TITLE: Excipients List

Department Production
Prepares By: Dr. Atiq -ur- Rehman

Concentration with
reference

Functional
Chemical

category
to core weight
Name &
Excipients Formula Uses
Common
(coc.per mg of tab or
Names
cap ÷ core wt. of tab
or cap)
Starch quantities of
3–10% w/w can act as an
antiadherent and lubricant
in tableting and capsule
filling.
In tablet formulations,
Tablet and freshly prepared starch  Starch is a versatile excipient
capsule paste is used at a
Maize starch, (diluent, concentration of 3–20% used primarily in oral solid-
Starch Potato starch, Disintegrant) w/w (usually 5–10%, dosage formulations where it is
Corn starch. Tablet binder, depending on the utilized as a binder, diluent, and
thickening Starch type) as a binder for
agent. wet granulation. disintegrant.
Starch is one of the most
commonly used tablet
disintegrant at
Concentration of 3–25%
w/w; a typical concentration
is 15%.
Use Con, (%)  Partially pre-gelatinized starch is a modified
Diluent (hard 5–75 starch used in oral capsule and tablet
gelatin formulations as a binder, diluent, and
capsules) disintegrant.
Tablet and
Tablet binder  In comparison to starch, partially pre-
capsule 5–20
(direct gelatinized starch may be produced with
Starch, pregelatinized Pregelatinized starch (diluent, compression) enhanced flow and compression
(Starch 1500) (Starch 1500) Disintegrant)
characteristics such that the pre-gelatinized
Tablet Tablet binder 5–10
(wet material may be used as a tablet binder in
Binder.
granulation) dry-compression or direct compression
Tablet processes.
disintegrant 5–10  In such processes, pre-gelatinized starch is
self-lubricating.
 Lactose is widely used as a filler and diluent
in tablets and capsules.
O-b-D-
Tablet binder;  Fine grades of lactose are used in the
Galactopyranosyl-
tablet and preparation of tablets by the wet-granulation
Lactose mono-hydrate (1--- 4)-a-D-
method or when milling during processing is
capsule
glucopyranose
(diluent, filler). carried out, since the fine size allows better
monohydrate
mixing with other formulation ingredients
and utilizes the binder more efficiently.
Spray-dried lactose is a Directly  Spray-dried lactose is widely used as a
mixture of amorphous compressible binder, filler-binder, and flow aid in direct
lactose, which is a 1:1 tablet excipient; compression tableting.
Lactose, Spray Dried mixture of (a-and-b- Tablet and capsule
lactose, and Lactose (diluent,
monohydrate). Filler).
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

Directly  Anhydrous lactose is widely used in direct

compressible compression tableting applications, and as
O-b-D- tablet a tablet and capsule filler and binder.
Galactopyranosyl- excipient;  Anhydrous lactose can be used with
Lactose, Anhydrous (1---4)-b-D- moisture-sensitive drugs due to its low
Tablet and
glucopyranose capsule moisture content. It may also be used in
(diluent, intravenous injections.
Filler).

