THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECTUS IN DELIVERY: A SYSTEMATIC REVIEW

Prachi Pandey et al, International Journal of Pharmaceutical Sciences & Medicine (IJPSM),
Vol.8 Issue. 10, October- 2023, pg. 76-106
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© 2023, IJPSM All Rights Reserved, www.ijpsm.com 76
THE CURRENT STATUS IN MUCOSAL
DRUG DELIVERY SYSTEM (MDDS)
AND FUTURE PROSPECTUS IN
DELIVERY: A SYSTEMATIC REVIEW
Prachi Pandey*1
; Rahul Pal2
; Sudhanshu Singh3
; Himangi Gupta4
;
Aryan Batham5
; Narendra Kumar6
; Arushi7
*1,2
Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan, 303121, India
3,4,5,6
Research Scholar, Invertis Institute of Pharmacy, Invertis University, Bareilly, Uttar Pradesh, 243123, India
7
Assistant Professor, Department of Pharmaceutics, Shiva Institute of Pharmacy, Chandpur, Himachal Pradesh, 174004, India
*Corresponding Author: Prachi Pandey
Email Id.: pandeyprachi167@gmail.com (Prachi Pandey)
DOI: 10.47760/ijpsm.2023.v08i10.007
Abstract:
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Keywords: mucoadhesion, bio-adhesion, MDDS, transmucosal, mucosal layer, permeability.

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INTRODUCTION
The field of drug delivery has witnessed significant advancements in recent years, with a
particular focus on developing innovative strategies to enhance drug absorption and
bioavailability. Among these strategies, mucosal drug delivery systems have emerged as a
promising approach due to their numerous advantages. Mucosal surfaces, such as the nasal,
oral, ocular, and vaginal routes, offer a convenient and non-invasive means of drug
administration, bypassing the need for injections or invasive procedures [1].
Mucosal drug delivery systems (MDDS) have emerged as a promising approach for efficient
drug delivery, offering numerous advantages over conventional delivery routes. Mucosal
surfaces, such as the oral, nasal, ocular, pulmonary, and vaginal routes, provide a large
surface area with rich blood supply, enabling rapid drug absorption and direct access to target
tissues. Mucosal drug delivery is a specialized method of administering pharmaceutical
substances through the mucous membranes of the body, as opposed to the more conventional
oral or intravenous routes [2-3]. Mucosal surfaces are found in various areas, such as the
gastrointestinal tract, respiratory tract, ocular surface, and genitourinary tract, and they are
characterized by their moist and protective nature. Mucosal drug delivery systems leverage
these unique characteristics to improve drug absorption, enhance therapeutic effectiveness,
and reduce potential side effects.
Mucosal membranes are thin, moist layers of tissue that line the various body cavities, such
as the oral cavity, nasal cavity, respiratory tract, gastrointestinal tract, and urogenital tract.
MDDSs offer a number of advantages over other drug delivery routes, including:
 Rapid onset of action: Drugs delivered through mucosal membranes are absorbed directly
into the bloodstream, bypassing the first-pass metabolism that occurs in the liver.
 High bioavailability: Drugs delivered through mucosal membranes are often absorbed more
completely than drugs delivered through other routes. This is because the mucosal
membranes are highly vascularized and have a large surface area for absorption.
 Non-invasive administration: MDDSs are typically non-invasive and easy to administer,
which makes them ideal for patients who have difficulty swallowing pills or who have other
medical conditions that preclude other routes of administration [3-5].

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MDDSs are available in a variety of formulations, including gels, ointments, creams, films,
patches, and tablets. The specific formulation that is used depends on the drug being
delivered and the desired site of action. This review aims to comprehensively evaluate the
current status of MDDS and explore their future prospects in drug delivery.
IDEAL CHARACTERISTRICS OF MUCOSAL DRUG DELIVERY SYSTEM
An ideal mucosal drug delivery system should possess several key characteristics to
effectively and safely deliver drugs through mucous membranes. These characteristics are
essential for maximizing drug bioavailability, ensuring patient compliance, and minimizing
side effects. The ideal characteristics of mucosal drug delivery system (MDDS) discussed in
Table. 01 as below:
Table. 01: The ideal characteristics of Mucosal Drug Delivery System (MDDS) [5-8]
Characteristic Importance Application
Mucoadhesion Prolongs residence time of drug at site
of action
Improves bioavailability and
sustained drug release
Biocompatibility Prevents irritation or inflammation of
mucosal tissue
Ensures safety and tolerability of
MDDS
Controlled drug
release
Maintains therapeutic drug
concentration at site of action
Optimizes drug efficacy and
reduces dosing frequency
Targeted drug
delivery
Minimizes systemic exposure and
reduces side effects
Enhances therapeutic efficacy and
reduces toxicity
Ease of
administration
Improves patient compliance and
adherence to treatment
Promotes patient acceptance and
convenience
Stability Maintains integrity and drug content
during storage and administration
Ensures consistent drug delivery
and product quality
Reproducibility Ensures consistent formulation and
performance
Guarantees reliable therapeutic
outcomes
Cost-effectiveness Makes treatment more accessible to
patients and healthcare providers
Promotes wider adoption and
affordability of MDDS

