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United States Patent (19) 11) Patent Number: 4,740,373 Kesselman Et Al

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United States Patent (19) 11) Patent Number: 4,740,373 Kesselman Et Al United States Patent (19) 11) Patent Number: 4,740,373 Kesselman et al. (45) Date of Patent: Apr. 26, 1988 54 STABILIZATION OF 3,932,634 1/1976 Kardys ................................ 424/237 MULTIVITAMEN/TRACE ELEMENTS 4,228,159 10/1980 MacMillan .......................... 424/145 FORMULATIONS 4,268,529 5/1981 Davis et al............................ 426/72 (75 Inventors: Morris Kesselman, Belmar, N.J.; FOREIGN PATENT DOCUMENTS Abdur R. Purkaystha, Bronx; James 0161915 11/1985 European Pat. Off............. 514/970 Cahill, Riverdale, both of N.Y. 58-198416 11/1983 Japan ................................... 514/970 (73) Assignee: USV Pharmaceutical Corporation 1080626 8/1967 United Kingdom . 21 Appl. No.: 866,842 OTHER PUBLICATIONS 22) Fied: May 27, 1986 Chem. Abst., 99:10856s (1983)-Heidt. Chem. Abst., 105:1 1967h (1986)-Vervloet et al. 51 Int. Cl.' ..................... A61K 33/34; A61K 31/07; The Effects of Ascorbic Acid and Trace Elements on A61K 31/195; A61K 31/44 Vitamin B12 Assays, J. Am. Pharm. Assoc., 43:87-90, (52) U.S. C. ...................................... 424/141; 514/52; 1954. 514/167; 514/168; 514/249; 514/251; 514/276; 514/458; 514/474; 514/499; 514/548; 514/681; Primary Examiner-Douglas W. Robinson 514/905; 514/970 (57) ABSTRACT (58) Field of Search ................. 514/167, 168, 970, 52, 514/905, 251, 276, 458,548, 681, 249, 474, 499; Disclosed are aqueous multivitamin/trace elements 424/141 formulations stabilized by a water soluble, organic acid that contains carbon-to-carbon unsaturation and water 56) References Cited soluble salts thereof selected from the group consisting U.S. PATENT DOCUMENTS of maleic acid, fumaric acid, maleamic acid and acrylic acid. 2,731,390 1/1956 Tansey et al........................ 424/308 3,899,598 8/1975 Fischer et al. ........................ 426/73 3,914,419 10/1975 Haeger et al. ...................... 424/237 6 Claims, No Drawings 4,740,373 1. 2 generally known that the "essential elements', i.e. cal STABILIZATION OF MULTIVITAMEN/TRACE cium, magnesium, sodium and potassium, furthermore ELEMENTS FORMULATIONS zinc, manganese, copper, cobalt, chromium, iron, mo lybdenum, vanadium, selenium and nickel are indispens BACKGROUND OF THE INVENTION 5 able for the normal function of living organisms. The 1. Field of the Invention essential elements are the constituents or activators of This invention relates to a method of stabilizing aque numerous enzyme systems, they are in close correlation ous parenteral solutions of multivitamins in the presence with the level of certain vitamins in the organism and of trace elements and compositions produced thereby with the function of the hormone system. The defi for human and veterinary administration. O ciency of essential elements greatly suppresses the bio As is well known, in addition to the various basic synthesis of proteins, enzymes, hormones and other nutritive materials which are required by humans and biologically active substances required to control the animals, a variety of other nutrients and essential ele normal functions of the living organism as a whole. ments are also required for the maintenance of good The JPEN 5:424-429, 1981 reports on health disor health. The present invention is directed to nutrients 15 ders associated with the insufficiency of some essential and essential elements, sometimes called "micronutri trace elements in TPN: Zinc deficiency manifests in a ents', from which relatively very small amounts are variety of diseases including acrodermatitic skin lesions, needed to provide a well-balanced, healthy diet. For impaired immunity, poor growth, impaired wound heal convenience, the compositions of the invention will be ing, and mental disturbances; copper deficiency results described as relate to humans, however, the same can as 20 in hematologic abnormalities, usually anemia with leu well be used for veterinary purposes. While the compo kopenia and neutropenia; chromium deficiency has sitions of the invention may be used as regular supple been recognized to play a role in glucose intolerance, ments to nutrients obtained through the digestive sys weight loss, peripheral neuropathy or encephalopathy; tem, it especially concerns total parenteral nutrition to provide nutritional support for persons unable to meet 25 and selenium deficiency in experimental animals was their nutritional requirements through the digestive observed to cause liver necrosis, pancreatic atrophy, system, i.e. for nutritional rehabilitation of patients. and muscular dystrophy. Manganese is an actuator of Total parenteral nutrition (TPN) has been used for several enzymes being involved in protein synthesis and many years and an expanded knowledge of nutritional function of the central nervous system. It is essential for requirements led to the development of a wide array of 30 bone structure and reproduction. products from