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Stability of TPN solutions in a new double-bag
P.120
Since1992the pharmacy of the City hospitalin NUrnbeq (2.&X10 beds)has preparednearly60.01X1 total nutrientadnixtures (TN4 on 3-l bagsfor TFY. 4&50 bags are usedper day. Fillingis dcne in the pharmacy twicea wek. No severeccnplications duringapplication haveever seenth&s to perfectand rigwous asepticfillingtechniques. The proce&re is validated by fillinga definedshareof bagswith lhioglycolatand Caso-Bcuillcn. SNApwparedin stockand storedatt4"C - t8T. Both standardrqimens and special@@ns including fat are available. Stability and shelf-life of the fat ccntaining regimenswre determined mainlyby assessing fat dropletsize and distribution in the mixtureusinga Coulter CounterKC) and LightMicroscope 0-M).A special micr-oscopet&niqwwas develcpedinordertodetectsinglebigdroplets enrichedatthemixture'ssurface and not detectable with CC. lN4 I: 100 g AA, 400 g Glucose,100 g Fat in 3 1. lNA II: 1Wg AA, 403 g Glucose, 100 g Fat, 120 mm1 Nat, in 3 1, all preparedin bagsmade 80 ml Kt, 5 mm1 Ca+k. 12 ml PO&, 1,5 mm1 My-t, trace el ., vitariins of pure EVA-foil(EF)and/orbagsmade of a specialnrlti-layer-EVA-foil M_EF). Mixturelstoragetime 1 bag I EF, m after 5 weks II
LM
ICC
I assesm
shareof drcqlettl~: 91%46,5%few singledrc~s6-1Q.m carp& fewsingledrqx 6-4.m 1 ccnpat.
after6 days
EF, M_EF shareof drcpletcllnx97%
after15 days
EF
shareof drcpletclpn:97%+96% lot of biggerdrops6-1~rwn-q~.
after15 days
M_EF
shareof dropletO_m:9?%+96,5%few singledrops6-l@n
carp.
Thoughthe CC-analysis showedno alteration of the averagefat dropletdistribution, the Lkl-technique revealeda specificenrichnent of biggerdropsin lNA II in pure EVA-bagsafter15 days storagetime. Ccnclusions:Usingperfectfillingtechnique a big hospital may alsobe supplied totallywith TPNmixtures jj&&?iinhe pharmacy. For stability assessment of fat-containing mixturesthe specific rr.icrosccpic technique besidesCwlter Ccunteris recarmended.
P.121
STABILITY OF TPN SOLUTIONS IN A NEW DOUBLE-BAG. G.Hardy and C.Davies [Oxford Nutrition, P.O.Box 31, Oxford OX43UH.U.K.) Episodes of catheter blockage, especially in home patients, have been reported from centres using complex all-in-one TPN mixtures that have been stored under refrigeration prior to infusion. We have investigated the stability of solutions in a new double compartment bag proposed by Pennington and Richards [Mixieva 0029611 The 3 litre bags have a 2 litre compartment (Al into which was aseptically transferred 1 litre Synthamin 14 (85g aminoacids, Na 73mmol,K 60mmol. Mg 2.5mmo1, P30mmoll I,litre Glucose 50% [2000 kcall and 10 ml Trace element vial (Zn lOmg.Cu 4mg,Mn 'lmg Cr 40ug.Se 2OOugl. Into the second compartment (81 f litre Intralipid 20% [IO00 kcall was separately transferred. Sealed bags were refrigerated at 4-8'C. Stability parameters measured on three different bags, initially and after 15 days were: (Al Selected amino acids, glucose, pH, particulate matter at 2u and 5u. and colour. (61 Soya oil, free fatty acids, -pH, Particle size distribution[PSOlat 0.4 IOU. Both compartments were sterility tested at the end of the study and found to be sterile. In compartment A changes in amino acids and pH were less than 2%. Colour increased slightly. Particle counts decreased by approx. 10% and glucose losses averaged 4% which are acceptable. The Intralipid assays in compartment B were essentially unchanged.
This system therefore allows fat emulsion to be stored separately from the other solutions in a closed single container until ready for infusion via a Y-set. Mixing occurs just prior to entering the catheter which may help to prevent blockage and the patient has fewer manipulations to perform.
