4.7 Article

The influence of medium-chain triglycerides on the stability of all-in-one formulations

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INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 240, 期 1-2, 页码 1-10

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DOI: 10.1016/S0378-5173(02)00036-4

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long-chain triglycerides; medium-chain triglycerides; emulsion; stability

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When mixed with parenteral nutrients as an all-in-one admixture, previous data have demonstrated that lipid emulsions composed of medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs) yield more stable formulations compared with those compounded with pure LCT lipid emulsions. We investigated the physical stability of various preparations of intravenous lipid emulsions as all-in-one admixtures. Each final lipid emulsion used to compound the all-in-one formulation was a 20%, w/v mixture containing MCTs and LCTs as either a single emulsion containing both triglycerides. or an emulsion made extemporaneously from separate starting emulsions of pure MCT and LCT. The first emulsion was composed of a 50:50 (by weight) physical mixture of MCTs and LCTs, and consisted of 50%, MCT:40% omega-6 LCT (soybean oil): 10% omega-3 LCT (fish oil) that was available as a single 20% w/v lipid emulsion. The second and third emulsions were specially prepared from separate stock dispersions containing pure 20% w/v MCT and pure 20%, w/v LCT (soybean oil) lipid emulsions. and were made in volume ratios of 75%, MCT:25%, omega-6 LCT and 50% MCT:50% omega-6 LCT, respectively. This was done in order to investigate whether the method of emulsion preparation and, or ratio of MCT to LCT influenced all-in-one admixture stability. Each all-in-one admixture was Studied at four intervals over 30 It at room temperature conditions by light extinction (or obscuration) using a single-particle optical sensing (LE/SPOS) technique. The data. performed in duplicate at each interval, is expressed as the volume-weighted percent of fat (PFAT) globules > 5 mum. The results confirm the stabilizing effects of MCTs when made as a physical oil mixture as a single lipid emulsion. However. stabilization is lost if the MCT and LCT emulsions are mixed from separate starting emulsions and then compounded as an all-in-one formulation. The extemporaneous mixing of commercial lipid emulsions is not recommended. (C) 2002 Elsevier Science B.V. All rights reserved.

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