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Significance of Pharmaceutical Excipients – A Review

Article · January 2011

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 Prasanna Raju Y et al. /JITPS 2011, Vol.2 (6), 191-201.

ISSN: 0975–8593
Review Article
Available online at [Link]

Significance of Pharmaceutical Excipients – A Review

[Link] Raju1*, V. Jayasri1, B. Rubia Yasmeen1, V. Harini Chowdary1,

S. Satyanandam2
1
Sree Vidyanikethan College of Pharmacy, [Link], Tirupati – 517102
2
Srinivasa Institute of Pharmaceutical Sciences, Peddasetipalli, Proddutur,
Kadapa District, Andhra Pradesh.
Corresponding author email: drprasannaraju@[Link]
_________________________________________________________________________________
ABSTRACT
In the designing and development of drug products from active drug(s), some of the
important non-therapeutic substances are essentially included. These non-therapeutic
substances are broadly termed as excipients. The pharmaceutical excipients and their
significance have been reviewed in detail in this article. This article emphasizes the essential
criteria of excipients, reasons for the development of new excipients, different kinds of
existing excipients, new grades of novel excipients, combinations of different excipients and
some of the new applications of existing excipients.

Keywords: Pharmaceutical excipients, Therapeutic substances, Drug release, Hupu gum,

Gum karaya, Cellulose.
___________________________________________________________________________
Introduction available, there is a need for new
Therapeutic moieties cannot be excipients with varied characteristics. This
administrated as such, so they are modified is because of introduction of novel drug
to various dosage forms for the reasons of delivery systems and new drug moieties.
patient compliance, dose accuracy and Most of the new drugs are poorly soluble
consistency, improving bioavailability, in water thereby having dissolution related
aesthetics and reduction of side effects. bioavailability problems. So, various
Excipients are the fundamental technologies such as lipid drug delivery
requirements to these modifications systems, solid dispersions. (1)
allowing formulation scientists to achieve Inclusion complexes with cyclodextrins,
their objectives. Excipients in brief can be micronization etc., were used in the
defined as “The components of a improvement of dissolution rate of poorly
formulation other than the active water-soluble drugs.
ingredient”. Development of new excipient chemical
Excipients play a very important role in entities and their evaluation is a costly
the design of dosage forms, as drugs procedure, modification of existing
cannot be administered in pure form. excipients is very easy, more economical
Though there are number of excipients and less time consuming.

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The two major hurdles in convincing dosage forms, and thus assist in the
formulators to incorporate new excipients extension of patent life (6).
into their formulations are obtaining The following criteria are essential for
regulatory approval for the use of new excipient selection and use (7):
excipients and breaking the tradition of
Physiological inertness.
conventional formulation development.
Physical and chemical stability.
Despite these challenges, many new
Conformance to regulatory agency
excipients have been successfully requirements.
introduced and are used in the
No influence on drug bioavailability.
pharmaceutical industry so far (2).
Free from pathogenic microbial
Compared to existing excipients, the organisms.
improved physical, mechanical, and/or
Cost effectiveness.
chemical properties of such excipients In fact, no single excipient would
have aided in solving formulation satisfy all the above criteria; therefore, a
problems such as flowability, compromise of different requirements has
compressibility, hygroscopicity, to be made. For example, although lactose
palatability, dissolution, disintegration, is being widely used in the pharmaceutical
sticking, and dust generation. tablet and capsule formulations as a
International Pharmaceutical Excipients diluent, it may not be suitable for patients
council of America (IPEC) (3) has defined who lack the intestinal enzyme lactase
the excipients as any substance other than which is essential to break down the sugar,
the active drug or prodrug, which has been thus leading to gastrointestinal tract
appropriately evaluated for safety and is symptoms such as cramps and diarrhoea.
included in a drug formulation system to The role of excipients varies substantially
(4). depending on the individual dosage form

Aid processing of the system during (8).
manufacture. In recent past, many new

Protect, support or enhance stability, excipients or modified forms of existing
bioavailability or patient compliance. excipients have been introduced. In

Assist in the identification of product. addition to the conventional dosage forms,

Enhance any other attribute of the these new excipients of natural
overall safety and effectiveness of the poysacchrides such as gum karaya and
drug product during storage or use. hupu gum (9) are very useful for the
Although excipients are the non-active formulation of novel drug delivery
ingredients, they are essential in the systems.
successful production of acceptable dosage
forms such as tablets, powders, parenterals The development of new excipients (10):
(5), semi solids and liquid orals. In the The reasons to develop new excipients:
case of 1 mg dose tablet of potent drugs, a. Effective use of existing excipients:
compression would be exceedingly Identification of new applications for the
challenging. Excipients can add existing excipients is a relatively
functionality to pharmaceutical products. inexpensive and less time involving
They offer opportunities to introduce new process as compared to an entirely new

