1461-5347/00/$ see front matter 2000 Elsevier Science Ltd. All rights reserved.

PII: S1461-5347(99)00237-0
M It is a remarkable fact that, in the new millen-
nium, tablets still account for more than 80% of
all dosage forms administered to man.The princi-
pal reasons for their continued popularity include
their ease of manufacture, their convenience of
dosing, and their stability compared with liquid
and semi-solid presentations. One mode of tablet
manufacture is that of direct compression of the
active ingredient with other appropriate excipi-
ents to form a tablet, normally for medium- to
high-potency compounds where the drug con-
tent is less than 30% of the formulation. The ad-
vantages of direct compression are well-known,
the most important being fewer processing stages
and the elimination of heat and moisture effects.
This review will outline the various excipients
that have been used as fillers in direct compres-
sion formulations, with particular emphasis on
what is expected from such excipients in terms
of their functionality.
Direct compression (DC) manufacture
Direct compression is viewed as the technique of
choice for the manufacture of tablets containing
thermolabile and moisture-sensitive drugs
1,2
,
and although it affords many advantages it is still
not as popular as wet granulation
13
.
The existing popularity of wet granulation can
be understood when considering the compaction
process. As a powder is compressed within a die,
the various stages of the compaction process can
be separated as follows
1
:

rearrangement where particles move within

the die cavity to occupy void spaces that exist
between particles;

deformation when particles can no longer

rearrange themselves, the material will start to
deform elastically;

compaction when the elastic limit of the

material is exceeded, the material will deform
either plastically or destructively (fragmen-
tation or brittle fracture). Either mechanism
can occur and is dependent upon the material
characteristics, the compaction speed, com-
paction pressure and particle size. Plastic de-
formation will aid bonding because it in-
creases the contact area between particles and
fragmentation produces newer surfaces which
also favours strong bonding.

relaxation once a compressional force has

been withdrawn from a compressed mass
(during punch withdrawal and ejection from
the die cavity) the compact will undergo re-
laxation; if these elastic forces exceed the ten-
sile strength of the tablet, then tablet integrity
will fail.
Successful tablet production will depend upon
achieving the right balance of brittle fracture and
plastic behaviour within the compression mix,
which, in turn, is dependent upon the compres-
sional characteristics of the drug substance and the
excipients. Theoretically, materials will compress
by plastic deformation, such as microcrystalline
An overview of the different
excipients useful for the direct
compression of tablets
Mira Jivraj, Luigi G. Martini and Carol M. Thomson
M. Jivraj
The London School of
Pharmacy
University of London
Brunswick Square
London
UK WC1N 1AX
Luigi G. Martini* and
Carol M. Thomson
SmithKline Beecham
Pharmaceuticals
Pharmaceutical Technologies
New Frontiers Science Park
(South)
Harlow
UK CM19 5AW
*tel: 44 1279 62000
fax: 44 1279 644100
e-mail: Luigi_G_Martini@
sbphrd.com
or Carol_M_Thomson@
sbphrd.com
reviews research focus
58
PSTT Vol. 3, No. 2 February 2000
The humble tablet dosage form still accounts for more than 80% of
all dosage forms administered to man. This review will outline the
various excipients that have been used as fillers in direct compression
formulations, with particular emphasis on what is expected from such
excipients in terms of their functionality. It is intended that this
overview (which is by no means exhaustive) will serve as an aide-
memoire to the formulation scientist.
cellulose, or brittle fracture, such as dicalcium phosphate dihy-
drate, but, in practice, most excipients and drugs will compact
as a combination of these mechanisms. The most commonly
employed excipients have been ranked in ascending order in
terms of their brittleness: microcrystalline cellulose spray-
dried lactose -lactose -lactose -lactose monohy-
drate dicalcium phosphate dihydrate.
The main advantage of wet granulation is that the poor com-
pressional and flow properties exhibited by many drug sub-
stances can be masked as a result of their incorporation into a
granule, allowing batch-to-batch differences to be submerged
in a sea of starch paste or povidone
2
. However, with the judi-
cious choice of excipients combined with an appropriate drug
substance, the reward for establishing a direct compression
process can be substantial.
A summary of the general advantages and disadvantages
of direct compression have been outlined in Box 1, although
formulation-specific differences may manifest with different
drug substances
3
.
Direct compression excipients
Although the principles governing direct compression have
been well known for many years, the technique has only re-
cently become more established as a result of the introduction
of excipients specifically designed for direct compression
5
.
These excipients are not only directly compressible themselves,
but can also be mixed with a large proportion of drug sub-
stance with no significant deterioration in tablet quality
6
. In
addition to excipients possessing good flow and compression
properties, they must also possess the following attributes:

