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Stability of aqueous cysteine solutions for TPN
P.83 Stability of aqueous for TPN G. HardyandA.Alif?aja
cysteine
P.84 Aminophylline availability form the complete parenteral nutrition system - aminox + lipovenoes. A. Niestepska, M. Ciszewsk, A. Knyt, M. Pertkiewicz
solutions
Oxford Nutrition PO Box 37 OX4 3UH U.K.
Dept. of Applied Pharmacy and Clinic of Gastroenterological Surgery, Warsaw, Poland
L-Cysteine (CYS) has been considered a non-essential amino acid, but when cystathionase activity is decreased, as in premature infants or surgical stress, it may become essential. Unfortunately, CYS is susceptible to oxidation in solution, especially when heated in the presence of trace elements, and has not therefore been incorporated into currently available amino acid solutions for TPN. We have investigated the stability of sterile CYS solutions stored in oxygen-impermeable Ultrastab bags (Miramed Italy) for 30 days at refrigerated temperature. Two solutions containing (A) 0.1 mmol/ml (paediatric) and (6) 0.7 mmol/ml (adult) CYS (as the hydrochloride) were prepared in oxygen-free water then transferred aseptically in triplicate into sterile 100 ml bags and stored at 4 C. Samples were taken immediately, then at 14 d and 30 d, treated with acid ninhydrin reagent and analysed spectrophotometrically for CYS. Colour, particulate matter and pH were also measured. No visible colour changes were observed, pH remained essentially constant (181.9) and particle counts at 2 urn and 5 urn remained within the pharmacopoeia1 limits for intravenous solutions. CYS content decreased by 3.2% (A) and 4.4% (B) after 14 d, then 3.8% (A) and 4.9% (B) after 30 cf. Thus more than 95% of added CYS remained available after one month storage The results indicate that CYS solutions prepared and stored in an oxygen-free environment could be manufactured aseptically in the hospital pharmacy for addition to paediatric or adult TPN mixtures This should further increase the potential for preparing “tailormade” regimens for clinical use.
Aminophylline is often added into Al0 nutrients admixtures. Aminomix is a new convenient TPN system. According to manufacturers, aminophylline is compatible with Aminomix (amino acids+glucose) 6 hours only, but compatibility and availability from Aminomix+Lipovenoes complete mixture has not been studied so far. Amino acids and glucose with electrolytes were mixed by breaking seal between the two chambers of Aminomix 1 1000 ml (amino acids 50 g, glucose 200 g) or 1500 ml (amino acids 75 g, glucose 300 g) bag and Lipovenoes 20% 250 ml was added using Freka Lipoflow system. Aminophylline 0.5 g or 0.75 g was added into 1250 or 1750 ml complete mixture via the injection port. pH, osmolarity, particle size distribution using Coulter ZM and theophylline concentration were measured immediately after preparation and every 6 hours during 24 hours long simulated infusion. Aminophylline was counted from theophylline concentration PSD > 6 urn = 0.
Aminophylline Aminophylline. PSD < 2.5 urn Aminophylline PSD < 2.5 urn Aminophylline Ammophylline. PSD < 2.5 urn Amlnophylline. PSD < 2 5 urn
O/l 0 99 0 99 O/l
.25 83% 76% .75
0 h 24 h
z9.7296 0 99 73%
?fGZ5 99.83% 100% 99.74%
ZY .25 99.79% 100% 99.66%
TOt75 99.76% 100% 99.78%
YzY.75 99.80% 100% 99 12%
Aminophylline in presented concentration available from Aminomix 1 +Lipovenoes impact on the emulsion
Topic 19-RESEARCH
is stable and 100% without negative
METHODS
signal was temperature dependent: at 40” only unsaturated fatty acids were mobile, at 80” all lipids. The same dry sample was then reconstituted and measured by (VK). Results: There was a strong relation between NMR data obtained at 80X, expressed as g of proton originating from lipids, and VK data (NMR BOX= 0.119 VK+0.18 n =88. r = 0.96). There was‘ a significant difference by ANOVA between nutrition groups when results were expressed as the ratio R of NMR 40”/NMR 80” (OPN =0.62_fO.26, ON =0.53_+0.23, CTL 0.38kO.24). The diagram of the lipidic concentration (LC) per g of dry weight as a function of the ratio R allowed a differentiation of some groups of pathologies: Control patients had low LC ( -c.03) and low R (< .5). Short bowel had high values of LC and R, Coeliac disease high LC and low R, Crohn and radiation enteropathy patients had scattered data. Conclusion: NMR seems to be a powerful tool to measure total fecal lipids; it may provide further information on saturated vs unsaturated fecal fat in malabsorption syndromes.
Proton NMR of analysis of fecal lipids in P.85 gastroenterological patients (GE). F. Thuillier. M. Eugtine’, L. Le Moyec’. R. Modigiiani”. J. C. Rambaud, B. Messing INSERM lJ290. St-Lazare Hospital. and St-Louis’ Paris, France
0 h 24 h
hospital,
Measurement of fecal lipids by the reference method (Van de Kamer (VK)) is tedious and not informative on the composition of fatty acids (saturated, unsaturated). The aim of this study was to compare the efficiency of NMR vs VK to assess quantitatively and qualitatively the fecal lipids. This study was performed in controls (CTL n = 19) and in 69 GE patients presenting various malabsorption syndromes. Patients received either oral nutrition (ON n = 21) or oral and parenteral nutrition (OPN n =48). 72 h stools were homogenized and lyophilized. After irradiation, the relaxation of the dry sample was analyzed by NMR with a Minispec PC20 BRUKER at 20 MHz at 40” and 80”. The value used was the long time (T2L) specific to lipids. The amplitude of 61
cysteine
P.84 Aminophylline availability form the complete parenteral nutrition system - aminox + lipovenoes. A. Niestepska, M. Ciszewsk, A. Knyt, M. Pertkiewicz
solutions
Oxford Nutrition PO Box 37 OX4 3UH U.K.