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Mucosal Drug Delivery System example of application is given as follows- A mucoadhesive
buccal patch for delivering a drug to treat oral ulcers. The patch adheres to the buccal
mucosa, providing sustained drug release directly to the site of the ulcers.
ADVANTAGES AND DISADVANATGES
Mucoadhesive drug delivery systems offer several advantages, but they also come with some
disadvantages. It's important to consider these factors when deciding whether to use
mucoadhesive systems for drug delivery. The several merits and demerits of mucosal drug
delivery system discussed in the given Table. 02 as below followings:
Advantages of mucoadhesive drug delivery systems (MDDSs):
 Rapid onset of action: Drugs delivered through mucosal surfaces are absorbed directly into
the bloodstream, bypassing the first-pass metabolism that occurs in the liver. This results in a
more rapid onset of action than other routes of administration.
 High bioavailability: Drugs delivered through mucosal surfaces are often absorbed more
completely than drugs delivered through other routes. This is because the mucosal surfaces
are highly vascularized and have a large surface area for absorption.
 Improved patient compliance: MDDSs can be designed to be comfortable and convenient to
use, which can lead to improved patient compliance.
 Targeted delivery: MDDSs can be designed to deliver drugs to specific mucosal surfaces,
which can help to reduce systemic side effects.
Disadvantages of MDDSs:
 Potential for irritation: MDDSs can irritate the mucosal surface, especially if they are used
for extended periods of time.
 Limited drug loading capacity: MDDSs have a limited drug loading capacity, which means
that they may not be suitable for drugs that need to be delivered in high doses.
 Short residence time: MDDSs may have a short residence time on the mucosal surface,
which can reduce drug absorption [6-9].
These disadvantages, MDDSs offer a number of advantages over traditional routes of drug
administration. Researchers are continuing to develop new and improved MDDSs that

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address the challenges associated with this technology. MDDSs have the potential to
revolutionize the way that many drugs are delivered, and they offer a promising alternative
for the treatment of a wide range of diseases and conditions.
Table 02- The various advantages and Disadvantages of Mucoadhesive Drug Delivery
System (MDDS) [4-9]
Feature Description Importance Application
Advantages
Localized drug
delivery
Delivers drugs
directly to the site of
action
Improves drug efficacy
and reduces systemic
side effects
Treatment of local conditions,
such as oral ulcers, nasal
congestion, or eye infections
Sustained drug
release
Provides prolonged
drug release over
time
Reduces dosing
frequency and
maintains therapeutic
drug levels
Long-term management of
chronic conditions, such as
asthma or hormone
replacement therapy
Improved
patient
compliance
Convenient and
comfortable for
patients
Enhances adherence to
treatment regimens
Administration of drugs to
patients who have difficulty
swallowing or are needle-
phobic
Disadvantages
Limited drug
absorption
Mucosal surfaces
have limited
absorption capacity
for some drugs
May require higher
drug doses or
alternative routes of
administration
Not suitable for drugs that
require rapid or high systemic
absorption
Enzymatic
degradation
Mucosal enzymes
can degrade certain
drugs
May require drug
protection or
modification to
prevent degradation
Not suitable for drugs that are
susceptible to enzymatic
breakdown

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Mucosal Drug Delivery System example of application is given as follows- A mucoadhesive
nasal spray for delivering a drug to treat migraine headaches. The spray delivers the drug
directly to the nasal mucosa, providing rapid absorption and onset of action.
STRUCTURE AND COMPOSITION OF BUCCCAL (MUCOSA) MUCUS LAYER
The buccal mucosa is the moist lining of the inner cheek and plays a vital role in the mucosal
drug delivery system, as it provides a route for drugs to enter the bloodstream directly. The
composition and structure of the buccal mucosa mucus layer are important factors that
influence drug absorption and adhesion [10]. The structure and composition of the buccal
mucosa mucus layer:
Structure of the Buccal Mucosa:
1. Stratified Squamous Epithelium: The buccal mucosa is covered by a stratified squamous
epithelium, which consists of multiple layers of flat, tightly packed cells. This epithelium
provides a protective barrier against mechanical damage and the external environment.
2. Basement Membrane: Beneath the stratified squamous epithelium lies the basement
membrane, a thin, acellular layer that separates the epithelium from the underlying
connective tissue.
3. Connective Tissue: The connective tissue layer contains blood vessels and nerves, which
provide nourishment and innervation to the buccal mucosa [11].
Figure. 01: The structure representation of mucosa layer or mucosa

