Galencial Preparations

IMRAN TARIQ (Assistant Professor)

 Galenicals
Definition:
- Medicines prepared according to the formulae of Galen.

- A medicinal preparation composed mainly of herbal or vegetable

matter.

- It is prepared by extraction of crude vegetable drugs (active

principles) with suitable solvent(s).

- The term is now used to denote standard preparations containing

one or more active constituents of a plant and made by a process
that leaves the inert and other undesirable constituents of the plant
un-dissolved.
Galenicals
Galen is a Greek anatomist
whose theories formed
the basis of European

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medicine until the
Renaissance
(between 4th and 17th )
- Pharmaceutical preparations are
divided into:
1. Galenical preparation
2. Non-Galenical preparations
Galenicals
Nomenclature:
Galenicals:
Owing to Galen who discovered it.
Menstrum:
Solvent used for extraction (ex. water, alcohol, ether)
Marc:
The inert fibrous and other insoluble materials remaining
after extraction
Types:
Infusions- Decoctions- Fluid extracts- Semisolid extracts
– Dry extracts- Tinctures- Medical oils…..
 Galenicals
General method of Preparation:
1- Comminution (reducing substances to small size).
2- Penetration of the crude drug by the menstrum.
3- Dissolution of the active principles by the
menstrum.
4- Diffusion of the dissolved active principles
through the cell wall to the surrounding
menstrum.
5- Separation of the dissolved active principles from
the marc by straining, filtration or expression.
2- Infusion 6
Drug
Crude drugs of light structure without dense tissues and containing
water-soluble constituents.
The drug may be freshly broken, thinly sliced, cut small, or coarsely
powdered in order to facilitate the solvent penetration.
Menstrum
Always water (cold or boiling).
Time
Determined according to the amount of drug constituents to be extracted and
the ease or difficulty with which the water penetrate the drug.
Examples
Teas- Senna infusion- Infusion of senega
This method is used for those drugs are soft in nature.
In this process, drug is cut to suitable size and menstrum is added
in teapot or infusion pot for the stated period, usually 15 minutes
with occasional stirring and finally filtering off.
Coffee pot or tea pot is the simplest form of apparatus used for
preparing infusion.
The drug is placed at the bottom of the pot. Menstrum is added
and is well stirred.
Menstrum penetrate the soft tissue of plant & diffuses the active
constituents in to menstrum.
After the specified time content is strained, marc is not pressed
and filtered. The filtrate used as it is without dilution.
Infusion processes are two types: Fresh infusion and Concentrated
infusion.

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 Preparation
Fresh (Dilute) Infusion
The simplest of all methods of extraction
A definite weight of the crude drug in a certain state of subdivision (cut small,
powdered…) is prepared
The calculated amount of hot or boiling menstrum (usually water) is added to
the crude drug
Soak for a definite time
During the period of infusion, the heat should be retained in the container
and the content should be stirred
After the time of infusion, the liquid is poured off or strained
Do not press or squeeze the marc otherwise colloidal cell contents may be
forced out giving a cloudy infusion
Such fresh infusion should be used within 12 hours

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 Concentrated (stock) infusion
To avoid rapid decomposition to which the fresh (dilute) infusions are
subjected.

These preparations are not made by the concentration of the dilute

infusion by evaporation, since thermal treatment will result in loss of the
volatile principles.

Concentrated infusions prepared with alcoholic menstrum or contain

alcohol as a preservative.

Concentrated infusion are not intended to be dispensed in the

concentrated state, but upon use, are diluted with at least seven times
their volume of water

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 Examples of infusion
Concentrated infusion of Quassia (‫(خشب المر‬
Rx. 10
Quassia, cut small………………..80 gm
Alcohol (90%)…………………….250 ml
Distilled water, cold Q.S to……...1000 ml

Prepared by triple maceration.

1- Macerate Quassia with 650 ml of cold water for one hour, mix occasionally, strain
and reserve the clear liquid.

2- Repeat maceration process twice, using 500 ml of cold water for each maceration.

3- Combine second and third maceration and evaporate to 100 ml.

4- Mix liquid 3 with liquid 1, add alcohol and adjust the volume to 1000 ml with cold
distilled water
.

Dose: 2 to 4 ml
N.B: alcohol is added to the final product as a preservative
Use: Anti-malaria, Appetite stimulant (bitter stomachic).

