Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No.

14, Pages: 59-64 ISSN 0976 – 044X

Review Article

Starch as Pharmaceutical Excipient

1,2 2 2 2*
Barmi Hartesi , Sriwidodo , Marline Abdassah , Anis Yohana Chaerunisaa
1
Program Studi Farmasi, STIKES Harapan Ibu Jambi, Jalan Tarmizi Kadi No 71, Kota Jambi, Indonesia.
2
Pharmaceutical Technology Departement, Faculty of Pharmacy, Universitas Padjadjaran, Jalan Raya Bandung-
Sumedang Km.21, Jatinangor 45363, Sumedang Indonesia.
*Corresponding author’s E-mail: [email protected]

Accepted on: 12-09-2016; Finalized on: 30-11-2016.

ABSTRACT
It is very well known that none of pharmaceutical preparations either for internal or external use can be manufactured without
excipients. Excipient is defined as any substance other than active drug or pro-drug that is included in the manufacturing process or
is contained in finished pharmaceutical dosage forms. Selecting best excipients, however, requiring a balance between time and cost
efficiencies as well as anticipated product performance. Starch is one of the traditional excipients used in the manufacture of
tablets. Chemically, starches are polysaccharides, composed of a number of monosaccharides or sugar (glucose) molecules linked
together with α-d-(1-4) and/or α-d-(1-6) linkages. Starch has been investigated as an excipient in novel drug delivery systems for
nasal, oral, periodontal, and other site-specific delivery systems. Depending on the application, specific starches are available for use
as disintegrants, fillers or binders. As a result of its partial cold water solubility, starch functions exceptionally well in tablet
manufacture by wet granulation applications and performs dual functions of both a disintegrant and a binder. In capsule filling
processes, Starch and Star Cap Co-Processed Starch Excipients function as effective binders. As a result of its partial cold water
solubility, starch functions exceptionally well in tablet manufacture by wet granulation applications and performs dual functions of
both a disintegrant and a binder. In capsule filling processes, Starch function as effective binders. Starch is also one of the most
commonly used tablet disintegrants at concentrations of 3–15% w/w. However, unmodified starch does not compress well and
tends to increase tablet friability and capping if used in high concentrations. As a diluent, starch is used to facilitate subsequent
mixing or blending processes in manufacturing operations.
Keywords: Starch, Binder, Disintegrants, Diluent.

INTRODUCTION source of energy. Although starch is widespread,

abundantly available, cheap, degradable, pollution-free

A ccording to the international pharmaceutical

excipient council, Excipient is defined as “Any
substance other than active drug or pro-drug that
is included in the manufacturing process or is contained in
finished pharmaceutical dosage forms”. The US
and renewable, it has many short falls, i.e., insoluble in
cold water, easy to dehydration, low emulsifying power
and unstable in acid, due to which commercial application
is limited.3 A survey of the literature shows that the
usefulness of starches from various botanical sources as
pharmacopoeia-National formulary (USPNF) categorizes
pharmaceutical excipients. Starches are widely available
excipients according to the functions they perform in the
and have been very useful in tablet production due to
formulations e.g. Binders, disintegrants etc1. Choosing
their inertness, cheapness and utilization as fillers,
the right excipients can make all the difference in the
binders, disintegrants and glidants. 4
efficient production of robust tablets. Pharmaceutical
formulators are seeking ways to improve the Chemically, starches are polysaccharides, composed of a
manufacturing process and product quality through the number of monosaccharides or sugar (glucose) molecules
use of functional excipients. Selecting the best excipients, linked together with α-d-(1-4) and/or α-d-(1-6) linkages.
however, is a juggling act, requiring a balance between Starch consists of 2 main structural components, the
time and cost efficiencies as well as anticipated product amylose, which is essentially a linear polymer in which
performance. glucose residues are α-d-(1-4) linked typically constituting
15–20% of starch, and amylopectin, which is a larger
Excipients are pharmaceutical additives, the inactive
branched molecule with α-d-(1-4) and α-d-(1-6) linkages
ingredients used to make up a medication. They include
and a major component of starch. Amylose is linear or
dyes, flavors, binders, emollients, fillers, lubricants,
slightly branched with a degree of polymerization up to
preservatives, and many more classifications. Common
6000, and has a molecular mass of 105–106 g/mol. The
excipients used as fillers include corn starch, lactose and
chains can easily form single or double helices.
Dibasic Calcium phosphate dehydrate.1,2
Amylopectin on the other hand, has a molecular mass of
Starch is one of the most abundant natural carbohydrates 107–109 g/mol. It is highly branched and has an average
stored in plants. It is found in many different plant organs degree of polymerization of 2 million, making it one of
including seeds, fruits, tubers and roots, functioned as a the largest molecules in nature. Chain lengths of 20–25