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Composition of Buccal Mucosa Mucus Layer:
The mucus layer in the buccal mucosa plays a crucial role in drug delivery and is composed
of several components, including:
 Mucin: Mucins are the major structural components of mucus and are large glycoproteins.
They form a gel-like network that helps to trap and transport drug molecules. Mucin
glycoproteins have carbohydrate side chains that extend from the mucosal cell surface and
provide binding sites for drugs.
 Water: The mucus layer is primarily composed of water, making it a hydrated gel. This water
content contributes to the lubrication of the buccal mucosa and helps in the dissolution and
absorption of drugs.
 Electrolytes: The mucus layer contains electrolytes, such as sodium and potassium ions,
which help maintain the ionic balance and contribute to the overall composition of the mucus.
 Enzymes: Enzymes present in the mucus layer can metabolize certain drugs and nutrients.
The buccal mucosa mucus may contain enzymes like amylase and lipase.
 Glycoproteins and Proteoglycans: These molecules, along with mucins, contribute to the
viscosity and lubrication properties of the mucus layer.
 Antibodies and Immunoglobulins: The buccal mucosa mucus can contain antibodies and
immunoglobulins that are part of the immune defense system and help protect against
infections [11-12].
The composition and structure of the buccal mucosa mucus layer can vary among individuals
and can be influenced by factors like hydration, diet, and overall health. The composition of
mucus membrane in different organs shown in the given Table. 03 as below:
Table. 03: The comparison of mucus membranes in different organs [11-13]
Mucus
Membrane
Mucus
Surface
Area
Thickness
of Mucus
Layer
Layers
Turnover Time
Buccal 30 cm2
0.1–0.7 mm
Epithelium, basement membrane,
and connective tissues
5–6 days
Nasal 160 cm2
5–20 µm
Both keratinized and nonkeratinized
epithelial cells
10–15 min

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Ocular 3–10 µm
Pithelium, Bowman’s layer,
stroma, Descemet’s
membrane, and endothelium
15–20 h
Vaginal 6–10 cm2 10–15
layers
The epithelial layer consists
of the lamina propia and
stratified squamous
epithelium
7 days
Rectal 300 cm2
50 µm
Single layer of cylindrical cells and
goblet cells secreting mucus
90 h
These variations can impact drug absorption and adhesion when utilizing the buccal route for
drug delivery. Understanding the characteristics of the buccal mucosa mucus layer is
essential for designing effective drug delivery systems that can overcome these variations and
ensure consistent drug release and absorption.
The buccal mucosa is covered by a thin layer of mucus. The mucus layer is composed of a
mixture of water, proteins, and carbohydrates. The proteins in the mucus layer include
mucins, which are responsible for the sticky and viscous properties of mucus [13]. The
carbohydrates in the mucus layer include glycoproteins and proteoglycans, which also
contribute to the viscosity of mucus.
Role of Mucus: Mucus plays a number of important roles in the body, including:
 Protection: Mucus protects the linings of the body from physical abrasion, chemical
irritation, and microbial infection. For example, the mucus layer in the respiratory tract traps
inhaled dust, pollen, and bacteria, preventing them from entering the lungs.
 Lubrication: Mucus lubricates the linings of the body, making it easier for organs and tissues
to move against each other. For example, the mucus in the joints helps to reduce friction and
wear and tear.
 Immune function: Mucus contains immune cells and antimicrobial peptides that help to
protect the body from infection. For example, the mucus in the respiratory tract contains IgA
antibodies, which can neutralize viruses and bacteria.
Mucus is produced by specialized cells called goblet cells. Goblet cells are found in the lining
of many organs and tissues, including the respiratory tract, digestive tract, reproductive tract,
and urinary tract. The production of mucus is regulated by a number of factors, including

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hormones, allergens, and irritants. For example, when a person is exposed to an allergen,
such as pollen or dust mites, the body releases histamine, which triggers the production of
mucus in the nose and throat. This is why people with allergies often have a runny nose and
itchy eyes. Mucus is also produced in response to infection. When the body detects the
presence of a virus or bacteria, the immune system releases cytokines, which stimulate the
production of mucus [12-14]. This helps to trap the invaders and prevent them from
spreading to other parts of the body.
MUCOADHESION AND BIOADHESION
Mucoadhesion and bio-adhesion are two related concepts in the field of pharmaceuticals and
drug delivery that involve the binding or adherence of substances to biological surfaces, such
as mucosal membranes or tissues. These processes play a crucial role in the development of
various drug delivery systems and medical applications [15].
Mucoadhesion refers to the process of a material or substance adhering to the mucus layer on
the surface of mucous membranes in the body, such as the buccal (oral), nasal,
gastrointestinal, vaginal, or rectal mucosa. The primary objective of mucoadhesive drug
delivery systems is to extend the contact time between the drug and the mucosal membrane,
allowing for enhanced drug absorption and therapeutic effects. Some key points about
mucoadhesion include:
 Mechanism: Mucoadhesion can be achieved through various mechanisms, including
electrostatic interactions, hydrogen bonding, Van der Waals forces, and covalent bonding.
These interactions enable the adhesive material to bind to the mucin glycoproteins present in
the mucus layer [16]. The mechanism of mucoadhesion and bio-adhesion shown in Table. 04
and Fig. 02 with description:

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Figure. 02: The structural representation of mucoadhesion mechanism
The complete description of all the mechanisms of mucoadhesion and bio adhesions as below
Table. 04 with their complete description.
Table. 04: The mechanism of mucoadhesion and bio-adhesion with their description
[14-18]
Mechanism Mucoadhesion Bio-adhesion Description
Wetting and
spreading
The mucoadhesive
material must be able to
wet and spread on the
mucosal surface. This
allows for intimate
contact between the two
surfaces and increases the
surface area available for
bonding.
The bioadhesive
material must also be
able to wet and spread
on the biological
surface. This is
important for
maximizing the
surface area available
for bonding.
Wetting and spreading is
influenced by the surface
tension of the
mucoadhesive or
bioadhesive material, as
well as the surface
properties of the mucosal
or biological surface.
Interpenetration The mucoadhesive
material must be able to
interpenetrate the mucus
layer. This allows for the
formation of physical
The bioadhesive
material can also
interpenetrate the
biological surface,
which can lead to the
Interpenetration is
influenced by the
molecular weight, size,
and shape of the
mucoadhesive or

