Phytopharmaceutical

Technology
CJB 40303
 Method of Assesment
• Tests 20%
• Lab Report 40%
• Assignment 10%
• Final Exam30%
• Total100%
 Objective
• To impart knowledge onto students on the
various type and form of phyto
pharmaceutical including product and
quality control.
 Learning Objectives
• At the end of this module the students will be
able to:
– Describes forms of medicine available
– Prepare certain types of phytopharmaceuticals
products
– Identify materials used phytopharmaceuticals
– Describes methods applied in phytopharmaceuticals
production
– Describe and use apparatus and machineries involve
in phytopharmaceuticals production
– Describe the quality assurance method to be applied
 Contents
1. Medicinal Form
2. Material in Phytopharmaceutical
3. Product Processing
4. Apparatus and Machinery
5. Quality Assurance in
Phytopharmaceuticals
 Topic 1:Medicinal Form
1.1 Introduction to Phytopharmaceuticals
Technology
• Phytopharmaceuticals are those
products derived from plant materials.
• Produced from fresh or dried, preserved
plant parts by expression, extraction,
distillation,and other operations.
 Topic 1:Medicinal Form cont..
• Manufacturing process include stages to
remove ballast material such as:
chlorophyll, tannins, resins, etc.
• Produce a selective enrichment of the
active principles continued to finally pure
active substance isolated.Still don’t define
phytopharmaceuticals
 Topic 1:Medicinal Form cont..
• Pure natural products such as:
– Morphine
– Hyoscyamine
– K-strophantin
• Are not regarded as phytopharmaceuticals
• Phyotpharmaceuticals should always contains
the active principles together with coexisting
materials from the source plant,these additional
materials having a lesser or greater beneficial
influence upon the activity of the drug.
 Topic 1:Medicinal Form cont..
• A phytopharmaceutical may frequently not
represent the final dosage form
administered to the patient.
• Eg: Dry extract are further processed to
produce powder mixtures, tablets,
suppositories and other dosage forms.
• List of phytopharmaceuticals to aid
formulation such as de-enzymized acacia
gum and gum tragacanth.
 Topic 1:Medicinal Form cont..
• Use of phytopharmaceuticals in medicine
also called phytotherapy.
• Differences opinion are often encountered
concerning the use of this term.
 1.2 Medicinal Forms from Fresh
Plant
1.2.1 Fruit Pulps
• Solid or pasty viscid preparations which to be
taken internally
• After removal of any hard components parts of
fruit to be used are crushed
• Fruit pulps with certain additives still used
medicinally though now as purgatives
• Pharmacopoeias tend not to include pulps
• Fruit pulps are important as intermediate
products in the food industry, in soft drinks
industry.
 1.2.2 Juices. Succi
• Juice or Succi used for wide variety of
phytopharmaceutical preparations
manufactured.
• Different from conventional
• Succi Inspissati obtained by careful
concentration of aqueous extract.
• Other plant juices such as aloes, opium or
crude rubber are not classified as
juices.(Juices not obtained by expression)
 1.2.2.2 Press Juices
• Obtained from fresh fruits or other juice rich
plant parts
• When fresh parts of plant are pulverized and
crushed, especially such pulps left to stand,
enzymatic processes take place and original
plant constituents are modified.
• Stabilization is necessary if uncontrollable
enzymatic reaction alterations are to be
prevented.
 1.2.2 Syrups
• Liquid preparations with a higher sugar
content,which when they contains juices or
alcoholates can be regarded as plant
preparations.
• Mostly used as flavourings
• Some dispensatories permit the addition of
polyalcohols eg. Sorbitol and glycerol,
starch PEG to retard crystallization
 1.2.2.1 Blackcurrent syrup (BP
2005)
• Can be prepared from the clarified juice of
black currants or from commercially
available concentrated juice.
• Black Currant Syrup is prepared either
from the clarified juice of Black Currant or
from concentrated black currant juice of
commerce. It contains a suitable
antioxidant. Permitted food grade colours
may be added.
 1.2.2.1 Blackcurrent syrup (BP
2005) cont…
• Production
• It is prepared by dissolving 700 g of Sucrose
either in 560 ml of clarified juice, previously
diluted with Water to a weight per ml of 1.045 g,
or in 560 ml of a solution of the same weight per
ml prepared from the concentrated juice of
commerce and Water, and adding to this
solution sufficient Benzoic Acid to give a final
concentration of not more than 800 ppm, or
sufficient Sodium Metabisulphite or other
suitable sulphite to give a final concentration of
not more than 350 ppm of sulphur dioxide.
 1.2.2.1 Blackcurrent syrup (BP
2005) cont…
• Storage
• Black Currant Syrup should be kept in a well-
filled container and protected from light.
• Black Currant Syrup contains, in 10 ml, about
7.5 mg of ascorbic acid.
• The requirement for Content of ascorbic acid
does not apply when Black Currant Syrup is
used as a flavouring agent for pharmaceutical
purposes.
 1.2.2.2 Raspberry BP
• Can be prepared by diluting 1 volume of
concentrated raspberry juice with 1 l
volumes of sugar syrups.
• Addition of permitted food colourings is
allowed
 1.2.2.3 Cherry syrup USP
• Can be prepared by dissolving 800 g of
sucrose in 475 ml of cherry juices by
gentle heating in a water bath.
• The solution is then cooled and froth
formed removed.
• Ethanol (20 ml) and water added to bring
to final volume to 1 L.
 1.2.3 Homoeopathic Preparations
from Fresh Plant
• Medicinal plants used in homoeopathy are made
from fresh plants, or plant parts.
• Juice content and its composition are important
as they govern the choice between various
method of preparing the ‘mother tinctures’
• According to Hahnemann the fresh plant
material and hence the mother tinctures
generally prepared by one of the methods from
HAB 1 Homoeopathic Pharmacopeia
 1.2.3 Homoeopathic Preparations
from Fresh Plant cont..
• Method 1
– If the plants contains more than 70%
expressible juice but neither ethereal oils,
resins nor mucus.
• Method 2a or 2b
– If the plants contains more than 70%
expressible juice, more than 60% moisture
(loss upon drying) and no ethereal oils or
resins.
 1.2.3 Homoeopathic Preparations
from Fresh Plant cont..
• Method 3a, 3b or 3c.
– If the plants contain ethereal oils and resins or
less than 60% moisture (loss upon drying).
 1.2.4 Alcoholates
• Prepared from fresh plants, or part of plants, by
maceration with ethanol.
• Generally recovered only from those plants
which the essential contituents would be
completely or partially lost during drying
• The plants are ground and macerated with cold
ethanol.
• Stabilized alcoholates obtained by extraction
from fresh plants or plants part by boiling under
reflux (To denature plant enzyme which impair
the preserving propoerties of alcoholates
 1.3 Dosage Forms from Drugs
• In German pharmaceuticals Drogen = Drugs
signifies dried whole plants or parts.
• Drugs are named after the part of the plants
used. Dilg and Juttner produced a table of
nomenclature. Part of drug plants
Plant part Meaning Example