International Journal of Pharmaceutical Sciences Review and Research

Available online at www.globalresearchonline.net 59
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No. 14, Pages: 59-64 ISSN 0976 – 044X

glucose units between branch points are typical of products are usually differentiated based on the
amylopectin. About 70% of the mass of starch granule is manufacturing process to be used. Dry binders used for
regarded as amorphous and about 30% as crystalline. The direct compaction must exhibit cohesive and adhesive
amorphous regions contain the main amount of amylose, forces so that when compacted the particles
and a considerable part of the amylopectin. The agglomerate.
5,6
crystalline region consists primarily of the amylopectin.
Binders used for wet granulation are hydrophilic and
The corn plant (Zea mays) is a high-capacity, factory for soluble in water and are usually dissolved in water to
efficiently converting large amounts of radiant energy form a wet mass that is then granulated. Binders function
from the sun into stable chemical energy. This energy is as binder for both direct compression and wet
stored as cellulose, oil and starch in the corn plant and in granulation. As a dry binder, it compresses well,
the corn kernel. The corn plant is also one of nature's predominately deforming plastically. It has been shown to
greatest multipliers. Approximately four months after produce cohesive dry blends due to its granular
planting, a single kernel of corn weighing about one one- morphology and superior adhesive characteristics. As a
hundredth of an ounce will yield 800 kernels weighing result of its partial cold water solubility, starch functions
eight ounces. In comparison to this 800-fold seed exceptionally well in tablet manufactur by wet
multiplication in corn, wheat will produce a 50-fold yield granulation applications and performs dual functions of
per seed planted. Corn Starch is one of the traditional both a disintegrant and a binder. In capsule filling
excipients used in the manufacture of tablets. Depending processes, Starch and Star Cap Co-Processed Starch
on the application, specific starches are available for use Excipients function as effective binders improving the
as disintegrants, fillers or binders. tablet and capsule uniformity of the capsule fill as well as forming a stable
7,8 11
diluent; tablet and filler. capsule plug.
Starch has been investigated as an excipient in novel drug Binders are pharmaceutical excipients that are commonly
delivery systems for nasal, oral, periodontal, and other used in tablet formulation to impart cohesion on the
site-specific delivery systems. Starch is also used in topical powder mix 12,13. The resultant cohesiveness ensures that
preparations; for example, it is widely used in dusting the tablet remains intact after compression 14. Binders are
powders for its absorbency, and is used as a protective used either in solutions or dry form depending on the
covering in ointment formulations applied to the skin. other ingredients in the formulations and the method of
Starch mucilage has also been applied to the skin as an preparation especially in wet granulation 13,15. The
emollient, has formed the base of some enemas, and has quantity of binders used has a considerable influence on
been used in the treatment of iodine poisoning.9 the characteristics of the compressed tablets 8,16.
Increasing the binder concentration invariably raises the
Isolated starch is typically a dry, soft, white powder. It is
disintegration times. 17
insoluble in cold water, alcohol, ether and most organic
solvents. Starch, if kept dry, is stable in storage for In tablet formulations, freshly prepared corn starch paste
indefinite periods. Though starch granules are physically is used at a concentration of 5–25% w/w in tablet
durable, they can be disrupted quite easily. If granules in granulations as a binder. Selection of the quantity
water suspension are gradually heated, they begin to required in a given system is determined by optimization
absorb water. The granules hydrate, increase in size and studies, using parameters such as granule friability, tablet
finally lose their structural integrity. This results in loss of friability, hardness, disintegration rate, and drug
9
characteristic birefringence and opacity, an increase in dissolution rate.
viscosity, and the eventual formation of a paste or gel.
Classification of Binders
This process is referred to as starch pasting or
 Solution binders are dissolved in a solvent (for example
gelatinization. The temperature at the which
water or alcohol can be used in wet granulation
gelatinization of a starch occurs — the gelatinization
processes). Examples Corn Strach.
temperature — is dependent upon such factors as starch
concentration, pH of the suspension, rate of heating, the  Dry binders are added to the powder blend, either after a
wet granulation step, or as part of a direct powder
presence of certain salts, and the specific procedure being
compression (DC) formula. Examples include cellulose,
followed. Under well-defined conditions, starches can be
methyl cellulose, polyvinylpyrrolidone and polyethylene
classified using gelatinization temperature as a means for
differentiation. The properties of the starch granule are glycol. 11
dependent upon the arrangement of the bonds which link Oyi, et al (2009), conducted a research on “Comparative
glucose units to one-another within the starch molecule Binding Effects of Wheat, Rice and Maize Starches in
itself. 10 Chloroquine Phosphate Tablet Formulations” Formula
chloroquin tablets are made with various binder and with
Starch As Binder
various concentrations.
Binders are used in the formulation of solid oral dosage
forms to hold the active pharmaceutical ingredient and
inactive ingredients together in a cohesive mix. Binder

