Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions

Marianne Lilletvedt Tovsen; Gro Smistad; Trude Marie Bjerke; Hanne Hjorth Tønnesen; Solveig Kristensen

doi:10.5731/pdajpst.2015.01036

References

1.↵
1. Tønnesen H. H.
1. Kristensen S.
Photostability of Parenteral Products. In Photostability of Drugs and Drug Formulations, 2nd ed.; Tønnesen H. H. Ed.; CRC Press: Boca Raton, FL, 2004; pp 303–332.
2.↵
1. Williams M. F.,
2. Hak L. J.,
3. Dukes G.
In vitro evaluation of the stability of ranitidine hydrochloride in total parenteral nutrient mixtures. Am. J. Health-Syst. Pharm. 1990, 47 (7), 1574–1579
OpenUrl Abstract
3.↵
1. Winfield A. J.,
2. Richards R. M. E.
1. Hutchinson S. L.
Hospital at Home: The Alternative Care Setting. In Pharmaceutical Practice, 2nd ed., Winfield A. J., Richards R. M. E. Eds.; Churchill Livingstone: London, 1998; pp 274–288.
4.↵
1. Trissel L. A.
Handbook on Injectable Drugs; American Society of Health-System Pharmacists: Bethesda, MD, 2001; pp 1373–1386.
5.↵
1. Smith J. L.,
2. Canham J. E.,
3. Wells P. A.
Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J. Parenter. Enteral. Nutr. 1988, 12 (4), 394–402.
OpenUrl Abstract/FREE Full Text
6.↵
1. Billion-Rey F.,
2. Guillaumont M.,
3. Frederich A.,
4. Aulagner G.
Stability of fat-soluble vitaminsA (retinol palmitate), E (tocopherol acetate), and K1 (phylloquinone) in total parenteral nutrition at home. J. Parenter. Enteral. Nutr. 1993, 17 (1), 56–60.
OpenUrl Abstract/FREE Full Text
7.↵
1. Ribeiro D. O.,
2. Pinto D. C.,
3. Lima L. M.,
4. Volpato N. M.,
5. Cabral L. M.,
6. de Sousa V. P.
Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use. Nutr. J. 2011, 10 (47), 1–9.
OpenUrl CrossRef PubMed
8.↵
1. Lobo B. W.,
2. da Veiga V. F.,
3. Cabral L. M.,
4. Michel R. C.,
5. Volpato N. M.,
6. de Sousa V. P.
Influence of the relative composition of trace elements and vitamins in physicochemical stability of total parenteral nutrition formulations for neonatal use. Nutr. J. 2012 11 (26), 1–12.
OpenUrl CrossRef PubMed
9.↵
1. Reed R. A.,
2. Harmon P.,
3. Manas D.,
4. Wasylaschuk W.,
5. Galli C.,
6. Biddell R.,
7. Bergquist P. A.,
8. Hunke W.,
9. Templeton A. C.,
10. Ip D.
The role of excipients and package components in the photostability of liquid formulations. PDA J. Pharm. Sci. Technol. 2003, 57 (5), 351–368.
OpenUrl Abstract/FREE Full Text
10.↵
1. Halliwell B.,
2. Gutteridge J. M. C.
Free Radicals in Biology and Medicine; Clarendon Press: Oxford, 1985; pp 15–18.
11.↵
1. Silva E.,
2. Gonzalez T.,
3. Edwards A. M.,
4. Zuloaga E.
Visible light induced lipoperoxidation of a parenteral nutrition fat emulsion sensitized by flavins. J. Nutr. Biochem. 1998, 9 (3), 149–154.
OpenUrl
12.↵
1. Allwood M. C.,
2. Martin H. J.
The photodegradation of vitamins A and E in parenteral nutrition mixtures during infusion. Clin. Nutr. 2000, 19 (5), 339–342.
OpenUrl CrossRef PubMed Web of Science
13.↵
1. Ulbricht R. J.,
2. Northup S. J.,
3. Thomas J. A.
A review of 5-hydroxymethylfurfural (HMF) in parenteral solutions. Fundam. Appl. Toxicol. 1984, 4 (5), 843–853.
OpenUrl CrossRef PubMed Web of Science
14.↵
1. Brustugun J.,
2. Tønnesen H. H.,
3. Edge R.,
4. Navaratnam S.
Formation and reactivity of free radicals in 5-(hydroxymethyl)-2-furaldehyde. J. Photochem. Photobiol., B 2005, 79 (2), 109–119.
