Problems associated with the provision of micronutrients to parenteral nutrition patients

• Main Author: Said, Siti Norlina Md
• Published: Cardiff University 2006
• Subjects: 612.3
• Online Access: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.583870

Parenteral Nutrition PN provides nutrition to patients through the intravenous route, and is comprised of carbohydrates, fats, proteins, vitamins, trace elements, electrolytes and fluids. The vitamins are a major limiting factor in the shelf life determination of a PN formulation and are generally added just before administration. This thesis reports on some stability studies of a multivitamin infusion for the possible development of a minibag which may be stored before administration to PN patients. The physicochemical stability of the water-soluble vitamins contained in Solivito N Adult Injection Fresenius Kabi, the fat-soluble vitamins contained in Vitlipid N Adult Injection Fresenius Kabi and the combined admixture of the water-soluble and fat-soluble vitamins, prepared in 100 ml 0.9 sodium chloride in Freeflex Fresenius Kabi minibags was investigated. Physical tests include nephelometry, pH, dissolved oxygen, microscopy and particle size determination by laser diffraction, while the chemical tests used validated stability indicating reversed phase HPLC methods. The vitamins investigated were pyridoxine, nicotinamide, thiamine, folic acid, riboflavin sodium phosphate, Vitamin A and Vitamin E. The water-soluble vitamins and the fat-soluble vitamins were found to be stable, with more than 90 remaining, at 4 °C for 168 hours. For samples stored at 25 °C, they remained stable for 168 hours only if light-protected. During simulated clinical conditions, the water-soluble and fat-soluble vitamins, and the combined vitamin admixture were found to be stable for up to 30 days storage at 4 °C, and remained stable for a further 24 hours at 25 °C if light protected. The light protective effects of different coloured plastic covers to be used during delivery of the vitamin minibags were also investigated. The stability data showed promising results with the vitamins in the minibag remaining stable when assessed under simulated clinical conditions and these longer shelf-life vitamin minibags would benefit PN patients in the hospital and home settings.