Preservative injectable solutions

Dosage form Leukine is formulated as a sterile, preserved, injectable solution (500pg/l) in a 1ml vial. Lyophilized Leukine is a sterile, preservative-free powder (250 pg) that requires reconstitution with sterile water for injection or bacteriostatic water for injection. 

A new antiviral agent, developed for treatment of CMV retinitis, can be administered by intravitreal injection. Formivirsen sodium is a phosphorothioate oligonucleotide that inhibits CMV replication through an antisense mechanism. It is formulated as a sterile and preservative-free solution and supplied in single-use vials (Vitravene ). The product is administered directly into the vitreous cavity posterior to the limbus through a 30-gauge needle. This procedure can be performed on an... 

Glycerin is used occasionally in injectable formulations. Glycerin comprises of 2.5% of the idarubicin formulation, Idamycin PFS (preservative-free solution) and is administered undiluted by IV infusion. Glycerin comprises of 2.2%i of the propofol formulation, Diprivan 1%, and is administered undiluted by IV bolus or infusion. The dose of Diprivan 1% is up to 30 ml, which is 6.75 ml of glycerin per dose, representing the estimated maximum amount administered intravenously. 

Allergic contact dermatitis, characterized by erythema, palpable edema, and raised borders, was attributed to benzyl alcohol (2). In this case, the benzyl alcohol was present as a preservative in an injectable solution of sodium tetradecyl sulfate, a sclerosing agent used for the treatment of varicose veins. The author provided a hst of 151 injectable formulations (48 for subcutaneous administration) that contained benzyl alcohol as a preservative in the range 0.5-2.0%. The list included hormones and steroids, antihypertensive drugs (reserpine), vitamin formulations (vitamins B12 and Bg), ammonium sulfate, antihistamines, antibiotics, heparin (17 brands), tranquillizers, and sclerosing agents (sodium morrhuate and sodium tetradecyl sulfate). 

Sterile aqueous solutions prepared with high purity ascorbic acid and pyrogen-free distilled water in glass-lined equipment under absolute sanitary operations and filled into ampules are necessary for injectable solutions for parenteral use in humans and animals. For all injectable products, it is important to select container, stopper, preservative, and other ingredients that are compatible. 

Each syringe contains 6 mg of pegfilgrastim (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pFI 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection. 

The most common way to formulate injections is to dissolve the drug in an aqueous vehicle. Excipients are added to control solubility, osmotic pressure, pH, stability, specific gravity, and preservation. Injections may also be formulated as oily solutions, disperse systems like suspensions and emulsions (aqueous and oily), and liposomal dispersions. Drug formulation is an essential factor in photochemical stability of the drug substance. Excipients or impurities in the formulation can also participate in photochemical reactions, leading to decomposition of the drug substance or the formulation. 

DOXORUBICIN, CONVENTIONAL (Adriamycin RDF preservative-free solution for injection 2 mg/mL)... 

For IV infusion, inamrinone lactate and milrinone lactate Injection solutions may be diluted In sodium chloride solution for injection. Inamrinone lactate for injection is preserved with sodium metabisulfite and needs protection from light. It should not be diluted with solutions containing dextrose, because a chemical Interaction occurs over 24 hours. For milrinone, an immediate chemical interaction with furosemide with the formation of a precipitate is observed when furosemide is injected into an infusion of milrinone. Patients who are sensitive to bisulfites also may be sensitive to inamrinone lactate injection, which contains sodium metabisulfite. 

Anakinra is the first IL-1 Ra to be approved for use in adults with moderate to severe active rheumatoid arthritis who have not responded adequately to conventional DMARD therapy. It may be used either alone or in combination with methotrexate. Anakinra Is supplied in single-use, prefilled, glass syringes as sterile, clear, preservative-free solution that is administered daily as a self-administered subcutaneous injection under the skin. Some potential side effects include injection site reactions, decreased white blood cell counts, headache, and an increase in upper respiratory infections. There may be a slightly higher rate of respiratory infections in people who have asthma or chronic obstructive pulmonary disease. Persons with an active infection are advised not to use anakinra. Its elimination half-life after sc administration is 4 to 6 hours. 

Benzyl alcohol (Fig. 5.4) has both antiseptic and mild local anaesthetic properties and is used in lotions and ointments for topical application. It is also used as a preservative in injection solutions. 

