The Propaganda for Reform in Proprietary Medicines, Vol. 1 of 2Council on Pharmacy and Chemistry (American Medical Association)
Science
The Propaganda for Reform in Proprietary Medicines, Vol. 1 of 2
Council on Pharmacy and Chemistry (American Medical Association)
Patent medicines
The nature of the problems involved necessitates a somewhat extended
discussion of the subject.
Digalein (liquid) is said to contain 1 part of soluble amorphous
digitoxin Cloetta in 1,000 parts of glycerin and 1,600 parts of water
with 7.5 per cent. of alcohol. One c.c. is said to contain 0.0003 gm.
of the amorphous digitoxin.
Digalen was accepted by the Council[27] and the following footnote
was appended to the description in New and Nonofficial Remedies:
[27] The Journal A. M. A., Sept. 11, 1909, p. 869.
“The Council has not determined whether digalen contains ‘soluble
amorphous digitoxin’ or not, but accepts it simply as a soluble
digitalis preparation.”
Tablets of Digalen were accepted by the Council as a dosage form of
Digalen. Each tablet is said to represent 0.5 c.c. (eight minims) of
Digalen (liquid).
One of the principal considerations which led the Council to accept
Digalen was that it was regarded as affording a fairly constant
and stable preparation of digitalis suitable for intravenous
administration. If Digalen is not fairly stable and of fairly constant
composition it has no obvious advantage over an active soluble
digitalis preparation, such as digitalein.
The evidence now at hand seems to show: 1. Digalen is not of constant
composition or activity. 2. The manufacturers, or their agents,
continue to make misleading statements. 3. It is merely a solution of
certain digitalis principles, probably of digitalen mainly, in impure
form.
COMPOSITION
Cloetta[28] prepared a soluble amorphous substance which he called
“Digitoxinum solubile Cloetta,” but no information concerning the
method of preparation has been published.
[28] Cloetta: München. med. Wchnschr., 1904, No. 33.
Cloetta reported the result of an elementary analysis of his product
which he compared to the analyses of digitoxin (crystalline) made by
Schmiedeberg and by Kiliani, and stated that there could be no doubt
concerning the chemical identity of the two substances.
Kiliani[29] characterized as preposterous Cloetta’s claim that the
active constituent of Digalen is chemically identical with digitoxin
and stated that Digalen was merely an impure digitalein. Kiliani
has recently reiterated the statement that the so-called “amorphous
digitoxin” is not identical with digitoxin.[30]
[29] Kiliani: München. med. Wchnschr., 1907, p. 886.
[30] Kiliani: Am. Jour. Pharm., 1913, lxxxv, 224.
Cloetta’s failure to publish his method of preparing Digalen places
an additional burden of proof on him (or the manufacturers of
Digalen), concerning the identity of the product, and in the face of
Kiliani’s denial of the correctness of Cloetta’s contention we must
have strong corroborative evidence of Cloetta’s claim before we can
accept it as being established.
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