Add time:08/11/2019         Source:sciencedirect.com

Several emulsion formulations (e.g., mixtures of drug with a nutritional emulsion, e.g., Liposyn®, ready-to-use w/o/w emulsion, and ready-to-use o/w emulsions) were developed and tested for potential use as a less-painful i.v. formulation of clarithromycin. The formulations contained 5 mgml drug. Formulations were tested in one or more animal models to estimate the level of pain reduction as compared to an aqueous solution of clarithromycin lactobionate. Most formulations demonstrated 20–80% reduction in pain. However, the nutritional emulsion mixtures and the w/o/w emulsions demonstrated chemical or physical stability problems. On the other hand, a ready-to-use o/w emulsion, composed of 0.5% w/v drug, 2% w/v soybean oil, 5% w/v egg phosphatide, 0.6% w/v oleic acid, 0.3% hexanoic acid and 2.5% w/v glycerin in water, demonstrated adequate physical and chemical stability for clinical development. Additional in vivo studies with this emulsion revealed it to be as efficacious as clarithromycin lactobionate solution and clarithromycin base aqueous suspension in the treatment of Staphylococcus aureus, S. pyogenes and Streptococcus pneumoniae infections. In dogs, the plasma distribution of 100 mg drug infused as emulsion closely compared with clarithromycin lactobionate solution. The data suggest that emulsion formulations may be useful for the parenteral delivery of painful compounds.

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