International Journal of Pharmaceutical Sciences Review and Research

Available online at www.globalresearchonline.net 60
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No. 14, Pages: 59-64 ISSN 0976 – 044X

Table 1: Form ular for chloroquine phosphate granules formulated using the selected starch as binder.

Table 2: Granule properties of chloroquine phosphate formulated using the selected starches as binder

Table 3: Tablet properties of chloroquine phosphate tablets formulated using the selected starches as binder

Tablet hardness was observed to be higher with wheat paracetamol granules by wet massing. The granules
starch at all the concentrations employed compared to were compressed at different compression loads
those of rice and maize starches. This indicates that (arbitrary units on the load scale; 8, 9 and 9.5).7
lower concentration of wheat starch could be used to
Table 4: Effect of binder type and concentration on the
achieve the same level of bond strength and probably
tensile strength (T) and packing fraction (Pf) of the
granules made from wheat starch mucilage were more
tablets.
readily deformed than those produced with either rice
or maize starch, but the corn starch can be used as a
14
binder.
Uhumwangho, et al (2006) conducted a research on
“Influence of some starch binders on the brittle fracture
tendency of paracetamol tablets”. The study was carried
out to compare the binder effects of cassava and
cocoyam starch with that of maize starch BP. The
parameters investigated were the brittle fracture index
(BFI), the tablet packing fraction (Pf), and tensile
strength (T). Mucilages of the starches of varying The results (Table 4) showed that cassava starch binder
concentrations; 15, 20, and 25% (w/v) were formed; produced harder and more compact tablets compared
their viscosities were determined and used to form with the cocoyam and the maize starch binders. Cassava
starch is therefore the more effective binder which is
International Journal of Pharmaceutical Sciences Review and Research
Available online at www.globalresearchonline.net 61
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No. 14, Pages: 59-64 ISSN 0976 – 044X

