Excipients

SL Excipients Application % Use Safety

No Name
01 Microcrystalline Diluents are fillers used to Binder/Diluent & Adsorbent (20–90)%. Microcrystalline cellulose is not
Cellulose increase the bulk volume of a Binders are used to hold the API and absorbed systemically
(Avicel PH-101) tablet. Provide adequate weight Excipients together in a cohesive mix. following oral administration
and size. Adsorbent and thus has little toxic
potential.
02 Polyvinyl Binder, Suspending agent; Binder/diluent (0.5–5)% A temporary acceptable daily
Pyrrolidone Hygroscopic powder Eye drops ( 2–10)% intake for povidone has been
(Povidone k-30) Suspending agent Up to 5% set by the WHO at up to 25
mg/kg body-weight.
03 Lactose Diluent & filler. excellent Maillard reaction occurs between Most adults consume about 25
(Milk Sugar) compressibility properties. carbonyl group of reducing sugar (such g of lactose per day (500mL of
Anhydrous Lactose is also a reducing sugar as lactose) and the amino group of drugs milk) without symptoms. When
Monohydrate and undergoes Maillard Reaction (like aminophylline and amphetamine). symptoms appear, they are
usually mild and dose-related.
04 Pregelatinized Used in oral capsule Diluent (hard gelatin capsules) (5-75)% Pregelatinized starch is
Starch and tablet formulations as a Tablet Binder (direct compression) generally regarded as a
binder, diluents and disintegrant. (5–20)% nontoxic and nonirritant
Tablet Binder (wet granulation) (5–10)% excipient. However, oral
Tablet Disintegrant (5–10)% consumption of large amounts
of pregelatinized starch may be
harmful.

05 Colloidal Glidant, Suspending agent Glidant (0.1–1)%, Suspending and Aerosil-200 is generally
Anhydrous Silica viscosity-increasing agent. thickening agent (2-10)%. Colloidal regarded as an essentially
(Aerosil-200) Anhydrous Silica is widely used in oral nontoxic and nonirritant
and topical pharmaceutical products excipient.

06 Talc Lubricant to reduced the Glidant and lubricant (1 –10)% It has been suggested that there
Magnesium sticking and increase flow Tablet and capsule diluent (5 –30)% is an increased risk of ovarian
Silicate property. Talc has been extensively investigated cancer in women using talc, the
(Purified Talc) Glidant to increase the flow for its carcinogenic potential evidence is inconclusive.
property
07 Sodium Starch Tablet and capsule Disintegrant Disintegrant (2-8)% Nontoxic and Nonirritant
Glycolate (SSG) (Superdisintegrant) material. Oral ingestion of large
(Primojel) quantities may be harmful.

08 Croscarmellose Superdeisintegrant Disintegrant in tablets (0.5–5)% The WHO has not specified an
Sodium To enhance dissolution & Disintegrant in capsules (10–25)% acceptable daily intake for
(Primellose) disintegration properties. carboxy methylcellulose
sodium as a food additive since
the levels necessary to achieve
a desired effect were not
considered to be a hazard to
health.
09 Crospovidone Superdisintegrant. It rapidly Water soluble Tablet disintegrant & Nontoxic and nonirritant
exhibits high capillary activity dissolution agent used at ( 2–5)% material. An acceptable daily
and pronounced hydration intake in humans has not been
capacity. specified by the WHO

