Definition, Functions of excipients, Ideal properties, Advantages, Disadvantages of herbal excipients, Classification of excipients Natural colorants, Natural sweeteners, Natural binders, Natural diluents, Viscosity builders, Disintegrating agents, Natural perfumes & flavoring agents

1. HERBAL EXCIPIENTS
Presented By:
Mahewash Sana A. Pathan

2. Contents:
• Definition
• Functions of excipients
• Ideal properties
• Advantages, Disadvantages of herbal excipients
• Classification of excipients
• Natural colorants
• Natural sweeteners
• Natural binders
• Natural diluents
• Viscosity builders
• Disintegrating agents
• Natural perfumes & flavoring agents
2

3. PHARMACEUTICAL EXCIPIENTS:
• According to International Pharmaceutical Excipients
Council-
“substance other than the active drug substance which
has been appropriately evaluated for safety & are included
in a drug delivery system to either aid the processing of the
drug delivery system during its manufacture, protect,
support or enhance stability, bioavailability, assist in
product identification, or enhance any other attributes of
the overall safety & effectiveness of the drug delivery
system during storage or use.”
• Pharmaceutical excipients are inactive substances added to
medicinally active compounds to formulate dosage form.
3

4. FUNCTIONS OF EXCIPIENTS
• Add bulk to the formulation
• During manufacturing, helps to handle API.
• Assist in drug administration
• Enhance patient compliance
• Enhance drug solubility & bioavailability.
• Avoid drug degradation
• Give robust & reproducible result of formulation
• Modify the pH & osmolarity of liquid dosage form.
• Helps in particle dispersion
• Helps to mask unpleasant taste, odor, color.
• Helps to maintain stability.
4

5. 5

6. IDEAL PROPERTIES OF EXCIPIENTS
• They can be used practically.
• They should be non toxic & nonirritant
• Should be non volatile in nature.
• Should not be affected by temperature, light & hydrolysis.
• Should be easily available & cheap.
• Should not have specific color, odor & taste.
• Should possess good water & lipid solubility.
• Should be compatible with active ingredient in the
preparation
• Should be pharmacologically inert.
6

7. 7

8. • ADVANTAGES OF HERBAL EXCIPIENTS: Natural
excipients are Biocompatible, economic, easily available, less
toxic, have soothing action & nonirritant, safe &
biodegradable, and can be chemically modified.
• DISADVANTAGES OF HERBAL EXCIPIENTS: they are
prone to microbial contamination, yield & chemical
composition of natural excipients vary in different conditions,
there are possibilities of heavy metal contamination.
8

9. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on regulatory aspects-
Herbal excipients
Approved
excipients
Intermediate
category essentially
new excipients
New compounds
9

10. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Source-
Herbal
excipients
Animal source
E. g. Bees wax, cochineal, honey, etc.
Vegetable source
E.g. Pectin, starch, cardamom, vanilla, etc.
Mineral source.
E. g. bentonite, kaolin, paraffin, etc.
Marine Source
E. g. Agar, chitin, alginates, etc.
Synthetic products
E. g. PEG’s, Povidone, etc.
10

11. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Chemical nature-
Herbal
excipients
Alcohols Esters,
ethers,
Aldehydes,
carboxylic
acids.
Glyceride
s &
waxes
Carbohyd
rates
Hydrocarbon
& halogen
derivatives
Polymers
Minerals
Proteins
Preservatives,
dyes,
sweeteners,
surfactants.
11

12. CLASSIFICATION OF HERBAL EXCIPIENTS
Based on Application of excipients-
Herbal
excipients
Filler
lubrican
ts
Binders
Disinteg
rating
agents
Coating
agent
Anti
oxidant
Colouring
agent
Flavoring
agent
Buffering
agent
Solvent
Chelating
agent
Viscosity
builder
Surface
active
agent
12

13. NATURAL COLOURANTS
Natural colorants are highly colored compound capable to
impart colour to fabric, leather, drugs, cosmetics, & plastic.
Advantages of natural colorants:
1. Natural colourants are soft, lustrous and soothing.
2. Wide ranges are available.
3. They are usually renewable.
4. Eco-friendly & stable.
5. Non hazardous to human health.
6. Show some medicinal properties.
13

