Sterile solutions

Pharmacology and Uses. Lincomycin hydrochloride (Lincocin) is available in oral dosage forms and as a sterile solution for injection. After... 

Miconazole. Miconazole (Fig. 2, 7a) is also available as a sterile solution for intravenous infusion. Miconazole has a therapeutic effect on systemic mycoses due to C albicans A.spergillusfumigatus Cyptococcus neoformans Blastomyces dermatitidis Histoplasma capsulatum Coccidioides immitis Paracoccidioides brasiliensis and Petriellidum boydii. 

USP XXII general dihydrate 99-107% CaCl2-2 H2O calcium chloride for injections, sterile solution in water, 95—105% of labeled CaCL-2 H,0 ... 

Sometimes a eombined cleansing and sterilizing solution is desirable, in which case the two agents must be compatible. 

Most contact lenses are worn for optical reasons as an alternative to spectacles. Contact lenses are of two types, namely hard lenses, which are hydrophobic, and soft lenses, which may be either hydrophilic or hydrophobic. The surfaces of lenses mnst be wetted before nse, and wetting solntions (section 4.5.1) are nsed for this pnrpose. Hard and, more especially, soft lenses become heavily contantinated with protein material dnring nse and must therefore be cleaned (section 4.5.2) before disinfection (section 4.5.3). Contact lenses are potential sonrees of eye infection and conseqnentiy nticroorganisms should be removed before the lens is again inserted into the eye. Lenses mnst also be clean and easily wettable by the lacrimal secretions. Contact-lens solntions are thns sterile solutions of the varions types described below. Apart fiom... 

III. SPECIALIZED LARGE-VOLUME PARENTERAL AND STERILE SOLUTIONS... 

Large-volume parenterals designed to provide fluid (water), calories (dextrose solutions), electrolytes (saline solutions), or combinations of these materials have been described. Several other specialized LVP and sterile solutions are also used in medicine and will be described here, even though two product classes (peritoneal dialysis and irrigating solutions) are not parenteral products. 

Two basic methods are used to prepare parenteral suspensions (a) sterile vehicle and powder are combined aseptically, or (b) sterile solutions are combined and the crystals formed in situ. Examples of these procedures may be illustrated using Penicillin G Procaine Injectable Suspension USP and Sterile Testosterone Injectable Suspension USP. 

In the first example, procaine penicillin, an aqueous vehicle containing the soluble components (such as lecithin, sodium citrate, povidone, and polyoxyethylene sorbitan monooleate) is filtered through a 0.22 pm membrane filter, heat sterilized, and transferred into a presterilized mixing-filling tank. The sterile antibiotic powder, which has previously been produced by freeze-drying, sterile crystallization, or spray-drying, is aseptically added to the sterile solution while mixing. After all tests have been completed on the bulk formulation, it is aseptically filled. 

Most proteins are not sufficiently stable in aqueous solution to allow formulation as a sterile solution. Instead, the protein is freeze-dried and reconstituted before use. Development of a freeze-dried protein formulation often requires special attention to the details of the freezing process (potential pH shifts and ionic strength increase with freezing) as well as to potential loss of activity with drying. Formulation additives, such as sugars and polyhydroxy compounds, are often useful as cryoprotectants and lyoprotectants. Residual moisture may also be critical to the stability of the dried preparation [33],... 

All production processes, such as ampoule washing and sterilization, solution filtration, equipment set-up and operation, sorting, and freeze-drier cleaning and operation, should be covered in detail in a procedure manual to ensure that all operations are understood as well as carried out properly and uniformly. Cleaning, sterilization, sterile filtration, filling, and aseptic processing operations must be validated. 

In general, aqueous ophthalmic solutions are manufactured by methods that call for the dissolution of the active ingredient and all or a portion of the excipients into all or a portion of the water and the sterilization of this solution by heat or by sterilizing filtration through sterile depth or membrane filter media into a sterile receptacle. If incomplete at this point, this sterile solution is then mixed with the additional required sterile components, such as previously sterilized solutions of viscosity-imparting agents, preservatives, and so on, and the batch is brought to final volume with additional sterile water. 

Miconazole injection is a sterile solution of miconazole in water for injection. It contains not less than 90% and not more than 110% of the labeled amount of... 