Povidone(PVP)  Povidone is used in a variety of

Concentration
Different Grades of
PVP.
Use (%)
pharmaceutical formulations, it is primarily
used in solid-dosage forms. In tableting,
K-
Approx, povidone solutions are used as binders in
Molecular Disintegrant; wet-granulation processes.
value
weight  Povidone solutions may also be used as
dissolution
(Povidone PVP) 12 2500 Tablet coating agents or as binders when coating
enhancer;
15 8000 (binder, active pharmaceutical ingredients on a
PVP-K30, K-90 suspending
diluent,)
17 10,000 agent, 0.5–5% support such as sugar beads.
25 30,000 or  Povidone is additionally used as a
Tablet binder. coating
30 50,000 suspending, stabilizing, or viscosity-
agent
60 400,000 increasing agent in a number of topical and
90 1,000,000 oral suspensions and solutions.
120 3,000,000
Usual concentration  Sodium starch glycolate is widely used in
employed in a formulation oral pharmaceuticals as a disintegrant in
is between 2% and 8%, capsule and tablet formulations.
Sodium Starch Sodium with the optimum  It is commonly used in tablets prepared by
Tablet and
carboxymethyl concentration about 4%, either direct compression or wet-granulation
glycolate starch,
capsule
Although in many cases 2% processes.
(Primojel) disintegrant.
sodium salt. is sufficient. Disintegration
occurs by rapid uptake of
water followed by rapid and
enormous swelling.
Conc,(  Colloidal silicon dioxide small particle size
Use and large specific surface area give it desirable
Adsorbent, %)
Anticaking agent, flow characteristics that are exploited to improve
Emulsion the flow properties of dry powders in a number of
Silica( chem, name) Aerosols 0.5–2.0 processes such as tableting.
stabilizer,
Colloidal silicon
Glidant,  Colloidal silicon dioxide is also used as a tablet
dioxide, colloidal silica, Emulsion disintegrant and as an adsorbent dispersing agent
Aerosil(Fumed silica) Suspending agent, 1.0–5.0
fumed stabilizer for liquids in powders.
tablet
Silica, light anhydrous
disintegrant,  Colloidal silicon dioxide is a submicroscopic
silicic acid, Glidant 0.1–0.5 fumed silica with a particle size of about 15 nm. It
thermal stabilizer,
viscosity- is a light, loose, bluish-white colored, odorless,
increasing agent. Suspending and tasteless, non-gritty amorphous powder.
2 –10
thickening agent
Tablet and Use in concentrations  Magnesium stearate in pharmaceutical
Octadecanoic acid
Magnesium Stearate magnesium salt.
capsule between 0.25% and 5.0% formulations primarily used as a lubricant in
lubricant. w/w. capsule and tablet manufacturing.
 Isopropyl alcohol is also used as a solvent
Disinfectant, both for tablet film-coating and for tablet
Isoproply Alcohol IPA solvent. granulation, where the isopropyl alcohol is
subsequently removed by evaporation.
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

Anionic
surfactant,
emulsifying
 Sodium lauryl sulfate is an anionic surfactant
Sulfuric acid agent; skin Tablet lubricant 1.0–2.0%
Sodium lauryl employed in a wide range of non-parenteral
monododecyl ester penetrant; Wetting agent in dentrifices
Sulphate (SLS) 1.0–2.0% pharmaceutical formulations.
sodium salt. Tablet and
 Aid in tablet dissolution.
capsule
lubricant;
wetting agent.
Pharmacel, Conc,  Microcrystalline cellulose is widely used in
Avicel PH, Use pharmaceuticals, primarily as a
(%)
Cellulose (chem, Adsorbent; Adsorbent 20–90 binder/diluent in oral tablet and capsule
name). suspending Antiadherent 5–20 formulations where it is used in both wet-
Avicel PH Different Grades of agent; tablet and Capsule granulation and direct-compression
20–90
(Microcrystalline cellulose) Avicel PH (101, 102, capsule diluent; binder/diluent processes.
103, 105, 112, 113, Tablet Tablet  In addition to its use as a binder/diluent,
5–15
Disintegrant. disintegrant microcrystalline cellulose also has some
200, 301, 302).
Tablet
20–90
lubricant (and disintegrant properties that
binder/diluent make it useful in tableting.
Conc,  Sodium chloride is widely used in a variety
Use of parenteral and non-parenteral
(%)
pharmaceutical formulations, where the
Capsule diluent 10–80 primary use is to produce isotonic solutions.
 Sodium chloride has been used as a lubricant
Controlled and diluent in capsules and direct-
flocculation of ≤1
suspensions
compression tablet formulations in the past,
common salt; hopper Direct although this practice is no longer common.
Tablet and
salt; natural halite; compression 10–80  Sodium chloride has also been used as an
Sodium Chloride rock salt; saline; salt;
capsule diluent;
osmotic agent in the cores of controlled-
tonicity agent. tablet diluent
sea salt; table salt. release tablets. It has been used as a porosity
modifier in tablet coatings, and to control
drug release from microcapsules.
Water-soluble  The addition of sodium chloride to aqueous
5–20
tablet lubricant spray-coating solutions containing
hydroxypropyl cellulose or hypromellose
suppresses the agglomeration of crystalline
cellulose particles.
Coating agent;  Low-molecular-weight gelatin has been
film-former; investigated for its ability to enhance the
gelling agent; dissolution of orally ingested drugs. Other
suspending uses of gelatin include the preparation of
Gelatin Instagel, Solugel.
agent; pastes, pastilles, pessaries, and suppositories.
Tablet binder;  In addition, it is used as a tablet binder and
viscosity- coating agent.
increasing agent.
Dibasic calcium Anhydrous dibasic calcium  It is used in pharmaceutical products because
phosphate phosphate is abrasive and a of its compaction properties, and the good
Calcium lubricant is required for flow properties of the coarse-grade material.
Tablet and
Dicalcium Phosphate Phosphate, Dibasic tableting, for example 1%  Unlike the dibasic dihydrate, anhydrous
capsule diluent.
w/w magnesium stearate dibasic calcium phosphate when compacted
Anhydrous Or 1% w/w sodium stearyl at higher pressures can exhibit lamination
fumarate. and capping.
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