OpenUrl PubMed
15.↵
1. Brustugun J.,
2. Kristensen S.,
3. Tønnesen H. H.
Photosensitizing effect of 5-hydroxymethyl-2-furaldehyde in glucose infusion solutions. Pharmeuropa 2005, 17, 460–461.
16.↵
British Pharmacopoeia. Glucose Infusion. In British Pharmacopoeia; 2014.
17.↵
ICH Q1B. Guidelines for the photostability testing of new drug substances and products. Federal Register 1997, 62, 27115–27122.
OpenUrl
18.↵
Atlas. Suntest CPS/Suntest CPS+−. A comment on photostability testing according to ICH, Atlas material testing solutions, 1996.
19.↵
1. Wolf A. V.,
2. Brown M. G.,
3. Prentiss P. G.
CRC Handbook of Chemistry and Physics, 55th ed.; CRC Press: Boca Raton, FL, 1974; pp D-239, D-261.
20.↵
1. Gutteridge J. M.,
2. Quinlan G. J.
Malondialdehyde formation from lipid peroxides in thiobarbituric acid test: the role of lipid radicals, iron salts, and metal chelators. J. Appl. Biochem. 1983, 5 (4-5), 293–299.
OpenUrl PubMed
21.↵
1. Baertschi S. W.,
2. Alsante K. M.,
3. Tønnesen H. H.
A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): recommendation for revision. J. Pharm. Sci. 2010, 99 (7), 2934–2940.
OpenUrl PubMed
22.↵
1. Tønnesen H. H.
1. Anderson N. H.,
2. Byard S. J.
Photostability Testing: Design and Interpretation of Tests on New Drug Substances and Dosage Forms. In: Photostability of Drugs and Drug Formulations, 2nd ed.; Tønnesen H. H., Ed.; CRC Press: Boca Raton, FL, 2004; pp 137–159.
23.↵
1. Baertschi S. W.,
2. Clapham D.,
3. Foti C.,
4. Jansen P. J.,
5. Kristensen S.,
6. Reed R. A.,
7. Templeton A. C.,
8. Tønnesen H. H.
Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products. Part 1: Drug products administered by injection. J. Pharm. Sci. 2013, 102 (11), 3888–3899.
OpenUrl PubMed
24.↵
1. Greenwald R. A.
1. Aust S. D.
Lipid Peroxidation. In CRC Handbook of Methods for Oxygen Radical Research; Greenwald R. A. Ed.; CRC Press: Boca Raton, FL, 1986; pp 203–205.
25.↵
1. Dupont I. E.
Peroxidation of lipid emulsions: effects of changes in fatty acid pattern and alpha-tocopherol content on the sensitivity to peroxidative damage. Clin. Nutr. 1999, 18 (2), 113–116.
OpenUrl CrossRef PubMed Web of Science
26.↵
Norwegian Medicines Agency (accessed August 27, 2014); http://www.legemiddelverket.no.
27.↵
1. Sheskey P. J.,
2. Cook W. G.,
3. Cable C. G.
Handbook of Pharmaceutical Excipients Online, from Medicines Complete 2014 (accessed September 3, 2014): https://www.medicinescomplete.com/mc/excipients/current/1001942595.htm?q=olive%20oil&t=search&ss=text&p=1#_hit.
28.↵
1. Steger P. J. K.,
2. Muhlebach S. F.
In vitro oxidation of IV lipid emulsions in different all-in-one admixture bags assessed by an iodometric assay and gas-liquid chromatography. Nutrition 1997, 13 (2), 133–140.
OpenUrl CrossRef PubMed Web of Science
29.↵
1. Gutteridge J. M.,
2. Halliwell B.
The measurement and mechanism of lipid peroxidation in biological systems. Trends Biochem. Sci. 1990, 15 (4), 129–135.
OpenUrl CrossRef PubMed Web of Science
30.↵
1. Sue-Chu M.,
2. Kristensen S.,
3. Tønnesen H. H.
Photoinduced color changes in two different qualities of riboflavin in the solid state and in various tablet formulations. Photoreactivity of biologically active compounds. XX. Pharmazie 2009, 64 (7), 428–435.
OpenUrl PubMed