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bonds, such as
mechanical interlocking
and entanglement,
between the two
materials.
formation of physical
bonds.
bioadhesive material, as
well as the structure and
composition of the mucus
layer or biological
surface.
Bond formation Once the mucoadhesive
material has wetted,
spread, and
interpenetrated the mucus
layer, bonds can form
between the two
materials. These bonds
can be either physical or
chemical in nature.
Bonds between the
bioadhesive material
and the biological
surface can also form.
The type of bonds
that form will depend
on the properties of
the two materials
involved.
Bond formation is
influenced by the
chemical and physical
properties of the
mucoadhesive or
bioadhesive material and
the mucosal or biological
surface.
 Advantages: Mucoadhesive drug delivery systems offer several advantages, such as
increased drug bioavailability, reduced drug degradation, sustained release, and localized
drug delivery. They are particularly useful for drugs with low oral bioavailability or those
that require precise targeting.
 Applications: Mucoadhesion is utilized in various medical applications, including oral drug
delivery, ocular drug delivery, buccal and sublingual drug delivery, and vaginal and rectal
drug delivery.
Bio-adhesion:
Bio-adhesion is a broader concept that encompasses the adhesion of materials, not limited to
mucous membranes, to biological surfaces, which can include mucosal tissues, skin, and
other biological substrates. While mucoadhesion specifically deals with mucosal surfaces,
bio-adhesion can refer to adhesion to a broader range of biological surfaces and tissues. Some
important points about bio-adhesion include:

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 Types of Bio-adhesion: Bio-adhesion can be classified into two main categories: bio-
adhesion to biological surfaces, such as skin or corneal tissue, and bio-adhesion to synthetic
materials, such as medical devices (e.g., wound dressings, transdermal patches, and contact
lenses). Bioadhesive interactions are essential for ensuring the stability and effectiveness of
these devices.
 Applications: Bioadhesive materials have diverse applications in the medical field, including
wound care (adhesive bandages and surgical dressings), transdermal drug delivery (patches),
ocular drug delivery (contact lenses and eye drops), and tissue adhesives in surgery.
 Adhesive Mechanisms: Similar to mucoadhesion, bio-adhesion relies on various adhesive
mechanisms, including physical interactions (such as hydrogen bonding), chemical bonds,
and mechanical interlocking. The choice of adhesive mechanism depends on the specific
application and the properties of the adhesive and biological surfaces involved [19].
Mucoadhesion and bio-adhesion are important concepts in pharmaceuticals and medical
devices, as they allow for improved drug delivery and the development of effective medical
applications. The various differences of mucoadhesion and bio-adhesion shown in given
Table. 05:
Table. 05: The various featuring terms of mucoadhesion and bio-adhesion with their
application [18-22]
Feature Mucoadhesion Bio-adhesion
Definition Adhesion between a material and a mucosal
surface
Adhesion between any two
biological materials
Examples Nasal sprays, sublingual tablets, buccal
patches, vaginal creams and gels, rectal
suppositories
Skin adhesives, bone implants,
vascular grafts, tissue sealants
Applications Drug delivery, tissue engineering,
regenerative medicine
Medical devices, surgical
implants, wound dressings, dental
materials

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Sites of
adhesion
Mucosal surfaces (e.g., oral cavity, nasal
cavity, respiratory tract, gastrointestinal tract,
urogenital tract)
Any biological surface, including
skin, bone, blood vessels, tissues,
and organs
These processes involve the adherence of materials to biological surfaces, whether in the
form of mucosal membranes or other tissues, and they are essential for optimizing drug
absorption and the performance of various medical products.
PRINCIPLE OF MUCOADHESION AND BIOADHESION
The principle of bio-adhesion and mucoadhesion is a fundamental concept in the field of
biomedical sciences. Bio-adhesion refers to the ability of a material or substance to adhere to
biological surfaces, such as tissues or organs, while mucoadhesion specifically pertains to the
adhesion of materials to mucosal surfaces.
Mucoadhesion and bio-adhesion are closely related phenomena that involve the adhesion of
materials to biological surfaces. Mucoadhesion is a specific type of bio-adhesion that refers to
the adhesion of materials to mucosal surfaces, which are the moist linings of various body
cavities, such as the mouth, nose, and intestines. Mucoadhesion is mediated by a combination
of physical and chemical interactions between the mucoadhesive material and the mucus
layer that coats mucosal surfaces [19].
Bio-adhesion is a broader term that encompasses the adhesion of materials to any biological
surface, including skin, bone, and teeth. Bio-adhesion is also mediated by a combination of
physical and chemical interactions, but the specific mechanisms involved can vary depending
on the type of biological surface and the properties of the bioadhesive material.
Principles of mucoadhesion and bio-adhesion:
The adhesion of materials to biological surfaces is a complex process that is influenced by a
variety of factors, including:
 Surface properties of the material and the biological tissue: The surface properties of both
the material and the biological tissue play a crucial role in determining the strength of
adhesion. Factors such as surface roughness, hydrophilicity, and charge can all affect the
interaction between the two surfaces.