Use Conc,  Talc was once widely used in oral solid

Anticaking (%) dosage formulations as a lubricant and
agent; Glidant; Dusting diluent, although today it is less commonly
Purified Talc/ Tablet and powder
90.0–99.0 used.
Talcum powder Talc capsule (diluent, Glidant and  However, it is widely used as a dissolution
1.0–10.0
lubricant). tablet lubricant Retardant in the development of controlled-
Tablet and release products.
capsule 5.0–30.0  Talc is also used as a lubricant in tablet
diluent formulations, and also used as an adsorbent.
Conc,  Zinc stearate is primarily used in
Use pharmaceutical formulations as a lubricant in
(%)
Tablet tablet and capsule manufacture at
Tablet and 0.5–1.5
Octadecanoic acid lubricant concentrations up to 1.5% w/w.
Zinc Stearate zinc salt
capsule
 It has also been used as a thickening and
lubricant. Water- opacifying agent in cosmetic and
repellent 2.5
pharmaceutical creams and as a dusting
ointments
powder.
Croscarmellose sodium at  Croscarmellose sodium is used in oral
concentrations up to 5% pharmaceutical formulations as a disintegrant
w/w may be used as a tablet for capsules, tablets, and granules.
Disintegrant, although  In tablet formulations, croscarmellose
normally 2% w/w is used in sodium may be used in both direct-
Cellulose, tablets prepared by direct compression and wet-granulation processes.
carboxymethyl ether, Tablet and compression and 3% w/w  When used in wet granulations, the
Cross Carmellose
sodium salt, capsule in tablets prepared by a croscarmellose sodium should be added in
Sodium crosslinked. disintegrant. wet-granulation process. both the wet and dry stages of the process
Primellose. Conc, (Intra- and extragranularly) so that the
Use wicking and swelling ability of the
(%)
Disintegrant in disintegrant is best utilized.
10–25
capsules
Disintegrant in
0.5–5.0
tablets
 Sucralose is used as a sweetening agent
Pharmaceutical applications. It has a
Sweetening It is Used in Concentration sweetening power approximately 300–1000
Polysucralose Sucralose agent. (%) of (0.03–0.24%). times that of sucrose and has no aftertaste. It
has no nutritional value, is no cariogenic, and
produces no glycemic response.
 Hydroxypropyl cellulose is widely used in
Use Conc, oral and topical pharmaceutical formulations.
(%)  In oral products, hydroxypropyl cellulose is
Coating agent;
Extended primarily used in tableting as a binder, film-
Emulsifying
release-matrix 15–35 coating, and extended-release matrix former.
agent;
former Concentrations of hydroxypropyl cellulose of
Stabilizing
2–6% w/w may be used as a binder in either
agent;
HPC, Cellulose, 2- Tablet binder 2–6 wet-granulation or dry, direct-compression
Hydroxy Propyl Suspending
hydroxypropyl ether, tableting processes. Concentrations of 15–
Cellulose agent; tablet
Methocel 35% w/w of hydroxypropyl cellulose may be
binder;
used to produce tablets with an extended
thickening
drug release. The release rate of a drug
agent; viscosity-
Tablet film increases with decreasing viscosity of
increasing
coating 5 hydroxypropyl cellulose. The addition of an
Agent.
anionic surfactant similarly increases the
viscosity of hydroxypropyl cellulose and
hence decreases the release rate of a drug.
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

