The document summarizes the specific roles of various excipients used in tablet production, including diluents, binders, disintegrants, lubricants, glidants, coloring agents, sweetening agents, and coating agents. It describes the mechanisms by which each excipient functions and provides examples. Key excipients discussed include lactose, microcrystalline cellulose, starch, polyvinyl pyrrolidone, sodium starch glycolate, talc, magnesium stearate, silicon dioxide, ferric oxide, sucrose, methyl cellulose, ethyl cellulose, and hydroxypropyl methylcellulose.

1. Specific role of excipients in tablet production
Prepared By:
DR. ANANDA KUMAR.CH
Assoc. Prof
Department of pharmaceutics
Lydia college of pharmacy
Subject: Pharmaceutical
Formulation
Pharm.D IIIrd Year

2. CONTENTS
• Diluents
• Binder
• Disintegrants
• Lubricants
• Glidants and anticaking agents
• Coloring agents
• Sweetening agents
• Coating agents

3. Diluents
• These are components that are incorporated into tablet or
capsule dosage forms to increase volume and weight. Some
times referred to as fillers, its often comprise a significant
proportion of the dosage form, and the quantity and type of
diluent selected often depends on its physical and chemical
properties. Because may comprise a large portion of the dosage
form, successful manufacturing and dosage form performance
depend on the measurement and control of these critical
attributes.
• Mechanism: its role is desirable manufacturing properties(eg:
powder flow, tablet compact strength, wet or dry granule
formation, homogeneity) and performance (eg: content
uniformity, disintegration, dissolution, tablet integrity, friability,
physical chemical stability . Some diluents (microcrystalline
cellulose) occasionally dry binders because high degree of tablet
strength they important to the final compressed tablet.

4. Diluents
• Physical properties: Tablet/ capsule primary properties are
direct effect on diluent and formulation performance.
1. Particle size and size distribution 2. particle shape 3. bulk/
true/tapped density, 4. specific surface area 5. crystallinity, 6.
moisture content, 7. powder flow, 8. solubility, 8. compaction.
Diluents and specific role:
1. Lactose ( anhydrous and monohydrate): it is used for direct
compression due to superior compressibility.
2. Microcrystalline cellulose: it is used for direct compression
now included in granules due to its excellent compressibility.
3. Dextrose or Glucose: direct compression , used in chewable
tablets

5. Diluents
4. Starch and Derivatives: Versatile material that can be used as
diluent binder, disintegrant.
5. Calcium Carbonate: Brittle material, an inert material used as
filler.
6. Dicalcium Phosphate: Excellent flow properties
7. Magnesium Carbonate: Direct compression diluent.
Eg of Diluents: Kaolin Starch, Lactose, Pregelatinised starch,
Modified Cellulose, Tapioca Cellulose, Powdered
Maltodextrin Starch, Wheat Starch Maltose, sucrose dextrin
Mannitol, Sugar, Calcium Carbonate Etc….

6. Binder
• These are incorporated into formulations to facilitate the
agglomeration of powder into granules during mixing with
granulating fluid such as water, hydroalcoholic mixture, other
solvents.
Mechanism: Tablet/ capsule binders are soluble or partially soluble
in granulating solvent or in the case of native starches, can be
made soluble. The concentrated binder solutions also have
adhesive properties. Upon addition of liquid, binders typically
facilitate the production of moist granules by altering
interparticle adhesion.
Physical Properties: Dispersion/ dissolution of binder in the
granulation liquid depends on its physical properties like surface
tension, particle size distribution, solubility, viscosity is more
important.

7. Binder
Specific binders role in tablet production:
1. Starch: the most commonly used binder, it has to be prepared
as paste, before use.
2. Pregelatinised starch: soluble in cold water so easy to
prepare than starch.
3. Acacia: it used as preparation of paste, retard the disintegration
times if used at high concentration.
4. Polyvinyl Pyrrolidone: available in the range of M.w,
viscosity; soluble in water and ethanol.
5. HPMC&Mc: low viscosity grades widely used.
Eg: Acacia, Alginic acid, Ammonio Methacrylate Copolymer,
Corbomer Copolymer, Gelatin, Glucose, Guar Gum, HPC,
Cellulose Maltodextrin, Povidone, Starch, Corn starch, Potato
starch.