14. 1. HENNA
Synonym: Egyptian private, Mignonnette,
Mahendi.
B/S: Dried leaves of Lawsonia inermis, Family-
Lythraceae.
G/S: North Africa, India, Srilanka.
C/C: Lawsone (2,5-Dihydroxy-1,4-
naphthoquinone),
phenolic glycosides, coumarians,
xanthene,flavonoides,
fats,resine, tannins.
Chemical test: on addition of acid in decoction of henna, orange
red colour vanishes. On addition of alkali colour darkens.
Application: as hairdye, colourant in other cosmetics.
14

15. 2. TURMERIC
• Synonym: Haldi, Indian saffron.
• B/S: Dried, fresh rhizomes of plant Curcuma
longa, family- Zingiberaceae.
• G/S: India, china, Malaysia, Italy & Australia.
• C/C: 5% volatile oils, resin & diaryl heptanoid
yellow couring substance called as
Curcuminoids. Other phytoconstituents are
atlantone, demethoxycurcumine, tumerone,
sugars, minerals, etc.
• Chemical test: Curcumin gives crimson red
colour with sulphuric acid.
Application: As a
colourant in various
phrmaceutical
dosage forms,
cosmetics & food
products.
15

16. 3. ANNATO
• Synonym: chiote tree, lipstick tree
• B/S: dried seeds of Bixa orellana, fam-
Bixaceae.
• G/S: Central & South America, India.
• Description: Bixin occurs as orange
yellow crystals or dark red brown to red-
purple powder.
• Chemical test: annatto dissolved in
acetone shows absorbance maxima at
about 425, 475 & 487 nm.
• Applications: Colouring & coating agent
for solid & liquid pharmaceutical dosage
forms. In manufacture of wood stains &
varnishes & for silk dyeing.
16

17. 4. INDIGO
• Synonym: Neel, indigo
• B/S: Leaves of Indigo tinctoria, I.
suffruticosa, family- Leguminoseae.
• G/S: India, America, Europe, Africa.
• Description: dye occurs as dark blue
crystalline powder. Dye is insoluble in water,
alcohol or ether but soluble in DMSO,
chloroform, nitrobenzene.
• C/C: glycoside Indican, rotenoids deglelin,
dehydrodeguelin, rotenol, rotenone,
tephrosin & sumatrol.
• Application: colourant in pharmaceutical &
food industry, dyeing of jeans, etc.
17

18. NATURAL SWEETENERS
• These are the substances which are added to drug formulation
to mask bitter taste & can be used by diabetic patients also.
• Natural sweeteners are sacharide & non-saccharide type. Non-
saccharide sweeteners are of various types such as terpenoids,
dihydrochalcones, dihydrocoumarins, sweet proteins, & steroidal
saponins.
• Advantages:
1. They are non-calorific in nature.
2. Have less possible side effects.
3. Quality & quantity can be improved by modern technologies.
4. Economic
5. No rise in blood sugar level
6. Avoid decay of teeth.
18

19. 1. STEVIA
• Synonym: honey leaf, sugar leaf
• B/S: extracted from plant Stevia
rebaudiana, Family- Compositae.
• G/S: Paraguay, South brazil, Japan,
South east Asia, USA, etc.
• C/C: diterpene glycoside, Stevioside. Application: natural
calorie free sweetener in
liquid or solid foods,
beverages. Substituent
for conventional sugars.
Sweetening agent of
choice for diabetic
patients.
19

20. 2. LIQUORICE
• Synonym: Yashtimadha, mulethi,
Liquorice root.
• B/S: dried peeled, unpeeled roots &
stolons of plant Glycyrrhiza glabra,
Fam- Leguminoseae.
• G/S: mediterranean region & china,
france, italy, spain, USA, england, Asia
& India.
C/C: pentacyclic triterpenoid
saponin, Glycyrrhizin.
Chemical test: with 80%
sulphuric acid, it shows deep
yellow colour.
Application: sweetener,
flavouring agent, foam
stabilizer. 20

21. 3. SERENDIPITY BERRY
• Synonym: Monellins
• B/S: Fruits of plant Dioscoreophyllum
volkensii, family- Menispermaceae.
• G/S: Tropical Africa
• Description: Readily soluble in water,
denatures at higher temperature.
• C/C: Sweet protein, Monellin.
• Use: As table top sweetener.
21