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 Presence of mucus: Mucus, a viscous fluid that coats mucosal surfaces, plays a key role in
mucoadhesion. The interaction between the mucoadhesive material and the mucus layer is
mediated by various mechanisms, including hydrogen bonding, electrostatic interactions, and
physical entanglement.
 Environmental conditions: The environment in which adhesion occurs can also influence the
process. Factors such as pH, temperature, and the presence of enzymes can affect the stability
and effectiveness of mucoadhesive and bioadhesive materials [20-22].
THEORIES OF MUCOADHESION
Theories on the phenomenon of mucoadhesion have been extensively studied and analyzed in
the field of pharmaceutical sciences. Mucoadhesion refers to the ability of certain substances
or formulations to adhere to the mucosal surfaces of biological tissues, particularly in the
context of drug delivery systems [23]. Various theories have been proposed to explain the
mechanisms underlying mucoadhesion, aiming to provide a comprehensive understanding of
this phenomenon.
The basics of the theories of mucoadhesion as Table. 06 as below following description:
Table. 06: The list of theories of mucoadhesion with their biological reactive system [22-24]
Theory
Chemical and
Physical
Reaction
Biological Reactive
System Result
Electronic theory
Electron transfer
reaction
Mucus and the
mucoadhesive
system
Electrical double layer of charges at the
mucus and mucoadhesive interface
Adsorption theory
Hydrogen
bonding
reaction
Mucus and the
mucoadhesive
system
Adhesive interaction between the substrate
surfaces
Diffusion theory Adhesive force
Mucus and the
mucoadhesive
system
Interpenetration of both polymer and
mucin chains to a sufficient depth
Wetting theory
Spreading
property
Mucus and the
mucoadhesive
system
Attachment regarding to contact angle
Fracture theory
Detachment of
polymer
moieties
Mucus and
polymer moieties Relates the force for polymer detachment

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Mucoadhesion is a complex process, and several theories have been proposed to explain the
mechanisms behind the adhesion of materials to mucosal surfaces. Understanding these
theories is crucial for the design and development of effective mucoadhesive drug delivery
systems.
The all theories generally classified on the basis of their physical and chemical situations as
per the Fig. 03 as below followings:
Figure. 03: The classification of theories of mucoadhesion as per physical and
chemically
The several key theories of mucoadhesion with their complete description shown in given
Table. 06, 07 as below followings:
1. Wetting Theory: This theory suggests that mucoadhesion occurs when the adhesive material
wets the mucosal surface, similar to the spreading of a liquid on a solid surface. The adhesive
must have a lower contact angle with the mucosal surface to ensure good wetting. Good
wetting promotes close contact between the adhesive and mucosa, allowing for stronger
adhesive interactions.
2. Adsorption Theory: According to the adsorption theory, mucoadhesion is driven by the
adsorption of adhesive molecules onto mucin glycoproteins present in the mucosal layer.

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Mucins have abundant hydroxyl and amino groups that can form hydrogen bonds with
adhesive molecules. The formation of reversible bonds, such as hydrogen bonds, electrostatic
interactions, and Van der Waals forces, contributes to the adhesion process [25].
3. Electronic Theory: The electronic theory emphasizes the role of charge interactions in
mucoadhesion. Adhesive materials and mucosal surfaces may carry opposite charges
(positive or negative), leading to electrostatic interactions that promote adhesion. The
formation of ionic bonds or electrostatic attractions between the adhesive and mucosal
surfaces is essential in this theory.
The all theories shown as per the Fig. 04 as below section:
Figure. 04: The structure representation of various theories of mucoadhesion; [A].
Wetting, [B]. Adsorption, [C]. Electronic, [D]. Fracture, [E]. Diffusion theories of
mucoadhesion
4. Diffusion Theory: The diffusion theory proposes that mucoadhesion occurs through the
diffusion of adhesive molecules into the mucosal layer. This diffusion is driven by a
concentration gradient, and adhesive penetration into the mucosal layer can enhance
adhesion. The rate and extent of adhesive diffusion into the mucosal tissue play a significant
role in this theory.

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5. Mechanical Interlocking Theory: This theory focuses on the physical aspects of
mucoadhesion. It suggests that adhesion occurs when adhesive materials form mechanical
interlocks with the irregularities or microstructures of the mucosal surface. The formation of
physical entanglements or interlocking structures can enhance the adhesion of the material to
the mucosa.
6. Covalent Bonding Theory: In some cases, mucoadhesion may involve the formation of
covalent bonds between the adhesive and mucosal surfaces. Adhesive materials with
functional groups that can react with mucosal tissue may form strong, irreversible bonds.
Covalent bonding can lead to prolonged adhesion and sustained drug release [26-28].
The brief description about the theories of mucoadhesion describes in the Table. 07 as below
discussion as following:
Table. 07: The list of theories of mucoadhesion with their examples [25-29]
Theory Description Examples
Wetting
theory
Mucoadhesion is mediated by the wetting
and spreading of the mucoadhesive
material on the mucosal surface. This
allows for intimate contact between the
two surfaces and increases the surface area
available for bonding.
A mucoadhesive material with a low
surface tension will be able to wet and
spread on the mucosal surface more
easily than a mucoadhesive material
with a high surface tension.
Adsorption
theory
Mucoadhesion is mediated by the
adsorption of the mucoadhesive material to
the mucosal surface. Adsorption can occur
through a variety of mechanisms, such as
electrostatic interactions, hydrogen
bonding, and mechanical interlocking.
A mucoadhesive material with a
positive charge will be attracted to the
negatively charged mucus layer by
electrostatic interactions.
Diffusion
theory
Mucoadhesion is mediated by the diffusion
of the mucoadhesive material into the
mucus layer. This allows for the formation
A mucoadhesive material with a low
molecular weight will be able to
diffuse into the mucus layer more