10 Sodium Lauryl Tablet and Capsule lubricant; Tablet lubricant (1 – 2)%. Prolonged The probable human lethal oral
Sulfate (SLS) wetting agent, emulsifying agent inhalation of sodium lauryl sulfate will dose is 0.5–5.0 g/kg. Toxic
damage the lungs. effects to the lung, kidney, and
liver.
11 Magnesium Tablet and Capsule Lubricant Lubricant in capsule 0.25% Oral consumption of large
Stearate Lubricant in tablet 5% quantities may produce a
laxative effect or mucosal
irritation.
SL Excipients Application % Use Safety
No Name
12 Poly ethylene Lubricant; Ointment base; Therapeutically, up to 4 L of The WHO has set an estimated
Glycol- plasticizer- increase an aqueous mixture of electrolytes and acceptable daily intake of
6000[PEG], the plasticity or viscosity of a high-molecular-weight polyethylene polyethylene glycols at up to 10
BP-Macrogols material. glycol is consumed by patients mg/kg body-weight.hydrophilic
undergoing bowel cleansing. substances. Nonirritant to the
skin
13 Carboxy methyl Stabilizing agent; Suspending Gel-forming agent (3–6)% The WHO has not specified an
Cellulose agent; Tablet binder; viscosity- Injections (0.05–0.75)% acceptable daily intake for
Sodium (CMC increasing agent. Oral solutions (0.1–1)% carboxy methylcellulose
Na) Tablet binder (1–6)% sodium as a food additive since
the levels necessary to achieve
a desired effect were not
considered to be a hazard to
health.
14 Carbomer Emulsifying agent; Suspending Suspending agent (0.5–1)% In humans, oral doses of 1–3 g
agent; tablet Binder; Viscosity- Tablet binder (5 –10)% of carbomer have been used as
increasing agent Emulsifying agent (0.1–0.5) a bulk laxative.

15 Propylene Water miscible Co-solvent to Preservative- The WHO has set an acceptable
Glycol increase solubility, Solutions & Semisolids (15–30)% daily intake of propylene glycol
. Preservative; disinfectant; Solvent or cosolvent – at up to 25 mg/kg body-weight.
plasticizer; solvent; stabilizing Oral solutions(10-25)% Formulations containing 35%
agent;. Formulations containing Aerosol solutions (10-30)% propylene glycol can cause
35% propylene glycol can Parenterals (10–60)% hemolysis in humans.
cause hemolysis in humans. Topicals (5–80)%
16 Sorbitol Sweetening agent, Humectant; Oral solutions (20–35)% Sorbitol is not readily
70% Solution plasticizer; stabilizing agent.. Oral suspensions 70% fermented by oral
Plasticizer for gelatin & cellulose (5– microorganisms and has little
20)% effect on dental plaque pH;
hence, it is generally considered
to be noncariogenic.

17 Saccharin Sweetening Agent (0.02–0.5)% w/w. Its sweetening power The WHO has set a temporary
is approximately 300–600 times that of acceptable daily intake for
sucrose. saccharin, including its
18 Sodium Sweetening Agent Oral solution (0.075–0.6)% calcium, potassium, and sodium
Saccharin Oral syrup (0.04–0.25)% salts, at up to 2.5 mg/kg body-
weight.
19 Aspartame Sweetening Agent Sweetening power is 180–200 times that The WHO has set an acceptable
of sucrose. daily intake for aspartame at up
to 40 mg/kg body-weight

