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DUDEKULA MURTHUJAVALI
MIPER
KURNOOL
Classification of pharmaceutical additives:
Solid dosage forms Liquid dosage forms Semi solid dosage form Nano formulations
Anti-adherents Solvents
Bases/structure forming
agents Polymers
Binders Cosolvents Preservatives Lipids
Coating agents Buffers Antioxidants Cross linkers
Distintegrants Preservatives Solubilizers Gelling agents
Fillers Wetting agents Gelling agents Mucoadhesive agent
Lubricants Surfactants Emollients Cryoprotectants
Glidants Anti-foaming agent Penetration enhancers Preservatives
Sorbents Thickening agents Stabilizers
Solubilizing agent Plasticizers
Vehicles
Preservatives
Orgonoleptic additives as
colors, flavors, sweeteners
examples
Solid dosage forms Examples
Anti-adherents Magnesium stearate, talc, starch, colloidal silica, sodium lauryl sulfate,
Binders
Mainly natural or synthetic polymers e.g. starches, sugars, sugar alcohols and
cellulose derivatives
Coating agents
Cellulosics such as hydroxypropyl methyl cellulose (HPMC), Hydroxypropyl
cellulose (HPC), and ethyl cellulose (EC) Vinyl’s, such as polyvinyl alcohol.
Acrylics, such as methacrylic acid / ethylacrylate copolymers
Distintegrants Starch, cellulose, crosslinked polyvinyl pyrrolidene, sodium starch glycolate,
sodium CMC.
Fillers
Lactose, dibasic calcium phosphate, cellulose, sucrose, glucose, mannitol,
sorbitol, calcium carbonate.
Lubricants Stearic acid and its salts (e.g. magnesium Stearate)
Glidants Sugar compounds e.g. lactose, dextrin, glucose, sucrose, sorbitol.
Inorganic compounds e.g. silicates, calcium and magnesium salts, sodium or
potassium chloride.
Cant…
Sorbents
Natural sorbents: peat moss, sawdust, feathers & anything else natural that
contains
carbon. Synthetic sorbents: polyethylene and nylon.
Solubilizing agent Ethanol, benzyl alcohol, propylene glycol glycerol, Diethylelene glycol
monoethyl ether.
Vehicles Purified water, Petrolatum, dimethyl sulfoxide and mineral oil
Coloring agent
Artificial coloring agent: BrilliantBlue, Indigotine, FastGreen, AlluraRed,
Erythrosine, Tartrazine, Sunset Yellow,
Natural: Turmeric, Saffron, Paprika, Elderberry
Flavoring agent  Almond Oil, Sweet, Benzaldehyde, Menthol, Crystal, Ethyl Acetate, Ethyl
Vanillin,L-Menthol, Crystal, Methyl Salicylate, Peppermint Oil,
Sweetening agents Natural: sucrose, glucose, dextrose, fructose, isomaltose.
Artificial: acesulfame-f, sucralose, neotame
Liquid dosage forms Examples
Solvents
 Ethanol,
 Ethylene,
 Bromide,
 Propylene glycol,
 Ethyl ether,
 tetra-Butyl methyl ether,
 Pyridyne acetonitrile ethyl acetate.
Cosolvents
 Ethanol,
 Propylene glycol,
 Glycerine,
 Glycofural, and
 Polyethylene glycols.
Buffers
 Citric acid,
 Acetic acid,
 KH2PO4,
 N-Cyclohexyl-2-aminoethanesulfonic acid(CHES),
 Borate.
Preservatives
 Benzalkonium chloride (conce.0.01%),
 Benzyl alcohol (conc. 0.5%)
 butyl paraben (conc. 0.015%),
Plasticizers
 Glycerin,
 Diethyl Phthalate,
 Polyethylene Glycol,
 tri-ethyl citrate,
 acetylated
Wetting agents
Oral: polysorbets(tweens),sorbitan ester(spans)
Parental: polysorbates, poloxamers, lecithin,
External: sodium lauryl sulphate
Surfactants
Anionic: Alkyl sulphate, soap,
Cationic: quaternary ammonium salts,
Nonionic: Ethoxylated aliphatic alcohols,
polyoxyethylene surfactants ,
Zwitterionic: Betaines, amphoacetates.
Anti-foaming Octnol, ether, castor oil, & silicones
Thickening agents
Roux:
 clarified butter + flour + cooked to desired color.
Slurry:
 starch + cold water.
 Corn starch, potato starch, rice flour, arrowroot.
 White wash = water
Liason:
 Cream + egg yolk
Canti…..
Semi solid dosage form Examples
Bases/structure forming agents
Hydrocarbon bases:
Soft paraffin, liquid paraffin,
Water miscible bases:
Glycerin, emulsifying ointment,
Water soluble bases:
Poly ethylene glycol.
Preservatives Methyl hydroxy benzoate, propyl hydroxy benzoate, chorocresol, benzoic
acid, phenyl mercuric nitrate.
Antioxidants Butylated hydroxy anisole(BHA), Butylated hydroxy tocopherols(BHT),
Solubilizers Myrcene, limonene, estrogol, etc.
Gelling agents tragacanth, pectin, starch, carbomer, sodium alginate, gelatin, cellulose
derivatives, polyvinyl alcohol clays, etc.