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of physical bonds, such as entanglement
and mechanical interlocking, between the
two materials.
easily than a mucoadhesive material
with a high molecular weight.
Fracture
theory
Mucoadhesion is mediated by the
formation of microfracture bonds between
the mucoadhesive material and the
mucosal surface. These microfracture
bonds are formed when the two surfaces
are separated, and they can provide a
strong adhesive force.
A mucoadhesive material that is
highly flexible and elastic will be
more able to form microfracture
bonds with the mucosal surface than a
mucoadhesive material that is rigid
and brittle.
Electronic
theory
Mucoadhesion is mediated by the transfer
of electrons between the mucoadhesive
material and the mucosal surface. This
electron transfer can create a weak electric
field that attracts the two surfaces together.
A mucoadhesive material that is
electron-rich will be more likely to
donate electrons to the electron-
deficient mucosal surface.
Mucoadhesion is often a multifaceted process, and multiple mechanisms can contribute to
adhesion simultaneously. The specific mechanisms involved may vary depending on the
properties of the adhesive material, the mucosal surface, and the environmental conditions.
The selection and design of mucoadhesive materials should take into account the relevant
theories to optimize adhesion and drug delivery efficacy. These theories provide valuable
insights into the complex phenomenon of mucoadhesion, contributing to the development of
effective drug delivery systems and formulations that can optimize the therapeutic outcomes
[30]. Further research and experimentation are necessary to validate and refine these theories,
ultimately advancing the field of mucoadhesion in pharmaceutical sciences.
POLYMERS IN MUCOSAL DRUG DELIVERY SYSTEM
Polymers play a crucial role in mucosal drug delivery systems. They are often used to design
drug delivery formulations that adhere to mucosal surfaces, release drugs in a controlled
manner, protect drugs from degradation, and improve patient compliance. Various types of

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polymers are employed in mucosal drug delivery systems, each with specific properties and
advantages. Here are some commonly used polymers in mucosal drug delivery:
Natural Polymers:
 Chitosan: Chitosan is derived from chitin, which is found in the shells of crustaceans. It is a
widely used mucoadhesive polymer due to its biocompatibility and ability to form a
protective barrier, enhancing drug absorption. Chitosan can be used in oral, nasal, and ocular
drug delivery systems.
 Hyaluronic Acid: Hyaluronic acid is a natural polymer found in connective tissues and the
extracellular matrix. It is used in ophthalmic drug delivery to improve drug retention on the
ocular surface.
 Alginate: Alginate is a polysaccharide extracted from brown algae. It is often used in buccal
drug delivery systems, as it can form gels and provide sustained drug release [31].
Synthetic Polymers:
 Polyvinyl Alcohol (PVA): PVA is a synthetic water-soluble polymer used in ocular drug
delivery. It can be incorporated into eye drops or contact lenses to enhance drug
bioavailability and retention.
 Poly (lactic-co-glycolic acid) (PLGA): PLGA is a biodegradable and biocompatible synthetic
polymer often used in the formulation of microparticles or nanoparticles for mucosal drug
delivery. It allows for sustained drug release and controlled release kinetics.
 Polyethylene Glycol (PEG): PEG is a synthetic polymer used to improve the solubility and
stability of drugs in various mucosal drug delivery systems, including nasal and ocular
formulations.
Cellulose Derivatives:
 Hydroxypropyl Methylcellulose (HPMC): HPMC is a semisynthetic polymer used in various
drug delivery systems, including ocular and nasal formulations. It improves viscosity and
mucosal retention.
 Sodium Carboxymethylcellulose (NaCMC): NaCMC is a water-soluble cellulose derivative
used in ophthalmic drug delivery to enhance drug solubility and retention.

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Polymethacrylates:
 Eudragit: Polymethacrylates like Eudragit are often used for designing enteric-coated tablets.
These polymers protect drugs from gastric acid degradation and enable drug release in the
intestine.
Gelatin: Gelatin is a protein-based polymer that can be used in oral drug delivery systems as
a matrix for controlled drug release [32-33].
The choice of polymer depends on the specific drug, target tissue, desired release profile, and
biocompatibility considerations. The combination of polymers with mucoadhesive properties
and drug release-controlling polymers allows for the development of effective and patient-
friendly mucosal drug delivery systems.
TRANSMUCOSAL PERMEABILITY
The mechanism of transmucosal permeability in mucoadhesive drug delivery systems
(MDDS) involves a multi-step process that enables drugs to traverse the mucosal barrier and
reach their intended site of action. This process involves overcoming the protective mucus
layer, penetrating the epithelial cell layer, and navigating through the underlying tissue.
1. Interaction with the mucus layer: The mucus layer, a viscous fluid coating mucosal
surfaces, acts as the first line of defense, preventing direct contact of drugs with epithelial
cells. Mucoadhesive polymers in MDDS can intertwine with mucus glycoproteins,
establishing a strong adhesive bond that prolongs drug residence time at the mucosal surface.
2. Penetration through the epithelial barrier: The epithelial cell layer forms a tight barrier
regulating drug passage. Drugs can cross this barrier via two main pathways:
 Paracellular transport: Drugs pass through the spaces between epithelial cells. This route is
favored by small, hydrophilic molecules.
 Transcellular transport: Drugs pass directly through epithelial cells. This route is preferred
by lipophilic molecules or those utilizing specific transport proteins.
3. Transport through the underlying tissue: Once across the epithelium, drugs diffuse
through the underlying connective tissue, reaching blood vessels or target cells. The drug's
physicochemical properties and tissue characteristics influence this diffusion process.

