List Of Pharmaceutical Excipients And Their Uses

Excipients Definition: Excipients in pharmaceuticals are substances other than the active pharmaceutical ingredient (API).

To produce a drug substance in a final dosage form requires pharmaceutical excipients.

For example, in the preparation of solutions, one or more solvents are used to dissolve the drug substance, flavors and sweeteners are used to make the product more palatable, colorants are added to enhance the appeal, preservatives may be added to prevent microbial growth, and stabilizers, such as antioxidants and chelating agents, may be used to prevent decomposition.

For the preparation of tablets, diluents or fillers are commonly added to increase the bulk of the formulation, binders to cause adhesion of the powdered drug and pharmaceutical substances, anti-adherent or lubricants to assist smooth tablet formation, disintegrating agents to promote tablet breakup after administration, and coatings to improve stability, control disintegration, or enhance appearance.

Ointments, creams, and suppositories acquire their characteristic features from their pharmaceutical bases. Thus, for each dosage form, the pharmaceutical ingredients establish the primary features of the product and contribute to the physical form, texture, stability, taste, and overall appearance.

PHARMACEUTICAL EXCIPIENTS/INGREDIENTS

Ingredient/ Excipient	Example		Example	Conc.(%)
Preservatives: Used in liquid and semisolid preparations to prevent growth of Micro-organism.	Based on chemical Class	Acidic	Phenol	0.2-0.5
			Chlorocresol	0.05-0.1
			O-Phenyl phenol	0.005-0.1
			Alkyl ester of parahydroxybezoic acid	0.001-0.2
			Benzoic acid & its salts	0.1-0.3
			Boric acid & Its salt	0.5-1.0
			Sorbic acid & Its salt	0.05-0.2
		Neutral	Chlorobutanol	0.5
			Benzyl alcohol	0.1
			Beta- Phenylethyl alcohol	0.2-1.0
		Mercurial	Thimerosal	0.001-0.1
			Phenylmercuric acetate & Nitrate	0.002-0.005
			Nitromersol	0.000-0.1
		QAC (Quaternary Ammonium Compound)	Benzalkonium chloride	0.004-0.02
		QAC (Quaternary Ammonium Compound)	Cetypyridimium	1.01-0.02
	Based on Micro-organism	Antifungal	Butylparaben Ethylparaben Methylparaben Benzoic acid Propylparaben Sodium benzoate Sodium propionate
	Based on Micro-organism	Antimicrobial	Benzoic acid & Its salt Ex.Benzalkonium chloride etc
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Antioxidant: Used to prevent deterioration of preparations by oxidation	Compounds	Reducing agent Antioxidant	Ascorbic acid	0.02-0.1
			Sod. Bisulfite	0.1-0.15
			Sod. Metasulfite	0.1-0.15
			Sof. Formaldehyde sulfoxylate	0.1-0.15
			Thoiurea	0.005
		Blocking agent Antioxidant	Ascorbic acid esters	0.1-0.15
			BHT (Butyl hydroxytoluene), BHA	0.005-0.02
			Tocopherol/vit E	0.05-0.075
		Chelating agent as antioxidant	EDTA (Ethylenediaminetetraacetic acids)	0.01-0.075
		Content provided by http://thepharmapedia.com/
		Synergists antioxidant	Ascorbic acis	0.01-0.05
			Citric acid	0.005-0.01
			Citraconic acid	0.03-0.45
			Phosphoric acid	0.005-0.01
			Tartaric acid	0.01-0.02
	Air displacement	Nitrogen gas	Agent employed to displace air (oxygen) in a hermetically sealed container to enhance product stability

