A purified extract may be obtained by extracting the drug with a selective solvent and/or by removing

the inert subtances by various methods (defatting, passing over absorption resins) after the primary
extraction. inert substances applies chiefly hindrance in the preparation of pharmaceutical form,
especially solid form. Because they are hygroscopic, sticky, and so give rise to formulation problems.
Traditional extracts may turn be devided into fluid extracts, soft extracts, and dry extracts with which all
pharmaceutical technologist are familiar. Purified extracts on the other hand are as a rule in the dry
state. Their content of active principles varies enormously in the main we may say that the minimum
content is about 20% of the entire extract , though in the some cases in may be as high as 60 tom70%

A point that does not fall secificially within the scope of this chapter but that nonetheless must be
made is that a purified extract does not constitute a halfway house between the total or traditional
extract and the pure product. It is not an intermediate for subsequent transformation into a pure
product. Purified extracts have an indentity and validity of their own because the are natural mixtures of
chemically related subtances. The isolation from these natural mixtures of a particular consistent in the
pure state may be pharmacological and economi nonsense, justified only in certain cases by the need for
a single more easily identifiable principle, especially in studies of pharmacokinetics.

Example of purified extracts are extracts of senna with a 45 to 60% content of sennosides, of cascara or
of frangula containing 20 to 25% hydroxyanthracene derivatives, of vaccinium myrtillus containing 32 to
37% antocy nosides, and of silybum narianum containing 60 to 70 % hydroxyphenylchromanones
(silymarine). Many go a stage beyond the total extract and possess activity comparable with that of pure
product.

Preparation of a purified extract must be preceded by confirmation that activity og the drug is
conversed; total exctracts often contain subtances such as saponins and polyphenols that are regarded
as inert but they may be crucial to the absorption of the active principles. One has to ve sure that this
property has not been lost in the purified extract.
Crippa, who was lomg concerned with all the pomblems relating to the formulation of extracts into
dosage form, cites by way of example two formulation of tablets containing a granular extract of
cascara, both prepared by dry mixing of the various constituents and direct compression (t1)

The substitution of powdered silica gel and microcrystalling cellulose for traditional excipient such as
talc and kaolin yielded distinct improvement in hardness, friability and disintegration, especially when a
rotary tableting machine was used (2)

Dry dosage form present no particular promblems of stability because in the dry state there is practically
no degradation due to hydrolysis, exudation, polymerization, etc. in formulation containing more than
one extract, on the other hand interaction may accur between the components of the different extract
with the formation of products endowed, for example with new solubility sharacteristics. This may occur
when formulating an extract containing alkaloids with one containing tannins or whit the alkaloids: in
one case the formulation of alkaloid-tannin derivates may lead to sparingly soluble products (of slow
bioavaibility) and in the other there may be formulation of soluble salt (rapid bioavaibility)

These problems can easily be solved by preparing separate granules of each extract, suitably coated
with resins, which can then be mixed and tableted.

For the preparation of hard gelatin capsule nonhygroscopic free-running granules are essential. Since
the hard gelatin shell does not protect the granules containing in the capsule against humidity, the
granules should be protected by coating with resins or metylcellulose. This coating is always advisable to
ensure that thde moisture filtering through the gelatin shell does not cause degradation of very labile
products or not simply, but very frequently, transformation of initially free-running granules into a
compact block that is poorly soluble