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Factors affecting transmucosal permeability:
1) Mucus layer: The mucus layer that coats mucosal surfaces acts as a barrier to drug
absorption. The thickness and composition of the mucus layer can vary depending on the
mucosal site, and this can affect the permeability of drugs.
2) Epithelial cells: The epithelial cells that form the mucosal barrier also play a role in
regulating drug permeability. The tightness of the junctions between epithelial cells and the
expression of transport proteins can influence the passage of drugs across the epithelium.
3) Drug properties: The physicochemical properties of the drug itself, such as its molecular
weight, lipophilicity, and charge, can also affect its ability to penetrate the mucosal barrier.
4) Formulation factors: The formulation of the MDDS can also influence transmucosal
permeability. The choice of mucoadhesive polymers, excipients, and drug delivery vehicles
can affect the release and penetration of the drug into the mucosal tissue [34-35].
Strategies to enhance transmucosal permeability:
1. Mucoadhesive polymers: Mucoadhesive polymers can increase the residence time of the
MDDS on the mucosal surface, providing more time for drug absorption.
2. Permeation enhancers: Permeation enhancers can temporarily disrupt the mucosal barrier,
allowing for increased drug penetration. However, the use of permeation enhancers must be
carefully considered due to potential safety concerns.
3. Nanocarriers: Nanocarriers, such as liposomes or nanoparticles, can encapsulate drugs and
protect them from degradation, while also facilitating their transport across the mucosal
barrier.
4. Physical methods: Physical methods, such as iontophoresis or electroporation, can be used to
enhance drug transport across the mucosal barrier by applying an electrical current or voltage.

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THE FORMULATION CONSIDERATION (DOSAGE FORMS) OF BUCCAL DRUG
DELIVERY SYSTEM
Buccal drug delivery systems (BDDS) offer a promising approach for delivering drugs
directly through the buccal mucosa, the lining of the inner cheek. This route provides several
advantages, including bypassing first-pass metabolism, sustained drug release, and improved
patient compliance. However, formulating effective BDDS requires careful consideration of
various factors to ensure optimal drug delivery and patient acceptability [36].
Key formulation considerations for BDDS:
1. Mucoadhesion: The BDDS should adhere to the buccal mucosa for a sufficient period to
allow for drug absorption. This requires selecting appropriate mucoadhesive polymers, such
as chitosan, carbopol, or hyaluronic acid, which can form strong bonds with the mucosal
surface.
2. Drug release: The BDDS should release the drug at a controlled rate to maintain therapeutic
drug levels in the bloodstream or target tissues. This can be achieved through various
mechanisms, such as diffusion, erosion, or swelling. The choice of drug release mechanism
depends on the desired drug profile and the physicochemical properties of the drug.
3. Permeation enhancement: The BDDS may need to incorporate permeation enhancers to
facilitate drug transport across the buccal mucosa. Permeation enhancers can temporarily
disrupt the mucosal barrier, allowing for increased drug penetration. However, their safety
must be carefully evaluated to avoid mucosal irritation or damage.
4. Taste masking: The BDDS should have an acceptable taste and avoid causing any unpleasant
sensations in the mouth. This can be achieved by using taste-masking agents or encapsulating
the drug in taste-neutral carriers.
5. Biocompatibility: The BDDS should be biocompatible with the buccal mucosa and not cause
irritation, inflammation, or allergic reactions. The materials used in the formulation should be
non-toxic and non-irritating.
6. Physical properties: The BDDS should have appropriate physical properties, such as
flexibility, thickness, and size, to ensure comfortable application and retention in the buccal

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cavity. The formulation should also be stable under storage conditions and during
administration.
7. Manufacturing considerations: The BDDS should be manufacturable on a large scale using
cost-effective and reproducible methods. The formulation should be compatible with various
manufacturing processes, such as compression, casting, or extrusion [37-38].
Table. 08: The list of formulation consideration (dosage form) of Buccal Drug Delivery
System [36-39]
Dosage Form Description Examples
Gels Gels are a popular formulation for MDDSs because
they are easy to apply to the mucosal surface and can
provide a sustained release of the drug.
Nasal gels, vaginal gels,
rectal gels
Films Films can be adhered to the mucosal surface and
provide a controlled release of the drug.
Buccal films, sublingual
films, vaginal films
Patches Patches are similar to films, but they are typically
larger and designed to adhere to the mucosal surface
for longer periods of time.
Buccal patches, vaginal
patches
Microparticles Microparticles can be dispersed on the mucosal
surface and release the drug slowly over time.
Nasal sprays, pulmonary
sprays, vaginal
microparticles
Tablets Tablets can be formulated to dissolve quickly on the
mucosal surface, such as sublingual tablets, or to
release the drug slowly over time, such as buccal
tablets.
Sublingual tablets,
buccal tablets, vaginal
tablets
Powders Powders can be insufflated into the nasal cavity or
dusted onto other mucosal surfaces.
Nasal powders, vaginal
powders
Sprays Sprays can be used to deliver drugs to the nasal
cavity, oral cavity, or other mucosal surfaces.
Nasal sprays, oral
sprays, vaginal sprays
These are the some above dosage forms and formulation of mucosal drug delivery systems as
well as buccal drug delivery in Table. 08 as above.