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development. Chitosan is one of such e. Patient or subject compliance:

existing excipients, which has found new Some excipients, which are used now-a-
applications in recent years. days, are unacceptable for the reasons of
The modified chitosan with silicon dioxide patient safety and comfort. Lactose
(11) is a new excipient developed based on intolerance occurs in persons, who are
co precipitation of chitosan and silica deficient in the enzyme lactase, leading to
which can be used as a superdisintegrant abdominal cramps, diarrhoea, distension
with improved flow and compaction and flatulence.
properties. It also acts as filler (12). f. Specialized drug delivery systems:
b. The excipients with desirable The development of novel or specialized
properties: drug delivery systems requires the use of
There are a number of existing excipients special excipients (13). In metered dose
which lack some of the desirable inhalation devices require excipients of a
properties during some formulations, such particular size grade or development of
as soluble tablets, an ideal lubricant should mucoadhesive preparation necessitated the
be water soluble with effectiveness similar utilization of new bioadhesive polymers
to that of magnesium stearate. It is (14). Types and example of new
required to switch to second line of excipients:
excipients due to the lack of an ideal The new excipients can be discussed under
water-soluble lubricant. the following four headings.
c. Drugs developed by genetic 1. New chemical entities under
engineering: investigation as excipients (15):
As new drugs are being developed, their Excipients are low cost items, compared to
compatibility with the existing excipients drugs, which are not developed for direct
sometimes poses a big question. Hence, use by the patients or consumers. The
new excipients will be necessary to patent extension also possesses a limitation
overcome these problems. The drugs of as these are available for new drugs but
protein and peptide class require stabilizers not for new excipients. Therefore the
of a different nature when compared to development of new chemical entities as
that of conventional oral solid dosage excipients is not commonly beneficial
forms. (16).
d. Advances in production process and New chemical compounds proposed and
equipment: targeted to be used as excipients require
The developments or improvements in detailed safety testing procedure similar to
pharmaceutical process and equipments that of new drugs. The safety aspects
particularly increase in production rates at evaluation of a new excipient requires
low cost, lead to the need for new considerable investment in terms of time
excipients. The newly developed tablet and money. The safety studies of new
machines require materials with better excipients are required by IPEC, America
compressibility because they operate with on the basis of proposed regulatory
shorter dwell and contact times, as administration (17).
compared to early machines that require Despite all the above-mentioned reasons,
materials with good flow properties. in terms of cost involvement and

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regulatory considerations, there have been properties than the cellulose itself.
tremendous innovations and developments Modification of β-cyclodextrin to
in pharmaceutical excipients for oral use. hydroxypropyl β-cyclodextrin
Most of the information on new chemical significantly improves its solubilization
entities as excipients is unpublished and potential.
proprietary in nature, making it difficult to Modified starch was prepared by
access. enzymatic degradation of potato starch
2. New grades of existing excipients (18): followed by precipitation (retrogradation),
During the development of new grades for filtration and washing with ethanol. The
the existing excipients, the physical advantages include ease of tablet
characteristics of the materials are preparation, the potential of a constant
modified while the chemical nature is release rate for an extended period of time
preserved to a large extent. The and ability to incorporate high percentages
development of these types of excipients is of drugs with different physicochemical
economically beneficial, because the properties (20).
detailed toxicity and safety aspects of Few examples of excipients made by
excipients are not much required. modification of the existing excipients are,
Although several methods are available to silicified microcrystalline cellulose,
alter the physical characteristics of the thermally modified lactose, granulated
existing excipients, these can be broadly lactitol and sorbitol instant.
divided into two categories i.e., physical 3. New combinations of existing
methods and chemical methods. Particle excipients or co-processed excipients (21):
engineering or physical methods are used The aim of developing the combination
to modify particle structure, intended to excipients is to produce a product with
improve the performance of the bulk synergy between the components related to
excipient (19). Some of the physical functionality and cost. In general, a
parameters which are modified include relatively inexpensive excipient is
particle size distribution, surface area, bulk combined with optimal amount of value
density and moisture content. Increase in added material to obtain a superior product
particle size leads to an increase in as compared to the simple physical blend
flowability and compressibility, while or granulates. The added material
reduction of particle size results in the improves the properties of the inexpensive
increase of segregation potency. The component during co-processing. At the
enlargement of particle porosity increases same time, the beneficial properties of the
compressibility and solubility. value added material are retained in the
Chemical modification of the existing final product. The important
excipients is an entrenched method to considerations in the development of these
modify their properties. Minor chemical novel excipients are selection of the
modification or derivatization of cellulose individual excipients, their quantity,
(such as methyl cellulose, ethyl cellulose, technological process and validation of
hydroxypropyl cellulose, and sodium reproducibility in manufacturing (22).
carboxymethyl cellulose) leads to the The co-processed excipients are to have
advent of number of excipients with better better flow and compression properties for