particle size distributions that are similar for most active drug
substances, thus avoiding segregation during processing;

a high bulk density;

Batch-to-batch quality must be reproducible.

These attributes are the most critical for direct compression
functionality. The remaining attributes are required for all ex-
cipients, in that they should also be:

physically and chemically stable when in contact with mois-

ture, air and heat;

chemically inert; that is, do not accelerate the degradation of

active ingredients or other excipients;

compatible with packaging components;

available worldwide, and preferably from more than one

supplier.
In addition, it is important to note that many excipients can
possess multi-functionality, which is dependent upon the
concentration at which they are employed. For example, micro-
crystalline cellulose (see below) can be used as an anti-adherent
(520%), a disintegrant (515%) and as a diluent (2090%)
7
.
Materials that are currently available as direct compression
vehicles can be classified according to their disintegration and
flow properties, and these are summarized in Box 2.
Disintegrants and poor flow
Microcrystalline cellulose
Microcrystalline cellulose is a purified, partially depolymerized
cellulose, which is prepared by treating -cellulose with min-
eral acids, producing bundles of needle-like microcrystals. In
terms of appearance, this excipient is a white, crystalline pow-
der composed of agglomerated porous particles
7
. In a survey
conducted within the pharmaceutical industry, Shangraw and
Demarest
8
concluded that many formulation scientists ranked
microcrystalline cellulose as the most useful filler for direct
compression. Its popularity can be ascribed to its excellent
compactibility at low pressures, high dilution potential and su-
perior disintegration properties. However, using paracetamol
and potassium phenethicillin as model compounds, Khan et al.
9
59
PSTT Vol. 3, No. 2 February 2000 reviews research focus
Box 1. Advantages and disadvantages of direct
compression
Advantages
Requires fewer unit operations compared with wet
granulation (shorter processing time and lower energy
consumption)
Fewer stability issues for actives that are sensitive to heat
or moisture
For certain compounds, faster dissolution rates may be
generated from tablets prepared by direct compression
compared with wet granulation; for example, norfloxacin
4
Fewer excipients may be needed in a direct compression
formula
Disadvantages
Issues with segregation these can be reduced by matching
the particle size and density of the active drug substance
with excipients
In general, the drug content is limited to approximately
30% or approximately 50 mg
May not be applicable for materials possessing a low bulk
density because after compression the tablets produced
may be too thin
Not suited for poorly flowing drug compounds
Static charges may develop on the drug particles or
excipients during mixing, which may lead to agglomeration
of particles producing poor mixing
found that the compactibility of microcrystalline cellulose de-
creased with a reduction in its moisture content.
However, when microcrystalline cellulose with high mois-
ture levels were employed (7.0%) the tablets formed were
prone to capping. These workers postulated that moisture
within the porous structure of microcrystalline cellulose facili-
tated the slippage of individual microcrystals, upon defor-
mation, and that an optimum amount of moisture was needed
to encourage hydrogen bonding between particles, thus pre-
venting elastic recovery. Previous reports have shown that com-
pacts of microcrystalline cellulose stored under high humidity
tended to swell as a result of disruption of the hydrogen bonds
that bind the cellulose fibres together
10
.
Particle size has very little effect on compactibility
11,12
and,
as a result of its low bulk density, microcrystalline cellulose has
a high dilution potential. In addition, despite its plastic behav-
iour upon compression, Bolhuis et al.
13
found that microcrys-
talline cellulose compressed both with and without magnesium
stearate (0.5%) still produced extremely hard compacts, al-
though tablets are seldom manufactured without a lubricant
and, as such, this is probably an academic point.
Microcrystalline cellulose is regarded as being chemically
inert and compatible with most drugs. The limitation of poor
flow can be offset by mixing with another filler with good
flowability, such as -lactose monohydrate or dicalcium phos-
phate dihydrate. Experimental findings
14
showed that micro-
crystalline cellulose and extra fine lactose had the best overall
