Extraction and preparation of Galenicals

1. 1
EXTRACTION
AND
GALENICALS
Presented By
NARESH GORANTLA, M.Pharm.., (Ph.D)
Asso. Professor,
Balaji college of Pharmacy,
Ananthapuramu

2. Extraction:
• Extraction is the method of removing active
constituents from a solid or liquid (plant or
animal tissues ) using a liquid solvent.
 Extraction defined as the treatment of the plant or
animal tissues with solvent, whereby the
medicinally active constituents or API are
dissolved & most of the inert matter remain
undissolved.
 Menstruum: solvent used for extraction.
 Marc: the insoluble material that remains after
extraction.

3. GALENICALS
GALEN a Greek pharmacist of Rome who
described various methods of extracting the
crude drugs for the first time & hence the
branch dealing with the extraction of plant &
animal drugs is known as Galenical pharmacy &
the products as Galenicals.

4. Types of extracts
◦ Dry extract (Tab, cap.)
E.g. belladonna extract
◦ Soft (Ointment, suppository)
E.g. glycerrhiza extract.
◦ Liquid : As tincture.
• Extract : Extracts can be defined as preparations of
crude drugs which contain all the constituents which
are soluble in the solvent.
What are Extracts ???

5. Solvents used in Extraction
 Following solvents are generally used for extraction
 Water & Alcohol
 WATER: it is used as a solvent for protein, colouring
matter, gums, glycosides, sugars, alkaloidal salts,
enzymes, many organic acids & most of the organic
salts. Waxes, fats, fixed oils & most alkaloids are
insoluble in water.
 Disadvantages: fermentation, decomposition of the
preparation, chance to produce undesirable
substances & interfere with clarity of the preparation.
 Use of preservatives.

6. Water causes hydrolysis of many substances.
Larger amount of heat is required to
prepare aqueous preparations.
 ALCOHOL: it is used as a solvent for alkaloids, alkaloidal
salts, glycosides, volatile oils & resins. It also dissolves
many forms of colouring matter, tannins, many organic
acids & salts. Gums, albuminous matter, waxes, fats,
fixed oils & sugar those are not soluble in alcohol.
 ADVANTAGES: bacterial growth not occurs, if the
solution contains more than 20% alcohol, non-toxic,
small amount of heat is required.

7. Factors affecting extraction process
• Nature of drug
• Solvent
• Temperature
• p H
• Particle size
8

8. Methods of extraction
• Infusion
• Decoction
• Digestion
• Maceration
• Percolation
• Continues hot extraction
• Supercritical fluid extraction
• Counter current extraction
• Microwave assisted extraction
• Ultrasonication-Assisted Extraction

9. Infusion :
Types of Infusion :
• Fresh Infusion : e.g. Infusion of orange
• Concentrated Infusion : e.g. Conc. infusion of Quassia
It consists of pouring water over
the drugs and then allowing it to
keep in contact with water for the
stated period, usually 15 minutes,
with occasional stirring and
finally filtering off the liquid.
 The marc is not pressed.
 The boiling water is commonly used as a solvent, since
it has a greater solvent action than cold water.

10.  For the preparation of infusions the coffee pots or tea
pots or special infusion pots are used.
 In that, firstly drug is placed in bottom of the pot.
 Then add hot water & stirred three or four times
during the period of infusion.
 Infusion also prepared in muslin cloth. In that drug is
placed in muslin cloth & enclose & then suspending it
just below the level of the water in a beaker.

11.  FRESH INFUSION:
 Aqueous liquid used as a menstruum.
 It is prepared by…
 Coarse drug + Hot water then filter after some time.
 As per pharmacopoeia it is used within 12 Hrs after
formulation.
 e.g. fresh infusion of Quassia.
 CONCENTRATED INFUSION:
 It is eight times stronger than fresh infusion.
 In that 20 to 25 % alcohol conc. used as a menstruum.
 It is prepared by double or triple maceration process.
 It can be stored for a longer time of period.
 e.g. Concentrated infusion of Quassia.