attributable to the higher gel strength of its mucilages. directionally to push apart the adjoining components,
19
Increase in binder concentration generally led to an thereby initiating the break-up of the tablet matrix.
increase in Pf and T values irrespective of the nature of
Disintegration leads to the breakup of the tablet into
the binder. It is known that binders promote plastic
the component granules, thereby presenting a greater
deformation of particles and thereby increase the area
surface area of the tablet to the dissolution medium
of contact for interparticulate bonding. Hence, an
before the active drug substance is finally released from
increase in T is invariably associated with an increase in
the tablet. An immediate release tablet formulation of a
Pf values of the tablets. The results (Table 4) thus
drug is usually not useful until it‘s active component is
showed that granules made with the cassava starch
made available for absorption hence the disintegrant
mucilage were more readily deformable than those
arguably become the most important excipient in a
produced with either cocoyam or maize starch, but the
tablet to facilitate immediate drug release. Although
corn starch can be used as a binder.7
modified release dosage forms is the focus of most
Table 5: Effect of compression load on the brittle research due to their benefits such as reduced dosing
fracture tendency of the tablets. frequency and attendant improved patient adherence,
reduced side effects and increased duration of
therapeutic action; immediate release dosage forms still
occupy a crucial space in drug delivery especially in
20
disease conditions that require rapid onset of action.
Musiliu et al (2009), conducted a research “Disintegrant
activities of natural and pregelatinized trifoliate yams,
rice and corn starches in paracetamol tablet” Results is
shown by Fig. 1.

The study has shown that cassava starch mucilage is a

more effective binder than the mucilage of maize starch
BP, producing harder tablets with lower brittle fracture
tendency. Also, the study underscores the need to
moderate the applied loads if the incidence of brittle
fracture is to be minimized during tableting. 7
Starch as Disintegran
Starch is one of the most commonly used tablet
disintegrants at concentrations of 3–15% w/w.3,11
However, unmodified starch does not compress well
and tends to increase tablet friability and capping if
used in high concentrations. In granulated formulations,
about half the total starch content is included in the
granulation mixture and the balance as part of the final
blend with the dried granulation. Also, when used as a Figure. 1: Plots of disintegration time (Dt) versus
disintegrant, starch exhibits type II isotherms and has a relative density (R) for paracetamol tablets formulated
high specific surface for water sorption.9 with 6% w/w natural starch exo-disintegrants (Musiliu
et al., 2009)
Disintegrants bring about tablet matrix break-up in an
aqueous medium and are commonly classified further in The disintegrant activity of starches is determined by
literature as disintegrants and superdisintegrants. their nature, form, mode of incorporation and their
“Normal” disintegrants include starch- and cellulose- concentration. Physicochemical parameters as water
based excipients such as corn starch, partially solubility, swelling capacity as well as water absorption
pregelatinized starch, microcrystalline cellulose, and capacity exhibit some direct effect on disintegrant
lowsubstituted hydroxypropyl cellulose. Some clays activity of the starches. Pregelatinized starches
(e.g., Veegum HV),gums (e.g., agar, guar, tragacanth, produced better combined disintegrant properties of
alginate), resins (e.g., polacrilin potassium), and finely (Cs/Fr)/Dt than natural starches. White T. yam starch
divided solids (e.g., colloidal silicon dioxide, magnesium gave the best (Cs/Fr)/Dt ratio of all the starches. Tablets
aluminum silicate) have also been employed as formulated with official corn starch disintegrant
disintegrants.19 exhibited the lowest disintegration time values, but
generally all the tablets containing the experimental
The most accepted mechanism for tablet disintegration starches also passed the official disintegration time
is by disintegrant swelling. Swelling is associated with test.21
dimensional amplification where particles enlarge omni-

International Journal of Pharmaceutical Sciences Review and Research

Available online at www.globalresearchonline.net 62
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No. 14, Pages: 59-64 ISSN 0976 – 044X

Starch As A Diluent REFERENCES

As a diluent, starch is used for the preparation of 1. Chaudhari, S.P and Patil, P.S., Pharmaceutical Excipients:
standardized triturates of colorants or potent drugs to A review. International Journal Of Advances In
facilitate subsequent mixing or blending processes in Pharmacy, Biology And Chemistry., Vol.1 (1), 2012.
manufacturing operations. Starch is also used in dry- 2. Liu L, Chen G, Fishman ML, Hicks KB. Pectin gel vehicles
filled capsule formulations for volume adjustment of the for controlled fragrance delivery. Drug Deliv., 12, 2005,
fill matrix.22 149–57.

