COLLOSOL COCAINE NOT ADMITTED TO N. N. R

Report of the Council on Pharmacy and Chemistry

The report which appears below was adopted by the Council and sent to the Anglo-French Drug Co., Ltd., New York, for comment in December, 1918. No explanation has been received from the manufacturer. For the information of the profession the Council has now authorized publication of the report.

W. A. Puckner, Secretary.

“Collosol Cocaine” was submitted to the Council in October, 1918, by the Anglo-French Drug Co., Ltd., New York, under the claim that it was an “absolute colloid” and that it contained “1 per cent. cocain.” The label on the submitted specimen declares:

“Collosol Cocaine 1-100”

“... the Cocaine exists as the pure alkaloid in the Colloidal state—the condition in which it is isomorphic with the protein of the body fluids. The effect is more prolonged than that of a molecular Cocaine Solution and being non-toxic absorption presents no practical danger.”

The product was assigned to the Committee on Pharmacology for consideration. The following report was submitted and its adoption by the Council recommended by the committee:

“Collosol Cocaine” is said to be a colloidal form of cocain and is alleged to possess a remarkably low toxicity. The subjoined report of the A. M. A. Chemical Laboratory, however, shows that the preparation does not have the composition claimed for it and it is, in effect, misbranded. In fact, the English manufacturers concede that it is not an “absolute colloid” and that the declaration with regard to the percentage of cocain is incorrect.

It is recommended that, without considering other conflicts with the rules of the Council at this time, “Collosol Cocaine” be declared inadmissible to New and Non­official Remedies for conflict with Rule 1 which requires that the composition of an article must be correctly declared. The report of the A. M. A. Chemical Laboratory is appended.

REPORT OF THE A. M. A. CHEMICAL LABORATORY

Simpson, Hewlett and Eyre (Lancet, April 28, 1917, p. 660) reported “Collosol Cocaine” to be much less toxic than cocain. These writers, however, did not verify the statements as to the composition and in the light of subsequent chemical examination it is not to be wondered at that “Collosol Cocaine 1.0 per cent.” was much less toxic than a solution containing 1.0 per cent. of cocain hydrochlorid.

Barger, Dale and Durham report from the Department of Biochemistry and Pharmacology, Medical Research Committee (Lancet, Dec. 1, 1917, p. 825), that they examined “Collosol Cocaine” and found it to contain but 0.25 per cent. of cocain. They also found that the cocain was not present in a colloidal form. Discussing the low toxicity claimed by the manufacturers, these investigators state:

“In the samples which we examined the toxicity was, indeed, much lower than that of an ordinary 1 per cent. solution of a cocain salt; but the local anesthetic action was low to a corresponding degree, and both actions corresponded satisfactorily with the proportion of cocain chemically recoverable from the solution.”

Stroud, of the Crookes Laboratory (which manufactures the preparation), who apparently had been informed of this work in advance of publication, admits the correctness of it, and states (British Medical Journal, Nov. 24, 1918, p. 710) that “whilst the colloidal protective apparently absorbs a portion of the cocain, the remainder is found not to exhibit the attributes of a colloid,...”

The specimen of “Collosol Cocaine” submitted to the Council and labeled “Collosol Cocaine 1-100” was found to contain at most 0.4 per cent. cocain. The examination was made in accordance with the method used by Barger, Dale and Durham and calculated as cocain. This method, however, probably would not distinguish between cocain and basic decomposition products, but would include all as cocain in the amount found. The specimen of “Collosol Cocaine” examined was neutral or slightly acid, a fact which tends to confirm the conclusion of the British investigators that “Collosol Cocaine” contains cocain in noncolloidal form and precludes an increased physiologic effect due to alkalinity.

The Council adopted both the report submitted by the committee and that of the A. M. A. Laboratory and declared “Collosol Cocaine” inadmissible to New and Non­official Remedies.—(From The Journal A. M. A., April 12, 1919.)