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Synthesis, cytotoxicity in vitro, apoptosis, cell cycle arrest and comet assay of asymmetry ruthenium(II) complexes
Jundishapur J Nat Pharm Prod. 2017 May; 12(2):e34267.
doi: 10.5812/jjnpp.34267.
Published online 2016 January 31.
Review Article
A Review on Fast Dissolving Systems: From Tablets to Nanofibers
Sara Bahrainian,1,2,* Mohammadreza Abbaspour,3 Maryam Kouchak,1,4 and Pooria Taghavi
Moghadam1,4
1
Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
3
Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
4
Department of Pharmaceutics, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
2
*
Corresponding author: Sara Bahrainian, Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Tel/Fax: +98-6133738378, E-mail:
sara.bahrainian@yahoo.com
Received 2015 November 02; Revised 2015 December 01; Accepted 2015 December 08.
Abstract
Context: Oral administration of drugs remains the most common and preferred route for many active pharmaceutical ingredients
(APIs). However, solid oral dosage forms may be limited for patients who have swallowing problems or fear of choking. Furthermore
in the case of solid dosage forms, disintegration and dissolution of dosage forms are rate limiting steps mostly for hydrophobic
drugs’ absorption and bioavailability. Liquid oral dosage forms such as syrups, emulsions or suspensions may be used to overcome
these disadvantages but higher costs of their production and larger volume and dimensions of their packaging along with the lower
precision in dose intake make the liquid oral dosage form less acceptable for patients and pharmaceutical industries.
Evidence Acquisition: In order to merge the advantages of both solid and liquid oral dosage forms, fast dissolving drug delivery
systems have been developed over the years. The current review aimed to discuss the pros and cons of different preparations of oral
fast dissolving dosage forms including tablets, films and nanofibers.
Results: Fast dissolving dosage forms rapidly dissolve in mouth without the need for additional liquid or chewing, providing ease
of use for consumers, a fast absorption of drug, quick onset of action, and improved bioavailability. Various technologies to fabricate
these dosage forms such as lyophilization, spray drying, solvent casting, hot melt extrusion, compaction and electrospinning are
also addressed.
Conclusions: Fast dissolving drug delivery systems are the promising approach in oral drug delivery systems, which can provide
patient compliance especially in case of pediatrics and geriatrics. They can also lead to quick action of drugs and enhanced bioavailability.
Keywords: Drug Delivery Systems, Solubility, Nanofibers, Tablets
1. Context
Oral route is the most preferred and acceptable route
for patients and medical practitioners that is the reason
pharmaceutical companies are encouraged to develop oral
dosage forms for various patients (1, 2). Although, despite
their convenience, development of dosage forms which
can be used orally without the need for water and with fast
acting properties is still in progress (3). Fast dissolving systems (FDS) are drug dosage forms which dissolve in the
oral cavity without the need for drinking water or chewing (4). These systems were first developed in 1970 and became favorable very quickly (5, 6). At first these systems
were in the form of tablets (7) but with the advancement of
technology, different dosage forms such as films (8), wafers
(9, 10), buccal (11, 12) and sublingual (13) patches (14) were
formed. They can be used for local or systemic delivery of
drugs.
2. Evidence Acquisition
The current review studies the major types of fast dissolving systems studied in research papers or commercially produced; including tablets, films and nanofibers.
The advantages and disadvantages of these fast dissolving
systems are addressed, and their preparation and evaluation techniques are discussed.
3. Results
3.1. General Advantages of Fast Dissolving Systems
As defined by their name, fast dissolving systems are
used in conditions where there is a need for local or systemic fast delivery of drug, which makes them possible to
be administered anytime and anywhere without water (4,
15-20). Due to these characteristics, fast dissolving dosage
forms are suitable for geriatrics (21), pediatrics (21), people with swallowing problems, nauseated people, people
Copyright © 2016, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. This is an open-access article distributed under the terms of the Creative
Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in
noncommercial usages, provided the original work is properly cited.
Bahrainian S et al.
who have fear of choking (22, 23) when swallowing a solid
dosage form, bedridden patients and people who do not
have access to water (24-26). Fast dissolving drug delivery systems have better patient compliance and may offer improved biopharmaceutical properties, improved efficacy and better safety compared to the conventional oral
dosage forms (27). Rapid onset of action, improved stability, first pass effect by-pass and increased bioavailability lead to increase the demand in pharmaceutical market (28, 29). In addition to their fast dissolution in water (saliva) and absorption from the oral cavity, they can
enter the systemic blood circulation without undergoing
first pass effect (30, 31). Therefore, they may have higher
bioavailability, a lower Tmax and a higher Cmax . (20, 32).
Other advantages include availability in a variety of shapes
and sizes, not leaving a residue in mouth, and having acceptable taste (33).
