Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Recombinant or stably-transformed bacterium encoding one or...
Patent
1982-09-29
1984-11-06
Friedman, Stanley J.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Recombinant or stably-transformed bacterium encoding one or...
A61K 3104
Patent
active
044812205
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a preparation that can be dissolved in water to form an approximately isotonic nitroglycerine solution having a concentration of approximately 1 mg of nitroglycerine/ml of solution, and to an approximately isotonic aqueous nitroglycerine solution having a content of approximately 1 mg of nitroglycerine/ml of solution.
It should be possible to manufacture the approximately isotonic nitroglycerine solution having a concentration of approximately 1 mg of nitroglycerine/ml of solution from the preparation according to the invention by dissolving the preparation in water. This nitroglycerine solution could be used for infusions. The concentration of 1 mg of nitroglycerine/1 ml of solution would offer the user a simple basis for calculating amounts infused and further dilutions. Further advantages would be that patients would be subjected to relatively small infusion volumes and that, in the case of intensive treatment, infusion piston pumps would rarely need to be changed.
TABLE 1 __________________________________________________________________________
Known nitroglycerine solutions
Solvent
After dilution
with water to
Nitroglycerine 1 mg nitro-
concentration glycerine/ml
No.
(mg/ml) solution
Remarks
Literature
__________________________________________________________________________
1 1 approx. 100% ethanol
-- a,b Rote Liste 1980
2 5 approx. 100% ethanol
20% ethanol +
a,b "
80% water
3 5 approx. 100% ethanol
20% ethanol +
a,b "
80% water
4 3.1 1,2-propylene glycol +
? a,b "
(unspecified)
ethanol
5 0.63 1,2-propylene glycol +
impossible
c "
(unspecified)
ethanol
6 ? approx. 100% ethanol
a,b Trissel, "Handbook
of Injectable D ugs"
2nd Edition, 1980
7 0.15 water impossible
c Trissel, "Handbook
of Injectable D ugs"
2nd Edition, 1980
8 10 approx. 100% ethanol
10% ethanol +
a,b,d
Gstirner, "Grund-
stoffe und Verfahren
der Arzneibereitung" P.
387, Stuttgart 1960
9 10 90% ethanol +
9% ethanol +
a,b,d
Martindale
10% water 91% water p. 1646, London
10 10 approx. 100% ethanol
10% ethanol +
a,b,d
Dean and Baun,
90% water Am. J. Hospital
Pharm. 32 (1975)
1036
11 0.4 4% ethanol +
-- c Dean and Baun,
96% water Am. J. Hospital
Pharm. 32 (1975)
1036
__________________________________________________________________________
Remarks:
a: toxicologically undesirable; see, for example, Kuhn and Loogen,
Internist, 19 (1978) 97-106
b: Not isotonic; an isotonic solution contains only 1.28% ethanol or 2.0%
propylene glycol
c: concentration too low
d: Risk of nitroglycerine precipitation
TABLE 2 __________________________________________________________________________
Dissolution of tablets (NG = Nitroglycerine)
NG NG total
Tablets concen-
amount
(mg NG/
Solution tration
(mg)/
No.
tablet)
solution medium
(mg/ml)
mixture
Remarks Literature
__________________________________________________________________________
1 0.6 water 0.15 ? c Flaherty et al.,
Circulation, 51
(1975) 132
2 0.4 0.9% NaCl +
0.4 8 c Kaplan et al.,
99.1% water Anesthesiology,
45 (1976) 14
3 0.6 water 1 ? hypertonic
Cottrell and
approx. 17%
Turndorf, Am.
solids in case
Heart J., 96
of 100 mg
(1978) 550
tablet
4 water 0.4 ? c Sturek et al.,
5 5% dextrose +
0.4 ? c Am. J. Hosp.
0.4 95% water Pharm., 35
6 0.9% NaCl +
0.4 ? c (1978) 537
99.1% water
7 0.4 0.9% NaCl +
0.08 87.2 c McNiff et al.,
99.1% water Am. J. Hosp.
Pharm. 36
(1979) 173
8 0.4 (a) 0.9% NaCl +
0.03 8 c
99.1% water +
(b) 5% dextrose +
95% water
(a):(b) = 10:240
or 20:230
9 0.4 0.9% NaCl +
1 40 hypertonic
Swerling,
99.1% water approx. 25%
Hosp. Pharm.,
solids in case
14 (1979)
of 100 mg
420
tablet
__________________________________________________________________________
TABLE 3 _______________
REFERENCES:
patent: 3789119 (1974-01-01), Fusari et al.
Merck Index, (1976), 9th Ed., p. 1017.
Giesselmann Ewald
Munch Ulrich
Friedman Stanley J.
Muserlian Charles A.
Sanol Schwarz GmbH
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