A Coulter Counter, Model TAII was used to determine both solubility and dissolution rate from suspensions of griseofulvin and hydrocortisone acetate, where the initial particle size and shape had been characterized. The method assesses the weights and surface areas of particles remaining undissolved as a function of time. A comparison with a conventional method, assessing dissolved quantities of materials, showed that solubility data of the same order of magnitude can be obtained. The TAII data fitted a previously established equation that linearly relates log solubility and log of the intrinsic dissolution rate and indicated that the dissolution process was not diffusion controlled. The TAII method described is a rapid and convenient means of estimating the solubility and dissolution rate where no adequate technique for analysing the dissolved fraction exists.
A typical All-in-One (AIO) parenteral nutrition mixture in a 3-litre polymeric infusion bag will consist of lipid emulsion, amino acids, glucose, electrolytes, trace elements and vitamins. This varied mixture of chemical entities provides the potential for a number of chemical and physicochemical interactions that can compromise the clinical safety and efficacy of the product. The destabilisation of the lipid emulsion in the presence of electrolytes is a major problem. Although a predictive equation for the maximum concentrations of mono-, di-and trivalent ions causing instability has been proposed, it is too simplistic to be of significant value. The reasons for this are discussed as well as the stability implications of other additives to the parenteral nutrition mixture.
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