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Keywords

[1] 1.↵
Tønnesen H. H.
Kristensen S.
Photostability of Parenteral Products. In Photostability of Drugs and Drug Formulations, 2nd ed.; Tønnesen H. H. Ed.; CRC Press: Boca Raton, FL, 2004; pp 303–332.

[2] Tønnesen H. H.

[3] Kristensen S.

[4] 2.↵
Williams M. F.,
Hak L. J.,
Dukes G.
In vitro evaluation of the stability of ranitidine hydrochloride in total parenteral nutrient mixtures. Am. J. Health-Syst. Pharm. 1990, 47 (7), 1574–1579
OpenUrl Abstract

[5] Williams M. F.,

[6] Hak L. J.,

[7] Dukes G.

[8] 3.↵
Winfield A. J.,
Richards R. M. E.
Hutchinson S. L.
Hospital at Home: The Alternative Care Setting. In Pharmaceutical Practice, 2nd ed., Winfield A. J., Richards R. M. E. Eds.; Churchill Livingstone: London, 1998; pp 274–288.

[9] Winfield A. J.,

[10] Richards R. M. E.

[11] Hutchinson S. L.

[12] 4.↵
Trissel L. A.
Handbook on Injectable Drugs; American Society of Health-System Pharmacists: Bethesda, MD, 2001; pp 1373–1386.

[13] Trissel L. A.

[14] 5.↵
Smith J. L.,
Canham J. E.,
Wells P. A.
Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J. Parenter. Enteral. Nutr. 1988, 12 (4), 394–402.
OpenUrl Abstract/FREE Full Text

[15] Smith J. L.,

[16] Canham J. E.,

[17] Wells P. A.

[18] 6.↵
Billion-Rey F.,
Guillaumont M.,
Frederich A.,
Aulagner G.
Stability of fat-soluble vitaminsA (retinol palmitate), E (tocopherol acetate), and K1 (phylloquinone) in total parenteral nutrition at home. J. Parenter. Enteral. Nutr. 1993, 17 (1), 56–60.
OpenUrl Abstract/FREE Full Text

[19] Billion-Rey F.,

[20] Guillaumont M.,

[21] Frederich A.,

[22] Aulagner G.

[23] 7.↵
Ribeiro D. O.,
Pinto D. C.,
Lima L. M.,
Volpato N. M.,
Cabral L. M.,
de Sousa V. P.
Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use. Nutr. J. 2011, 10 (47), 1–9.
OpenUrl CrossRef PubMed

[24] Ribeiro D. O.,

[25] Pinto D. C.,

[26] Lima L. M.,

[27] Volpato N. M.,

[28] Cabral L. M.,

[29] de Sousa V. P.

[30] 8.↵
Lobo B. W.,
da Veiga V. F.,
Cabral L. M.,
Michel R. C.,
Volpato N. M.,
de Sousa V. P.
Influence of the relative composition of trace elements and vitamins in physicochemical stability of total parenteral nutrition formulations for neonatal use. Nutr. J. 2012 11 (26), 1–12.
OpenUrl CrossRef PubMed

[31] Lobo B. W.,

[32] da Veiga V. F.,

[33] Cabral L. M.,

[34] Michel R. C.,

[35] Volpato N. M.,

[36] de Sousa V. P.