which the TPN solutions can be formu 2. Description of the Prior Art lated. The Nutritional Advisory Group of the Ameri In general, liquid multivitamin preparations of the can Medical Association (AMA) has developed recom prior art are packaged in two separate vials or syringes, mendations for the parenteral use of multivitamin prep or double compartment vials or syringes to prevent 35 interaction between some of the vitamins. Such interac arations. The guidelines for adult formulations are as tion results in discoloration of the solution and loss of follows (JPEN 3: 258-262, 1979) potency. Another approach to solve the interaction problem resulted in lyophilizing multivitamin prepara Daily tions and reconstituting the same just prior to injection. Vitamin Administration 40 The ingredients interaction problem is even more A 3,300 IU D 200 IU serious when, in addition to containing multivitamins, E 10 IU the preparation also contains trace elements, especially Ascorbic Acid 100 mg copper. To circumvent the problem, the prior art, Folacin 400 mcg again, provided a two or three package system, one or Niacin 40 mg 45 two of which contained the multivitamins and one the Riboflavin 3.6 mg Thiamin 3 mg trace elements. The contents of the packages were ei Pyridoxine (B6) 4 mg ther separately infused into the patient or were admixed Cyanocobalamin (B12) 5 mcg just prior to infusion. While the former method is unde Pantothenic Acid 15 mg Biotin 60 mcg sirably cumbersome, the latter method is unsatisfactory SO for the reason that the reactions between the trace ele ments and the multivitamins are so rapid that the The medical profession has focused increasing atten browning reaction and turbidity can be observed within tion on the importance of trace elements in the nutri minutes of admixing the two phases. In addition, the tional management of medical, surgical, and traumatic interaction could cause clogging of the infusion needle conditions. The AMA has also published guidelines for 55 and the introduction of solid particles into the vein of trace element preparations for parenteral use (JPEN 3: the patient. This problem could be especially serious 263-267, 1979): with infusions mixed several hours prior to addition to TPN Solutions. Daily The present invention is designed to solve the above Trace Elements Administration 60 described problems and to provide multivitamin/trace Zinc 2.5-4 mg elements formulations in aqueous solution for parenteral Copper 0.5-1.5 mg administration to patients. Chronium 10-15 mcg Manganese 0.15-0.8 mg SUMMARY OF THE INVENTION 65 It is a main object of the present invention to adminis The AMA did not address other trace elements, how ter to patients multivitamins and trace elements to ever, there are increasing data for the role of these gether as one entity in an infusion mixture. Heretofore various trace elements in good nutritional support. It is such administration was not possible due to the instanta 4,740,373 3 4 neous reaction of trace elements with several of the elements considered advantageous for use in TPN for vitamins forming darkly colored, turbid solutions with mulations. heavy precipitation occuring within minutes. Examples TABLE I of such undesirable reactions include reaction of copper with vitamin C, riboflavin, folic acid and vitamin B12. Vitamin Range It is another object of the present invention to pro Preferred vide a multivitamin/trace elements formulation which Active Forms Broad Range Range" Vitamin A, alcohol, palmitate, 230-10,000 3,300-5,000 is stable for at least 4 to 8 hours at room temperature or IU acetate 12 to 24 hours refrigerated so as to allow normal manip Vitamin B1, hydrochloride, 0.05-45.0 3.0-6.0 ulative time in hospital infusion. 10 ng nonditate, It has been surprisingly discovered that the rapid phosphate esters inter-reactions between vitamins and trace elements can Vitamin B2, riboflavin, 0.07.0.0 3.0-6.0 ng riboflavin-5-phosphate be prevented by the use of a water soluble, organic acid sodium salt that contains carbon-to-carbon unsaturation and water Vitamin B6, hydrochloride 0.04-2.0 4.0-6.0 soluble salts thereof. Such organic acids include: maleic 15 fing acid, fumaric acid, maleamic acid and acrylic acid. Witamin C, Vitamin C, sodium 4--,000 00-200 ng ascorbate Water soluble saturated weak organic acids, such as Vitamin D, ergocalciferol, 44-1,000 200-400 citric acid, acetic acid, tartaric acid, gluconic acid, suc IU calciferol cinic acid, lactic acid, and oxalic acid showed no stabi Vitamin E, d or d1 tocopheryl, 0.66-10 S.O lizing effects. Cyanoacetic acid which has an unsatu IU d or di tocopheryl acetate rated carbon to nitrogen bond was also ineffective in Niacinamide, niacinamide, 0.25-100 40-60 stabilizing the multivitamin/trace elements formula Ing niacin tions. Pantothenic d-panthenoi, 0.3-25 10-5 In accordance with this discovery, several embodi Acid, mg calcium pantothenate 25 Vitamin K, phytonadione, 0.04-1.0 0.10-0.5 ments of the invention are provided as will be described Ing menadiole, menadione hereunder. bisulfite, a.
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