Concerning the method of preparation of this alcoholic extract and the amount used in the preparation of Syrup Leptinol the Balsamea Company replied as follows:
“The alcoholic extract of the Leptotaenia, which we have termed ‘Leptinol’ is a preparation of definite and uniform strength, as determined by two methods: (a) the gravity test using the U. S. Hydrometer Scale for spirits, by which Leptinol registers 52 degrees at 60 degrees F., and (b) by gentle evaporation of the alcohol content and the measuring of the active constituents, which measures twenty-five per cent. by weight.
“The alcoholic extract ‘Leptinol’ is glycerinated in a machine, using one part of the alcoholic concentration to four parts of glycerin. This is then added to eleven parts of a heavy syrup, containing 71⁄2 pounds of sugar to the gallon of syrup, and thoroughly mixed in an agitating machine. Leptinol is the sole active ingredient of Syrup Leptinol. Syrup Leptinol is a preparation of uniform strength. It is far more uniform in strength than most of the syrups of the U. S. P. made from fluid extracts which are made from crude drugs which are not uniform in strength.”
This claim cannot be allowed as meeting the conflict with Rule 1. It is well known that plants vary in their composition at different times of the year; under different conditions of cultivation and growth; and under other conditions; hence the claim that alcoholic extracts of equal specific gravity insure uniformity of composition in active principles must be considered entirely illogical, especially since the exact nature of the active principles, if any be present, is unknown. If these are known their nature should be stated and tests for their identity be given. If they are unknown it is manifestly misleading to state that the preparation is of uniform strength.
It is evident that the Council cannot approve of the use of a preparation of unknown composition without satisfactory evidence of its value, especially when it is recommended in a variety of serious infectious diseases such as influenza and pneumonia. The mere fact that a small number of patients who have received the drug recover is no evidence of its curative value, and until carefully controlled clinical tests of the preparation are made, it is not entitled to the consideration of physicians.—(From The Journal A. M. A., June 5, 1920.)
FORMITOL TABLETS, II
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following supplementary report on Formitol Tablets.
W. A. Puckner, Secretary.