A REVIEW
ON
MUCOADHESIVE
BUCCAL FILMS
BY:
R.BHUVANESHKUMAR
(561994513)
• Mucoadhesion can be defined as an
interfacial phenomenon in which the two
materials, in which one may be artificial such
as mucoadhesive polymer and other may be
the mucin layer of the mucosal tissue, are
held together by means of interfacial forces
of attraction.
INRODUCTION
• Such films are comprised of
multiple layers and are predominantly
indicated for prolonged drug release within
the administration site.
Buccal/oral
Nasal
Mucosal drug
deliveries for Ocular
drug transport
Vaginal
Rectal
Buccal delivery is the administration
of medications through the mucosal
membrane lining the cheeks.
Rapid delivery of medications and
improved drug bio-availability can be
BUCCAL obtained by this dosage form.
FILMS They have unique characteristics
including flexibility, rapid onset of
drug delivery, sustained drug release
and rapid decline in the serum drug
concentration when the patch is
removed.
Characteristics of an Ideal Buccal Mucoadhesive
System
Safe and non-toxic
Sufficient patient compliance without affecting normal
function such as talking, eating and drinking
Good mechanical strength
Immediate adherence to the buccal mucosa
Controlled drug release
Optimum drug absorption
ADVANTAGES
It provides a rapid onset of action when compared to other
non - oral routes
Easy application of dosage forms in comparison to the
injection’s and don’t cause any painful sensation
Administration and removal of a dosage form is easy
Due to high extent of perfusion the rate of drug absorption is
faster
The side effects that can arise due to oral administration such
as nausea and vomiting can be avoided completely
LIMITATIONS
Drugs that irritate oral mucosa, cause allergic reactions
and discoloration of teeth cannot be formulated
Patient’s feel discomfort in eating, drinking and
speaking
Drugs that are unstable to buccal pH cannot be
administered
Moisture sensitive drugs may degrade by saliva
Dilution or loss of drug due to constant secretion of
saliva
MECHANISM OF
MUCOADHESION
Contact stage
Consolidation
stage
THEORIES OF
MUCOADHESION
Electronic theory
According to this theory, there is difference
in the electronic structure of mucin
surfaces and bio adhesive system which
results in attaining a electronic gradient
Due to presence of this electronic
difference, the transfer of electrons occurs
between these two systems when they
come in contact with each other
Due to this an electronic bi-layer is formed
at the interface of two surfaces.
The interfacial bi-layer exerts an attractive
force that produce an effective
mucoadhesion
Adsorption theory
• Weak Vander Waals forces and hydrogen
bond mediated adhesion involved in
adsorption theory is most accepted theory
of mechanism of mucoadhesion
• It involves primary and secondary bonding
in exhibiting semi permanent surface
interactions
Wetting theory
This theory is based on the
mechanism of spreadability of drug
dosage form across the biological layer
This theory is mainly applicable to
liquids or low viscous mucoadhesive
system
According to this theory, the active
components penetrate into the
surface irregularities and gets harden
it that finally results in mucoadhesion
Diffusion theory
This theory describes the involvement
of a mechanical bond between the
polymeric chain of drug delivery
system and polymeric chain of mucus
membrane, that is, glycoproteins
This theory suggests that
mucoadhesive polymer diffuses into
mucus layer by breaking glycoprotein
chain network
The diffusion is time dependent and
depends on diffusion coefficient and
molecular weight of both phases
Fracture theory
This is the second most accepted theory, which
explains the forces required to detach the two
surfaces following adhesion
The force required to detach the polymeric chain
from the mucin layer is the strength of their
adhesive forces and is known as fracture strength
or tensile strength
G= (E.e/L)½
Where,
• G – Fracture strength,
• E – Young’s modules of
electricity
• e – Fracture energy
• L – Critical crack length
GENERAL CONSIDERATIONS IN
DESIGNING DOSAGE FORM
Physiological aspects
Pathological aspects
Pharmacological aspects
Pharmaceutical aspects
Drug substance
Polymers
Plasticizers
Sweetening agents
Components Flavoring agents
used in Penetration or permeation enhancers
formulation Agent that stimulates saliva
Coloring agent
Surfactants
Agents for thickening and stabilizing
Solvent casting method
Hot melt extrusion method
MANUFACTURING
METHOD FOR Solid dispersion extrusion
BUCCAL FILMS
Semisolid casting
Rolling method
1. Solvent casting method
METHOD :
Step 1: Preparation of the casting solution.
Step 2: Deaeration of the solution.
Step 3: Cascade the mould with the correct amount of solution.
Step 4: Allow the casting solution to dry.
Step 5: Cut the finished dosage form so that the desired amount of
medicine is contained as per the requirement.
2. Hot melt extrusion method
METHOD: Step 1: In solid form, the
medication and carriers are
added together in this process.
Step 2: Through heating, the
mixture is allowed to get
liquefied and to obtain in fluid
form.
Step 3: Finally, the dies mould
the melted mixture into films.
3. Solid dispersion extrusion
This process involves extruding immiscible components with the medication
Further based on above process solid dispersions are prepared
Finally, dies are used to mould the solid dispersions into films
4. Semisolid casting
METHOD:
A solution of water-soluble film forming polymer is created initially in
the semisolid casting procedure in order to enhance faster absorption of
the medication.
The resultant solution is allowed to get mixed with an ammonium or
sodium hydroxide solution of acid insoluble polymer (cellulose acetate
phthalate, cellulose acetate butyrate) for the formulation of buccal
films.
The appropriate amount of plasticizer is then added, resulting in a gel
mass. Finally, heat-controlled drums are used to diffuse the gel mass
and convert it into films or ribbons. The film is around 0.015-0.05 inches
thick. The acid insoluble producing polymer should be used in a 1:4
ratio.
5. Rolling
Method
A drug-containing solution or
suspension is rolled on a carrier in
the rolling method
Water and water-alcohol mixtures
are the simplest solvents to be
used in this particular method
The film is cut into suitable shapes
and sizes after removing moisture
by drying on rollers
Organoleptic properties
Weight of the film
Thickness
Tensile resistance
Percentage moisture loss
Buccal films are Percentage moisture uptake
Film Surface pH
evaluated as Folding endurance
In-vitro Disintegration studies
In-vitro dissolution studies
Stability study
Swelling studies
Packaging
CONCLUSION
The present review concludes that the buccal film is the most
accurate and acceptable dosage form, which bypasses the hepatic
first pass effect and shows good bioavailability
This is the most promising and innovative technology, which is useful
to all the age groups, specifically pediatric, geriatric patients and also
to the patients with swallowing difficulties
Due to more advantages as compared to other dosage forms, buccal
films acquire tendency in replacing traditional dosage forms, including
rapid disintegrating tablets, due to their benefits over traditional
dosage forms and their low cost of manufacture
THANK YOU