Diluents are fillers used to increase the bulk volume of a 3. Hu A, Jiao S, Zheng J, Li L, Fan Y, Chen L, Zhang Z.
tablet or capsule. By combining a diluent with the active Ultrasonic Frequency Effect On Corn Starch And Its
Cavitation. LWT - Food Science and Technology 60 (2015)
pharmaceutical ingredients, the final product is given
941- 947
adequate weight and size to assist in production and
handling. 4. Adetunji, O.A., Odeniyi, M.A and Itioala, O.A.
Compression, Mechanical and Release Properties of
To provide satisfactory performance in a tablet dosage Chloroquine Phosphate Tablets containing corn and
form, a diluent should be: Trifoliate Yam Starches as Binders. Tropical Journal of
Pharmaceutical Research, December 5 (2), 2006, 589-
 Inert so as not to cause pharmacological activity of 596
its own.
 Compatible with the drug substance and other 5. Rodrigues, A and Emeje, M., Recent applications of
starch derivatives in nanodrug delivery. Carbohydrate
excipients used in the formulation.
Polymers: 8 (2012) 987– 994
 Non-hygroscopic so the formulation does not
absorb significant amounts of moisture from its 6. Beninca, C., Demiate, I.M., Lacerda., Filho, C. Ionashiro
surroundings. and Schnitzler, E. Thermal. Behavior Of Corn Starch
Granules Modified By Acid Treatment At 30 And 50°C.
 Compactable and of similar particle size to the
Ecl. Quim., Sao Paulo, , 33(3), 2008, 13-18
active ingredient.
7. Uhumwangho, M.U., Okor, R.S., Eichie, F.E. and Abbah,
Diluents may serve multiple functions in addition to C.M. Influenceof some starch binders on the brittle
being filler. Multifunctional starch excipients, such as fracture of paracetamol tables. African Journal of
Starch 1500® partially pregelatinized maize starch and Biotechnology, 5(20), 2006, 1950-1953.
Star Cap 1500® co-processed starch excipient can serve
8. Musa H., Gambo, A. And Bhatia, P.G. Studies on some
as binders, disintegrants, flow aids, lubricants and/or
physicochemical properties of native and modified
taste masking. They also promote formulation flexibility starches from Digitaria iburua and Zea mays.
by complementing and enhancing the functionality of International Journal of Pharmacy and Pharmaceutical
other excipients.11 Sciences, 3(1), 2011, 28-3.
Study on the physicochemical properties of Saudi starch 9. Rowe, R.C., Sheskey, P.J., dan Owen., S.C., Handbook of
as a tablet excipient was carried out by Alanazi et al23. Pharmaceutical Excipients. Ed V. Royal Pharmaceutical
The Saudi corn starch was compared to an imported Society of Great Britain London. 2006 Corn Refiners
corn starch that is used by a leading pharmaceutical Association, Pennsylvania, Washington, D.CShalin S,
company. The comparison included the following Advantages and Applications of Nature Excipients. Asian
J. Pharm. Res. Vol 2, Issue 1, 2012, 30-39,
examinations: quality control data, physical
characterization, binding properties, granulation effect 10. Musa, H., Ochu, S.N. and Bhatia, P.G. Evaluation of the
and disintegrant properties. Theophylline was used as a tablet binding properties of barley (Hordeum vulgare)
model drug to evaluate its release behavior from tablet starch. International Journal of Applied Pharmaceutics,
prepared from both the Saudi and the imported starch. 2(4), 2010, 4-7.
Different dissolution parameters were evaluated such 11. Patil, B.S., Soodam, S.R., Kulkarni, U. and Korwar, P.G.
as percent dissolution and relative dissolution rate. The Evaluation of Moringa oleifera gum as a binder in tablet
two compared starches were also subjected to freeze or formulation. International Journal of Research in
spray drying process to enhance their pharmaceutical Ayurveda and Pharmacy, 1(2), 2010, 590-596.
properties. 12. Oyi, A.R., Allagh, T.S. and Olayemi, O.J. Comparative
binding effects of wheat, rice and maize starches in
CONCLUSIONS chloroquine phosphate tablet formulations. Research
Therefore, the correct selection of excipient will hugely Journal of Applied Sciences, Engineering and Technology,
affecting the preparation result. Starch is a very good 1(2), 2009, 77-80.
excipient and has a lot of advantages wheather as a 13. Chalapathi, V., Yuvaraj, T.V. and Jaganathan, A.
binder, disintegrant and diluent. Formulation of paracetamol tablets using a novel binder
isolated from Manihot esculenta. L and its evaluation.
International Journal of Chem Tech Research, 2(1), 2010,
406-411.