Typically, a 5% w/w solution of

hydroxypropyl cellulose may be used to film-
coat tablets.
 Hypromellose is widely used in oral,
ophthalmic and topical pharmaceutical
Coating agent;
formulations.
film-former;
 In oral products, hypromellose is primarily
rate-controlling
used as a tablet binder, in film-coating, and
polymer for
as a matrix for use in extended-release tablet
sustained
Concentrations between 2% formulations.
release;
Hydroxy Propyl HPMC, Methocel E- and 5% w/w may be used  High-viscosity grades may be used to retard
stabilizing
methyl Cellulose 15. as a binder in either wet- or the release of drugs from a matrix at levels of
agent;
dry-granulation processes. 10–80% w/w in tablets and capsules.
suspending
 Depending upon the viscosity grade,
agent; tablet
concentrations of 2–20% w/w are used for
binder;
film-forming solutions to film-coat tablets.
viscosity-
Lower-viscosity grades are used in aqueous
increasing agent.
film-coating solutions, while higher-viscosity
grades are used with organic solvents.
 Crospovidone is a water-insoluble tablet
disintegrant and dissolution agent used at 2–
5% concentration in tablets prepared by
direct-compression or wet- and dry-
granulation methods. It rapidly exhibits high
capillary activity and pronounced hydration
capacity, with little tendency to form gels.
Crospovidone is a water- Studies suggest that the particle size of
insoluble tablet disintegrant crospovidone strongly influences
and dissolution agent used disintegration of analgesic tablets. Larger
polyvinylpolypyrroli Tablet
Crospovidone done; PVPP; disintegrant.
at 2–5% concentration in particles provide a faster disintegration than
tablets prepared by direct- smaller particles.
compression or wet- and  Crospovidone can also be used as a solubility
dry-granulation methods. enhancer. With the technique of co-
evaporation, crospovidone can be used to
enhance the solubility of poorly soluble
drugs. The drug is adsorbed on to
crospovidone in the presence of a suitable
solvent and the solvent is then evaporated.
This technique results in faster dissolution
rate.
Citric acid Anhydrous
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

 Sodium bicarbonate is generally used in pharmaceutical formulations as a

source of carbon dioxide in effervescent tablets and granules.
 In effervescent tablets and granules, sodium bicarbonate is usually
formulated with citric and/or tartaric acid, combinations of citric and tartaric
acid are often preferred in formulations as citric acid alone produces a sticky
mixture that is difficult to granulate, while if tartaric acid is used alone,
granules lose firmness. When the tablets or granules come into contact with
water, a chemical reaction occurs, carbon dioxide is evolved, and the
product disintegrates. Melt granulation in a fluidized bed dryer has been
suggested as a one-step method for the manufacture of effervescent granules
composed of anhydrous citric acid and sodium bicarbonate, for subsequent
compression into tablets.
 Tablets may also be prepared with sodium bicarbonate alone since the acid
of gastric fluid is sufficient to cause effervescence and disintegration.
Alkalizing Sodium bicarbonate is also
Baking soda;
agent; used in tablet formulations to buffer drug molecules that are weak acids,
Sodium Bicarbonate Carbonic acid
therapeutic
monosodium salt thereby increasing the rate of tablet dissolution and reducing gastric
agent. irritation.
 The effects of tablet binders, such as polyethylene glycols, microcrystalline
cellulose, silicified microcrystalline cellulose, pre-gelatinized starch, and
povidone, on the physical and mechanical properties of sodium bicarbonate
tablets have also been investigated.
 Therapeutically, sodium bicarbonate may be used as an antacid, and as a
source of the bicarbonate anion in the treatment of metabolic acidosis.