3.2. Disadvantages of Fast Dissolving Systems
Although the hygroscopicity is preferred for fast dissolving of the drugs, it is also the most important drawback of these systems (7), which need special requirements
such as packaging. Furthermore, particular dosage forms
may have their own disadvantages including choking for
tablets and inefficiency for high drug loading in films and
nanofibers (13, 32). Released drug from fast dissolving
dosage form in the mouth has a strong contact with taste
buds on the tongue, this could be challenging for drugs
with bitter taste (17, 33-35), which needs taste masking techniques.
3.3.1.2. Saliva Stimulating Agents
Since FDS are supposed to be used without water, they
need to be dissolved in saliva; hence, to increase the rate
of dissolution, the saliva stimulating agents can be used in
some formulations. However drugs such as ascorbic acid
and nicotinamide can stimulate the excretion of saliva by
itself (4, 49).
3.3.1.3. Flavoring Agents
Most drugs have bitter taste and because these dosage
forms are absorbed through the oral cavity, contact with
taste buds is very likely. Flavoring agents are added to mask
the bitter taste of drugs (50).
3.3.1.4. Coloring Agent
Some drugs and excipients have different shades of
color and a non-uniform appearance is not attractive for
the patients. Therefore, coloring agents and opacifiers are
used to maintain a uniform color and appearance (51, 52).
3.3.1.5. Surfactants
In FDS formulations with some insoluble or poorly soluble ingredients, an appropriate surfactant may be used to
improve the dissolution rate of the drug (53-55).
3.3.2. Specific Ingredients
In addition to general ingredients that can be used for
all FDS, each system could have its own specific ingredients
that are mentioned in Table 1 and explained briefly.
3.3. Formulation Ingredients
3.3.2.1. Polymers
Depending on the type of fast dissolving system that is
to be manufactured, different ingredients are used. They
are more or less the same in different dosage forms and will
be explained briefly (35-38). It should be noted that not all
ingredients are common for all types of FDS (28, 29).
3.3.1. General Ingredients
3.3.1.1. Active Pharmaceutical Ingredient (API)
Several drugs of different pharmacological classes
are used to prepare fast dissolving systems including
analgesics such as acetaminophen and caffeine (28), indomethacin (39), ibuprofen (40) and diclofenac (41, 42),
anti-migraines such as donepezil (43, 44) and sumatriptan
(13, 45), anti-emetics such as metoclopramide and dimenhydrinate, antibiotics (46) and miscellaneous categories
(15, 31, 33, 47, 48).
2
Are among the most important excipients used in
FDS. Interaction between API and polymer determines the
amount of loading and rate of dissolution. Hydrophilic
natural or synthetic polymers can be used to prepare fast
dissolving films or strips (61-65). Some of the common
polymers used to manufacture films or nanofibers are poly
(lactide-glycolide) (40, 66), chitosan (67, 68), collagen (69),
poly (lactide-caprolactone) (70, 71), cellulose acetate phthalate, polyvinyl alcohol (53, 72, 73), polyethylene glycol,
polyvinyl pyrrolidone (12, 27, 47, 74-77) and cellulose derivatives such as hydroxypropyl methylcellulose (HPMC) and
hydroxypropyl cellulose (HPC) (48).
3.3.2.2. Plasticizers
They are used to improve the film’s mechanical
strength and prevent breaking due to fragility (63, 78, 79).
Jundishapur J Nat Pharm Prod. 2017; 12(2):e34267.
Bahrainian S et al.
Table 1. Specific Ingredients of Different Fast Dissolving Systems Dosage Forms
Fast Dissolving Tablets (35, 37, 56-59)
Fast Dissolving Films (36, 60)
Fast Dissolving Nanofibers (1, 29)
Super disintegrant
Polymer
Polymer
Binder
Plasticizer
-
Lubricant
-
-
Filler
-
-
3.3.2.3. Super Disintegrants
These excipients including microcrystalline cellulose,
hydroxypropyl methyl cellulose, modified starch, crosspovidone and crosscarmellose are used in a concentration
of 5 - 10% to ensure rapid disintegration of tablets in order to enhance dissolution rate and quick absorption of
drug. Super disintegrants do their function through different mechanisms; they can swell in contact with water
or improve the absorption of water into the dosage form
(80-84).
3.3.2.4. Binders
Also called as adhesives, are added to the tablet formulation to ensure the required strength to compact the powder, and is used in very low amounts (1% - 2%) (58, 85).
3.3.2.5. Lubricants
Lubricants are used to lower the friction and adhesion
between the tablet surface and die during tablet ejection
(86, 87). Although, it should be noted that hydrophobic lubricants such as calcium or magnesium stearate may delay
the disintegration of the fast dissolving tablet; hence it is
suggested to use hydrophilic lubricants such as sodium or
potassium benzoate for these dosage forms (88).