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use in direct compression with the ultimate Lipids such as oleic acid or its salts are
goal of cost effectiveness, such as (23) Di- reported to retard gastric emptying and
pac (sucrose and modified dextrin), also act as an ilial brake. This provides
Chitosan-EDTA and carbomer, Xylitab longer time for dissolution and absorption
(Xylitol with polydextrose or sodium in the small intestine. Citric acid and other
CMC), Scleroglucan and Gellan gum, organic acids also have been revealed to
Pectin and chitosan. slow gastric emptying. However, the levels
4. New applications of existing excipients required for such effects may be
(24, 25): impractical for most dosage forms.
In recent years, new applications have The small intestine is drained by the
been identified for several existing hepatic portal vein, making the liver the
excipients. Many of these excipients are first part of scrutinizer for orally absorbed
used either alone or in combination as drugs. Therefore, high hepatic metabolism
mono or multifunctional excipients in will compromise systemic availability.
controlled drug delivery systems. They Enhancement of lymphatic absorption
are economically more beneficial than the offers the prospective for avoiding such
new chemical entities. Some of them are, first-pass metabolism. It also aids in
chitosan, xanthan gum, guar gum, poly targeting anticancer agents to lymphatic
(DL–Lactic acid), polyox water- soluble carcinomas. Materials such as dextran
resins. sulfate, chylomicron and carbon colloid
Few excipients from natural source have have been used in formulating the drugs
been evaluated for their aptness for new for lymphatic delivery.
applications in dissolution and absorption (ii) Enhancers for other modes of
enhancement such as gum karaya and absorption
hupu gum. The following are the areas, in Many physical and enzymatic barriers may
which existing excipients or modified prevent successful delivery of active
forms of excipients have been evaluated. pharmaceutical ingredients by
(i) Oral absorption enhancement by noninvasive, non-oral routes. It is not
excipients astonishing, therefore, that there is great
Excipients indirectly aid in the oral interest in excipients that can overcome
absorption by promoting the release of such obstacles.
drug from the dosage form, or facilitating Materials used to enhance its permeability
the dispersion and dissolution prior to through the skin layers have ranged from
passage to the systemic circulation. simple solvents such as ethanol or
Excipients that promote absorption by propylene glycol to aromatic chemicals
itself are less widely used. However, lipids such as terpenoids. Such penetration
have been widely used to enhance enhancers appear to work by disrupting the
absorption of hydrophobic active lipid domains in the stratum corneum that
ingredients. Dissolution or dispersion of decrease the permeability. A bespoke
drug in such materials provides a substrate penetration enhancer, laurocapram was
for lipolysis, resulting in an emulsion of developed in the late 1970s for exploiting
drug and lipid that provides improved in transdermal delivery but its use in
surface area for dissolution and absorption. commercial products appears to be limited.

