EXCIPIENTS

Delivered By :Mehtab Ali

Faculty of Pharmacy
Salim Habib University.

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 EXCIPIENTS
• Any substance other than active drug

• According to IPEC(International
Pharmaceutical Excipients Council)
“any substance other than active drug that is
included in manufacturing process or is
contained in finished pharmaceutical dosage
form”.
ACTIVE DOSAGE
EXCIPIENTS
DRUG FORM
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 CLASSIFICATION OF EXCIPIENTS
• They are divided into two category.

• Based on their Origin

• Based on Function

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 Based on their Origin
1.Animal source
e.g. Lactose, Bees wax, Honey, Gelatin
2.Vegetable source
e.g. Peppermint, Starch, Acacia, Gum
3.Mineral source
e.g. Talc, Calcium phosphate
4.Synthetic
e.g. Boric acid, Lactic acid, Polyethylene glycol
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 Based on Function
• Binder
• Diluents
• Lubricants
• Disintegrating agent
• Plasticizer
• Anti-microbial agents
• Solvents
• Co-solvents
• Sweetening agents
• Flavors
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 Selection of excipients
• Chemically stable
• Non-reactive
• Low process sensitive
• Inert to human body
• Non-toxic
• Organoleptic acceptable
• Economical
• Efficient
• Free from any incompatibility
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 Drug excipient interaction
• Excipients are in contact with active ingredient
in the dosage form, this is present in greater
quantity than active, so sometime the
excipients may show incompatibility with the
active (drug).

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 Interaction of excipients
• Drug-Excipients interactions

• Excipient-Excipients interactions

• Package-Excipients interactions

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 Drug excipients interactions includes
1.Physical interactions
a. Complexation
b. Adsorption
c. Solid dispersion
2.Chemical interactions
a. Hydrolysis
b. Oxidation
c. Racemization
d. Photolysis
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 Drug excipients interactions includes

3.Biopharmaceutical interactions
a. Premature breakdown
b. Interaction due to adjunct therapy
c. Increase in GIT motility

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Excipients used in liquid dosage form

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1.Solvents
• Dissolving the active pharmaceutical
ingredient and/or solute.
• E.g. water, alcohol, acetic acid, acetone, ethyl
acetates.

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2.Co-solvents
• Increase the solubility of solute by
combination of liquids.
• E.g. ethanol, Water, Glycerin.

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3.Buffers
• Maintain the PH of the formulation.
• E.g phosphate, acetates and citrates buffers.

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4.Anti-microbial agents
• Prevent from the microbial growth in
formulation.
• E.g. benzyl alcohol, phenol, butyl paraben.

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5.Anti-oxidants
• Prevent or Control the oxidation in the
formulation.
• E.g. ascorbic acid, sodium bi sulphate,
thiourea, butyl hudroxy toluene(BHT)

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6.Wetting agents
• Help in wetting and dispersion of hydrophobic
particles in the formulation.
• E.g. sodium lauryl sulphate(SLS), Tween 80

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7.Anti-foaming agnets
• Discourage the formation of stable foam.
• E.g. simethicone, alcohols, paraffin oils.

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8.Thickening agents
• Prevent from settling or sedimentation of
particles in a dispersion medium.
• It increase the viscosity of medium.
• E.g. methyl cellulose, hydroxy ethyl cellulose.

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9.Humectants
• It prevent evaporation of aqueous vehicle from
the dosage form.
• E.g. propylene glycols, poly ethylene glycol,
glycerol.

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10.Emulsifying agents
• Help in the formulation of emulsion.
• Reduce the interfacial tension between two
liquids.
• E.g. SLS, Cetrimide.

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11.Flocculating agents
• Prevent the formation of cake.
• E.g. starch, sodium alginate.

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12.Sweetening agents
• Give sweetness to the formulation.
• E.g. sucrose, sorbitol, saccharin, aspartame.

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13.Coloring agents
• Give color to the formulation.
• E.g. amaranth, erythrosine, eosin.

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14.Flavors
• Give the flavor to the formulation.
• E.g. aromatic water, syrup

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Excipients used in semi-solid
dosage form

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1.Preservative
• Preserve the formulation from the growth of
microbes.
• E.g. benzyl alcohol, methyl and propyl
paraben.

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2.Anti-oxidants
• Prevent the oxidation.
• E.g. butyl hydroxyl toluene, ascorbic acid.

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3.Solubilizer
• Enhance solubility of the active ingredients.
• E.g. lanolin, cholesterol.

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4.Gelling agents
• It form gels
• E.g. carbomer934, CMC, HPMC, Xanthan
gum.

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5.Emollients
• It modify the vehicle or base charteristics and
help in penetration of active ingredient in the
skin.
• Also modify the characteristics of skin.

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6.Suppository base
• Base in this suppositories are to be form.
• E.g. cocoa butter, glycerine, coconut oil,
Theobroma oil.

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