Evaluation of Films

Evaluation Parameters
1. Physical properties
Thickness and weight variation
Tensile strength
Folding endurance
Swelling properties
Moisture content
Matrix erosion
Surface morphology
Surface pH

Evaluation Parameters
2. Mucoadhesive studies
3. In vitro drug release
4. Permeation studies

Thickness and weight of film

The thickness of the films is usually measured at five different
locations (centre and four corners) using well calibrated
electronic digital micrometer, screw gauge, vernier caliper or
by SEM images.
The measurement of thickness of the film is essential to
ascertain the uniformity of the film thickness as it is directly
related to the accuracy of dose in the film.
Film weight is calculated using digital weighing balance.

Tensile strength
The tensile strength measures the strength of the film as
diametric tension or tearing force. The sample under test is
stretched until it tears and the stress needed represents the
tensile strength.
It is calculated by dividing the force (N) at which the film
breaks with the cross sectional area (m2) of the film.
Several methods are used to measure tensile strength of
films.
Texture analyzer is equipment which determine the tensile
strength of the film. Here film strips are held between two
clamps positioned at a distance of 3 cm. Then the strips are
pulled by the top clamp at a rate of 2 mm/s and the force is
measured when the films breaks.

Folding endurance
The flexibility of film is an important physical character
needed for easy application on the site of administration.
The flexibility of the films can be measured quantitatively in
terms of folding endurance and is determined by repeatedly
folding the film at 180 angle of the plane at the same plane
until it breaks or folded to 300 times without breaking.
The number of times the film is folded without breaking is
computed as the folding endurance value.

Swelling properties/Degree of
hydration
The degree of hydration of the polymeric film helps to
increase mucoadhesive strength. The hydration of polymer is
essential for the relaxation and interpenetration of polymer
chains but, excess hydration generally leads to decreased
mucoadhesion and/or retention due to the formation of
slippery mucilage.
The swelling properties of films are generally determined by
evaluating the percentage hydration.
Pieces of film are weighed (W1) and immersed in simulated
saliva fluid for predetermined time and are taken out and
wiped off to remove excess of surface water and weighed
(W2).
%Hydration=[(W2W1)100/W1]

Matrix erosion
The erosion characteristics of films are evaluated by
determining the % polymer erosion.
Pieces of film are weighed (W) and immersed in appropriate
medium for predetermined time and the swollen films are
dried and reweighed (W1).
The matrix erosion percent was calculated according to the
following formulas:

% Matrix erosion= [(WW1)100/W].

Moisture content
The amount of moisture affects the brittleness of films.
The amount of moisture present in the film is generally
determined using moisture content testing equipment, Karl
fisher titration method or by weighing method.
Typically, a specific size of pre-weighed film is heated to 100
120 C until it attains constant weight and the difference in
weight gives the amount or degree of moisture present in the
film. Moisture content can be calculated as:

The moisture content in an ideal film should be <5%.

Surface morphology
Various
surface
properties
like
surface
texture
(smooth/rough),
drug
distribution
(homogeneity,
aggregated/scattered), thickness etc. of prepared films can be
determined using SEM, electron microscopy and scanning
tunnelling microscopy.
But SEM is most widely used method in which films are
mounted on stubs, sputter coated with gold in an inert
environment and photographed using SEM to obtain suitable
magnified images.
The use of SEM has been reported in identifying the shape,
size and number of pores in the films and the possible
influence of plasticizer.

Surface pH
A film with too much acidic or basic pH affects the area of
application and causes damages to oral mucosal membrane
leading to patient discomfort.
In general, the surface pH of the prepared film was measured
after allowing it to swell by keeping it in contact with distilled
water for a short period (~2 h) at room temperature using the
pH meter.

Mucoadhesion studies
The mucoadhesive strength of film can be measured on a
modified physical balance.
A piece of mucosa of appropriate animal tied to the mouth of
a glass vial filled completely with appropriate medium. The
glass vial is tightly fitted in the centre of a beaker filled with
medium at 371C.
Films are stuck to the lower side of rubber stopper with glue
and the mass(g) required to detach the films from the
mucosal surface is taken as the mucoadhesive strength. The
following parameters are calculated from the mucoadhesive
strength.

Modified physical balance used to measure

mucoadhesive strength

Release study
Release of drug from the prepared films is a prerequisite for
permeation through biological membrane. Release studies
determine the cumulative drug release from the formulation
in a given period of time. No specific in vitro method has yet
been developed for the drug release studies of films.
Most of the studies have used paddle over disc method to
assess the release of drug from the prepared films.
Briefly, the film is fixed on a glass plate and is immersed in the
dissolution medium and the paddle is rotated at fixed speed.

Schematic illustration of the apparatus used for

the dissolution studies of films

Permeability study
Permeation of drug molecules following application of a film
means the absorption of this compound across the mucosal
tissue to the systemic circulation.
Various kinds of permeability chambers (vertical and horizontal)
such as FDC or side-by side diffusion cell, Using chambers, and
continuous flow perfusion chambers have been used to examine
the permeability of drug molecules across the mucosa.
A typical permeability chamber consists of donor and receiver
compartments. The freshly excised mucosa of animal origin is
usually used as the barrier membrane in permeation studies
since it most closely simulates the in vivo situation.

Continued
In an experiment, the excised mucosal tissue, with specific
integrity, of animal species is used as diffusion barrier
between the donor and receptor compartments of the FDC.
The mucosal tissue is mounted between two chambers and
securely held to prevent leakage. The prepared film is applied,
under occlusion, on the mucosal surface in the donor
compartment and the rate at which it permeates across the
barrier is determined from the receiver chamber.
The solution in the receiver chamber, generally the simulated
saliva, should be stirred to avoid stagnation and should be
continuously replaced to maintain sink condition. In general,
the temperature is maintained at 370.5 C.

Schematic representation of a vertical Franz

diffusion cell

Reference
Anroop B. Nair et al, In vitro techniques to
evaluate buccal films, Journal of Controlled
Release, 166 (2013) ,1021.
Mohamed S. Pendekal, Formulation and
evaluation of a bioadhesive patch for buccal
delivery of tizanidine, Acta Pharmaceutica
Sinica B, 2012 2(3),318324