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Entry of excipients via nasal or buccal usually feasible due to the hostile
mucosa facilitates the delivery of peptides environment and enzymatic barriers along
or other labile drugs that are highly potent the GI tract. Parenteral administration is
(low-dose drugs) and that do not have hardly suitable for chronic therapy.
steep dose-response relationships. Therefore, many biotechnology products
Absorption enhancement should augment need to be combined with materials that
the contact time and lessen the clearance afford protection against destruction,
rate (in the case of nasal delivery), thereby reduce elimination rate, or target a specific
optimizing conditions for mucosal site so that activity is enhanced and
diffusion. Excipients that improve nasal toxicity minimized. The level of interest
absorption include phospholipids to and activity in this area supports the view
enhance mucosal permeability and agents that novel drug delivery systems are
that imbibe water and become required if the promise of biotechnology is
mucoadhesive (glyceryl monooleate). In to be realized. Hence, it is probable that
addition, the gelling agents such as the search for absorption-enhancing
hydroxypropyl cellulose and polyacrylic excipients for such materials will continue
acid promote the absorption of insulin in unabated.
dogs. However, these findings have not Carriers for biopharmaceutical therapeutic
been used to find a commercially viable agents range from ingrained excipients of
product for intranasal delivery of insulin, natural origin to custom-made synthetic
presumably due to insulin's narrow materials with putatively enhanced
therapeutic index. However, intranasal protective or targeting features. Natural or
delivery systems for calcitonin, a semisynthetic materials prevail however
macromolecule with a much safer dose- (28). Sources as diverse as primitive
response relationship, have been marine plants (chitosans and alginates),
commercialized. plant or animal phospholipids (egg and
(iii) Excipients for Drug Targeting (26) seed lecithin), and mammalian collagens
The 1990s saw an explosion in knowledge (gelatin) are being mined for valuable
and understanding the roles of natural delivery or targeting aids, as well as for
mediators in physiological and components of complex formulations such
pathological processes. At the same time, as microemulsions or liposomes. More
biotechnology has made it feasible to esoteric materials that bestow target
manufacture such mediators relatively specificity include glycoproteins,
cheap and in large quantities, thereby recombinant proteins, or monoclonal
affording possibilities for use as antibodies. To date, clinical performance
therapeutic agents. However, effective of such carrier systems has been
delivery still remains a formidable unsatisfactory. Further refinement of
challenge from the efficacy, safety, and concepts and materials may be obligatory
patient-convenience perspective (27). before the performance matches the
Most natural mediators are highly potent, promise.
extremely labile, and may need to be (iv) Excipients as Stabilizers
delivered to a specific organ or cellular Product quality can be compromised
target. Conventional oral dosage is not during manufacture, package, transport,

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storage or use. The causes of deterioration (v) Excipients as Process Aids (30)
can be diverse and product-specific. They The majority of medicinal products are
include microbial spoilage or chemical manufactured by high-speed, largely
transformation of the active drug or automated processes for reasons that are
physical changes that alter performance in- related as much to safety and quality as to
vivo. Deterioration can compromise safety cost of goods. Excipients that aid in
or make the medication less attractive, processing include the following:
which means it may not be used. 1. The universal use of lubricants such as
Excipients may contribute to or cause such stearates in tablets and capsules to reduce
changes unless carefully screened for friction between moving parts during
possible interactions in preformulation compression or compaction.
studies. (29) 2. Excipients that aid powder flow in
Stabilization strategies of drug products tablet or capsule manufacture. Materials
with suitable excipients include: such as colloidal silica improve flow from
1. Formulation with an excipient whose hopper to die and aid pack down in the die
light absorption spectrum overlaps that of or capsule shell. Accuracy and consistency
the photolabile drug. This is the so-called of fill and associated dose is thus improved
spectral overlay approach. (31).
2. Using an antioxidant in formulations 3. Compression aids to form a good
that are susceptible to degradation by compact, whether on dry granulation
oxidation. This approach has been (slugging) prior to tableting or on tablet
predominantly successful in vitamin- compression. Most of them are derived
containing products. from plant, animal, or mineral origin.
3. Using an excipient that hinders 4. Agents such as human or bovine serum
association of groups in the same molecule albumin are widely used in the
in adjacent molecules or in the vehicle that manufacture of biotechnology-based
can interact and cause degradation. There products. These avoid adsorption of the
are several cases of cyclodextrins effecting protein to flexible tubing, filters, and other
such steric stabilizations. Polyethylene process equipments.
glycol also has been known to stabilize an 5. Stabilizers are used to protect the drug
ointment formulation by preventing from processing conditions that might
formation of inactive rearrangement otherwise be deleterious. It is common to
products. use cryoprotectants such as sugars,
Less obscure but equally important polyhydric alcohols or dextrans in
stabilizers include preservatives in liquid lyophilized parenteral biotechnology
products to prevent microbial growth and products to prevent inactivation during
buffers to provide an environment freezing. A similar approach has also been
conducive to good stability where used to prevent liposomal aggregation and
degradation is pH-related. Chelating leakage (32).
agents are also used as stabilizers to avert Process aids do not usually contribute to
heavy metals from catalyzing degradation. the performance of the dosage form in
terms of quality or in vivo performance
(33). Indeed, lubricants, because of their

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hydrophobic nature, can hinder enduring interest in the area of natural

disintegration and dissolution of solid gums and their modifications with the aim
dosage forms unless the level and mode of to have better excipients for drug delivery.
incorporation is carefully characterized,
monitored and controlled. Thus, in
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