Cosolvents oral dosage forms

Self-emulsifying drug delivery systems are oral dosage forms consisting of drug, oils, surfactants, and sometimes cosolvents (Constantinides, 1995 Pouton, 1997 Pouton, 2000). On addition to water... 

In another example of a polyethylene glycol/surfactant, solid dispersion is presented by Dannenfelser et al. (2004) with a poor water-insoluble drug exhibiting only a g1i7iL aqueous solubility. At 40 mg/mL, the PEG 3350/polysorbate 80 solid dispersion exhibited similar exposure as that of a cosolvent-surfactant solution and a ten-time increase over a dry blend formulation, thus enabling a solid oral dosage form for clinical trials. 

Ethanol 96% Moderately hemolytic cosolvent in injectables, up to 25% used in oral dosage forms... 

Suspensions are two-phase systems consisting of a finely divided solid dispersed in a liquid, solid, or a gas (Table 6). They are appropriate when the drug to be incorporated is not sufficiently soluble in an ordinary solvent or cosolvent system. They are used orally and topically. Examples of compounded suspensions include pediatric oral liquids where a commercial pediatric dosage form is not available. Commercial tablets and capsules are formulated into a vehicle and can be individually flavored to the patient s preference. 

If the dosage form contains cosolvents (or if, for any reason, it may be expected to extract greater amounts of substances from plastic packaging components than water), then additional extractable information may be needed to address safety issues. Performance is typically not a factor for liquid-based oral drug products. 

When delivered parentally or orally, a drug in solution is more rapidly bioavailable compared to a solid dosage form. The cosolvent approach also has some limitations as pointed out for other solubilization techniques. When solubilization of a drug is achieved by use of cosolvent, it must meet certain requirements, such as nontoxicity, compatibility with blood, nonsensitizing, nonirritating, and above all physically and chemically stable and inert. 

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