the incorporated elements. Antifoaming agents reduce the stability of the froth by lowering the viscosity of the fluid ingesta. 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. Discuss the advantages of a transdermal dosage form. Gas dosage form. • Explain the correct techniques for administration of eye drops, metered-dose . The glass boluses are retained in the rumen for up to 9 mo. Bolus intravenous injection. Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. For example, controlled-release boluses have been developed to deliver antimicrobials, anthelmintics, production enhancers, nutritional supplements, and other drugs. Proper dip management requires attention to the factors described above for plunge dipping. This concern is addressed by ensuring the active ingredient is nontoxic, stable, palatable, and preferably of low solubility. The two phases of an emulsion are known as the dispersed phase and the continuous phase. It may be necessary to include a cosolvent to increase the solubility of the drug. Oral dosage forms require careful pharmaceutical formulation. Dosage Forms: Lamivudine ... Agency (EMA),3 the Food and Drug Administration (FDA)4 ortheWHO,2 butalsoserveasacriticalevalu-ation of these regulatory documents. Typically, a suspoemulsion contains one or more solvent-soluble active ingredients in an emulsion phase, combined with one or more low solubility active ingredients in a continuous aqueous suspension phase. I. 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