International Journal of Pharmaceutical Sciences Review and Research

Available online at www.globalresearchonline.net 63
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
Int. J. Pharm. Sci. Rev. Res., 41(2), November - December 2016; Article No. 14, Pages: 59-64 ISSN 0976 – 044X

14. Ibezim, E.C., Emeje, M.O., Ofoefule, S.I., Onyishi V.I. and Disintegrant Properties of Rice Husk Cellulose, Corn
Odoh, U.E. The role of ginger starch as a binder in Starch and Avicel in Metronidazole.Tablet Formulation.
acetaminophen tablets. Scientific Research and Essay, Journal of Applied Pharmaceutical Science. Vol. 4 (12),
3(2), 2008, 46-50. 2012., pp. 112 117,
15. Chitedze J, Monjerezi M, Saka JDK and Steenkamp J. 19. Musiliu O. Adedokun and Oludele A. Itiola. Disintegrant
Binding Effect of Cassava Starches on the Compression activities of natural and pregelatinized trifoliate yams,
and Mechanical Properties of Ibuprofen Tablets. Journal rice and corn starches in paracetamol tablets. Journal of
of Applied Pharmaceutical Science 02 (04); 2012: 31-37 Applied Pharmaceutical Science 01 (10), 2011, 200-206
16. Kottke JM, Rudnic EM. Tablet dosage forms. In: Banker 20. Rowe, R.C., Sheskey, P.J., dan Weller, P.J. Handbook of
GS, Rhodes CT, eds. Modern Pharmaceutics. 4th ed. New Pharmaceutical Excipients, Fourth edition. London: The
York, NY: Marcel Dekker, Inc; 2002, 287.333. Pharmaceutical Press. 2003.
17. Desai, P.M., Liew, C.V., and Heng, P.W.S. Review of 21. Alanazi F K, El-Bagory I M, Alsarra I A, Bayomi M A and
Disintegrants and the Disintegration Phenomena. Abdel-kawy, M A, 2008, SAUDI-CORN STARCH AS A
Journal of Pharmaceutical Sciences xxx (2016) 1-11 TABLET EXCIPIENT COMPARED WITH IMPORTED
STARCH, Saudi Pharmaceutical Journal, Vol. 16, No.2,
18. Uwaezuoke O,J, Bamiro O,A, Ndidi C. Ngwuluka2, Ajalla
April 2008.
O.T , Okinbaloye, O,A. Comparative Evaluation of the

Source of Support: Nil, Conflict of Interest: None.

About Corresponding Author: Mrs. Anis

Mrs. Anis is graduated from Padjadjaran University - Bandung, Indonesia and

Ph D graduated from College of Pharmacy, Freie Universität Berlin, Germany.
She is now a lecturer Faculty of Pharmacy, Padjadjaran University, Bandung -
Indonesia. She is in Dept. of Pharmaceutical technology, handled Solid dosage
form projects at University, and also as head of under graduate program of
her faculty.

International Journal of Pharmaceutical Sciences Review and Research

Available online at www.globalresearchonline.net 64
© Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.