Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Patent
1997-06-26
1998-12-08
Spivack, Phyllis G.
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
424678, 424679, 424681, 514 23, A61K 3170, A61K 3314, A61K 3306
Patent
active
058465723
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 PCT/GB95/03032 filed Dec. 22, 1995.
The present invention relates to body fluid replacement solutions suitable for intravenous infusion.
The normal metabolism of the human body results in more or less continuous losses of Na (sodium), K (potassium) and water and in order to maintain normal functioning of the body it is essential that the levels of these in the body should be maintained within more or less closely defined limits. Where a patient is unconscious or under a "nil oral intake" regime for one reason or another e.g. pre- or post-operative, then it is necessary for these levels to be maintained by intravenous infusion of suitable solutions. Also in cases of shock it is normal practice to increase the volume of fluid in the circulation in order to maintain blood pressure within safe limits.
Conventional medical practice is based on the administration of standard "quantities of solutions of dextrose (5% w/v aqueous) and physiological saline (0.9% w/v aqueous NaCl), with the occasional addition of potassium salt to one or other of the above solutions. Typically patients are provided daily with 2 liters (4.times.500 ml units) of dextrose and 1 liter (2.times.500 ml units) of saline with from 0 to 3 ampoules of aqueous potassium chloride (15% w/v KCl) incorporated into one of the dextrose or saline units. These dosages are however usually applied without regard to the patients' bodyweight which has a substantial effect on the K/Na requirements--e.g. the requirements for a 100 kg patient will generally be 100% higher than those for a 50 kg patient. As a result many patients receive incorrect amounts of K and/or Na. This can have quite serious consequences which can aggravate a patient's condition rather than stabilise or help to improve it. Thus excess Na can result in edema whilst too little Na can give rise to muscular contractions and cramps. High or low levels of K can induce arrhythmias of the heart.
In the past a wide variety of body fluid replacement solutions have been proposed for various purposes. Many of these include bicarbonate (HCO.sub.3), stabilized by packing under carbon dioxide (Co.sub.2) given in bicarbonate precursors such as acetate or lactate. These can affect the CO.sub.2 :HCO.sub.3 balance in the body and give rise to adverse effects on the patient if they are not carefully controlled. Such adverse effects can moreover be particularly serious in the case of patients who have an underlying problem such as acidosis resulting from kidney failure or CO.sub.2 retention in the lungs, or alkalosis resulting from respiratory problems with excessive loss of CO.sub.2 from the lungs. If the solution used has a pH and/or HCO.sub.3 /CO.sub.2 bias which aggravates that of the underlying condition, then the patient's condition may be seriously exacerbated.
Insofar as bodyfluid replacement solutions are often used in emergency situations and/or in a very routine manner i.e. without detailed consideration of the patient's specific requirements there is accordingly a need for a solution which can be used with a high degree of safety as easily as possible. It is an object of the present invention to avoid or minimize one or more of the abovementioned disadvantages of the prior art.
The present invention provides a sterile pyrogen-free body fluid electrolyte replacement solution for intravenous infusion and consisting essentially of an aqueous solution containing from 30 to 100 mMol Na (per 1000 mls) as a physiologically acceptable salt; from 15 to 50 mMol K (per 1000 mls) as a physiologically acceptable salt; an effective amount of a physiologically acceptable osmolality control agent for providing an osmolality of from 260 to 320 mOsm per kg of solution, said solution being substantially free of material having a molecular weight greater than 5000, and substantially free of any material capable of significantly affecting acid-base balance in vivo.
Thus with a solution of the present invention it is possible to provide effective body fluid replacement and critical electroly
REFERENCES:
patent: 3356570 (1967-12-01), Butcher
patent: 4592909 (1986-06-01), Winer et al.
Abstract--Japanese Patent No. 57091911, Date Jun. 8, 1982, WPI Acc No: 82-58468E.
Abstract--Japanese Patent No. 57091912, Dated Jun. 8, 1982, WPI Acc No: 82-58469E.
East & Midlothian NHS Trust
Spivack Phyllis G.
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