159
Since1992the pharmacy of the City hospitalin NUrnbeq (2.&X10 beds)has preparednearly60.01X1 total nutrientadnixtures (TN4 on 3-l bagsfor TFY. 4&50 bags are usedper day. Fillingis dcne in the pharmacy twicea wek. No severeccnplications duringapplication haveever seenth&s to perfectand rigwous asepticfillingtechniques. The proce&re is validated by fillinga definedshareof bagswith lhioglycolatand Caso-Bcuillcn. SNApwparedin stockand storedatt4"C - t8T. Both standardrqimens and special@@ns including fat are available. Stability and shelf-life of the fat ccntaining regimenswre determined mainlyby assessing fat dropletsize and distribution in the mixtureusinga Coulter CounterKC) and LightMicroscope 0-M).A special micr-oscopet&niqwwas develcpedinordertodetectsinglebigdroplets enrichedatthemixture'ssurface and not detectable with CC. lN4 I: 100 g AA, 400 g Glucose,100 g Fat in 3 1. lNA II: 1Wg AA, 403 g Glucose, 100 g Fat, 120 mm1 Nat, in 3 1, all preparedin bagsmade 80 ml Kt, 5 mm1 Ca+k. 12 ml PO&, 1,5 mm1 My-t, trace el ., vitariins of pure EVA-foil(EF)and/orbagsmade of a specialnrlti-layer-EVA-foil M_EF). Mixturelstoragetime 1 bag I EF, m after 5 weks II
LM
ICC
I assesm
shareof drcqlettl~: 91%46,5%few singledrc~s6-1Q.m carp& fewsingledrqx 6-4.m 1 ccnpat.
after6 days
EF, M_EF shareof drcpletcllnx97%
after15 days
EF
shareof drcpletclpn:97%+96% lot of biggerdrops6-1~rwn-q~.
after15 days
M_EF
shareof dropletO_m:9?%+96,5%few singledrops6-l@n
carp.
Thoughthe CC-analysis showedno alteration of the averagefat dropletdistribution, the Lkl-technique revealeda specificenrichnent of biggerdropsin lNA II in pure EVA-bagsafter15 days storagetime. Ccnclusions:Usingperfectfillingtechnique a big hospital may alsobe supplied totallywith TPNmixtures jj&&?iinhe pharmacy. For stability assessment of fat-containing mixturesthe specific rr.icrosccpic technique besidesCwlter Ccunteris recarmended.
P.121
STABILITY OF TPN SOLUTIONS IN A NEW DOUBLE-BAG. G.Hardy and C.Davies [Oxford Nutrition, P.O.Box 31, Oxford OX43UH.U.K.) Episodes of catheter blockage, especially in home patients, have been reported from centres using complex all-in-one TPN mixtures that have been stored under refrigeration prior to infusion. We have investigated the stability of solutions in a new double compartment bag proposed by Pennington and Richards [Mixieva 0029611 The 3 litre bags have a 2 litre compartment (Al into which was aseptically transferred 1 litre Synthamin 14 (85g aminoacids, Na 73mmol,K 60mmol. Mg 2.5mmo1, P30mmoll I,litre Glucose 50% [2000 kcall and 10 ml Trace element vial (Zn lOmg.Cu 4mg,Mn 'lmg Cr 40ug.Se 2OOugl. Into the second compartment (81 f litre Intralipid 20% [IO00 kcall was separately transferred. Sealed bags were refrigerated at 4-8'C. Stability parameters measured on three different bags, initially and after 15 days were: (Al Selected amino acids, glucose, pH, particulate matter at 2u and 5u. and colour. (61 Soya oil, free fatty acids, -pH, Particle size distribution[PSOlat 0.4 IOU. Both compartments were sterility tested at the end of the study and found to be sterile. In compartment A changes in amino acids and pH were less than 2%. Colour increased slightly. Particle counts decreased by approx. 10% and glucose losses averaged 4% which are acceptable. The Intralipid assays in compartment B were essentially unchanged.
This system therefore allows fat emulsion to be stored separately from the other solutions in a closed single container until ready for infusion via a Y-set. Mixing occurs just prior to entering the catheter which may help to prevent blockage and the patient has fewer manipulations to perform.
159