[37] 9.↵
Reed R. A.,
Harmon P.,
Manas D.,
Wasylaschuk W.,
Galli C.,
Biddell R.,
Bergquist P. A.,
Hunke W.,
Templeton A. C.,
Ip D.
The role of excipients and package components in the photostability of liquid formulations. PDA J. Pharm. Sci. Technol. 2003, 57 (5), 351–368.
OpenUrl Abstract/FREE Full Text

[38] Reed R. A.,

[39] Harmon P.,

[40] Manas D.,

[41] Wasylaschuk W.,

[42] Galli C.,

[43] Biddell R.,

[44] Bergquist P. A.,

[45] Hunke W.,

[46] Templeton A. C.,

[47] Ip D.

[48] 10.↵
Halliwell B.,
Gutteridge J. M. C.
Free Radicals in Biology and Medicine; Clarendon Press: Oxford, 1985; pp 15–18.

[49] Halliwell B.,

[50] Gutteridge J. M. C.

[51] 11.↵
Silva E.,
Gonzalez T.,
Edwards A. M.,
Zuloaga E.
Visible light induced lipoperoxidation of a parenteral nutrition fat emulsion sensitized by flavins. J. Nutr. Biochem. 1998, 9 (3), 149–154.
OpenUrl

[52] Silva E.,

[53] Gonzalez T.,

[54] Edwards A. M.,

[55] Zuloaga E.

[56] 12.↵
Allwood M. C.,
Martin H. J.
The photodegradation of vitamins A and E in parenteral nutrition mixtures during infusion. Clin. Nutr. 2000, 19 (5), 339–342.
OpenUrl CrossRef PubMed Web of Science

[57] Allwood M. C.,

[58] Martin H. J.

[59] 13.↵
Ulbricht R. J.,
Northup S. J.,
Thomas J. A.
A review of 5-hydroxymethylfurfural (HMF) in parenteral solutions. Fundam. Appl. Toxicol. 1984, 4 (5), 843–853.
OpenUrl CrossRef PubMed Web of Science

[60] Ulbricht R. J.,

[61] Northup S. J.,

[62] Thomas J. A.

[63] 14.↵
Brustugun J.,
Tønnesen H. H.,
Edge R.,
Navaratnam S.
Formation and reactivity of free radicals in 5-(hydroxymethyl)-2-furaldehyde. J. Photochem. Photobiol., B 2005, 79 (2), 109–119.
OpenUrl PubMed

[64] Brustugun J.,

[65] Tønnesen H. H.,

[66] Edge R.,

[67] Navaratnam S.

[68] 15.↵
Brustugun J.,
Kristensen S.,
Tønnesen H. H.
Photosensitizing effect of 5-hydroxymethyl-2-furaldehyde in glucose infusion solutions. Pharmeuropa 2005, 17, 460–461.

[69] Brustugun J.,

[70] Kristensen S.,

[71] Tønnesen H. H.

[72] 16.↵
British Pharmacopoeia. Glucose Infusion. In British Pharmacopoeia; 2014.

[73] 17.↵
ICH Q1B. Guidelines for the photostability testing of new drug substances and products. Federal Register 1997, 62, 27115–27122.
OpenUrl

[74] 18.↵
Atlas. Suntest CPS/Suntest CPS+−. A comment on photostability testing according to ICH, Atlas material testing solutions, 1996.

[75] 19.↵
Wolf A. V.,
Brown M. G.,
Prentiss P. G.
CRC Handbook of Chemistry and Physics, 55th ed.; CRC Press: Boca Raton, FL, 1974; pp D-239, D-261.

[76] Wolf A. V.,

[77] Brown M. G.,

[78] Prentiss P. G.

[79] 20.↵
Gutteridge J. M.,
Quinlan G. J.
Malondialdehyde formation from lipid peroxides in thiobarbituric acid test: the role of lipid radicals, iron salts, and metal chelators. J. Appl. Biochem. 1983, 5 (4-5), 293–299.
OpenUrl PubMed

[80] Gutteridge J. M.,

[81] Quinlan G. J.