8. Disintegrants
• Tablet formulation the breakdown of the tablet into granules
when it reaches the GIT fluid. In case of enteric coated or
controlled release tablets disintegrants are an important in
formulation(disintegration of conventional tablets occur within
15 min).
• Specific role in tablet production:
1. Starch: capillary action and swelling minimal at body tem.
2. MCC: strong capillary action
3. Gum: swell on react with water; viscous gels that retard
dissolution, thus limiting conc. That can be used.
4. Alginic acid: swell like gum but less viscous gel
5. Sodium starch glycolate Croscarmalose sodium: when
swell in react with water and strong capillary action.

9. Mechanism Physical properties Examples
It increase the porosity and wettability of
the compressed tablet matrix. The
gastrointestinal fluids may readily
penetrate the tablet matrix they are often
referred as super disintegrants.
It is insoluble in water and
facilitating the transport of
liquid into the core of tablet,
with the consequence tablet
breaks into fragments
Starch, MCC,
gelatin, Gums,
sodium starch.
It may operate by swelling in the presence
of Aq. Fluids, there by expediting tablet
disintegration due to increase in the
internal pressure within the tablet matrix.
They are often super disintegrants .
It is insoluble in water,
absorb water and swell,
facilitate the disintegration
of the tablets.
sodium starch
glycolate
croscarmellose
sodium ( a cross
linked sodium
carboxymethylcell
ulose)
Whenever the tablets reacts Aq. Fluid the
tablet disintegration by the production of
gas. it is mechanism of effervescent
tablet.
Tablet contains a mixtue of
sod. Bicarbonate and tartaric
or citric acid will
effervescent when added
water
Sodium
bicarbonate,
tartaric acid, citric
acid

10. lubricants
• It used to reduce the fractional forces between particles and metal
contact surfaces of manufacturing equipment such as tablet punches
and dies used in the manufacturing the solid dosage forms.
Mechanism Physical properties Examples
It is adhering to solid
surface and reducing
the particle particle
friction or the
particle metal friction
The primary properties
that are possibly
important for
boundary lubricants
include particle size,
surface area, hydration
state, and polymirphic
form.
Calcium Stearate,
SLS, Talc, SSF,
Vegetable oil,
Hydrogenated, Mg.
Stearate, Starch, Zinc
Stearate, Mineral Oil,
Light Stearic acid,
Polyethylene Glycol

11. lubricants
Specific role in tablet production:
1. Talc: fine crystalline powder used as lubricant and diluent has
small particle size and large surface area helps in covering
surface imperfection of granules.
2. Silicon dioxide: used as adsorbent antitacking agent
disintegrant and glidant .
3. Starch: used as binder, disintegrant, and diluent but also used
for glidant.
4. SLS: anionic surfactant, lubricant, and wetting agent.
5. Mg. Stearate and Mineral Oil: Hydrophobic can be applied
to either formulation or tooling

12. Glidants and anticaking agents
• There are used to promote powder flow and reduce the caking
or clumping that can occur when powders are stored in bulk.
Mechanism Physical properties Examples
It is combination of
adsorption onto the
surface of larger
particles and reduction
of particle- particle
adhesive and cohesive
forces, thus particles to
move more easily
relative to one another.
Potential importance of
glidants and anticaking
agents are particle size,
particle size
distribution, and
surface area. It may be
slightly hygroscopic.
Calcium Silicate,
Silicon dioxide,
Colloidal Mg.
Stearate, Talc.