12. Apparatus used for Infusion
(made of earthen ware,
stainless-steel, ceramic,
glass, porcelain…) to which
is fitted at certain height a
perforated tray upon which
the crude drug may be
allowed to rest in water
being poured over it.
The plant may be enclosed
loosely in a small muslin
bag and suspended in the
jar at a height where it will
be just covered by the
liquid.
Consist of covered jar

13. Decoction :
• In this process, the crude drug is
boiled in a specified volume of
water for a defined time; it is then
cooled and strained or filtered.
• After boiling, the liquid is strained
and water is passed through the
content of the strainer to make the
required volume.
• This procedure is suitable for
extracting water-soluble, heat stable
constituents.
e.g. Tea , Coffee

14. Digestion
• This is a form of maceration in
which gentle heat is used
during the process of
extraction.
• I t is used when moderately
elevated temperature is not
objectionable. The solvent
efficiency of the menstruum is
thereby increased.
e.g. Extraction of Morphine

15. Maceration:
• In this process solid ingredients are
placed in a stoppered container with the
whole of the solvent and allowed to
stand for a period of at least 3 days (3 - 7
days) with frequent agitation, until
soluble matter is dissolved.
• The mixture is then strained (through sieves / nets), the
marc is pressed and the combined liquids clarified
(cleaned by filtration) or by decantation, after standing.

16. Process of maceration :
Plant Material
(Crushed or cut small
or Moderately coarse
powder)
Placed in a closed vessels
Whole of the selected solvent
(Menstruum)added
Allowed to stand for seven
days shaking occasionally
Liquid strained off
Solid residue (marc)
pressed(Recover as much as
occluded solution)
Strained and
expressed liquids
mixed
Clarified by subsidence or
filtration
Evaporation and
Concentration

17. Types of maceration :
 Simple maceration: for organized and unorganized
Crude drug
e.g. i) Tincture of Orange
ii) Tincture of Lemon
 Double maceration : Concentrated infusion of orange
 Triple maceration: The maceration process
may be carried out with help of heat or
stirring

18. 16
SIMPLE MACERATION: for organized drugs e.g.
roots, stems, leaves etc.
 Alcohol is used as a menstruum.
 In this process, the drug is placed with the
menstruum in a closed vessel for seven days.
 At this period shaking is done occasionally.
 After seven days, the liquid is strained & marc is
pressed.
 The expressed liquid is mixed with strained
liquid.
 Then again filter for obtaining the clear liquid.
 The final volume is not adjusted.

19.  MODIFIED MACERATION or MACERATION WITH
ADJUSTMENT :
 for Unorganized drugs e.g. Gum, Resins, Gum-resins,
Oleo gum-resins.
 In this process, the unorganized drug is placed with
4/5th volume of menstruum in a closed vessel for seven
days.
 At this period shaking is done occasionally.
 After the stated period, the liquid is filtered & not
necessary to press the marc.
 After that, the final volume is adjusted with the
remaining quantity of 1/5th volume of menstruum
through the filter.

20.  DOUBLE MACERATION PROCESS: it is carried out in the
same way as simple maceration process, but menstruum
used is divided into two parts.
 In that process drug is macerated twice by using the
menstruum which is divided into two parts in such a
manner that the same volume is used for each
maceration.
i. Volume of menstruum req. for first maceration
Total Vol.of menstruum - Vol.to be retained by the drug + Vol.to be retained
by the drug
2
ii. Volume of menstruum req. for second maceration
Total vol.of menstrum – Vol. of menstruum used in first maceration

21.  In this process the whole drug is macerated for 48 hrs
with quty. of menstruum for first maceration.
 Strain the liquid & press the marc after 48 hrs.
 Then again macerated for 24 hrs with remaining quty.
of menstruum for second maceration.
 Strain the liquid & press the marc after 24 hrs.
 Then mix the liquids obtained from the two maceration
& allows it to stand for 14 days & then filter.
 e.g. Concentrated infusion of orange and Concentrated
compound infusion of chirata

22.  TRIPLE MACERATION PROCESS: it is carried out in the
same way as simple maceration process, but menstruum
used is divided into three parts.
 In that process drug is macerated thrice by using the
menstruum which is divided into three parts in a such
manner that the same volume is used for each maceration.
i. Volume of menstruum req. for first maceration
Total Vol.of menstruum - Vol.to be retained by the drug + Vol. to be retained
by the drug
3
ii. Volume of menstruum req. for 2nd & 3rd maceration
Total vol.of menstrum – Vol. of menstruum used in first maceration
2