In contrast, parenteral suspensions have relatively low solids contents, usually between 0.5 and 5%, with the exception of insoluble forms of penicillin in which concentrations of the antibiotic may exceed 30%. These sterile preparations are designed for intramuscular, intradermal, intralesional, intraarticular, or subcutaneous injection. Syringeability is an important factor to be taken into consideration with injectable dosage forms. The viscosity of a parenteral suspension should be sufficiently low to facilitate injection. Common suspending vehicles include preserved isotonic saline solution or a parenterally acceptable vegetable oil. Ophthalmic and optic suspensions that are instilled into the eye/ear must also be prepared in a sterile manner. The vehicles are essentially isotonic and aqueous in composition. The reader should refer to Chapter 12 for further discussion on parenteral products. 

Aqueous products that are at greatest risk from microbial spoilage include solutions, suspensions, and emulsions for repeated oral, parenteral, or external use and include critical products such as multidose injections and eye drops. Unpreserved products without adequate antimicrobial efficacy should not be presented in containers intended for use on more than one occasion unless justified. When antimicrobial preservatives are used, their efficacy has to be demonstrated using the Ph Eur test for antimicrobial preservative efficacy. Factors to be taken into account in designing a preserved product include the nature of the preservative, its concentration in the product, the... 

Formulation Aranesp is formulated as a sterile, colorless, preservative-free protein solution for intravenous (IV) or subcutaneous (SC) administration. There are two formulations the polysorbate solution includes excipients such as polysorbate 80, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, and sodium chloride in water-for-injection while the albumin solution contains albumin, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, and sodium chloride in water-for-injection. The pH for both formulations is 6.2 + 0.2. 

Parenterais The most important criterion for parenterals is that they have to be sterile for injection or infusion administration. Excipients are added to make parenterals isotonic with blood, improve solubility, and control pH of the solution. The solvent vehicles include water-for-injection, sterile sodium chloride, potassium chloride, or calcium chloride solution, and nonaqueous solvents such as alcohol, glycol, and glycerin. Preservatives, antioxidants, and stabilizers are normally added to enhance the properties of the drug product. 

Bacteriostatic sodium chloride Do not use in newborns. Benzyl alcohol as a preservative in bacteriostatic sodium chloride injection has been associated with toxicity in newborns. These solutions have not been reported to cause problems in older infants, children, and adults. 

Local - Occasionally, redness, swelling, and itching at the injection site may develop. This reaction occurs if the injection is not properly made, if the skin is sensitive to the cleansing solution, or if the patient is allergic to insulin or insulin additives (eg, preservatives). 

Dosage form ReoPro is a sterile, preservative-free, buffered solution for intravenous use. Each single-use vial contains abciximab 2mg/ml in water for injection. 

Dosage form Vitravene is a sterile, aqueous, preservative-free, buffered solution supplied in 0.25 ml single-use vials for intravitreal injection. Each ml of Vitravene solution contains fomivirsen sodium 6.6 mg. 

The OPA method is based on the formation of a highly fluorescent isoindole derivative by reaction with o-phthalaldehyde and 2-aminoethanol in mildly basic aqueous solution (331. The advantage of this technique is that a large variety of thiols and other reduced sulfur compounds can be detected at subnanomolar to nanomolar concentrations. Its disadvantage is that the fluorescent derivative, which preserves the thiol in its reduced stage, is unstable and must be formed just prior to injection. These characteristics preclude the delayed analysis (e.g., in the laboratoiy) of large numbers of samples collected in the field. 

Once the sample preparation is complete, the analysis is carried out by an instrument of choice. A variety of instruments are used for different types of analysis, depending on the information to be acquired for example, chromatography for organic analysis, atomic spectroscopy for metal analysis, capillary electrophoresis for DNA sequencing, and electron microscopy for small structures. Common analytical instrumentation and the sample preparation associated with them are listed in Table 1.1. The sample preparation depends on the analytical techniques to be employed and their capabilities. For instance, only a few microliters can be injected into a gas chromatograph. So in the example of the analysis of pesticides in fish liver, the ultimate product is a solution of a few microliters that can be injected into a gas chromatograph. Sampling, sample preservation, and sample preparation are... 

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