Ingredient/ Excipient	Definition	Example
Adsorbent	An agent capable of holding other molecules onto its surface by physical or chemical (chemisorption) means	Powdered cellulose Activated charcoal
Acidifying agent	Used in liquid preparations to provide acidic medium for product stability	Citric acid Acetic acid Fumaric acid Hydrochloric acid Nitric acid
Alkalinizing agent	Used in liquid preparations to provide alkaline medium for product stability	Ammonia solution Ammonium carbonate Diethanolamine Monoethanolamine Potassium hydroxide Sodium bicarbonate Sodium borate Sodium carbonate Sodium hydroxide Trolamine
Aerosol propellant	Agent responsible for developing the pressure within an aerosol container and expelling the product when the valve is opened	Carbon dioxide Dichlorodifl uoromethane Dichlorotetrafl uoroethane Trichloromonofl uoromethane
Buffering agent	Used to resist change in pH upon dilution or addition of acid or alkali	Potassium metaphosphate Potassium phosphate, Monobasic Sodium acetate Sodium citrate, Anhydrous and dihydrate
Chelating agent	Substance that forms stable water-soluble complexes (chelates) with metals; used in some liquid pharmaceuticals as stabilizers to complex heavy metals that might promote instability. In such use, they are also called sequestering agents	Edetic acid Edetate disodium
Colorant	Used to impart color to liquid and solid (e.g., tablets and capsules) preparations	Caramel, Ferric oxide & Regulatory approved color
Clarifying agent	Used as a filtering aid for its adsorbent qualities	Bentonite
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Emulsifying agent	Used to promote and maintain dispersion of finely subdivided particles of liquid in a vehicle in which it is immiscible. End product may be a liquid emulsion or semisolid emulsion	Acacia Cetomacrogol Cetyl alcohol Glyceryl monostearate Sorbitan monooleate Polyoxyethylene 50 stearate
Encapsulating agent	Used to form thin shells to enclose a drug for ease of administration	Gelatin
Flavorant	Used to impart a pleasant flavor and often odor to a preparation. In addition to the natural flavorants listed, many synthetic ones are used	Anise oil Cinnamon oil Cocoa Menthol Orange oil Peppermint oil Vanillin
Humectant	Used to prevent drying of preparations, particularly ointments and creams	Glycerin Propylene glycol Sorbitol
Levigating agent	Liquid used as an intervening agent to reduce the particle size of a powder by grinding, usually in a mortar	Mineral oil Glycerin Propylene glycol
Ointment base	Semisolid vehicle for medicated ointments	Lanolin Hydrophilic ointment Polyethylene glycol ointment Petrolatum Hydrophilic petrolatum White ointment Yellow ointment Rose water ointment
Plasticizer	Component of fi lm-coating solutions to make fi lm more pliable, enhance spread of coat over tablets, beads, and granules	Diethyl phthalate Glycerin
Solvent	Used to dissolve another substance in preparation of a solution; may be aqueous or not (e.g., oleaginous). Cosolvents, such as water and alcohol (hydroalcoholic) and water and glycerin, may be used when needed. Sterile solvents are used in certain preparations (e.g., injections)	Alcohol Corn oil Cottonseed oil Glycerin Isopropyl alcohol Mineral oil Oleic acid Peanut oil Purifi ed water Water for injection Sterile water for injection Sterile water for irrigation
Stiffening agent	Used to increase thickness or hardness of a preparation, usually an ointment	Cetyl alcohol Cetyl esters wax Microcrystalline wax Paraffi n Stearyl alcohol White wax Yellow wax
Suppository base	Vehicle for suppositories	Cocoa butter Polyethylene glycols (mixtures) PEG 3350
Surfactant (surface active agent)	Substances that absorb to surfaces or interfaces to reduce surface or interfacial tension. May be used as wetting agents, detergents, or emulsifying agents	Benzalkonium chloride Nonoxynol 10 Octoxynol 9 Polysorbate 80 Sodium lauryl sulfate Sorbitan monopalmitate
Suspending agent	Viscosity-increasing agent used to reduce sedimentation rate of particles in a vehicle in which they are not soluble; suspension may be formulated for oral, parenteral, ophthalmic, topical, or other route	Agar Bentonite Carbomer (e.g., Carbopol) Carboxymethylcellulose sodium Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Kaolin Methylcellulose Tragacanth Veegum
Sweetening agent	Used to impart sweetness to a preparation	Aspartame Dextrose Glycerin Mannitol Saccharin sodium Sorbitol Sucrose
Tablet-Antiadherents	Prevent tablet ingredients from sticking to punches and dies during production	Magnesium stearate