Rebif is produced via recombinant DNA technology in a CHO cell line. It displays an identical amino acid sequence to that of native human IFN-P-la and, like the native product, is glycosylated. After cell culture the interferon is purified using a series of chromatographic steps (affinity, ion-exchange, gel-filtration and reverse-phase liquid chromatography). It is formulated as a sterile solution in pre-filled syringes and contains mannitol, HSA, sodium acetate, acetic acid and sodium hydroxide as excipients. It is administered subcutaneously three times weekly. 

A truncated version of PTH (tradenames Forsteo and Forteo) has been approved for the treatment of osteoporosis in postmenopausal women. This 4 kDa polypeptide is identical in sequence to the N-terminal residues 1-34 of endogenous hPTH, it binds to the native PTH receptor and triggers the same effects. The product is produced in E. coli, purified and presented as a sterile solution containing 250 pg active substance per millilitre. 

Developed by the US company, Isis, Vitravene is used to treat cytomegalovirus (CMV) retinitis in AIDS patients. It is synthesized chemically and formulated as a sterile solution (6.6 mg active drug/ml) in WFI using a bicarbonate buffer to maintain a final product pH of 8.7. 

The RNA-based aptamer consists of 28 nucleontides of predefined sequence, chemically modified in order to render it resistant to nuclease degradation. Two 20 kDa PEG molecules are also covalently attached at one end of the nucleotide. The overall product molecular mass is 50 kDa. Final product is presented as a sterile solution containing sodium chloride and sodium phosphate as excipients. 

A blank and also a sterile solution containing Pb2+ of methyllead compounds showed no Pb content in the methanolic solution after the same treatment. The author concluded that Me4Pb was produced in the biomethylation of Pb2+ by bacteria123. Thompson and Crerar122 also observed that about 0.03% of lead as Pb(NC>3)2 underwent methylation and trimethyllead acetate, (CH3)3PbOAc, was methylated nearly quantitatively in incubation experiments with marine sediments from the British Columbia coastline. 

Immune sera are sterile solutions containing antibody derived from human (immune globulin [IG]) or equine (antitoxin) sources. 

Immune Globulin (IG) IG is a sterile solution containing antibodies from human blood. It is obtained by cold ethanol fractionation of large pools of blood plasma and contains 15-18 percent protein. Intended for intramuscular administration, IG is primarily indicated for routine maintenance of immunity of certain immunodeficient persons and for passive immunity against measles and hepatitis. IG does not transmit hepatitis B virus, human immunodeficiency virus (HIV), or other infectious diseases. 

A physician order for an intravenous infusion for a patient weighing 110 lb calls for a 0.25 mEq of potassium chloride per kilogram of bodyweight to be added to 500 mL of D5W. How many milliliters of a sterile solution containing 50 mEq of potassium chloride per 10 mL should be used in preparing the infusion ... 

Pneumococcal Disease In October 2002, the FDA approved the use of Prevnar for immunization of infants and toddlers against otitis media— middle ear infection. Prevnar is a pneumococcal seven-valent conjugate vaccine. It is formulated with a sterile solution of saccharides conjugated to the antigen, Streptococcus pneumoniae. 

The equipment needed is determined by the type and extent of the services chosen to provide. Hospitals already utilize laminar flow hoods for aseptic compounding of sterile solutions. The same hoods can be used to compound other sterile products such as eye drops. A balance, preferably electronic, is essential. Ointment slabs (pill tiles), along with spatulas of different types and materials, should be on hand. A few mortars and pestles (both of glass, ceramic, and/or plastic) should be obtained and some glassware. It may not be necessary to buy a roomful of equipment, but one should purchase what is needed to start the service, and build it up as the service grows and expands to different arenas. 

Coronel, P. and Simunovic, J. and Sandeep, K.P. and Cartwright, G.D. and Kumar, P. (2008). Sterilization solutions for aseptic processing using a continuous flow microwave system. Journal of Eood Engineering, 85, 528-536. 

A 4% solution of gelatin (often modified, i.e. succinylated gelatin) is also used as a plasma expander. For this application, 500ml-ll of the sterile solution is infused slowly. In rare occurrences, infusion (particularly rapid infusion) of the gelatin solution has been known to initiate hypersensitivity reactions. After its infusion, gelatin is excreted relatively quickly and mostly via the urine. 

Ear/eye/nasal drops are solution of drugs that are instilled into a ear, eye and nose with a dropper. The eye drops are sterile solutions. 

It is a sterile solution of hyperimmunoglobulin prepared from the placenta of healthy volunteers specifically immunised against tetanus. 

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