properties when compared with eleven other microcrystalline
celluloseexcipient combinations.
Starch 1500
Native starches possess good compression characteristics, but
their poor flow properties and high lubricant sensitivity does
make them less suitable for use in direct compression. They are
particularly useful as a result of their good binding and disin-
tegrant properties. Nevertheless, Starch 1500 continues to be
widely regarded as the next choice excipient after lactose and
microcrystalline cellulose
8
.
Starch 1500 is a form of pregelatinized starch that has been
modified to make it more compressible and flowable in char-
acter. In terms of appearance, it is a white to off-white powder
of a moderately coarse-to-fine nature. It is odourless, but is re-
ported to have a distinctive taste
7
.
During the manufacturing process, some of the hydrogen
bonding between amylose and amylopectin is partially rup-
tured, so that the product contains 5% free amylose, 15% free
amylopectin and 80% unmodified starch. The free amylose is
responsible for the disintegration properties and the free amy-
lopectin provides cold water solubility and aids the binding
properties
15
.
Starch 1500 is extremely sensitive to the softening effects of
alkaline stearate lubricants
16
. For this reason, the use of magne-
sium stearate should be avoided or kept at a level below 0.5%
w/w
13
because higher concentrations can have adverse effects
on tablet strength and dissolution. Consequently, stearic acid is
usually preferred as the lubricant to be used with pregelatinized
starch. Starch is a good disintegrant but this property may cause
longer-term problems because the compacts formed may be
friable. At high strain rates during compression a large propor-
tion of the deformation is elastic and hence, elastic recovery oc-
curs during the act of ejection, inducing capping
16,17
.
Free-flowing materials that do not disintegrate
Dicalcium phosphate dihydrate
Dicalcium phosphate (dihydrate) is a commonly used directly
compressible filler produced by a complicated process using
phosphoric acid and slaked lime. Although predominantly used
in vitamin and mineral supplements because of the high cal-
cium and phosphorus content, the use of dicalcium phosphate
is increasing in pharmaceutical preparations as a result of its
low cost and desirable flow and compression characteristics
7
.
The addition of a lubricant is necessary as non-lubricated
tablets made with dicalcium phosphate are difficult to eject
from dies. One of the main advantages of using dicalcium
phosphate as a filler or binder is that alkaline lubricants such as
magnesium stearate have practically no effect on its binding
properties
18
. This insensitivity to magnesium stearate has been
attributed to the fact that clean, lubricated surfaces are created
by crystal fragmentation during the process of consolidation
and compaction.
When placed in water, dicalcium phosphate tablets are
rapidly and completely penetrated by the liquid
19
. This rapid
penetration is caused by the hydrophilic nature of the ma-
terial
20
and the high porosity of the tablets. Despite the fast and
60
PSTT Vol. 3, No. 2 February 2000 reviews research focus
Box 2. Materials used as direct compression
vehicles classified according to their
disintegration and flow properties
Materials that act as disintegration agents with poor flow
characteristics, such as microcrystalline cellulose and
directly compressible starch
Free flowing materials that do not disintegrate, such as
dibasic calcium phosphate dihydrate
Free flowing powders that disintegrate by dissolution, such
as lactose, mannitol and maltose
Co-processed excipients that is, excipients that have been
combined together in a synergistic manner and which are
more beneficial than simple physical admixtures, such as
silicified microcrystalline cellulose
complete water penetration, dicalcium phosphate tablets do not
disintegrate because the excipient is relatively insoluble in
water and no disintegration force is developed
21
.Therefore, it is
important to include a disintegrant with an active mechanism
such as swelling, for example starch, povidone and sodium
starch glycolate, to induce the disintegration forces necessary to
break up the tablet.
Dicalcium phosphate is best used in direct compression
when combined with microcrystalline cellulose or starch
22,23
.
Good compression characteristics can be obtained with
1033% dicalcium phosphate and 6690% microcrystalline
cellulose with 0.5% magnesium stearate and as little as 0.1%
sodium starch glycolate. This combination of excipients can
convert up to 20% of a poorly compressible drug substance
into a directly compressible formulation