20 Sodium Citrate Buffering agent Buffering agent (0.3–2)% sodium citrate is used primarily
Alkalizing agent Injections (0.02–4)% to adjust the pH of solutions
Ophthalmic solutions (0.1–2)% and used to relieve the painful
irritation caused by cystitis, and
also to treat dehydration and
acidosis due to diarrhea.
21 Sucrose Sweetening agent; tablet binder; Syrup for oral liquid formulations 67% Sucrose is hydrolyzed in the
tablet and capsule diluent; Sweetening agent 67% small intestine by the enzyme
Coating agent, viscosity- Tablet binder (dry granulation) (2–20)% sucrase to yield dextrose and
increasing agent. Tablet binder (wet granulation) (50– fructose, which are then
67)% absorbed.When administered
Tablet coating (syrup) (50–67)% intravenously, sucrose is
excreted unchanged in the
urine.
22 Menthol Flavouring Agent. Very slightly Oral suspension 0.003% The WHO has set an acceptable
soluble in glycerin. The WHO Oral syrup (0.005–0.015)% daily intake of menthol at
has set an acceptable daily intake Tablets (0.2–0.4)% up to 0.4 mg/kg body-weight
of menthol at up to 0.4 mg/kg Topical formulations (0.05–10)%
body-weight
SL Excipients Application % Use Safety
No Name
23 Polysorbate Solubilizing agent; Suspending Solubilizing agent- The WHO has set an estimated
When heated to agent; Wetting agent. The WHO For poorly soluble active constituents in acceptable daily intake for
decomposition, has set an estimated acceptable lipophilic bases (1–15)% polysorbates 20, 40, 60, 65, and
the polysorbates daily intake for Polysorbates Wetting agent- For insoluble active 80, calculated as total
emit acrid smoke (Tween) 20, 40, 60, 65, and 80 constituents in lipophilic bases (0.1–3)% polysorbate esters, at up to 25
and irritating at up to 25 mg/kg body-weight. Polysorbate 20 Moderate toxicity by IP mg/kg body-weight.Moderately
fumes. and IV routes toxic by ingestion. Human skin
irritant.
24 Maize Starch Tablet and capsule diluent, tablet and capsule disintegrant (3-25)% Starch may also cause
Disintegrent, binder, thickening tablet binder (3-20)%. Add granulomatous reactions when
agent. Mix dry starch with boiling/steam water with Maize starch to applied to the peritoneum or the
enough cold water to make a makes a Translucent color. meninges.
slurry
25 Ascorbic Acid Antioxidant Agent (0.01–0.1)% w/v The WHO has set an acceptable
daily intake of ascorbic acid,
potassium ascorbate, and
sodium ascorbate, as
antioxidants in food, at up to 15
mg/kg body-weight in addition
to that naturally present in food
26 Benzalkonium Preservative Agent (0.01–0.02)% w/v The fatal oral dose of
Chloride benzalkonium chloride in
humans is estimated to be 1–3g
27 Benzoic Acid Preservative Agent IM and IV injections 0.17% The WHO acceptable daily
Oral suspensions 0.1% intake of benzoic acid has been
Oral syrups 0.15% set at up to 5 mg/kg body-
weight. The minimum lethal
human oral dose of benzoic
acid is 500 mg/kg body-weight.

28 Dextrose Tablet & capsules diluent; 5.05% w/v aqueous solution is iso- Excessive oral fructose
tonicity agent; sweetening agent osmotic with serum. Diluent(70-80)% consumption (>75 g daily) in
the absence of dietary dextrose
in any form (e.g., sucrose,
29 Fructose Dissolution enhancer; flavoring Pregranulation of fructose with 3.5%
starch,dextrin, etc.) may cause
agent; sweetening; tablet diluent povidone also produces a satisfactory
malabsorption in susceptible
tablet excipient.
individuals, which may result
inflatulence, abdominal pain,
and diarrhea.