22. 4. THAUMATIN
• Synonym: Talin, Katemafe fruit
• B/S: arils of fruits of the tropical
plant Thaumatococcus daneilli,
Fam- Marantaceae.
• G/S: West Africa
• C/C: Thaumatin protein.
• Description: 2000-10000 times
sweeter than sucrose. Water &
dilute alcohol soluble.
• Use: low caloric sweetener &
flavouring agent.
22

23. NATURAL BINDERS
• Binders are excipient which binds all ingredients used in
formulation to form suitable dosage form.
• Natural binders are less toxic, can be degraded naturally,
economic, available easily & abundantly & enhance stability &
texture to dosage form.
Binders
Solution binder
eg. Gelatin, cellulose
Dry binders
eg. MC, PEG.
23

24. 1. ACACIA
• Synonym: Indian gum, Babul.
• B/S: it is dried gummy exudation from the
stems & branches of Acacia arabica, A.
senegal, Fam- Leguminoseae.
• Description: it occurs as yellowish white or
white flakes, spherical spheres, powder,
granules, or spray dried powder.
• C/C: Arabinose, galactose, rhamnose, &
glycuronic acid.
• Chemical test: When acacia powder is
treated with lead sub acetate, it gelatinizes
the aqueous solution.
Use: As a natural
binder for tablets,
suspending agent,
emulsifying agent,
thickener. As base in
pastilles & lozenges.
24

25. 2. TRAGACANTH
• Synonym: Gum tragacanth, Persian tragacanth.
• B/S: dried gum obtained from plant Astragalus
gummifer, Fam- Fabaceae.
• G/S: Iraq, Iran, Syria, Turkey, Afghanistan, Pakistan &
Russia.
• Description: Tragacanth has flat, lamellated, curved
fragments, or straight or spirally twisted linear
pieces. It is white to yellowish in colour, translucent,
odourless with mucilagenous taste.
• C/C: water soluble & water insoluble
polysacharides. Bassorin, cellulose, starch, protein &
ash.
• Chemical test: when strong iodine solution is added
to tragacanth, it developes olive green colour.
• Use: used to make various pharmaceutical
formulations like creams, gels, & emulsions. 25

26. 3. STARCH
• Synonym: Amido, Amidon, Amylum
• B/S: it is polysaccharide obtained
from grains like corn (Zea mays) Fam- Gramineae,
potato (Solanum tuberosum) Fam- Solanaveae,
wheat (Triticum aestivum) &
rice (Oryza sativa), fam- Poaceae.
• Description: odourless, tasteless, fine white coloured powder.
Practically insoluble in cold ethanol & in cold water.
• C/C: Amylose & amylopectin & α-glucose.
• Chemical test: starch solution is heated with HCl & then neutralized
by NaOH, the solution is heated with Fehling’s solution, brick red
ppt is produced.
• Use: it is a binder of choice in wet granulation & tablet
formulation. Has wide applications in nasal, oral, periodontal novel
drug delivery system & to get site specific drug delivery.
26

27. 4. GELATIN
• Synonym: Byco, Cryogel, Instagel, Solugel
• B/S: it is a protein obtained by partial acid or alkaline hydrolysis of
animal collagen tissues like bone, skin, tendon & ligaments.
• Description: faintly yellow amber coloured vitreous, brittle solid.
Odourless & tasteless. Practically insoluble in water, most of organic
solvents, fixed oils & volatile oils. soluble in hot water, glycerol, &
acetic acid.
• C/C: Glycine (25-27%), alanine, glutamic acid, proline, arginine,
aspartic acid, hydroxy proline, isoleucine, leucine, phenyl alanine &
tryptophan.
• Chemical test: gelatin powder, when heated with soda lime, evolves
ammonia gas.
• Use: used in implantable delivery systems, mainly hard & soft
gelatin capsule. In formulation of suppositories, pastilles, pessaries,
pastes. Absorbable gelatin sponge acts as haemostatic agent.also
used in food industry & in photographic emulsion. 27

28. NATURAL DILUENTS
• Natural fillers or diluents are the substances which enhance
the bulk of solid dosage form or may dilute liquid
formulations.
• They are biodegradable, do not have toxicity, economic & eco-
friendly in nature.
• They provide proper structural form & assure proper weight
for easy administration.
28

29. 1. CELLULOSE
• Synonym: Arbocel, E460, Elcema,
Sanacel.
• B/S: It is a polysaccharide & is a
structural compound found in the cells of
plants, algae & few bacteria.
• Description; it is white, odorless, &
tasteless powder varying particle sizes.
Practically insoluble in water & most of
the organic solvents.
• Chemical test: with Schulze reagent
cellulose shows purple colour.
• Use: diluent for tablets, filler for hard
gelatin capsule, helps in direct
compression of granules, as a suspending
agent, in manufacturing of pellets & in
cosmetics & food industry.
29