13. Glidants and anticaking agents
Specific role in tablet production:
1. Talc: fine crystalline powder used as lubricant and diluent has
small particle size and large surface area helps to improve
flowability.
2. Silicon dioxide: Flowability; used as adsorbent, anticaking
agent, disintegrant, and glidant.
3. Calcium Silicate: Anticaking and free flow agent in
chemicals, excellent water and oil absorption, carrying agent
in animal feedstuff,

14. Coloring agents
• They are incorporated into dosage forms in order to produce a
distinctive appearance that may serve to differentiate a particular
formulation from others that have a similar physical appearance.
These are subdivided into dyes (water soluble substances)
• Lakes: insoluble forms of a dye that result from its irreversible
adsorption onto a hydrous metal oxide.
• Inorganic pigments: substance such as titanium dioxide or iron
oxides
• Natural colorants: colored compounds not considered as dyes
such as riboflavin .
*in the federal Food, Drug, Cosmetic act 1938 three categories of
coloring agents were created.

15. 1. FD&C colors: Those certifiable for use in coloring foods, drugs, and
cosmetics.
2. D&C colors: Dyes and Pigments considered safe in drugs and
cosmetics when in contact with mucous membranes or when ingested .
3. Ext. D&C colors: Colorants that because of their oral toxicity are not
certifiable for use in ingestible products but are considered safe for use
in externally applied products.
Mechanism Physical properties Examples
Water soluble dyes are
usually dissolved in a
granulating fluid for
use, although may also
be adsorbed onto
carriers such as starch,
lactose, or sugar form
aqueous or alcoholic
solutions
Particle size and size
distribution of dyes and
lakes can influence
product processing times
(blending and
dissolution), color
intensity, and uniformity
of appearance.
Ferric oxide, Red
Ferric oxide, Yellow
Ferric oxide Blends,
Caramel.

16. Sweetening agents
• They are used to sweeten oral dosage forms and to mask
unpleasant flavors.
Mechanism Physical properties Examples
It is bind to receptors on
the tongue that are
responsible for the
sensation of sweetness.
The longer the sweetener
molecule remains
attached to the receptor,
the sweeter the substance
is perceived to be. The
standard for sweetness is
sucrose.
The primary physical
properties relevant to
sweeteners relate to
their compatibility
with the other
ingredients in the
formulation.
Acesulfame,Aspartame
, Maltose, Sucrose
Saccharin Sugar,
Dextrose Saccharin,
Fructose, Sorbital
Galactose and sorbitol
Solution

17. Coating agents
• The pharmaceutical drug delivery systems include masking
unpleasant taste or odors, improving ingestion. Improving
appearance, protecting active ingredients from the environment,
controlling the rate of release of the active ingredient, and
controlling drug release in the gastrointestinal tract.
Specific role in tablet production:
1. Methyl cellulose: Soluble in cold water, GI fluids, and a range of
organic solvents.
2. Ethyl cellulose: Soluble in organic solvents, insoluble in water
and GI fluids; used alone in modified release formulation and in
combination with water- soluble cellulose for immediate release
formulations.
3. Hydroxyl propyl methyl cellulose: soluble in cold water, GI
fluids, alcohols.
4. Sodium carboxy methyl cellulose: soluble in water and polar
solvents

18. Coating agents
Mechanism Physical properties Examples
The coating system
forms a layer on the
substrate. Eg: a particle
or unit dosage form,
and changes its
appearance. On contact
with the secretions of
the GIT, the coating
makes the product slide
more easily over
mucosal surfaces and
helps control the rate
and site of drug release.
The necessary physical
properties for a coating
system include adequate
mechanical strength. The
film must be strong
enough to withstand
tumbling during the
coating process and resist
film erosion. The
solubility of the coating
material must be
adequate in either
aqueous or nonaqueous
solvents, depending on
the nature of the material
CMC, Cellulose
Acetate< Cellulose
Acetate Phthalate, EC,
Gelatin, HPC,
Methacrylic Acid
Copolymer, MC, Poly
ethylene Glycol,
Polyvinyl Acetate
Phthalate, Shellac,
Starch, Wax, Carnuba
Wax and
Microcrystalline wax.