30 Gelatin Coating; film-forming; binder, The gelatin used to form the soft shells There have been rare reports of
suspending, viscosity-increasing has a lower gel strength than that used gelatin capsules adhering to the
agent, shell forming agent for hard esophageal lining, which may
capsules. cause local irritation
31 Glycerin Antimicrobial preservative; Ophthalmic formulations (0.5–3)% Glycerin may be used orally in
cosolvent; humectant; Antimicrobial preservative <20% doses of 1.0–1.5 g/kg body
plasticizer; solvent; sweetening ; Solvent for parenteral formulations 50% weight
tonicity agent
32 Isopropyl Disinfectant; solvent Some antimicrobial activity and 70% v/v The lethal oral dose is
Alcohol (IPA) aqueous solution is used as a topical estimated to be about 120 -250
disinfectant mL although toxic symptoms
may be produced by 20 mL.
33 Sodium Buffering agent Adjust the pH of solutions and react At high concentrations it is a
Hydroxide with weak acids to form salts. Sodium corrosiveirritant to the skin,
hydroxide is generally regarded as a eyes, and mucous membranes.
nontoxic material at low concentrations
34 Lactic Acid Acidifying agent; acidulant Injections (0.012–1.16 )% A 1% v/v solution, for example,
Topical preparations (0.015–6.6)% is harmless when applied to the
skin
SL Excipients Application % Use Safety
No Name
35 Potassium Tonicity agent 1.19% w/v solution is iso-osmotic with Therapeutically, in adults, up to
Chloride serum 10 g orally, in divided doses
has been administered daily,
while intravenously up to 6 g
daily has been used.
36 Citric Acid Buffering agent Buffer solutions (0.1–2)% Excessive or frequent
Monohydrate Acidifying agent Antioxidant; Flavor enhancer for liquid consumption of citric acid has
Preservative Flavor enhancer. formulations (0.3-2)% been associated with erosion of
the teeth.
37 Mannitol Tonicity agent, tablet and In lyophilized preparations, mannitol Mannitol is a naturally
capsule diluent, plasticizer. (20–90% w/w) has been included as a occurring sugar alcohol found
5.07% w/v aqueous solution is carrier to produce a stiff, homogeneous in animals and plants
isoosmotic with serum cake that improves the appearance of the
lyophilized plug in a vial.
38 Methylparaben Antimicrobial preservative Ophthalmic & Oral solutions and The WHO has set an estimated
suspensions (0.015–0.2)% total acceptable daily intake
for methyl-, ethyl-, and
39 Propylparaben Antimicrovial Preservative Propylparaben (0.02% w/v) together propyl parabens at up to 10
with methylparaben (0.18% w/v) has mg/kg body-weight
been used for the preservation of various
Parenteral pharmaceutical formulations.
40 Butylparaben Antimicrovial Preservative Oral suspensions (0.006–0.05)% Systemically, no adverse
Topical preparations (0.02–0.4)% reactions to parabens have been
reported, although they have
been associated with
hypersensitivity reactions.
41 Carnauba Wax Polishing agent 10% w/v aqueous emulsion to polish The WHO has established an
(powder) sugar-coated tablet. acceptable daily intake of up
to 7 mg/kg body-weight for
carnauba wax
42 Polyvinyl Coating agent; lubricant; Emulsions 0.5% Polyvinyl alcohol is generally
Alcohol stabilizing agent; viscosity- Ophthalmic formulations (0.25–3)% considered a nontoxic material.
increasing agent It is nonirritant to the skin and
eyes at concentrations up to
10%; concentrations up to 7%
are used in cosmetics.
43 Sodium Chloride Tablet and capsule diluent, Capsule diluent & Direct compression About 5–12 g of Sodium
tonicity agent. tablet diluent (10–80)%. Toxic effects chloride is consumed daily, in
following the oral ingestion of 0.5–1.0 the normal adult diet.
g/kg body-weight.
44 Sodium Preservative, Anti-oxident antioxidant in oral, parenteral, topical WHO has set an acceptable
Metabisulfite pharmaceutical formulations (0.01–1)% daily intake of sodium
metabisulfite at up to 7.0 mg/kg
body-weight.
45 Simethicone Antifoaming agent; tablet Simethicone occurs as a translucent, Therapeutically, oral doses of
diluent; water-repelling agent gray-colored, viscous fluid.It contains 125–250 mg of simethicone,
not less than 90.5% and not more than 3/4 times daily, have been
99.0% of the polydimethyl siloxane and given as an antiflatulent. Doses
not less than 4.0% and not more than of 20–40 mg of simethicone
7.0% of silicon dioxide. have been given with feeds to
relieve colic in infants.
46 Benzyl Alcohol Antimicrobial preservative; Benzyl alcohol 10% v/v solutions also The WHO has set the estimated
disinfectant; solvent. have some local anesthetic properties, acceptable daily intake of the
which are exploited in some parenterals, benzyl/benzoic moiety at up to
cough products, ophthalmic solutions, 5 mg/kg body-weight daily.
ointments, and dermatological aerosol
sprays
Prepared by

Md. Radwan Hossain