Stability of micronutrients in PN what is known and what can be claimed? Prof. Mike.Allwood Pharmacy Consultant
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1 Stability of micronutrients in PN what is known and what can be claimed? Prof. Mike.Allwood Pharmacy Consultant
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3 Pharmaceutical interactions 1. Physical incompatibility = precipitation Caused by: Certain trace elements forming Insoluble salts to form sub-visible particles 2. Chemical instability = loss of activity Caused by chemical degradation of particular vitamins
4 Micro-precipitate detection Electron-dispersal X ray analysis linked to Electron-microscopy (EDX-SEM) Method - Analyse the filter surface after filtration of entire PN mixture Advantages: 1.Identifies each element present in precipitate 2.High sensitivity Allwood,M.C.&Greenwood,M(1992)Pharm.Weekblad:14;321-5
5 Scanning Electron Microscope (SEM) with X Ray Energy - Dispersive Spectroscope (EDX)
6 Sample Preparation In L F Cabinet 1. Filter entire content 0.45 mm Filter
7 SEM -EDX Preparation Sample Filter 0.5 cm square Gold Coat Carbon Coat SEM EDX
8 EDX Analysis Spectrometer X rays For Elemental Identification (A.W > 12)
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10 Compatibility of Trace elements Some micro-precipitates can be formed during storage in complete PN mixtures: Iron phosphate with Synthamin Avoid by using: a. Adding ascorbic acid ( or multivitamins) b. Use EF and organic phosphate Allwood et al. (1998) Clin.Nutrit.17:223-6
11 Copper sulphide Copper sulphide from hydrogen sulphide a degradation product of cysteine/cystine, as found in eg.vamin - limits shelf lives to 8 days ( Vamin 9) or 16 days ( Vamin 14;18)
12 selenium Selenate reduction to selenium ( insoluble) caused by low ph + high concentrations of ascorbic acid ( not a risk in practice) In practice, rarely observed Ganther,H.E.(1990).JPEN:14;223
13 Chemical stability of PN mixtures Stable constituents ( ie. Less than 10% degradation within nlt 28 days): Amino acids ( exception- cysteine/cystine?) Glucose Fat Electrolytes and trace elements Most vitamins
14 Vitamins - chemical stability Critical concern -. Chemical degradation during storage- Oxidation of ascorbic acid
15 Vitamin C degradation Pathway Ascorbic Acid O 2 Dehydro-ascorbic Acid H 2 O Diketo-Gulonic acid Oxalic Acid
16 Degradation of ascorbic acid Ascorbic acid degrades by oxidation = * Direct reaction with oxygen * Reaction catalysed by copper Degradation products: Stage 1: +oxygen fast reaction Dehydroascorbic acid ( biologically active) Stage 2: -hydrolysis- moderately fast reaction Diketo-gulonic acid ( biologically inactive) Stage 3:-further hydrolysis slower reaction Oxalic acid
17 Degradation after mixing How much ascorbic acid degrades in PN? Total amount lost depends on oxygen load from: Oxygen in ingredients ( glucose, saline,,electrolytes) Aeration of solutions during filling process Air in bag after sealing oxygen transmission across bag walls How quickly does ascorbic acid degrade?
18 % Ascorbic Acid remaining Degradation of Ascorbic Acid in EVA bags Storage period (days)
19 Multi-chambered bags Are they a barrier to gas ( air) entry into chambers before and after mixing? *Greater barrier than PVC or EVA. *Poorer barrier than multi-layered bags Gas entry from atmosphere prevented by gas-impermeable overwrap- until broken! Each chamber / solution in un-opened bag is oxygen-free.
20 Multi-chambered bags shelf lives after removing outer wrap Nutriflex + additional electrolytes, vitamins and trace elements Shelf life depends on vitamin source: Cernavit 7 C+ 1 day at RT Solivito N 6 C+1 day at RT Unaffected by : Bag volume ( ml regimens) PN formulation ( Lipid Peri; Lipid Plus etc.)
21 Estimating ascorbic acid losses Oxygen load 1litre glucose or saline leads to 50 mg ascorbic acid loss Air in bag 10 ml air leads to loss of 20 mg ascorbic acid EVA bag transmission rate leads to loss of 10 mg ascorbic acid /day Multilayered bag no losses by transmission. Allwood M.C. & Kearney,M.)1998).. Nutrition;14:687.
22 % Ascorbic Acid remaining Degradation of Ascorbic Acid in Synthamin containing PN mixture in multi-layer bag (cernevit ) Days storage Total Ascorbic Acid Dehydro Ascorbic Acid Ascorbic Acid Allwood,M.C.(1984).J.Clin.Hosp.Pharm:9;75
23 Ensuring ascorbic acid requirements Use multi-layered ( gas-impermeable) bags Remove all air before sealing Top-up with ascorbic acid injection for larger volume PN mixtures ( over litres) Shelf lives for complete PN mixtures including micro-nutrients ( in M/L bags) recommend 21 days
24 Can I add extra micro-nutrients? Trace elements Based on pharmaceutical considerations - Recommend double normal* quantities can be added : Selenium as Na selenite approx.0.8umol Zinc as Zn sulphate approx. 100 umol Iron as Fe chloride 20 umol * ie. based on Additrace or Decan
25 Vitamins Micronutrients contd. 1. Using multi-vitamin products ( Cernavit, solivito N, Vitlipid ) no constraints. But Vitlipid only to all-in-one mixture! 2. Using separate vitamin sources Folic acid 15 mg Biotin yes Ascorbic acid 200 mg
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