Emollients petrolatum; waxes; oils; silicones. Alone,
Penetration enhancers Sulphoxides, Azones, pyrrolidene, alcohols and alkanols, glycols

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Classification of pharmaceutical additives

  • 2. Classification of pharmaceutical additives: Solid dosage forms Liquid dosage forms Semi solid dosage form Nano formulations Anti-adherents Solvents Bases/structure forming agents Polymers Binders Cosolvents Preservatives Lipids Coating agents Buffers Antioxidants Cross linkers Distintegrants Preservatives Solubilizers Gelling agents Fillers Wetting agents Gelling agents Mucoadhesive agent Lubricants Surfactants Emollients Cryoprotectants Glidants Anti-foaming agent Penetration enhancers Preservatives Sorbents Thickening agents Stabilizers Solubilizing agent Plasticizers Vehicles Preservatives Orgonoleptic additives as colors, flavors, sweeteners
  • 3. examples Solid dosage forms Examples Anti-adherents Magnesium stearate, talc, starch, colloidal silica, sodium lauryl sulfate, Binders Mainly natural or synthetic polymers e.g. starches, sugars, sugar alcohols and cellulose derivatives Coating agents Cellulosics such as hydroxypropyl methyl cellulose (HPMC), Hydroxypropyl cellulose (HPC), and ethyl cellulose (EC) Vinyl’s, such as polyvinyl alcohol. Acrylics, such as methacrylic acid / ethylacrylate copolymers Distintegrants Starch, cellulose, crosslinked polyvinyl pyrrolidene, sodium starch glycolate, sodium CMC. Fillers Lactose, dibasic calcium phosphate, cellulose, sucrose, glucose, mannitol, sorbitol, calcium carbonate. Lubricants Stearic acid and its salts (e.g. magnesium Stearate) Glidants Sugar compounds e.g. lactose, dextrin, glucose, sucrose, sorbitol. Inorganic compounds e.g. silicates, calcium and magnesium salts, sodium or potassium chloride.
  • 4. Cant… Sorbents Natural sorbents: peat moss, sawdust, feathers & anything else natural that contains carbon. Synthetic sorbents: polyethylene and nylon. Solubilizing agent Ethanol, benzyl alcohol, propylene glycol glycerol, Diethylelene glycol monoethyl ether. Vehicles Purified water, Petrolatum, dimethyl sulfoxide and mineral oil Coloring agent Artificial coloring agent: BrilliantBlue, Indigotine, FastGreen, AlluraRed, Erythrosine, Tartrazine, Sunset Yellow, Natural: Turmeric, Saffron, Paprika, Elderberry Flavoring agent  Almond Oil, Sweet, Benzaldehyde, Menthol, Crystal, Ethyl Acetate, Ethyl Vanillin,L-Menthol, Crystal, Methyl Salicylate, Peppermint Oil, Sweetening agents Natural: sucrose, glucose, dextrose, fructose, isomaltose. Artificial: acesulfame-f, sucralose, neotame
  • 5. Liquid dosage forms Examples Solvents  Ethanol,  Ethylene,  Bromide,  Propylene glycol,  Ethyl ether,  tetra-Butyl methyl ether,  Pyridyne acetonitrile ethyl acetate. Cosolvents  Ethanol,  Propylene glycol,  Glycerine,  Glycofural, and  Polyethylene glycols. Buffers  Citric acid,  Acetic acid,  KH2PO4,  N-Cyclohexyl-2-aminoethanesulfonic acid(CHES),  Borate. Preservatives  Benzalkonium chloride (conce.0.01%),  Benzyl alcohol (conc. 0.5%)  butyl paraben (conc. 0.015%), Plasticizers  Glycerin,  Diethyl Phthalate,  Polyethylene Glycol,  tri-ethyl citrate,  acetylated
  • 6. Wetting agents Oral: polysorbets(tweens),sorbitan ester(spans) Parental: polysorbates, poloxamers, lecithin, External: sodium lauryl sulphate Surfactants Anionic: Alkyl sulphate, soap, Cationic: quaternary ammonium salts, Nonionic: Ethoxylated aliphatic alcohols, polyoxyethylene surfactants , Zwitterionic: Betaines, amphoacetates. Anti-foaming Octnol, ether, castor oil, & silicones Thickening agents Roux:  clarified butter + flour + cooked to desired color. Slurry:  starch + cold water.  Corn starch, potato starch, rice flour, arrowroot.  White wash = water Liason:  Cream + egg yolk Canti…..
  • 7. Semi solid dosage form Examples Bases/structure forming agents Hydrocarbon bases: Soft paraffin, liquid paraffin, Water miscible bases: Glycerin, emulsifying ointment, Water soluble bases: Poly ethylene glycol. Preservatives Methyl hydroxy benzoate, propyl hydroxy benzoate, chorocresol, benzoic acid, phenyl mercuric nitrate. Antioxidants Butylated hydroxy anisole(BHA), Butylated hydroxy tocopherols(BHT), Solubilizers Myrcene, limonene, estrogol, etc. Gelling agents tragacanth, pectin, starch, carbomer, sodium alginate, gelatin, cellulose derivatives, polyvinyl alcohol clays, etc. Emollients petrolatum; waxes; oils; silicones. Alone, Penetration enhancers Sulphoxides, Azones, pyrrolidene, alcohols and alkanols, glycols