30. 2. LACTOSE
• Synonym: milk sugar, Lactin, lactosum.
• B/S: It is a natural disaccharide of animal origin consisting of
galactose & glucose & obtained from milk of most of
mammals.
• Description: It is white crystalline powder, odorless, faintly
sweet taste. It is hygroscopic at high relative humidity.
• Chemical test: when lactose is mixed with water & heated on
water bath with 10M ammonia, it shows red colour.
• Use: as diluent in tablets, capsules, dry powder inhalations.
As a coating agent with sucrose. Used to prepare lyophilized
products.
30

31. 3. MANNITOL
• Synonym: Cordycepic acid, manna sugar, D-mannite, Mannogem
• B/S: It is exudation from the stem of Fraxinus ornus, fam-
Oleaceae.
• Descriptoin: It is white, crystalline powder or free flowing granules.
It is odourless, non-hygroscopic, & sweet powder. Soluble in
alkalies, ethanol(95%), glycerin & water. insoluble in ether.
• Use: diluent for tablet formulations, helps in direct compression,
acts as sweetening agent, in formulation of antacid preparations,
acts as thickening agent, plasticizer in soft gelatin capsules.
Therapeutically acts as osmotic diuretic, as diagnostic agent for
kidney function, in treatment of acute renal failure, cerebral edema
& to reduce intraocular pressure.
31

32. VISCOSITY BUILDERS
• These are the aqueous solutions to increase its viscosity
without altering properties.
• The inhibit crystal growth, improve physical stability, prevent
formation of stable crystal from metastable crystal.
• Types:
1. Natural gums E.g. acacia, tragacanth, xanthan gum, etc.
2. Cellulose derivatives E.g. Methyl cellulose, ethyl cellulose,
CMC
3. Chitosan
4. Synthetic polymers E.g. carbomer, PVA
5. Clays E.g. Magnesium aluminium silicates, bentonite, etc.
32

33. 1. XANTHAN GUM
• Synonym: corn sugar gum, Keltrol, Rhodigel.
• B/S: It is a polysaccharide produced by fermentation using the
bacterium like Xanthomonas compestris.
• Description: It is a cream or white coloured, odourless, free
flowing, fine powder. Practically insoluble in ethanol & ether,
soluble in cold or warm water. in market, it is available in potassium
& sodium salts.
• Chemical test: Xanthan gum is suspended in 0.1 N HCl, flask is
closed with formation bulb containing barium hydroxide & heated.
BaOH solution shows white turbidity.
• Use: It acts as good emulsifying agent, stabilizer & thickener,
viscosity enhancer for oral & topical pharmaceutical formulations,
cosmetics & foods. It can be added to sustained release matrix &
ophthalmic liquid dosage forms.
33

34. Fig: Xanthan gum
34

35. 2. CARRAGEENAN
• Synonym: Chondrus extract, Irish moss extract.
• B/S: It is sulphated polysaccharide obtained from the red algae
Chondrus crispus, family- Rhodophyllaceae.
• G/S: it is produced at North Atlantic coast of Europe, North
America, France, Spain, Denmark & USA.
• Description: It is yellow-brown to white coloured, coarse to fine
powder, without any taste. it is water soluble & stable at pH 9.
• C/C: It mainly consist of K, Na, ca, Mg, & ammonium sulfate esters
of galactose & 3,6-anhydrogalactose copolymers.
• Chemical test: It becomes translucent & gelatinous when soaked in
cold water.
• Use: In preparation of suspensions, emulsions, gels, creams,
lotions, eye drops, suppositories, tablets, capsules, etc. It is
excipient of choice for oral & buccal drug delivery. Also used for
microencapsulation of proteins & probiotic bacteria.
35

36. Fig: Carrageenan
36

37. 3. GUAR GUM
• Synonym: Guaran, guar flour, Jaguar gum
• B/S: It is a galactomannan polysaccharide obtained from
endosperm of the seeds of the guar plant, Cyamopsis
tetragonoloba, family- fabaceae.
• G/S: India, Pakistan, U.S, Australia & Africa.
• Description: It is white to yellowish white powder, odorless,
blend taste, insoluble in organic solvents.
• Chemical test: with 2% lead acetate, it gives precipitate.
• Use: As a binder, disintegrant, suspending, thickening, &
stabilizing agent, in controlled release carrier dosage forms.
Commonly used in food & cosmetic industry.
37