Dilute infusion of Quassia

Rx.
Concentrated infusion of Quassia……… 125 ml
Distilled water, cold Q.S to………………..1000 ml

Preparation: Just mix

Dose: 15 to 30 ml

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 General Notes
The drug is usually coarsely ground. Very fine powders
should be avoided due to difficulty of separation from the
infusion.

Where no specific directions are given, the following

general formula and procedure should be used :
50 gm Drug in 1000 ml boiling distilled water (moisten 50
gm drug with 50 ml of cold water and allow to stand for 15
minutes. Then, add boiling water to make 1000 ml
infusion).

Infusions of readily soluble active principles are prepared

by maceration in water cold.
General Notes

Hot water extract the desired constituents more

quickly than cold but has the disadvantages of:
1- extracting inert materials that may precipitate upon
cooling.
2- causing volatilization or destruction of certain
principles.
3- coagulation of albuminous matters within the drug
cell and thereby inhibit the extraction.
3- Decoction
Definition:

- Solutions of the water soluble constituents of plant drugs

prepared by boiling the drug with water.

For extraction of drugs with water soluble and non- volatile

constituents, and drugs of hard and woody nature.

Should be freshly prepared.

Preparation:
Previously sliced drug barks or wood (5 parts) is boiled with water (100
or 120 parts) in a vessel of enameled iron or earthenware for a definite
length of time (15 min.) counting from when the liquid starts to boil
with occasional stirring.

To obtain highly concentrated decoction, boiling is continued until the

liquid reduced to a certain volume.

Allow to cool to about 40ºC, press the marc and mix the resulting liquid
to the decoction.

At the end of decoction time, decoction is strained through fine muslin

or flannel according to the nature of marc. Then, sufficient water is
passed through the strainer to produce a definite volume.
,
Example: Cinchona bark
or wood )‫(خشب الكينا‬
(contains quinine)
Uses: treatment of fever,
malaria and as an appetite
Stimulant.
Also used in anemia,

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indigestion, gastrointestinal
disorders, general fatigue.
 Comparison between infusion and decoction
Item Infusion Decoction

1- Plant Soft structure (ex. Senna Hard woody structure

leaves) (ex. Cinchona bark)
2- Menstrum Boiling or cold water Boiling water

3- Procedure Infusing the drug with cold Boiling the drug with
or hot water water
4- Time Calculated as soon as water Calculated as soon as
is added to drug the water begins to boil
5- Adjustment No adjustment Adjustment is necessary
of final volume
6- Apparatus Infusion earthenware pot Any covered apparatus

7- Storage Used fresh within 12 hours Used fresh and when

stored in refrigerator
used within few days
.
Extracts

 Extracts are concentrated preparations of vegetable or animal

drugs obtained by removal of the active constituents of the
respective drugs with suitable menstrua, evaporation of all or
nearly all of the solvent, and adjustment of the residual
masses or powders to the prescribed standards.

 Extracts are potent preparations, usually between two and

six times as potent on a weight basis as the crude drug.
 They contain primarily the active constituents
of the crude drug, with a great portion of the
inactive constituents and structural components of
the crude drug having been removed.

 Their function is to provide in small amounts

and in convenient, stable physical form the
medicinal activity and character of the bulkier plants
that they represent. As such, they have use in
product formulation.
In the manufacture of most extracts, percolation is
employed to remove the active constituents from the
drug, with the percolates generally being reduced in
volume by distillation under reduced pressure to reduce
the degree of heat and to protect the drug
substances against thermal decomposition.

The extent of removal of the solvent determines the

final physical character of the extract.
Extracts are made in three forms:

(a) semiliquid extracts or those of a

syrupy
consistency prepared without the intent of
removing all or even most of the menstrum,
(b) pilular or solid extracts of a plastic
consistency prepared with nearly all of the
menstrum removed,
(c) powdered extracts prepared to be dry
by the removal of all of the menstrum insofar
as is feasible or practical.
Pilular and powdered extracts differ only by the slight
amount of remaining solvent in the former preparation,
but each has its pharmaceutical advantage because of its
physical form. For instance, the pilular extract is
preferred in compounding a plastic dosage form
such as an ointment or paste or one in which a pliable
material facilitates compounding, whereas the powdered
form is preferred in the compounding of such dosage
forms as powders, capsules, and tablets.
FLUIDEXTRACT
Are liquid preparations of vegetable drugs
Containing alcohol as a solvent or as a
preservative or both, and so made that each
mL contains the therapeutic constituents of 1g
of the standard drug that it represents
 Characteristics of Fluidextract

