Antimicrobial preservative agents

Table 5 Antimicrobial preservative agents in small-volume parenterals...

Akers MJ. Considerations in selecting antimicrobial preservative agents for parenteral product development. Pharm Technol 1984 8(5) 36-40, 43, 44, 46. 

Mineral oil and paraffins should not be used, because these are not metabolized and may irritate tissue. Various other additives are needed for stabiUty, stefihty, and isotonicity antimicrobial preservatives, antioxidants (qv), chelating agents (qv), and buffers. No parenteral container material is completely inert to parenteral solvent systems. 

Sulfur dioxide, sulfites, and metabisulfites have had extensive use as antimicrobial preservatives in the food industry. In pharmaceuticals they have had a dual role, acting as preservatives and antioxidants. The sulfa dmgs, or sulfonamides, the first effective chemotherapeutic agents to be employed... 

Substances that have been used as preservatives for disperse systems include chlorocresol, chlorobutanol, benzoates, phenylmercuric nitrate, parabens, and others [76,77]. The use of cationic antimicrobial agents such as quaternary ammonium compounds (e.g., benzalkonium chloride) is contraindicated in many cases because they may be inactivated by other formulation components and/or they may alter the charge of the dispersed phase. Clay suspensions and gels should be adequately preserved with nonionic antimicrobial preservatives. The use of preservatives is generally limited to products that are not intended for parenteral use. Intravenous injectable... 

Large-volume parenterals (LVPs) and small-volume parenterals (SVPs) containing no antimicrobial agent should be terminally sterilized. It is common practice to include an antimicrobial agent in SVPs that cannot be terminally sterilized or are intended for multiple-dose use. The general exceptions are products that pass the USP Antimicrobial Preservative Effectiveness Test [1] because of the antimicrobial activity of the active... 

Preservative/antimicrobial preservative, antimycotic agent, bacteriophage control agent, chemosterilant/wine maturing agent, disinfection agent... 

Benzyl alcohol Antimicrobial preservative, disinfectant, solvent Oxidizing agents, strong acids, plastic containers, and methylcellulose... 

Phenylethanol Antimicrobial preservative (not oral) Oxidizing agents, proteins, polysorbates... 

Shelf stability of a product is of critical importance because it is affected by longterm antimicrobial and antioxidizing activity enhanced by preservative agents compared to only antimicrobial agents that are added to dressings for thwarting infection in a wound. Preferably, a preservative can be added to a product that possesses broad-spectrum antimicrobial activity that will allow the product to maintain activity before reaching a planned expiration date, and prevent infection when applied to wounds. 

These are chemical agents that are included in preparations to prevent deterioration of manufactured products. Antimicrobial preservatives are used in sterile... 

Gels are relatively easier to prepare compare to ointments and creams. In addition to the gelling agent, medicated gels contain drug, antimicrobial preservatives, stabilizers, dispersing agents, and permeation enhancers. Some of the factors discussed below are essential to obtain a uniform gel preparation. 

Various additives are needed for stability, sterility, and isotonicity, including antimicrobial preservatives, antioxidants, chelating agents, and buffers. 

Formulation ingredients include the suspending agent, a wetting agent (if the suspending agent does not also serve this purpose), a buffer, and an antimicrobial preservative for multiple-dose products. 

The USP 28 describes albumin human as a sterile nonpyrogenic preparation of serum albumin obtained from healthy human donors see Section 13. It is available as a solution containing 4, 5,20, or 25 g of serum albumin in 100 mL of solution, with not less than 96% of the total protein content as albumin. The solution contains no added antimicrobial preservative but may contain sodium acetyltryptophanate with or without sodium caprylate as a stablizing agent. 

Antimicrobial preservative antiseptic disinfectant solubilizing agent wetting agent. 

Benzethonium chloride is a quaternary ammonium compound used in pharmaceutical formulations as an antimicrobial preservative. Typically, it is used for this purpose in injections, ophthalmic and otic preparations at concentrations 0.01-0.02% w/v. Benzethonium chloride may also be used as a wetting and solubilizing agent, and as a topical disinfectant. 

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