3.3.2.6. Fillers
Filler is used to increase the bulk volume of the powder
and the size of the tablet to form a tablet with suitable size
for handling when the drug is very potent, (59).
3.4. Preparation Methods of FDS
Preparation of different FDS dosage forms vary from
each other. The methods are shown in Table 2 and each
method is then explained briefly. It should be noted that
only some of these methods are commercialized for FDS
preparation and other techniques are mostly used in researches.
3.4.1. Tablet Preparation
3.4.1.1. Lyophilization
The process of drying at low temperature by sublimation technique gives the tablets a highly porous structure.
It is also useful for heat sensitive drugs (48, 93-95).
Jundishapur J Nat Pharm Prod. 2017; 12(2):e34267.
3.4.1.2. Spray Drying
An aqueous solution containing the drug, a specific
matrix and other excipients is sprayed to make a fine powder by vaporizing the solvent. The resulted fine particles
are then compressed into tablets (96).
3.4.1.3. Molding
It contains preparation of a suspension or moist powder followed by compression and drying in molded plates,
giving the tablet a less compact and porous structure (97,
98).
3.4.1.4. Sublimation
Is a technique to remove subliming material by sublimation from the compressed tablets giving it high porosity and rapid dissolution in saliva (37, 95-98).
3.4.1.5. Mass Extrusion
In this technique the ingredients are blended together,
making a moist mixture, then driven out through the extruder to form cylindrical extrudates witch can be cut into
tablets (99).
3.4.1.6. Direct Compression
It is a fast and simple technique in tablet manufacturing. The powder blend is compressed by the tableting machine to form tablets in different sizes and shapes without
the need to granulation process (100-103). This technique
may be the final stage of other methods to prepare tablets.
3.4.2. Film Preparation
3.4.2.1. Solvent Casting
In this technique the drug and all of the water soluble excipients are dissolved in a solvent to form a homogenous viscous solution which is then poured into a plate
and dried. In some cases the water soluble and water insoluble ingredients can be dissolved in specific solvents separately and then the two solutions can be mixed (6, 104,
105). Fast dissolving films of maltodextrin and verapamil
(4, 106) and fast dissolving films of meclizine (107) were
made by this technique.
3
Bahrainian S et al.
Table 2. Preparation Methods of Different Fast Dissolving Systems Dosage Forms
Tablets (35, 37, 56, 59)
Films (32, 36, 60, 61)
Nanofibers (29, 89-92)
Freeze drying/lyophilization
Solvent casting
Drawing
Spray drying
Semi-solid casting
Template synthesis
Molding
Hot melt extrusion
Phase separation
Sublimation
Rolling
Self-assembly
Mass extrusion
Solid dispersion extrusion
Electrospinning
Direct compression
Compaction
3.4.2.2. Semi-Solid Casting
A plasticizer and an acid insoluble polymer solution
are added to a solution of water soluble polymer, thus
forming a gel which is casted into films by heat controlled
drums (34, 62, 104).
most suitable choices to improve dissolution and hence
bioavailability of drugs and the method has gained attention due to its efficacy and advantages over traditional
preparation technologies (39, 117). The following part focuses on this method of preparation (28, 29, 69).
3.4.2.3. Hot Melt Extrusion
It is the process of applying heat and pressure to a
molten polymer and extruding it through an orifice in a
continuous process. This process is mostly used to make
granules, tablets, transdermal and transmucosal delivery
systems (36, 108, 109). The method is used to make fast dissolving films of maltodextrin (4).
3.4.3.1. Electrospinning Method
In the electrospinning process, a high voltage power
supply (118) is used to provide a desirable voltage between
the solution and the collector (28, 119). Spinning solutions
are carefully loaded into a syringe attached to a stainless
steel capillary metal-hub needle (28) and the specific feed
rate of the solution is maintained to avoid air bubbles. The
positive electrode of the high voltage power supply is connected to the needle tip (117). The earthed electrode is connected to a metal collector (29). Collectors have different
sizes and shapes due to their application. Increasing the
voltage between the two electrodes induces a tailor cone
formation at the tip of the needle and at a specific voltage
(89), depending on the concentration and type of polymer,
the solution exits the needle tip as a fiber jet and is shot toward the collector (28), thinning of the fibers to nanosize
and drying by solvent evaporation take place on the way to
the collector (118-120). Sometimes the melted polymer solutions can be used and the film is solidified by cooling on
the way to the collector (39, 121, 122). The distance between
the needle tip and collector, the voltage and the feed rate of
the syringe have to be adjusted to obtain a suitable fiber jet
and proper nanofibers (43, 118). Electrospun nanofibers are
usually collected as a film or strip and can be developed in
various sizes and shapes according to their administration
(39, 117, 122).
