Because of persistent conflict with Rule 6 (unwarranted therapeutic claims) and Rule 1 (composition) it is recommended that Digalen be omitted from New and Nonofficial Remedies; also that a copy of the report be sent to the manufacturers, and that publication of this report and the two previous reports submitted to the Council be authorized.
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:
“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.