CANNABIS EXTRACTDefinition per
The U.S.P 9th Edition (pg141)
Pilular Extracts are solid or semi-solid products prepared by exhausting drugs with appropriate solvents and carefully evaporating the solutions to the proper consistence. These extracts preserve the useful constituents of the drug in a concentrated, relatively uniform and permanent condition, and in a form suitable for medication.
The solvents or menstrua employed in the preparation of pilular extracts are water, alcohol, or mixtures of these in the proportions stated in the formulas. A few drugs require for their extraction the addition of an acid or an alkali to the solvent. Where alcohol is used in the extraction it may be recovered by distillation.
In the preparation of pilular extracts the concentration of the solutions should be completed without delay, and undue exposure to heat must be avoided. The limit of temperature for the evaporation, as stated in the formulas, should not be exceeded. In the manufacture of these extracts on a large scale an apparatus for distilling and evaporating under reduced pressure should be used. It is also important that the residue be frequently stirred so as to hasten the evaporation and to obtain a uniform product.
Pilular extracts are extensively used in pill masses and in ointments and, to facilitate -their use in these preparations, the degree of concentration is commonly directed to be that of a " pilular consistence."
Pilular extracts should be protected from exposure to sunlight and air by being kept in tightly-covered glass or earthen-ware containers.
Powdered Extracts differ from pilular extracts in that they are dry, fine powders. Powdered extracts are often preferred to pilular extracts for general use ' because they can be more accurately. weighed, more easily dispensed, and more conveniently preserved in tightly-stoppered bottles.
In the preparation of powdered extracts, it is necessary to use solvents that will extract the active principles of the drugs, and only a minimum amount of the inert substances. Where the drug contains an oily constituent that would be extracted by the menstruum directed, it becomes necessary to adopt in the process of manufacture a method for the separation of this oil so that the product will retain a satisfactory, pulverulent form.
The concentration of the liquids containing the extractive should be completed without delay and undue exposure to heat must be avoided.
The limit of temperature as stated in the formulas should not be exceeded, and the use of apparatus for concentrating under reduced pressure is recommended. The final drying of the soft extract can be greatly facilitated by spreading it upon plates of glass or tinned metal and exposing it to currents of warm, dry air. Powdered extracts must be, thoroughly dried, powdered and mixed with the diluent and preserved in tightly-stoppered, small, wide-mouthed, amber-colored bottles, and stored in a cool and dry place.
Alkaloidal standards have been adopted for Extracts that can be reliably assayed. Assay methods are directed for the determination of their strength, and to provide for standardization. When necessary, an inert diluent is directed to reduce the product to the standard. In the official formulas glucose is directed for the diluent in pilular extracts and dried starch and magnesium oxide are directed for powdered extracts, but it is permissible for the manufacturer to use as inert diluents for the latter, sugar, sugar of milk, powdered glycyrrhiza, magnesium carbonate or the finely powdered drug or marc from which the respective extract was made. For the convenience of the prescriber, the standards of strength for the Extracts have been adjusted, wherever possible, so that each bears a definite relation to that of the respective drug of average strength, and a statement of the standard precedes the formula.