24
.
Free-flowing powders that disintegrate by dissolution
Lactoses
Lactose is widely used as a filler or diluent in tablets and sev-
eral grades are commercially available with differing physical
properties. Spray-dried lactose was developed 30 years ago and
is a form of lactose designed specifically for direct compres-
sion. It comprises mainly -lactose monohydrate microcrys-
tals bound into spherical aggregates by small amounts of
amorphous lactose. Other types used for direct compression
are agglomerated lactose produced by fluid bed drying, anhy-
drous -lactose and anhydrous -lactose. Anhydrous -lactose
has the significant drawback of relatively slow disintegration,
and is not discussed further here. Hydrous lactose monohy-
drate is not directly compressible and is therefore used in wet
granulation formulations. The characteristics of some com-
monly employed lactoses have been summarized in Boxes 3
and 4.
A comparative evaluation of the use of six lactose-based ex-
cipients as direct compression excipients gave the following
rank order in terms of effectiveness: anhydrous -lactose, fol-
lowed closely by spray-dried lactose and Ludipress (see co-
processed excipients section)
26
.
Sorbitol
Sorbitol is a common tablet excipient suitable for direct com-
pression and is widely used in the manufacture of chewable
and sublingual tablets. It is a white, crystalline and odourless
solid with a pleasant, cooling, sweet taste
7
, and is a hygro-
scopic isomer of mannitol, produced on a commercial scale by
high-pressure catalytic hydrogenation of glucose in the pres-
ence of copper or nickel.
There are four different types (, , , and ) as well as an
amorphous form that is known to exist. The form is the most
stable and has the best compaction properties. It does, however,
require longer than other excipients, such as lactose, for disinte-
gration and dissolution to occur. The tableting properties of sor-
bitol are dependent upon particle structure, particle-size distrib-
ution and bulk density
27,28
.The addition of up to 2% magnesium
stearate to a sorbitol tablet formulation produced no deteriorative
effects on tablet hardness
28
. One limitation of sorbitol is that its
hygroscopic nature can accelerate the degradation of moisture-
sensitive compounds
7
. Other issues include the hardening of
tablets upon ageing, caused by the recrystallization of sorbitol.
However, the inclusion of pregelatinized starch within the for-
mulation has been shown to prevent recrystallization
29
.
Mannitol
Mannitol is commonly used in pharmaceutical formulations and
for food products. It occurs as a white, odourless, crystalline
powder or as free-flowing granules. It has a sweet taste and a
61
PSTT Vol. 3, No. 2 February 2000 reviews research focus
Box 3. Features of -lactose monohydrate
(crystalline)
Good flow characteristics
14
Unreactive, except for discoloration when formulated with
amines (Maillard reaction) and alkaline materials
7,25
Contains approximately 5% moisture but only 0.2% is free
moisture. The residue is water of crystallization, which is
unavailable to react with moisture-sensitive drugs
Commonly used in combination with microcrystalline
cellulose with synergistic effects on disintegration time and
improved crushing strength
24
Inexpensive
Box 4. Features of anhydrous -lactose and
spray-dried lactose
Anhydrous -lactose
Poor flowability
Can pick up moisture at elevated humidities, causing a
change in tablet dimension
Spray-dried lactose
Requires high compression pressures to produce hard
tablets
Compressibility is affected if it is allowed to dry below a
level of 3% moisture
Has high dilution capacity
A disintegrant is required
Requires a lubricant, but the lubricant does not affect
binding
cooling sensation in the mouth (negative heat of solution),
making it a useful excipient for lozenges and chewable tablets
7
.
Because mannitol is non-hygroscopic, it is possible to use it
with moisture-sensitive drugs. In addition, unlike sorbitol, the
metabolism of mannitol does not cause increases in blood
sugar levels, making it a viable filler for the formulation of dia-
betic medications
30
. Previous studies have identified several
polymorphic forms for mannitol, including the , , and
forms. Their performance under compression differed
markedly, suggesting that wet granulation of the form prior
to direct compression improved its poor flowability and bind-
ing properties
30
.
Granulated lactitol
Lactitol is a direct compression filler derived from the catalytic
hydrogenation of lactose. It is a wet granulated product com-
posed of microcrystalline agglomerates, and is chemically more