1. Because they contain alcohol and are highly concentrated,

fluidextracts are sometimes referred to as “100%
tinctures”

2. Fluidextracts of potent drugs are ten times as

concentrated or as potent as corresponding tincture
Example: Belladonna Tincture is 0.6mL while its
fluidextract is 0.06mL
Disadvantages of Fluidextract
1. Because of their concentrated nature, many
fluidextracts are considered too potent for safe
self administration

2. Too bitter tasting or otherwise unpalatable

Preparations of Fluidextracts
• Percolation is preferred in all cases because of
the exhaustive extraction required.

Example: Senna Fluidextract

Example: Aromatic Cascara Sagrada

 Official Preparation

1. Glycyrrhiza Fluidextract - Licorice root

Fluidextract - flavoring agent

2. Eriodictyon Fluidextract - Yerba Santa

Fluidextract - cathartic

3. Cascara Sagrada Fluidextract - Rhamnus

Purshiana Fluidextract
4. Aromatic Cascara Sagrada Fluidextract
5. Senna Fluidextract – Fluidextratum Sennae
 TINCTURES

defined as alcoholic or hydro alcoholic

solution prepared from vegetable material or
from chemical substance.
TOPICAL SOLUTIONS AND TINCTURES

Topical solutions employ an aqueous vehicle, whereas the

topical tinctures characteristically employ an alcoholic vehicle. As
required, co-solvents or adjuncts to enhance stability or the solubility of the
solute are employed.

Topical solutions and Tinctures are prepared by simple solution and self -
preserved.

Are usually packaged in glass bottles having an applicator tip

as part of the cap assembly, or in plastic squeeze bottles which deliver the
medication in drops.

All medication intended for external use should be clearly

labeled “FOR EXTERNAL USE ONLY” and kept out of the reach of
youngsters.
1. Green soap Tincture - Alcohol vehicle - Detergent.
Also contains 2% lavender oil as perfume
2. Iodine Tincture - Alcohol - water vehicle - Anti-
infective
3. Compound Benzoin Tincture - alcohol - Topical
protectant
Variations of Official Tinctures are on:
1. Method of Preparation
2. Strength of their active constituent
3. Alcohol content
4. Intended use in medicine or pharmacy

Method of Preparation of Tinctures

1. By simple solution ‐ tinctures prepared from chemical substances.

Example: Iodine, Thimerosal,
Nitromersol green soap tinctures

2. By extraction ‐ by maceration or percolation Examples: Compound

Cardamom Tincture
Preparation of Tinctures
1.Maceration
Examples: Compound Benzoin Tinctures; Sweet
Orange Peel Tincture and ToLu Balsam Tincture
2. Percolation
Examples: Belladonna Tincture and Vanilla Tincture

Strength of their Active components

• There is no set strength for compound tincture. They vary with

particular preparation.
• The amount of crude drugs used to prepare each 100mL of tincture is
generally as follows: (Belladonna Tincture)

• Potent drugs: Belladonna leaf –10 g

• Non potent drug: Tolu Balsam – 20 g
• Undried fresh fruit peel: sweet orange peel – 50 g
Alcohol Content
Tinctures are considered to be stable preparation containing alcohol
to protect against microbial growth.
Green soap Tincture - 28 to 32% alcohol
Tolu Balsam Tincture - 77 to 83% alcohol
Pharmaceutical Uses
As flavoring tinctures like vanilla, sweet orange peel, Tolu balsam
tinctures.
Iodine Tincture, Thimerosal, Nitromersol Tinctures - Anti-infective;
Compound Benzoin Tincture - Topical protectant;
Green soap Tincture Topical detergent;
Paregoric Tincture - Antiperistalsis;
Belladonna Tincture - Anticholinergic
Disadvantages of Tinctures

1. Unpleasant tasting
2. Physician will prefer single drug instead of
preparation from plants
3. High alcohol content
AROMATIC WATERS
The British Pharmacopoeia (BP) defines aromatic waters
as clear, saturated aqueous solutions of volatile oils or
other aromatic or volatile substances.
Aromatic waters can be categorized in two types as-

1. Simple aromatic waters: They contain purified

water as a solvent but do not contain alcohol and
are mainly used as vehicles e.g. Chloroform water.