23.  In that the drug is macerated for one hour witha part
of menstruum req. for first maceration & strained.
 Macerated again for one hour witha part of menstruum
for second maceration & strained.
 Macerated again for one hour with a part of menstruum
for third maceration & strained.
 After that, marc is pressed lightly.
 Then combine the liquids obtained from 2nd & 3rd
maceration & evaporated it to a specified extent.
 Then, mix it with the liquid obtained from 1st maceration
& add alcohol 90% equal to 1/4th of the volume of the
finished product.
 Then adjust the volume with water.
 Allow this solution for 14 days & then filter.
 e.g. Concentrated infusion of Quassia, Liquid extract of senna.

24. Percolation :
 It is continuous downward
displacement of the solvent
through the bed of crude drug
material to get extract.
 Most frequently used to extract
active ingredients in the
preparation of tinctures and
fluid extracts.
 It is the method of short
successive maceration.
A percolator (a narrow, cone-shaped vessel open at both
ends) is generally used.
conical cylindrical

25. 24

26. Steps in percolation :
1. Size reduction: The drug to be extracted is subjected to
suitable degree of size reduction, usually from coarse
powder to fine powder.
2. Imbibition: During imbibition the powdered drug is
moistened with a suitable amount of menstruum and
allowed to stand for four hours in a well closed
container.
3. Packing: After imbibition the moistened drug is evenly
packed into the percolator.
4. Maceration: After packing sufficient menstruum is added
to saturate the material. The percolator is allowed to stand
for 24 hours to macerate the drug.
5. Percolation: The lower tap is opened and liquid collected
therein is allowed to drip slowly at a controlled rate until
3/4th volume of the finished product is obtained.

27. Types of Percolation :
1.Simple Percolation :
Drug
e.g. i) Tincture of Belladonna
ii) Compound tincture of cardamom
2. Modified Percolation :
Repeated maceration is more effective than simple.
Multiple maceration – Solvent divided into equal
multiple time considering the solvent retained by plant
tissue.
Used to prepare concentrated preparation.
200gms
Imbibition
For 4 hours
Maceration
For 24 hours
Percolation and
collect the percolate
i.e.3/4th of the volume
of finished
preparation

28. 3. Reserved percolation:
• In this case the extraction is done through the general
percolation procedure.
• At the last, the evaporation is done under reduced
pressure in equipment like a Climbing evaporator to the
consistency of a soft extract (semi solid) such that all the
water is removed.
• This is then dissolved in the reserved portion which is
strongly alcoholic and easily dissolves the evaporated
portion with any risk of precipitation.

29. Merits :
Requires less time than maceration.
Extraction of thermolabile constituents can be possible.
Demerits :
Requires more time than soxhalation.
More solvent isrequired.
Skilled person is required.

30. Maceration
•Time consuming and also
extraction is not complete.
•Not required skilled operator
•For certain substances which are
very less soluble in solvent and
requires only prolonged contact
with solvent.
•Suitable method for less potent
and cheap drugs
Percolation
•short time and more complete
extraction
•Skilled operator is required
•Special attention should be paid
on particle size of material and
throughout process.
•Suitable method for potent and
costly drugs
Maceration Vs Percolation

31. Soxhalation
Side tube
Syphon
tube
Thimble
Distillation flask
Heating Mantle
Condenser

32. THE SOXHLET EXTRACTOR Continuous extraction of a
component from a solid mixture.
Boiling solvent vapors rise up through the larger side
- arm. Condensed drops of solvent fall into the porous
cup, dissolving out the desired component from a
solid mixture.
When the smaller side-arm fills to overflowing, it
initiates a siphoning action.
The solvent, containing the dissolved component, is
siphoned into the boiler below residual solvent then
drains out of the porous cup, as fresh solvent drops
continue to fall into the porous cup.
. . . and the cycle repeats . . .

33. Merits :
• Large amount of drug can be extracted with much
smaller quantity of solvent.
• Tremendous economy in terms of time, energy &
ultimately financial inputs.
• Small scale & used a batch-process.
• Becomes more economical when converted into
continuous extraction.
Demerits :
• Physical nature of drug.
• Solvent.
• Chemical constituent of drug.