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THE CURRENT AND FUTURE PERSPECTIVES
Mucoadhesive drug delivery systems (MDDS) have revolutionized drug administration by
offering a non-invasive and patient-friendly approach to deliver medications directly to
mucosal surfaces. These systems provide several advantages over traditional oral or
injectable routes, including:
1. Localized drug delivery: MDDS adhere to the mucosal surface, enabling targeted drug
release at the site of action, maximizing therapeutic effects while minimizing systemic
exposure and side effects.
2. Sustained drug release: MDDS can provide prolonged drug release over an extended period,
reducing dosing frequency and maintaining therapeutic drug levels.
3. Improved patient compliance: MDDS offer convenient and comfortable administration,
enhancing patient adherence to treatment regimens.
The future of Mucosal Drug Delivery Systems holds significant promise and potential for
development:
 Personalized Mucosal Therapies: Advances in precision medicine are likely to enable
personalized MDDS formulations, tailoring drug delivery to individual patient needs.
 Nanotechnology and Biologics: Nanoparticles and biologic therapies are expected to
revolutionize MDDS, providing targeted and controlled drug delivery for complex diseases.
 Vaccine Delivery: MDDS is anticipated to play a crucial role in vaccine administration, with
potential applications in COVID-19 and other infectious diseases, improving patient
compliance and immunity.
 Telemedicine and Remote Monitoring: MDDS may integrate with telemedicine and remote
patient monitoring, enabling healthcare providers to administer and monitor treatments from
a distance.
 Enhanced Drug Delivery Devices: The development of smart and connected drug delivery
devices is likely to provide real-time data and improve patient adherence [40-41.
MDDS have found widespread applications in various therapeutic areas, included in the
Table. 09 as below followings:

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Table. 09: The several application of mucosal Drug Delivery System (MDDS) [42-44]
Aspect Examples Applications
Current Applications
Oral MDDS Sublingual tablets for angina pectoris,
buccal patches for oral ulcers,
mucoadhesive gels for periodontal
disease treatment
Localized drug delivery for
oral conditions
Nasal MDDS Nasal sprays for migraine headaches,
nasal drops for allergic rhinitis,
mucoadhesive gels for nasal
decongestion
Rapid drug absorption for
systemic effects
Ocular MDDS Eye drops for glaucoma, contact
lenses for sustained drug delivery to
the eye, mucoadhesive gels for dry
eye treatment
Targeted drug delivery to the
eye
Rectal MDDS Suppositories for pain relief, enemas
for inflammatory bowel disease,
mucoadhesive gels for rectal
administration of hormones
Local or systemic drug
delivery via rectal route
Vaginal MDDS Vaginal tablets for yeast infections,
creams for bacterial vaginosis,
mucoadhesive gels for contraception
Local drug delivery for
vaginal conditions
Future Directions
Nanotechnology-based
MDDS
Nanoparticles, liposomes, dendrimers Enhanced drug absorption,
targeted drug delivery
Biomimetic MDDS Biomimetic polymers, cell-mimicking
structures
Improved biocompatibility,
enhanced mucosal interactions
Stimuli-responsive pH-sensitive, temperature-sensitive, Controlled drug release,

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MDDS enzyme-responsive systems targeted drug delivery
Personalized MDDS Genetically tailored, disease-specific,
patient-specific formulations
Optimized drug therapy based
on individual needs
Examples of Future
Applications
Nanoparticle-based
MDDS for cancer
therapy
Targeted delivery of chemotherapy
drugs to tumors
Reduced systemic toxicity,
improved treatment efficacy
Biomimetic MDDS for
mucosal vaccines
Enhanced mucosal immune responses
for improved vaccine effectiveness
Mimicking natural antigen-
presenting cells
Stimuli-responsive
MDDS for diabetes
management
Glucose-responsive insulin delivery
for precise glycemic control
Reducing hypoglycemic
episodes
Personalized MDDS for
inflammatory bowel
disease
Tailored drug release and targeting
based on individual patient's disease
severity
Optimized treatment
outcomes
CONCLUSION
MDDS are a promising new approach to drug delivery. They offer a number of advantages
over traditional drug delivery systems, including non-invasive administration, avoidance of
first-pass metabolism, improved drug bioavailability, reduced dosing frequency, and
increased patient compliance. MDDS are currently marketed for a variety of therapeutic
applications, and there are a number of promising new developments in the pipeline. The
future of MDDS is very promising, and they have the potential to revolutionize the treatment
of a wide range of diseases.

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Impact Factor: 5.9
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