3.4.2.4. Rolling
Two premix solutions containing a film forming polymer, a polar solvent and other excipients are made. API
is added to one solution, and then all the solutions are
poured into the feed tank and mixed together. After that,
the mixed solution is carried away by a roller and dried to
form a film using bottom drying (34, 62).
3.4.2.5. Solid Dispersion
The drug and hydrophilic polymers are dissolved or
dispersed in a solvent and left to dry in the shape of
films. The resulted films consist of an amorphous carrier
which its drug molecules or particles are dispersed homogenously in the matrix. This method is used to make
fast dissolving acetaminophen films (110-114).
3.4.2.6. Compaction
The method is commonly used as a dry granulation
technique in the pharmaceutical industry to produce
tablets with ingredients sensitive to heat and moisture.
This method is mostly used to make matrix films from two
different polymers (115, 116).
3.4.3. Nanofiber Preparation
There are different methods to prepare nanofibers (Table 2). However the electrospinning technique is a promising method to prepare nanofibers in research and industry. Nanofibers prepared by electrospinning are the
4
3.5. Special Advantages of Electrospun Nanofibers
Electrospinning process is preferred to prepare
nanofibers due to its efficiency and simplicity in fabrication, versatility in manufacturing different drugs and
polymers, low cost of production and possibility to scale
up to the industrial level (121, 123).
Electrospun nanofibers have a large surface area that
leads to fast dissolution and/or disintegration of the film
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Bahrainian S et al.
(85). These nanofiber films have merged the stability of
solid dosage forms with the bioavailability of liquid forms
because of high surface area to volume ratio (118) which
enhances fast dissolution and high solubility. A very useful advantage is the ability to be manufactured using just
an API and polymer (111, 124), thus reducing any side effects of excipients and lowering the cost of production. For
the process of electrospinning, crystallized or amorphous
drugs can be used, but researches show that even crystallized drugs turn into amorphous state through the electrospinning process, because of fast solvent evaporation
which gives the drug no time to crystal growth and making them more likely to dissolve rapidly (39, 120).
In addition to the benefits of electrospinning,
nanofibers prepared by this technique also have some
specific advantages. Drugs in the nanofiber structures
have a faster permeation rate across oral mucosa (117).
They can also be used to treat localized conditions in oral
cavity due to their mucoadhesive property (125) as well
as systemic absorption (28, 29). Encapsulating drugs as
nanofibers enhances the bioavailability of drugs due to
faster disintegration and dissolution (45, 126, 127). Furthermore, insoluble or swellabe polymers are used in
nanofibers to control the drug release (42, 120). Using
other drug delivery systems such as nanoparticles or
microemulsions in combination with nanofibers are also
under study (70, 119).
3.6. Evaluation of Fast Dissolving Systems
Although the evaluation techniques for tablets are different from films and nanofibers, the main ideas are the
same. However explaining all of the evaluation methods is
far from the scope of this review, they are only mentioned
briefly in Table 3 (32, 34, 36, 45, 47).
The FDS evaluation tests in some cases need special
conditions or modifications compared to the traditional
dosage forms; for example due to the fast dissolution and
disintegration of FDS, the test procedures should be filmed
by a high speed camera to make it possible to determine
the time of dissolution and disintegration. Also for films
and nanofibers, a low volume media are used for dissolution test (5 - 10 mL). Table 4 shows the dissolution and disintegration time for different FDS dosage forms (28, 29, 42)).
4. Conclusions
Nowadays, patients are looking for rapid effect of medications (40, 45) and due to the difficulties and bad compliance of injectable dosage forms, they prefer to use rapid
acting oral dosage forms (27). Oral fast delivery systems
are the most convenient forms for fast drug delivery (3,
Jundishapur J Nat Pharm Prod. 2017; 12(2):e34267.
39). They are available in different types of dosage forms
(47), and are developing in order to improve effectiveness,
feasibility, ease of production and administration (111). As
shown in Table 4, nanofibers have the fastest dissolution
time among different fast dissolving systems, which is due
to their very high porosity (28, 29). Thus they can be used
as novel drug delivery systems for fast dissolving purposes
(131).
Acknowledgments
The authors wish to thank Dr. Moghimipour, Dr. Salimi
and Dr. Kalantari for their support and helpful comments.
Footnote
Authors’ Contribution: Sara Bahrainian and Mohammadreza Abbaspour participated in study concept and design, acquisition of data, drafting the manuscript and its
critical revision, and Maryam Kouchak and Pooria Taghavi
Moghadam participated in revising the manuscript.
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