Injections active ingredient

Most injections are formulated as aqueous solutions, with Water for Injections BP as the vehicle. The formulation of injections depends upon several factors, namely the aqueous solubility of the active ingredient, the dose to be employed, thermal stability of the solution, the route of injection and whether the product is to be prepared as a multidose one (i.e. with a dose or doses removed on different occasions) or in a singledose form (as the term suggests, only one dose is contained in the injection). Nowadays, most injections are prepared as single-dose forms and this is mandatory for certain routes, e.g. spinal injections such as the intrathecal route and large-volume intravenous infusions (section 2.2). Multidose injections may require the inclusion of a suitable... 

Details of time-temperature regimens as dictated by injection volume and heat transfer to the whole of the product (section 2.2) and of possible interactions between active ingredients and containers must be considered (see also Chapter 20). 

Milbemectin consists of two active ingredients, M.A3 and M.A4. Milbemectin is extracted from plant materials and soils with methanol-water (7 3, v/v). After centrifugation, the extracts obtained are diluted to volume with the extraction solvent in a volumetric flask. Aliquots of the extracts are transferred on to a previously conditioned Cl8 solid-phase extraction (SPE) column. Milbemectin is eluted with methanol after washing the column with aqueous methanol. The eluate is evaporated to dryness and the residual milbemectin is converted to fluorescent anhydride derivatives after treatment with trifluoroacetic anhydride in 0.5 M triethylamine in benzene solution. The anhydride derivatives of M.A3 and M.A4 possess fluorescent sensitivity. The derivatized samples are dissolved in methanol and injected into a high-performance liquid chromatography (HPLC) system equipped with a fluorescence detector for quantitative determination. 

Fourth, we are interested in information on the various presentations of each product. The presentations differ in pharmaceutical form (tablets, capsules, injectables, creams and so on), the concentration of the therapeutic active ingredient (usually specified in milligrams) and the number of tablets, vials, or units in general, provided in each package. The Spanish data enable us to identify the number of units per package for all the observations. The... 

Katori et al [84] used a high performance liquid chromatographic method for the determination of primaquine phosphate tablets. Chromatography on a TSK Gel-4 (octadecylsilanized) column was used to determine the active ingredient in tablets and injections for treating tropical diseases. The mobile phase used is 26% acetonitrile in 0.05-M pH-3 phosphate buffer and the drug was detected at 260 nm. The peak area and peak height reproducibilities were <1.69%, and results compared well with those of other methods. 

Many drugs, including many biopharmaceuticals, are administered to localized areas within the body by, for example, s.c. or i.m. injection. Local toxicity tests appraise whether there is any associated toxicity at/surrounding the site of injection. Predictably, these are generally carried out by s.c. or i.m. injection of product to test animals, followed by observation of the site of injection. The exact cause of any adverse response noted (i.e. active ingredient or excipient) is usually determined by their separate subsequent administration. 

FIA has also found wide application in pharmaceutical analysis.214,215 Direct UV detection of active ingredients is the most popular pharmaceutical analysis application of FIA. For single component analysis of samples with little matrix interference such as dissolution and content uniformity of conventional dosage forms, many pharmaceutical chemists simply replace a column with suitable tubing between the injector and the detector to run FIA on standard HPLC instrumentation. When direct UV detection offers inadequate selectivity, simple online reaction schemes with more specific reagents including chemical, photochemical, and enzymatic reactions of derivatization are applied for flow injection determination of pharmaceuticals.216... 

Irritation. Tissue irritation upon injection, and the accompanying damage and pain, is a concern that must be addressed for the final formulation, which is to be either tested in humans or marketed, rather than for the active ingredient. This is because most irritation factors are either due to or influenced by aspects of formulation design (see Avis, 1985, for more information or parenteral preparations). These factors are not independent of the route (TV, IM, or SC) that will be used and, in fact (as discussed later), are part of the basis for selecting between the various routes. 

PEG-Intron PEG-Intron is used for the treatment of hepatitis C. The product consists of a covalent conjugate of the recombinant interferon- -2b with monomethoxy polyethylene glycol (PEG) supplied in vials with 74/rg, 118.4/rg, 177.6/rg, or 222/rg of the active ingredient and 1.11 mg sodium phosphate (dibasic,anhydrous),l.ll mg sodium phosphate (monobasic, dihydrate), 59.2 mg sucrose, and 0.074mg polysorbate 80. The powder is reconstituted with sterile water-for-injection. 

I.R. Last and K.A. Prebble, Suitabihty of near-infrared methods for the determination of moistnre in a freeze-dried injection prodnct containing different amonnts of the active ingredient, J. Pharm. Biomed. Anal., 11(11/12), 1071-1076 (1993). 

Rate of herbicide calculated as active Ingredient. Herbicide Injected at 10-15 cm level or preplant Incorporated In the 0-15 cm level. All plots duplicated. 