34. Preparation of Galenicals
• Infusions
• Tinctures
• Spirits
• Extracts

35. Tinctures
• According to IP, Tinctures can be defined as
alcoholic or hydroalcoholic solutions usually
containing active principles of vegetable or
animal origin.
• Methods of preparation:
1. Maceration Process ( Process M)
2. Percolation process ( Process P)

36. 1. Maceration (Process M):
• This method is suitable for drugs which
contain large portion of soluble constituents
and which can not be packed uniformly in
percolator.
• Place the solid material with the whole of the
menstruum in a closed vessel and allow to
stand for 7 days, shaking occasionally.
• Strain, press the marc and mix the liquids
obtained and clarify by filtration.
• Ex: Capsicum tincture, Compound cinchona
tincture.

37. 2. Percolation process (Process P):
Most commonly employed in the preparation of
official tinctures.
• Moisten the solid materials with a sufficient quantity of
the menstruum, allow to stand for 4 hours in a closed
vessel, pack in a parcolator and add sufficient of the
menstruum to saturate the materials.
• When the liquid commences to drip from the percolator,
close the outlet, add menstruum and alow to stand for 24
hrs.
• Allow percolate to proceed slowly until the percolate
measures about three quarters of the volume required.
• Press the marc, make up the volume with menstruum.
• Ex: Aconite tincture, Belladonna tincture, Compound
cardamom tincture.

38. Preparation of Compound cardamom tincture
• Cardamom seeds
• Caraway
• Cinnamon
• Amaranth
• Glycerin
• Alcohol (45 %) QS.
Preparation:
• Cardamom seeds, caraway, cinnamon are powdered and
mixed. Mixed powders are moistened with alcohol and
percolated to about 9/10th of the final product.
• Glycerine and Amaranth are added and the final volume
is made up with alcohol.
• Dose: 2-4 ml
• Use: Carminative.

39. SPIRITS
• Spirits consists of alcoholic or hydro alcoholic solutions
of volatile substances.
• Spirits are used internally for their medicinal value and
as flavoring agents, and also applied externally or used
by inhalation.
• For oral use, spirits are generally diluted with a portion
of water to reduce the pungency of the spirit.
• Spirits should be stored in tight, light resistant containers
and in a cool place.

40. Method of preparation of Spirits
1. Simple Dissolution: Majority of the spirits are
prepared by this method, which involves
dissolving the solute in alcohol by agitation.
Ex: Chloroform spirit, Spirit of Ether.
2. Solution with Maceration: Macerating the leaves
of the crude drug in a suitable solvent to extract
the desired constituents. Purified water is added
to extract the soluble matter. After expression
the macerated leaves are added to prescribed
quantity of alcohol, filtered and added to the
final liquid.
Ex: Peppermint spirit.

41. Method of preparation of Spirits
Cont…
3. Chemical reaction: Spirits are prepared by the
chemical reaction between the ingredients.
Ex: Aromatic Ammonia spirit USP, Ethyl nitrite Spirit.
4. Distillation: Spirits are prepared by using
distillation process.
Ex: Aromatic spirit of Ammonia, Brandy, Whiskey.

42. Preparation of Chloroform Spirit
• Chloroform
• Alcohol (90%) QS
• Chloroform spirit consists of a 5 % v/v solution
of chloroform in alcohol 90 %.
• It contains 83 to 87 % of alcohol.
• Dose: 0.3 to 1 ml
• Storage: Well closed container, in a cool place.

43. EXTRACTS
• Extracts are the isolated soluble material from an
insoluble residue, which may be liquid or solid, prepared
by treating with a solvent.
Types of Extracts:
• Aqueous extracts – prepared using water which are
medicinal preparations intended to be used immediately
after preparation.
• Liquid extracts – termed as fluid extracts, is a liquid
preparation of crude drugs which contain ethyl alcohol
as a solvent and also can act as preservative.
• Soft extracts – which are produced as semisolids or
liquids of syrupy consistency (Glycerrhiza extract)
• Dry extracts – also known as powdered extracts or dry
powders (Belladonna extract)

44. THANK