The Propaganda for Reform in Proprietary Medicines, Vol. 2 of 2Council on Pharmacy and Chemistry (American Medical Association)
Science
The Propaganda for Reform in Proprietary Medicines, Vol. 2 of 2
Council on Pharmacy and Chemistry (American Medical Association)
Patent medicines
1. The claim is made that the tablets disintegrate in the intestines;
experiments conducted by the Council indicated that in most cases they
would be broken up in the stomach. It was found that the tablets were
visibly changed immediately after being put into gastric juice or even
into distilled water; they disintegrated within from three to four
hours, not only in gastric juice (obtained from a dog) at 37 C., but
also in distilled water. It is quite usual for solids to remain in
the stomach for more than three hours. If they make their way out of
the stomach in less than that time the gastric movements must be so
vigorous as further to hasten the disintegration of the tablets.
2. The rules of the Council require that the name of a pharmaceutical
mixture shall indicate the potent ingredients. The name of this mixture
does not indicate the presence of the nitrites, the potassium nitrate,
the bicarbonate or the extract of hawthorne and the nondescriptive name
is likely to lead physicians to use the tablets without fully realizing
what they are giving.
3. No evidence was submitted that the tablets, as found on the market,
contained the amount of sodium nitrite and nitroglycerin claimed.
That is, it does not appear that the manufacturer checks the sodium
nitrite and nitroglycerin content by analysis. The Council did not
determine the nitrite content of the tablets. It maintains that when
a manufacturer places a product on the market the burden of proof is
on that manufacturer to show that the facts are in accordance with
his claims for his product. Further, the examination by the Council
of one or several specimens of any commercial product (particularly
in the case of nitroglycerin preparations) would not be a guarantee
of the constancy of its composition so long as the manufacturer does
not himself control the composition by analysis. The necessity of
such control of tablets containing nitroglycerin is evident from the
report[102] of L. F. Kebler of the U. S. Bureau of Chemistry. Dr.
Kebler said:
[102] J. A. M. A., Nov. 2, 1912, p. 1604.
“... nitroglycerin tablets have in a majority of cases been found
deficient in the nitroglycerin content declared.”
“... these commodities are manufactured largely by rule of thumb.
Little checking obtains in their manufacture and generally no
analyst is employed.”
A further proof that nitroglycerin tablets are likely to be deficient
in strength is contained in the convictions under the Food and Drugs
Act of manufacturers who sold tablets below the declared strength,
recorded from time to time (Notices of Judgments Nos. 3405, 2059, 1843,
1799).
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