Use Conc, (%)

Buffer in tablets 10–40

Effervescent tablets 25–50

Isotonic injection/infusion 1.39
 Mannitol is widely used in pharmaceutical
formulations. In pharmaceutical preparations
it is primarily used as a diluent (10–90%
w/w) in tablet formulations, where it is of
particular value since it is not hygroscopic
and may thus be used with moisture-sensitive
Diluent; diluent
active ingredients.
for lyphilized
In pharmaceutical  Mannitol may be used in direct-compression
preparations;
preparations mannitol is tablet applications, for which the granular
sweetening
Mannitol D-Mannitol
agent;
primarily used as a diluent and spray-dried forms are available, or in wet
(10–90% w/w) in tablet granulations. Granulations containing
tablet and
formulations. mannitol have the advantage of being dried
capsule diluent;
easily. Specific tablet applications include
tonicity agent.
antacid preparations, glyceryl tri-nitrate
tablets, and vitamin preparations.
 Mannitol is commonly used as an excipient
in the manufacture of chewable tablet
formulations because of its negative heat of
solution, sweetness, and ‘mouth feel’.
Dried Starch (cap)
Avicel pH 200 (cap) Same as for tabs mentioned above
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman

Magnesium Stearate
light (cap)
Same as for tabs mentioned above
Base for medicated confectionery; Con,  Sucrose is widely used in oral
coating agent; granulating agent; sugar Use pharmaceutical formulations.
(%)
coating adjunct; suspending agent; Syrup for oral  Sucrose syrup, containing 50–67% w/w
sweetening agent; tablet binder; tablet 67 sucrose, is used in tableting as a binding
liquid formulations
and capsule diluent; tablet filler; Sweetening agent 67 agent for wet granulation.
viscosity-increasing agent. Tablet binder (dry  In the powdered form, sucrose serves as a dry
2–20
granulation binder (2–20% w/w) or as a bulking agent
Tablet binder (wet and sweetener in chewable tablets and
Sucrose, Sugar 50–67
granulation) lozenges. Tablets that contain large amounts
Tablet coating of sucrose may harden to give poor
(syrup)
disintegration.
 Sucrose syrups are used as tablet-coating
50–67 agents at concentrations between 50% and
67% w/w. With higher concentrations, partial
inversion of sucrose occurs, which makes
sugar coating difficult.
 In pharmaceutical formulations, titanium
Coating agent;
dioxide is used as a white pigment in film-
Titanium dioxide Titanium oxide opacifier;
coating suspensions, sugar-coated tablets,
pigment.
and gelatin capsules.
Sodium benzoate has also  Sodium benzoate has also been used as a
Benzoic acid sodium Tablet and
been used as a tablet tablet lubricant at 2–5% w/w concentrations.
Sodium benzoate salt; benzoate of capsule
lubricant at 2–5% w/w
soda. lubricant.
concentrations.
Controlled-release vehicle; polishing agent;  In some oral formulations yellow wax is used
Bees wax Yellow beeswax
stabilizing agent; Stiffening agent. as a polishing agent for sugar-coated tablets.
 In solid-dosage formulations, higher-
molecular-weight polyethylene glycols can
enhance the effectiveness of tablet binders
and impart plasticity to granules. However,
they have only limited binding action when
used alone, and can prolong disintegration if
present in concentrations greater than 5%
w/w.
 Polyethylene glycols can also be used to
enhance the aqueous solubility or dissolution
Ointment base;
characteristics of poorly soluble compounds
plasticizer;
Solid grades of PEG by making solid dispersions with an
solvent;
Poly ethylene glycol Carbowax, appropriate polyethylene glycol.
PEG Macrogols
suppository (1000.2000,4000,  In film coatings, solid grades of polyethylene
base; tablet and 6000 and 20000). glycol (PEG 6000 ) can be used alone for the
Capsule
film-coating of tablets or can be useful as
lubricant.
hydrophilic polishing materials.
 Polyethylene glycol grades with molecular
weights of 6000 and above can be used as
lubricants, particularly for soluble tablets.
The lubricant action is not as good as that of
magnesium stearate, and stickiness may
develop if the material becomes too warm
during compression. An antiadherent effect is
also exerted, again subject to the avoidance
of overheating.
 TITLE: Excipients List
Department Production
Prepares By: Dr. Atiq -ur- Rehman