The history of parenteral nutrition (PN) and the contributions of industry cannot be told in dramatic or romantic terms, for it is a tale not so much of individuals but of evolving technical development. Certainly giant scientific and educational advances have been made during the last 25 y, and for these there are identifiable personalities to recognize. As we approach the silver anniversary of the European Society of Parenteral and Enteral Nutrition (ESPEN), a few names stand out in one’s own recollection of this exciting period of health care development. Fat-emulsion technology and development are synonymous with Arvid Wretlind and Kabi-Vitrum in Sweden. Refinement of amino acid formulations from the basic “Rose” or “Kartoffel-Ei” (potato-egg) patterns was for many years the specialty of the German industry. We owe a debt of gratitude to the late Werner Fekl (Pfrimmer) and to Burghard Weidler (Fresenius) for developing the many different solutions (not always commercially viable) that facilitated studies and improved our knowledge of amino acid pharmacokinetics in specific disease states. The generous research fellowships established by ESPEN, with support for many years from Ajinomoto and later from Nestle ´, Baxter, and Abbott Laboratories have also been invaluable. Industry in the United States was not inactive during those years, but will, I believe, be best remembered for its concentration on contamination-free containers, catheters, and administration systems. Nevertheless, the pioneering work of Norman Yoshimura (McGaw) with the famous F080 and other amino acid formulations certainly merits acknowledgment. In addition, I hope the reader will indulge me by paying tribute to the outstanding contributions of my own mentors Bob Ausman (Travasol/ Synthamin and the Infusor) and Hugh Tucker (Renamin/ Branchamin) at Baxter throughout the 1970s and early 1980s. The whirlwind trips around the major European metabolic research centers were extremely rewarding because we were able to help young clinicians and scientists begin their chosen nutrition research programs. Many of these research fellows are now eminent professors who have at various times served ESPEN in different capacities. PN is the second of two momentous advances in intravenous therapy that were made in the latter half of the 20th century. The first was the development of the closed system, which contributed so impressively to the safe and efficient collection of whole blood and its fractionation. Because all four major infusion incidents that were recorded on both sides of the Atlantic during the 1970s involved bottle and closure deficiencies, industries’ adaptation of the closed system to intravenous solutions and then to PN containers was a corollary triumph that brought significantly improved patient care to hospitals. The first goal of the pioneers involved in commercial manufacture of parenteral products was to prepare contamination-free fluids that would be safe and consistently effective for patients. Terminally sterilized, pyrogen-free, pharmaceutically elegant solutions gradually became commercially available, first in glass bottles and then throughout the 1970s, 1980s, and 1990s in flexible, non‐air-dependent, plastic containers. Today only some fat emulsions, some amino acid solutions, and small volume additives are produced in glass. Because the technology already exists, all PN products inevitably will be commercially available in plastic before the first decade of the 21st century is through. Despite increased use of closed systems, the risk of septicemia remains the most feared problem. Infection is generally believed to stem from poor preparation and handling of solutions, catheters, and administration equipment. The educational role developed by industry with its “in-service” program on aseptic techniques for nurses and pharmacists has significantly helped to minimize these risks. Advances in PN that occurred in the late 1960s after Dudrick and Wilmore’s seminal paper 1 included the industrial refinement of designs for silicone and polyurethane central venous catheters, making possible the infusion of high-calorie carbohydrate solutions and protein hydrolysates via the vena cava. PN was thus able to preserve many lives and has since extended opportunities for long-term care into several clinical areas. The results of nutrition studies on the biological value of protein mixtures (i.e., the defined requirements for certain combinations of amino acids) were taken into consideration during the development of new, commercially prepared, amino acid formulations. The highest biological value was determined for an oral mixture of potato and egg proteins, but for parenteral use a modification of this “Kartoffel-Ei” amino acid pattern was necessary for physiologic and technical reasons. Variations concerned the non-essential part of the amino acid pattern, especially with respect to the potentially high levels of ammonia, plus the toxicologic and pharmaceutical concerns about glutamic and aspartic
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Oct 16, 2006
Baiming Xiao + 2
Open Access