[82] 21.↵
Baertschi S. W.,
Alsante K. M.,
Tønnesen H. H.
A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): recommendation for revision. J. Pharm. Sci. 2010, 99 (7), 2934–2940.
OpenUrl PubMed

[83] Baertschi S. W.,

[84] Alsante K. M.,

[85] Tønnesen H. H.

[86] 22.↵
Tønnesen H. H.
Anderson N. H.,
Byard S. J.
Photostability Testing: Design and Interpretation of Tests on New Drug Substances and Dosage Forms. In: Photostability of Drugs and Drug Formulations, 2nd ed.; Tønnesen H. H., Ed.; CRC Press: Boca Raton, FL, 2004; pp 137–159.

[87] Tønnesen H. H.

[88] Anderson N. H.,

[89] Byard S. J.

[90] 23.↵
Baertschi S. W.,
Clapham D.,
Foti C.,
Jansen P. J.,
Kristensen S.,
Reed R. A.,
Templeton A. C.,
Tønnesen H. H.
Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products. Part 1: Drug products administered by injection. J. Pharm. Sci. 2013, 102 (11), 3888–3899.
OpenUrl PubMed

[91] Baertschi S. W.,

[92] Clapham D.,

[93] Foti C.,

[94] Jansen P. J.,

[95] Kristensen S.,

[96] Reed R. A.,

[97] Templeton A. C.,

[98] Tønnesen H. H.

[99] 24.↵
Greenwald R. A.
Aust S. D.
Lipid Peroxidation. In CRC Handbook of Methods for Oxygen Radical Research; Greenwald R. A. Ed.; CRC Press: Boca Raton, FL, 1986; pp 203–205.

[100] Greenwald R. A.

[101] Aust S. D.

[102] 25.↵
Dupont I. E.
Peroxidation of lipid emulsions: effects of changes in fatty acid pattern and alpha-tocopherol content on the sensitivity to peroxidative damage. Clin. Nutr. 1999, 18 (2), 113–116.
OpenUrl CrossRef PubMed Web of Science

[103] Dupont I. E.

[104] 26.↵
Norwegian Medicines Agency (accessed August 27, 2014); http://www.legemiddelverket.no.

[105] 27.↵
Sheskey P. J.,
Cook W. G.,
Cable C. G.
Handbook of Pharmaceutical Excipients Online, from Medicines Complete 2014 (accessed September 3, 2014): https://www.medicinescomplete.com/mc/excipients/current/1001942595.htm?q=olive%20oil&t=search&ss=text&p=1#_hit.

[106] Sheskey P. J.,

[107] Cook W. G.,

[108] Cable C. G.

[109] 28.↵
Steger P. J. K.,
Muhlebach S. F.
In vitro oxidation of IV lipid emulsions in different all-in-one admixture bags assessed by an iodometric assay and gas-liquid chromatography. Nutrition 1997, 13 (2), 133–140.
OpenUrl CrossRef PubMed Web of Science

[110] Steger P. J. K.,

[111] Muhlebach S. F.

[112] 29.↵
Gutteridge J. M.,
Halliwell B.
The measurement and mechanism of lipid peroxidation in biological systems. Trends Biochem. Sci. 1990, 15 (4), 129–135.
OpenUrl CrossRef PubMed Web of Science

[113] Gutteridge J. M.,

[114] Halliwell B.

[115] 30.↵
Sue-Chu M.,
Kristensen S.,
Tønnesen H. H.
Photoinduced color changes in two different qualities of riboflavin in the solid state and in various tablet formulations. Photoreactivity of biologically active compounds. XX. Pharmazie 2009, 64 (7), 428–435.
OpenUrl PubMed

[116] Sue-Chu M.,

[117] Kristensen S.,

[118] Tønnesen H. H.

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