38. Fig: Guar gum
38

39. DISINTEGRATING AGENTS
• They help in dispersion or disintegration of tablets & release
contents of capsules into small fragments.
• They act by various mechanism such as swelling , penetration,
de formation & repelling.
• They are effective in low concentration, do not affect
compressibility, more effective at intra-granular region.
• But, they have high cost, can cause side effects, have less
patient compliance.
39

40. 1. CHITOSAN
• Synonym: Deacetylated chitin.
• B/S: it is natural polysaccharide obtained from crab and
shrimp shells.
• Description: Odourles, white or creamy-whit powder or
flakes, sparingly soluble in water & conc. Organic acids.
• Chemical tests: with iodine and 10% sulphuric acid, it forms
deep violet colour
• Use: used in controlled drug delivery , mucoadhesive dosage
forms rapid release, improved peptide delivery, colonic drug
delivery systems, and for
40

41. 2. PREGELATINIZED STARCH
• Synonym: Compressible starch, Intastarch, Pharma-Gel, Prejel
• B/S: It is obtained from modification of potato starch.
• Description: It occurs as a moderately coarse to fine, white to
off-white colored powder which is odourless & has
characteristic taste. Practically soluble in organic solvents,
slightly soluble in cold water.
• Composition: 5% free amylose, 15% amylopectin, 80%
unmodified starch
• Chemical test: When solution is treated with iodine solution,
it forms reddish violet to blue color.
• Use: as a disintegrants, binder & diluent in tablets & capsules.
41

42. 3. MICROCRYSTALLINE CELLULOSE
• Synonym: Avicel, Celex, Cellulose gel
• B/S: obtained from partial depolymerisation of cellulose.
• Description: white, odorless, tasteless, crystalline powder
having porous particles. Slightly soluble in 5%w/v NaOH
solution & practically insoluble in water, dilute acids & organic
solvents.
• Chemical test: it is heated with phosphoric acid & catechol for
30 min, produce red color.
• Use: as a lubricant, disintegrating agent, binder or diluent in
oral tablet & capsule formulations.
42

43. NATURAL PERFUMES & FLAVOURING AGENTS
• Natural perfume are the mixture of essential oils or aromatic
compounds, fixatives, & solvents applied to the human body,
animal, food objects, pharmaceutical products & living spaces.
• Flavours are taste masking agents used to mask the
unpleasant taste or odour of dosage form & enhance the
flavour of medicine & patient compliance.
43

44. 1. SANDAL WOOD OIL
• Synonym: Chandan
• B/S: it is volatile oil obtained by steam distillation of
heartwood of Santalum album & S. spicatum, Family-
Santalaceae.
• Description: colorless to golden yellow in color with pleasant
woody odor. It is oily, viscous liquid, soluble in 5 vol of 70%
alcohol.
• Use: in aromatherapy, in cosmetics, soap, perfue, to treat
common cold, bronchitis, UTI & inflamation.
44

45. 2. ROSE OIL
• Synonym: Otto of rose, Attar of rose, Rose essence.
• B/S: It is volatile oil obtained by distillation of fresh flowers of
Rosa damascena, R. centifolia, family- Rosaceae.
• Description: colourless or yellow liquid with characteristic
odour of rose, rose oil is miscible in 1ml chloroform.
• Chemical test: rose oil is mixed with equal quantity of
chloroform & 90% alcohol, At 20°C, it deposits crystals within
5 min.
• Use: flavouring agent, perfume, hydrate dry skin, to treat
acne, reduces signs of ageing, scars & to treat eczema.
45

46. 3. LEMON OIL
• Synonym: Limbu, oleum limonis
• B/S: obtained from fresh peel of the ripe fruits of Citrus
lemon, Family- Rutaceae.
• Description: pale greenish-yellow in colour with sharp, fresh
smell, bitter taste & has watery viscosity.
• Chemical test: solution of lemon oil with 3 vol of alcohol is
neutral to slightly acidic in nature.
• Use: Flavouring agent, perfume, treat fever, throat infections,
bronchitis, asthma, constipation, dyspepsia & flu.
46

47. 47