TRW Systems, Inc., conducted a laboratory-scale incineration study for the U.S. Army from 1973 to 1975 (9). Eleven individual pesticide formulations and three mixed pesticide formulations containing six different active ingredients (chlordane, 2,4-D, DDT, dieldrin, lindane, and 2,4,5-T) were incinerated in a liquid injection incinerator. The experimental apparatus consisted of a fuel atomizer, combustion chamber, afterburner, quench chamber, and scrubber unit. Destruction efficiencies exceeded 99.99% for a minimum 0.4-s residence time at temperatures above 1000°C with 45 to 60% excess air. 

Developed by the US company Isis, Vitravene is used to treat cytomegalovirus (CMV) retinitis in AIDS patients. It is formulated as a sterile solution in WFI (Chapter 3) using a bicarbonate buffer to maintain a final product pH of 8.7. Administration is by direct injection into the eye (intravitreal injection) and each ml of product contains 6.6 mg of active ingredient. 

Also, the proportion of the active ingredient in the price of the finished drug varies widely. It can be below 1% in low-dosage, rarely administered, patented injectable drugs. In contrast, it can be up to 25% in generic drugs administered as powders. 

Conditioning. A Pavlovian explanation of placebo effects has been based on the traditional model of classical conditioning active ingredients serve as unconditional stimuli and the vehicles in which they are delivered (pills, injections), particularly the elements of therapeutic procedures, function as conditional stimuli. After repeated pairing of unconditioned and conditioned stimuli, the conditional stimulus elicits a conditional response even if the conditioned stimulus (e.g. the pill) is presented alone (without active ingredient). 

At the end of approval cleaning, the equipment should be rinsed with sterile water for injection. The water for hnal rinse shall be tested for its conductivity. As an alternative, run a placebo batch after a production batch and subsequent cleaning. Analyze the samples of placebo batch for the active ingredients of the previous run batch to ensure that there is no cross-contamination. 

For all these hormonal substances to exert their desired effect, the method of administration to the animal is most important. They can be administered to animals by intramuscular injections but some compounds can be also administered incorporated into the feeds. However, the best method is one in which they are administered in form of a subcutaneous implant in the ear. This allows for a controlled slow release of the active ingredients, exposing the animal to a constant stimulating effect of the anabolic agent. 

As reported later in Chapter 9.9 of this book, active-ingredient-containing polymeric micro-particles are widely used in technological and medical applications. For example, these particles are suitable as drug-delivery devices and can control the pharmaceutical release-rate over time. The particle size is absolutely important when dealing with drug-delivery devices. Very small particles can be inhaled, while larger ones can be injected into the blood stream. Therefore, it is important to control the microparticle size in the production. 

Tramadol is available as drops, capsules, and sustained-release formulations for oral use, suppositories for rectal use, and solution for intramuscular, intravenous, and subcutaneous injection. After oral administration, tramadol is rapidly and almost completely absorbed. Sustained-release tablets release the active ingredient over a period of 12 h, reach peak concentrations after 4.9 h, and have a bioavailability of 87 to 95% compared with capsules. One 100-mg dose given to healthy volunteers resulted in plasma levels of 375 ng/ml at 1.5 h.55 Tramadol is 20% bound to plasma protein and it is rapidly distributed in the body it is mainly metabolized by O- and A-demethylation forming glucuronides and sulfates that are excreted by the kidney. 

AAS also are manufactured in an injectable form. Most are used as deep intra muscular injections containing various oils and, in a few cases, sterile water. The active ingredient is suspended in the oil or water solution. 

Steroid hormones, especially those containing the A S-keto-chromophore group, are frequently marketed in the form of oily injections. Direct determination of the active ingredient content using the CD method is conveniently done by measuring the ellipticity of an aliquot of the injection after the very simple process of dilution with an appropriate solvent [22]. Problems that might arise in these analyses and the recommended method of examination are discussed in the case of an oily injection that contains testosterone phenylpropionate. 

Nie et al. used a flow injection chemiluminescence method for the determination of dipyridamole in Persantin tablets [51]. A flow injection analysis system equipped with a chemiluminescence detector was used. Sodium hypochlorite was used as a chemiluminescent substance, and Triton X-100 was used as an enhancer of the chemiluminescence reaction. Sample solutions (pH 4-6) was injected into 0.2% Triton X-100 and treated with 0.5% sodium hypochlorite, and the chemiluminescence intensity then measured. The calibration graph was linear from 0.04 to 10 pg/mL of Persantin tablets (as its active ingredient dipyridamole), with a detection limit of 11 ng/mL. Recoveries were quantitative and the relative standard deviation ( = 3) was 2.7%. The method has been used to determine Persantin in injection and tablets, and the results obtained using this method agreed with those obtained by the Chinese Pharmacopoeial method. 

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