Amylum Starch Amylum Tritici

Balsamum Balsam Balsamum

Copaivae
Radix Root Radix
Gentianae
 1.3 Dosage Forms from Drugs
• The so-called drugs, which are
coarse,uncut, and unground pieces of
starting materias (though finely particulate
starting materials of a similar nature (e.g.
starch) are also included), the degree of
pulverization is also used for the naming of
drugs, especially in pharmacopoeias
 1.3 Dosage Forms from Drugs
• Drugs in which largest particles have a maximum
diameter of 4 mm (coarsely shredded), 3 mm
(moderately finely shredded) or 2 mm (finely shredded)
are regarded as cut or shredded drugs.
• Drugs in which largest particles have a maximum
diameter of 0.75 mm (coarsely powdered), 0.30 mm
(moderately finely powdered) or 0.15 mm (finely
powdered) are regarded as powdered or pulverized
drugs.
• Granule or particle sizes for drugs given do not differ
significantly from one another in the sizes they quoted.
 1.3.1 Herbal Remedies, Herbal
Teas
• Simplest medicinal plant preparations are teas or
infusions made from one or mixture of drug plants.
• In Pharmacopoeias complete instruction to ground in
different sizes
• Grinding to required granule sizes usually done by drug
importer or manufacturer on an industrial scale.
• Necessary mechanical processing is carried out in the
pharmacy only when the herbal remedy has to be made
up by pharmacist or in the case of certain special drugs
such as linseed and Umbelliferae fruits or other ethereal
oil fruits as prescribe
1.3.1 Herbal Remedies, Herbal
Teas
 1.3.1 Herbal Remedies, Herbal
Teas
• Lab scale toothed disc mills,aka linseed
crushers, suitable for all small quantities
involved.
• The grinding should be done immediately
before despatch, loss of ethereal oils upon
storage and become rancid.
• Linseed used as mild laxative because
swelling, mucus-forming constituents.
 Standardized Drug Powders
• Accurate dosing of potent drugs requires the
exact determination of their active substance
content.
• Standardized powders are therefore used for
dispensing and in pharmacies
• Ph Eur and DAB 8 contain a series of
monographs which only briefly describe the
preparation of drug powders.
• A minimum and maximum value or content of
active constituents is given in every case.
 Standardized Drug Powders
• In all cases the active substance content of the
powdered drug to be standardize is then
determined for the given maximum granule or
particle size.

• In the latter case, where the powdered drugs is

too strong it must be adjusted to the required
content by mixing with an inert material. The
Pharmacopoeias recommend lactose or low-
content drug powders as such diluents.
 1.3.2 Drug Extracts
• Drug extracts are preparations obtained by extracting
drugs of certain particle size with suitable extraction
agents (menstrua).
• Extraction can be accomplished by various methods.
• The extracts obtained after separation of the liquid from
the drug residue is called miscella.
• May already represent the final liquid dosage form or
intermediate
• Five methods given for preparation of extracts. 3 of them
using are used for the preparation of ‘aqueous drug
extracts’: the others, maceration and percolation, partly
give ready to use medicinal preparations.
 1.3.2 Drug Extracts
• The pharmacopoeias permit the use of other
methods of preparation of ‘extract’ if products
with the same properties as those obtainable by
the pharmacopoeia method can be obtained.
This only applies to the extract listed in
Pharmacopoeia
• Aqueous drug extracts
• Decoctions
• Infusions
• Macerates
• Tinctures