2. Concentrated aromatic waters: They contain

alcohol as solvent for the volatile constituents.
Examples of concentrated aromatic waters are Camphor
Water BP, Concentrated Peppermint Water BP,
Concentrated Caraway Water BPC, Concentrated
Cinnamon Water BPC, Concentrated Dill Water BPC,
Concentrated Anise Water BPC etc.
Methods of Preparation
Aromatic waters may be prepared by distillation or solution of the aromatic
substance, with or without the use of dispersing agents.

1. Distillation Method

The distillation method involves the placing of the coarsely ground

odoriferous portion of the plant or drug from which the aromatic water is to be
prepared in a suitable still, with sufficient purified water. Most of the volume of
water is then distilled. The excess oil collected with the distillate rises to the top
of the aqueous product and is removed. The remaining aqueous solution,
saturated with volatile material requires clarification by filtration.

This is the common method of preparation of aromatic waters although it is

slow and expensive one, e.g. Strong Rose Water NF and Orange Flower Water NF
are prepared by this method. These waters have active volatile constituents in
small quantities so it may be necessary to repeat the distillation process several
times.
2. Solution Method

This method is simpler, quicker and more economical as compared

to distillation method.

In this method, aromatic water is prepared by intermittently

shaking 2 ml (if liquid) or 2 g (if solid) of the volatile
substance with 1000 ml of purified water in suitable container
for a period of 15 minutes.

After the period of agitation the mixture is set aside for 12 hours
or longer to permit the excess oil and the solid substance to
settle.

Without further agitation the mixture is passed through a wetted

filter paper and Purified water added as needed to bring the
volume of the filtrate up to the prescribed quantity.
3. Alternative Solution Method

By this method, the volatile oil or suitably comminuted aromatic

solid is thoroughly incorporated with 15 g of powdered talc or a
sufficient quantity of kieselghur or pulp filter paper and to this
mixture is added 1000 ml of purified water.

The resulting slurry is thoroughly agitated several times for the

period of 30 minutes and then filtered.

Powdered talc, kieselghur and pulp filter paper work as filter aid
which renders the formulation more clear and also as
distributing agents for the aromatic substances that ultimately
increases the surface area of aromatic substances exposed to the
solvent action of water.

The distributing agents should be inert in nature.

Preparation of Concentrated Aromatic Water
These products are alcoholic, non aqueous preparations containing
2% of volatile oils.

They are 40 times stronger than the ordinary aromatic waters.

Many volatile oils contain aromatic part and non-aromatic part. The
aromatic portion is much more soluble in a weak alcohol than the
non-aromatic portion. Hence when a solution of the oil in 90%
alcohol is diluted with a limited amount of water the aromatic portion
of the oil remains in solution while the non-aromatic portion is
precipitated off, separating as an oily layer.

Therefore 50 g of talc is added for 1000 ml of preparation,

which acts as a distributing agent, and will absorb the non-aromatic
part.

The solution is agitated and set aside for a few hours and filtered.
Therapeutic Uses

Aromatic waters are pharmaceutical aid and used principally for

perfuming and flavoring the formulation. They can be used as an
excipients or bases or vehicles for formulation of other
pharmaceutical preparations. Aromatic waters may be used for some
special purposes like,
(a) Camphor water has been used as the vehicle in ophthalmic
solutions owning to its
ability to contribute refreshing and stimulating effect to the preparation.
(b) Rose water has an antioxidant activity. The Rose water cleanses,
tones and protects
skin from harmful environmental impacts.
(c) Hamamelis water known as witch hazel is employed as a rub,
perfume and as an
astringent in various cosmetic preparations, particularly in after-shave
lotions.
(d) Chloroform water has been used as preservative apart from its
flavoring nature.
Dose
The dose of simple aromatic waters is usually 15 to 30 ml but varies
from water to water.

Storage Conditions
Aromatic waters deteriorate with time and hence should be made
in small quantities and protected from intense light and excessive
heat. They should be stored in airtight, light resistance container in
cool place.
Aromatic waters should be protected from strong light and
preferably stored in containers which are stoppered with purified
cotton to allow access of some air but to exclude dust.

Specific Labeling Requirement

The label should have the caution ‘PROTECT FROM SUN LIGHT’
with red ink due to the presence of volatile constituent in the
preparation. This caution is more important in case of Chloroform
water as chloroform gets converted into poisonous phosgene gas.