Pharmaceutical Ingredients

Pharmaceutical Ingredients (Definition, Use, Example)
Sl. No. Name of Ingredient Definition / Use Example
01 Acidifying agent Used in liquid preparations to provide acidic medium for product stability. HCL

Acetic acid

Citric acid

 

02

 

Alkalinizing agent

Used in liquid preparations to provide alkaline medium for product stability. NaOH, KOH

NaHCO3

Ammonia solution

03 Adsorbent An agent capable of holding other molecules onto its surface by physical or chemical means. Activated charcoal

Powdered cellulose

 

04

 

Aerosol Propellant

Agent responsible for developing the pressure within an aerosol container and expelling the product when the valve is opened.  CO2

Dichlorodifluoromethane

Dichlorotetrafluoroethane

05  

Air Displacement

Agent employed to displace air in a hermetically sealed (completely airtight) container to enhance product quality. CO2

Nitrogen

 

06

Antifungal Preservative Used in liquid and semisolid preparations to prevent growth of fungi. Methyl Paraben

Ethyl Paraben

Propyl Paraben

07 Antimicrobial Preservative Used in liquid and semisolid preparations to prevent growth of microorganisms. Benzalkonium Chloride
 

08

 

Antioxidant

Used to prevent deterioration of preparation by oxidation. Ascorbic acid

Butylated hydroxyanisole (BHA)

Butylated hydroxytoluene (BHT)

09 Buffering agent Used to resist change in pH upon dilution or addition of acid or alkali. Monobasic Potassium Phosphate

Potassium Metaphosphate

 

10

 

Chelating agent

Substances that form 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 agent. Edetic acid

Edetate disodium

11 Colorant Use to impart color to liquid and solid preparations. FD&C Red No. 3

FD&C Blue No. 2

12 Clarifying agent Used as a filtering aid for its adsorbent qualities. Bentonite
 

13

 

Emulsifying agent

Used to promote and maintain dispersion of finely subdivided particles of liquid in a vehicle in which it is immiscible. Acacia

Cetyl Alcohol

14 Encapsulating agent Used to form thin shells to enclose a drug for ease of administration. Gelatin
15 Flavorant Used to impart a pleasant flavor and often odor to a preparation. Menthol

Peppermint oil

16 Humectant Used to prevent drying of preparations particularly ointment and cream. Glycerin

Propylene Glycol

17 Levigating agent Liquid used as an intervening agent to reduce the particle size of a powder by grinding, usually in a mortar. Glycerin

Propylene Glycol

18 Ointment base Semisolid vehicle for medicated ointment. Lanolin

Petrolatum

 

19

 

Plasticizer

Components of film-coating solution to make the film more pliable (flexible), enhance easy spread of coat over tablets, breads, granules. Glycerin (Hydrophilic)

Diethyl Phthalate (Hydrophobic)

20 Solvent

Co-solvent

Used to dissolve another substance in preparation of solution; may be aqueous or oleaginous. Cosolvents such as water and alcohol; water and glycerin may be used when needed. Sterile solvents are used in certain preparation such as injections. Alcohol

Purified water

Water for injection

Sterile water for injection

Mineral oil

Glycerin

21 Stiffening agent Used to increase thickness or hardness of a preparation, usually an ointment. White wax

Yellow wax

Paraffin

22 Suppository base Vehicle for suppository. Cocoa butter
23 Surfactant /

Surface active agent

Substances that absorb to surfaces or interfaces to reduce surface or interfacial tension. May be used as detergents, wetting agents, emulsifying agents. Bezalkonium Chloride

Sodium lauryl sulphate

24 Suspending agent Viscosity increasing agent used to reduce sedimentation rate of particles in a vehicle in which they are not soluble. Agar

Tragacanth

Hydroxypropyl cellulose

Hydroxypropyl methylcellulose

25 Sweetening agent Used to impart sweetness in a preparation. Sucrose

Aspartame

26 Anti-adherent Prevent tablet ingredients from sticking to dies and punches during production. Magnesium stearate
27 Binder These are the dry powders or liquid which are added during wet granulation to promote granules or to promote cohesive compact during direct compression. Acacia, Traganth (in solution form concentration 10-25%)

Gelatin (10-20%)

Glucose (50%)

Methyl Cellulose

Ethyl Cellulose

Povidone

28 Diluents/Fillers Used to make required bulk of the tablet when the drug dosage itself is inadequate to produce the bulk. Lactose – anhydrous lactose, spray dried lactose.

Directly compressible starch, hydrolyzed starch

Microcrystalline cellulose – Avicel and other cellulose derivatives

Mannitol, Sorbitol

Sucrose, Dextrose

29 Disintegrant Added to a formulation to facilitates its breaking or disintegration when it comes in contact with water in the GIT.

Super Disntegrants: Swells up to 10 fold within 30 seconds when comes in contact with water.

 

Super Disntegrants

Crosscarmellose (Cross linked cellulose)

Crosspovidone (Cross linked povidone)

Sodium starch glycolate (Cross linked starch)

 

30 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 coating, film coating or thick covering around a tablet. Sugar coated tablets generally start to break up in the stomach. Unless it is enteric, film coated tablets dissolve in the stomach. Enteric coating passes through the stomach to break up in the intestines. Some water insoluble coatings (ethyl cellulose) are used to slow the release of drug in the GIT. Sugar coating:

Liquid glucose

Sucrose

Film coating:

Hydroxyethyl cellulose

Hydroxypropyl Metyl Cellulose

Ethyl Cellulose

Enteric coating

Shellac

Cellulose acetate phthalate

 

31 Glidant Used in tablet and capsule formulations to improve flow properties of the powder mixture. Talc

Cornstarch

32 Lubricant Used in tablet formulation to reduce friction during tablet compression. Mineral oil

Calcium stearate

Magnesium stearate

33 Opacifier Used to render a coating opaque. May be used alone or with a colorant. Titanium Dioxide
34 Polishing agent Used to render an attractive shine to coated tablet. White wax

Carnauba wax

35 Tonicity agent Used to render solution similar in osmotic-dextrose characteristics to physiological fluids e.g. in ophthalmic, parenteral, irrigation fluid. Sodium chloride
36 Viscosity increasing agent Used to render preparations more resistant to flow. Tragacanth

Povidone

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