Stability of carnitine in pédiatrie TPN and TNA formulations

M. C. Storm, B. Wang, Richard Helms

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Carnitine is required for transport of long chain fatty acids into the mitochondria for oxidation and energy production and is a conditionally essential nutrient in the pédiatrie patient who requires TPN. Our previous clinical results suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNs and TNAs has not been adequately addressed. Carnitine was added to pédiatrie TPN and TNA formulations at 130 or 200 mg/L and units were studied on day "zero" or stored at 4-5°C for 1, 7, 15, or 30 days. Units (including day "zero") were then maintained at room temperature (RT)- and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic technique that is stability indicating. Units were also monitored for pH change, color change, or observable precipitation. Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different formulations was 93.9 ± 5.31 % (mean ±SD of theoretical, range of 87.8-101%). The results for all periods of storage at 4-5°C were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ±7.30 % of theoretical (range of 81.0-102 %). Neither cysteine nor ranitidine appeared to influence the stability of carnitine. A simulateo infusion including Y-site addition of 20 % fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron filter, and after mixing with fat emulsion. Recovery of carnitine was 86.1 to 109 % of theoretical across all sampling sites and time points. Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or filter absorption.

Original languageEnglish (US)
JournalJournal of Parenteral and Enteral Nutrition
Volume22
Issue number1
StatePublished - 1998

Fingerprint

Carnitine
carnitine
Emulsions
emulsions
bags
ambient temperature
Color
Fats
Recovery Room
Temperature
Ranitidine
color
long chain fatty acids
lipids
Lighting
Cysteine
cysteine
lighting
storage time
Mitochondria

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Food Science

Cite this

Stability of carnitine in pédiatrie TPN and TNA formulations. / Storm, M. C.; Wang, B.; Helms, Richard.

In: Journal of Parenteral and Enteral Nutrition, Vol. 22, No. 1, 1998.

Research output: Contribution to journalArticle

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abstract = "Carnitine is required for transport of long chain fatty acids into the mitochondria for oxidation and energy production and is a conditionally essential nutrient in the p{\'e}diatrie patient who requires TPN. Our previous clinical results suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNs and TNAs has not been adequately addressed. Carnitine was added to p{\'e}diatrie TPN and TNA formulations at 130 or 200 mg/L and units were studied on day {"}zero{"} or stored at 4-5°C for 1, 7, 15, or 30 days. Units (including day {"}zero{"}) were then maintained at room temperature (RT)- and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic technique that is stability indicating. Units were also monitored for pH change, color change, or observable precipitation. Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different formulations was 93.9 ± 5.31 {\%} (mean ±SD of theoretical, range of 87.8-101{\%}). The results for all periods of storage at 4-5°C were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ±7.30 {\%} of theoretical (range of 81.0-102 {\%}). Neither cysteine nor ranitidine appeared to influence the stability of carnitine. A simulateo infusion including Y-site addition of 20 {\%} fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron filter, and after mixing with fat emulsion. Recovery of carnitine was 86.1 to 109 {\%} of theoretical across all sampling sites and time points. Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or filter absorption.",
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N2 - Carnitine is required for transport of long chain fatty acids into the mitochondria for oxidation and energy production and is a conditionally essential nutrient in the pédiatrie patient who requires TPN. Our previous clinical results suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNs and TNAs has not been adequately addressed. Carnitine was added to pédiatrie TPN and TNA formulations at 130 or 200 mg/L and units were studied on day "zero" or stored at 4-5°C for 1, 7, 15, or 30 days. Units (including day "zero") were then maintained at room temperature (RT)- and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic technique that is stability indicating. Units were also monitored for pH change, color change, or observable precipitation. Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different formulations was 93.9 ± 5.31 % (mean ±SD of theoretical, range of 87.8-101%). The results for all periods of storage at 4-5°C were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ±7.30 % of theoretical (range of 81.0-102 %). Neither cysteine nor ranitidine appeared to influence the stability of carnitine. A simulateo infusion including Y-site addition of 20 % fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron filter, and after mixing with fat emulsion. Recovery of carnitine was 86.1 to 109 % of theoretical across all sampling sites and time points. Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or filter absorption.

AB - Carnitine is required for transport of long chain fatty acids into the mitochondria for oxidation and energy production and is a conditionally essential nutrient in the pédiatrie patient who requires TPN. Our previous clinical results suggest a dally carnitine dosage of 20 mg/kg. However, the stability of carnitine in TPNs and TNAs has not been adequately addressed. Carnitine was added to pédiatrie TPN and TNA formulations at 130 or 200 mg/L and units were studied on day "zero" or stored at 4-5°C for 1, 7, 15, or 30 days. Units (including day "zero") were then maintained at room temperature (RT)- and exposed to constant fluorescent illumination. Units were sampled at 0, 6, 12, 18, and 24 hours. Carnitine concentrations were measured in duplicate by a C-14 radioenzymatic technique that is stability indicating. Units were also monitored for pH change, color change, or observable precipitation. Our results showed no change in pH, no change in color, and no visual precipitation in any of the units, even those stored for 30 days. Zero time recovery of carnitine in six different formulations was 93.9 ± 5.31 % (mean ±SD of theoretical, range of 87.8-101%). The results for all periods of storage at 4-5°C were similar. At 30 days of storage followed by 24 hours at RT, the recovery of carnitine was 93.3 ±7.30 % of theoretical (range of 81.0-102 %). Neither cysteine nor ranitidine appeared to influence the stability of carnitine. A simulateo infusion including Y-site addition of 20 % fat emulsion was also performed. Over the course of a 24 hour infusion, samples were obtained at the bag, distal to the in-line 0.22 micron filter, and after mixing with fat emulsion. Recovery of carnitine was 86.1 to 109 % of theoretical across all sampling sites and time points. Based on this data, we conclude that carnitine is highly stable in TPN and TNA formulations and that no clinically significant loss of carnitine occurs through bag, tubing, or filter absorption.

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