Dept. of Applied Pharmacy and Clinic of Gastroenterological Surgery, Warsaw, Poland
L-Cysteine (CYS) has been considered a non-essential amino acid, but when cystathionase activity is decreased, as in premature infants or surgical stress, it may become essential. Unfortunately, CYS is susceptible to oxidation in solution, especially when heated in the presence of trace elements, and has not therefore been incorporated into currently available amino acid solutions for TPN. We have investigated the stability of sterile CYS solutions stored in oxygen-impermeable Ultrastab bags (Miramed Italy) for 30 days at refrigerated temperature. Two solutions containing (A) 0.1 mmol/ml (paediatric) and (6) 0.7 mmol/ml (adult) CYS (as the hydrochloride) were prepared in oxygen-free water then transferred aseptically in triplicate into sterile 100 ml bags and stored at 4 C. Samples were taken immediately, then at 14 d and 30 d, treated with acid ninhydrin reagent and analysed spectrophotometrically for CYS. Colour, particulate matter and pH were also measured. No visible colour changes were observed, pH remained essentially constant (181.9) and particle counts at 2 urn and 5 urn remained within the pharmacopoeia1 limits for intravenous solutions. CYS content decreased by 3.2% (A) and 4.4% (B) after 14 d, then 3.8% (A) and 4.9% (B) after 30 cf. Thus more than 95% of added CYS remained available after one month storage The results indicate that CYS solutions prepared and stored in an oxygen-free environment could be manufactured aseptically in the hospital pharmacy for addition to paediatric or adult TPN mixtures This should further increase the potential for preparing “tailormade” regimens for clinical use.
Aminophylline is often added into Al0 nutrients admixtures. Aminomix is a new convenient TPN system. According to manufacturers, aminophylline is compatible with Aminomix (amino acids+glucose) 6 hours only, but compatibility and availability from Aminomix+Lipovenoes complete mixture has not been studied so far. Amino acids and glucose with electrolytes were mixed by breaking seal between the two chambers of Aminomix 1 1000 ml (amino acids 50 g, glucose 200 g) or 1500 ml (amino acids 75 g, glucose 300 g) bag and Lipovenoes 20% 250 ml was added using Freka Lipoflow system. Aminophylline 0.5 g or 0.75 g was added into 1250 or 1750 ml complete mixture via the injection port. pH, osmolarity, particle size distribution using Coulter ZM and theophylline concentration were measured immediately after preparation and every 6 hours during 24 hours long simulated infusion. Aminophylline was counted from theophylline concentration PSD > 6 urn = 0.
Aminophylline Aminophylline. PSD < 2.5 urn Aminophylline PSD < 2.5 urn Aminophylline Ammophylline. PSD < 2.5 urn Amlnophylline. PSD < 2 5 urn
O/l 0 99 0 99 O/l
.25 83% 76% .75
0 h 24 h
z9.7296 0 99 73%
?fGZ5 99.83% 100% 99.74%
ZY .25 99.79% 100% 99.66%
TOt75 99.76% 100% 99.78%
YzY.75 99.80% 100% 99 12%
Aminophylline in presented concentration available from Aminomix 1 +Lipovenoes impact on the emulsion
Topic 19-RESEARCH
is stable and 100% without negative
METHODS
signal was temperature dependent: at 40” only unsaturated fatty acids were mobile, at 80” all lipids. The same dry sample was then reconstituted and measured by (VK). Results: There was a strong relation between NMR data obtained at 80X, expressed as g of proton originating from lipids, and VK data (NMR BOX= 0.119 VK+0.18 n =88. r = 0.96). There was‘ a significant difference by ANOVA between nutrition groups when results were expressed as the ratio R of NMR 40”/NMR 80” (OPN =0.62_fO.26, ON =0.53_+0.23, CTL 0.38kO.24). The diagram of the lipidic concentration (LC) per g of dry weight as a function of the ratio R allowed a differentiation of some groups of pathologies: Control patients had low LC ( -c.03) and low R (< .5). Short bowel had high values of LC and R, Coeliac disease high LC and low R, Crohn and radiation enteropathy patients had scattered data. Conclusion: NMR seems to be a powerful tool to measure total fecal lipids; it may provide further information on saturated vs unsaturated fecal fat in malabsorption syndromes.
Proton NMR of analysis of fecal lipids in P.85 gastroenterological patients (GE). F. Thuillier. M. Eugtine’, L. Le Moyec’. R. Modigiiani”. J. C. Rambaud, B. Messing INSERM lJ290. St-Lazare Hospital. and St-Louis’ Paris, France
0 h 24 h
hospital,
Measurement of fecal lipids by the reference method (Van de Kamer (VK)) is tedious and not informative on the composition of fatty acids (saturated, unsaturated). The aim of this study was to compare the efficiency of NMR vs VK to assess quantitatively and qualitatively the fecal lipids. This study was performed in controls (CTL n = 19) and in 69 GE patients presenting various malabsorption syndromes. Patients received either oral nutrition (ON n = 21) or oral and parenteral nutrition (OPN n =48). 72 h stools were homogenized and lyophilized. After irradiation, the relaxation of the dry sample was analyzed by NMR with a Minispec PC20 BRUKER at 20 MHz at 40” and 80”. The value used was the long time (T2L) specific to lipids. The amplitude of 61