Tablet binders	Substances used to cause adhesion of powder particles in tablet granulations	Acacia Alginic acid Carboxymethylcellulose sodium Compressible sugar (e.g., Nu-Tab) Ethylcellulose Gelatin Liquid glucose Methylcellulose Povidone Pregelatinized starch
Tablet and capsule diluent	Inert filler to create desired bulk, fl ow properties, and compression characteristics of tablets and capsules	Dibasic calcium phosphate Kaolin Lactose Mannitol Microcrystalline cellulose Powdered cellulose Precipitated calcium carbonate Sorbitol Starch
Tablet coating agent	Used to coat a tablet to protect against decomposition by atmospheric oxygen or humidity, to provide a desired release pattern, to mask taste or odor, or for aesthetic purposes. Coating may be sugar, fi lm, or thick covering around a tablet. Sugar-coated tablets generally start to break up in the stomach. Film forms a thin cover around a formed tablet or bead. Unless it is enteric, film dissolves in the stomach. Enteric coating passes through the stomach to break up in the intestines. Some water-insoluble coatings (e.g., ethylcellulose) are used to slow the release of drug in the gastrointestinal tract	Content provided by http://thepharmapedia.com/
Sugar coating	Content provided by http://thepharmapedia.com/	Liquid glucose Sucrose
Film coating	Content provided by http://thepharmapedia.com/	Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Methylcellulose (e.g., Methocel) Ethylcellulose (e.g., Ethocel)
Enteric coating	Content provided by http://thepharmapedia.com/	Cellulose acetate phthalate Shellac (35% in alcohol, pharmaceutical glaze)
Tablet direct compression excipient	Used in direct compression tablet formulations	Dibasic calcium phosphate (e.g., Ditab)
Tablet disintegrates	Used in solid forms to promote disruption of the mass into smaller particles more readily dispersed or dissolved	Alginic acid Polacrilin potassium (e.g., Amberlite) Sodium alginate Sodium starch glycolate Starch
Tablet glidant	Used in tablet and capsule formulations to improve flow properties of the powder mixture	Colloidal silica Cornstarch Talc
Tablet lubricant	Used in tablet formulations to reduce friction during tablet compression	Calcium stearate Magnesium stearate Mineral oil Stearic acid Zinc stearate
Tablet or capsule opaquant	Used to render a coating opaque. May be used alone or with a colorant	Titanium dioxide
Tablet polishing agent	Used to impart an attractive sheen to coated tablets	Carnauba wax White wax
Tonicity agent	Used to render solution similar in osmotic-dextrose characteristics to physiologic fluids, e.g., in ophthalmic, parenteral, and irrigation fluids	Sodium chloride
Vehicle	Carrying agent used in formulating a variety of liquids for oral and parenteral administration Generally, oral liquids are aqueous (e.g., syrups) or hydroalcoholic (e.g., elixirs). Solutions for intravenous use are aqueous, whereas intramuscular injections may be aqueous or oleaginous
Flavoured, sweetened	Content provided by http://thepharmapedia.com/	Acacia syrup Aromatic syrup Aromatic elixir Cherry syrup Cocoa syrup Orange syrup Syrup
Oleaginous	Content provided by http://thepharmapedia.com/	Corn oil Mineral oil Peanut oil Sesame oil
Viscosity-increasing agent	Used to render preparations more resistant to fl ow. Used in suspensions to deter sedimentation, in ophthalmic solutions to enhance contact time (e.g., methylcellulose), to thicken topical creams, etc.	Alginic acid Bentonite Carbomer Carboxymethylcellulose Sodium Methylcellulose Povidone Sodium alginate Tragacanth

Mode of Action/Mechanism of action of Preservatives

Preservatives interfere with microbial growth, multiplication, and metabolism through one or more of the following mechanisms:

Modify cation of cell membrane permeability and leakage of cell constituents (partial lysis)
Lysis and cytoplasmic leakage
Irreversible coagulation of cytoplasmic constituents (e.g., protein precipitation)
Inhibition of cellular metabolisms, such as by interfering with enzyme systems or inhibition of cell wall synthesis
Oxidation of cellular constituents
Hydrolysis

Name of Preservatives	Modes/Mechanism of action
Benzoic acid, boric acid, p-hydroxybenzoates	Denaturation of proteins
Phenols and chlorinated phenolic compounds	Lytic and denaturation action on cytoplasmic membranes and for chlorinated preservatives, also by oxidation of enzymes
Alcohols	Lytic and denaturation action on membranes
Quaternary compounds	Lytic action on membranes
Mercurials	Denaturation of enzymes by combining with thiol (-SH) groups)

mode of action of preservative

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