stable than related disaccharide-based fillers as it is not a media-
tor for the Maillard reaction
31
. This form of lactose is freely sol-
uble in water, has reasonably good flow properties, and formu-
lations containing granulated lactitol do not require a glidant
31
.
Crystalline maltose
Crystalline maltose is a disaccharide carbohydrate used in the
food and pharmaceutical industry. It has a pleasant taste and
can be used for both chewable and non-chewable tablets. This
excipient is produced by a spray-drying process, creating
spherical, highly compressible and flowable particles. A study
revealed that when crystalline maltose (25%) was incorporated
into a 75% microcrystalline cellulose-based formulation and
then tableted, there was an improvement in the powder flow,
the disintegration times and the friability
32
.
Co-processed exicipients
Ludipress
Ludipress is a co-processed product consisting of three com-
ponents: a filler, a binder and a disintegrant. The exact concen-
trations of its constituents are stated below: 93.4% -lactose
monohydrate, 3.2% polyvinylpyrrolidone and 3.4% crospovi-
done. Ludipress has excellent flowability because the material
consists of spherical particles made up of a large number of
small crystals with smooth surfaces
33,34
. Good tablets can be
prepared at low compression forces and when Ludipress was
compared with six other lactose-based excipients, including
agglomerated lactose and the anhydrous form, it gave the
second best performance in terms of physical strength.
Initial studies showed the need for a glidant to be incorpo-
rated within a formulation because of the build up of friction
upon compression
33,34
. Of the two glidants used, 2% stearyl
fumarate showed the better improvement in friability, crushing
strength and disintegration time compared with magnesium
stearate, which appeared to increase both the friability and the
disintegration time. In general, the disintegration time of
formulations containing Ludipress is much longer than those
containing lactose, as a result of the presence of PVP. This limi-
tation can be overcome by the addition of microcrystalline cel-
lulose in the formula, promoting disintegration by a capillary
and wicking action. Alternatively, experiments have shown that
powerful disintegrants such as sodium starch glycolate may also
be of some value
35
.
Silicified microcrystalline cellulose
Silicified microcrystalline cellulose is a co-processed product,
which is made of 98% microcrystalline cellulose that is silici-
fied with 2% colloidal silicon dioxide. The two ingredients are
spray-dried together to produce agglomerated microcrystals
which are formed as a result of the strong physical association
between the two excipients (although no covalent bonds are
produced that classify it as a new chemical entity). Silicified
microcrystalline cellulose is claimed to have superior flow
properties compared with conventional grades of microcrys-
talline cellulose and a low lubricant sensitivity when blended
with magnesium stearate, producing tablets of an acceptable
hardness even after prolonged mixing. Results from experi-
ments also show that there is no difference in disintegration
time, friability and dissolution rate
36,37
.
Other factors that influence excipient selection
This overview has focused on the physicomechanical proper-
ties required from excipients; the assumption being that excip-
ients are inert and unreactive entities. It is imperative that a
comprehensive drugexcipient compatibility screening pro-
cedure is initiated before a dosage form development pro-
gramme commences. Often drugexcipient compatibility test-
ing will identify incompatibilities, such as lactoses and
amines
25
, but sometimes a positive interaction may be de-
sired
38
. In addition, the nature of the interaction testing may
itself yield false positives if the ratio of the drug to excipient is
not appropriate; the reader is referred to a recent publication
that elegantly describes the main issues involved in excipient
compatibility and selection for solid dosage forms
39
.
Summary
In conclusion, an overview of the main excipients used for
direct compression has shown that alternatives to lactose and
microcrystalline cellulose are available, and a summary of
their properties has been presented. It is up to the formulator
to test each potential excipient with each new chemical entity,
bearing in mind the physicochemical properties of each
component of the formulation.
62
PSTT Vol. 3, No. 2 February 2000 reviews research focus
Acknowledgement
The authors wish to thank Karrar Khan for his help with this
review.
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