DEFECTS IN COATED COMPRESSED WITH AQUEOUS FILM (Ray C.

y self darkens to theThe coating solution coating (

Rowe) deposit more film. penetrates the surface of concentration of
the tablet where the polymer and the rate
Introduction the surface is more porous, of penetration of the
Film coating is a process that involves the deposition of a membrane that causing disintegration solution in the
consists of polymer, plasticizer, dye, and possibly other additives on the located in the core and the surface of the
surface of a pharmaceutical dosage form, typically a tablet or a alteration of the coating. tablet).
granule. Compared to conventional sugar coating, the film coating
Picking Pegado
it is relatively thin, that is to say, typically from 10 to 100 microns. Although the technology
involved in the application of such a thin coating to a substance is not new,
Problem Causes Solutions
problems occur, resulting in a series of defects in the film. These
The tablets stick and when released Similar what in the rate of
they can affect the visual appearance of the coated tablet or, more importantly, will result
discontinuity can be observed of cracking is caused by application for
in the loss of continuity of the film and therefore affect the release of the
coating or darkening by a bed of pills spraying.
active ingredient since preparation.
polymer deposit if this happened excessively humid temperature of
at the beginning. entrance area.
Identification and Solutions
Coating defects are generally divided into three groups.
Pitting Picaduras
function of the complexity of the solution.
Defects Example Include
Problem Causes Solutions
They can be solved Temperature of the Blistering Cratering Stings was described by Only it produce Suppression of
Group easily changing air of Wrinkling Picking first time by Rowe and Forse when the temperature preheating
or 1 a o more than the entry Chipping Pitting
(4) in nuclei of from the nucleus of procedures in the
process conditions Speed of tablets that contain compressed exceeds the start of coating
sprayed. stearic acid. It is a defect melting point of (especially those who
for which they are produced the stearic acid, what implicate Temperatures
Blistering (Wrinkling) Ampollas ( Arrugas) holes on the surface of a it implies that it is the point above 60 ° C
Problem Causes Solutions tablet core without any of the particles. Modification of the T° of
The movie stands out It is caused by trapped gases. air intake visible interruption of the Can occur with drying (incoming air),
locally since the in or below the movie due to hot for coating movie. polyethylene glycol 6000 and so that the temperature of the
substrate, forming a a overheating yes sea dry the the stearin of core of the tablet
bottle. It is not very during spraying or at the end tablets vegetables with dots do not exceed the point of
common in the coating from the coating career. at the end of melting point of 60 °C and fusion del additive
of movies, since in the It worsens due to poor adherence. coating. 62 ° C, employee.
in most cases, the film substrate (formulations respectively.
blister collapses under the of core with a high proportion of
wear, leaving a inorganic excipient.
Defects Includes
movie with a
Only himself can remedy Blooming Infill
wrinkled appearance. Group
by means of the change of Blushing Mottling
o2
process and formulation of Color variation Orange Peel/Roughness
Chipping Astillado
film coating.
Problem Causes Solutions
The movie himself
Se produce cuando existe un Fluidization area.
Blooming Opacamiento
convert in high degree of wear rotation speed of the
splinters and dented, associated with the process of drum. Problem Causes Solutions
generally in coating as in the film hardness, degree It is a flaw that the It is due to the collection in Do not use hot air for
the edges of the coating case of of polymer molecular weight coating becomes the surface of the dry the tablets at the end
tablet. fluidized bed of tablets immediately opaque or low weight ingredients of the process.
big. after of a molecular included in the concentration of
storage formulation of plasticizer.
Cratering Cráteres prolonged a highs coating. In the molecular weight of
Problem Causes Solutions temperatures majority of circumstances, plasticizer.
The craters are observed If produce when the T° drying (air of the ingredient will be
like an explosion in the drying is inefficient o entry plasticizer.
surface of the tablet. where the application rate application rate by
It occurs during the of the solution of spraying Blushing Despigmentado, Rubor
stages initials del Coating is too much viscosity of the
coating process high. solution of Problema Causas Solutions
Spots Due to to the
polymer precipitate Avoid the use of sorbitol with spotted inside the substrate tablet due to poor opacity of the film
whitish exacerbated by the use of high temperature of hydroxypropylcellulose Coating. Mottling is a complex defect with many origins.
or cloudiness coating on or above the hydroxypropylmethylcellulose Inadequate dispersion of pigments: the typical pigment particle sizes are
from the movie. Thermal freezing temperature of the methyl cellulose and ethers of they are found in the submicrometric interval (11), but the presence of aggregates (> 10
polymers. cellulose. micras) is not uncommon. If these aggregates do not decompose and disperse from
The use of sorbitol in formulation Use polymer alone o effective way in the formulation of coating, mottling will occur due to the
what causes a greater drop in temperature mixed with differences in the absorption (color intensity) of the different sizes of the
gelification thermal of the polyethylene glycol o aggregates of pigment particles.
hydroxypropyl cellulose propylene glycol how Color migration: color migration occurs either due to the evolution of the solvent.
hydroxypropyl methylcellulose plasticizers. residual in the film or from the migration of the plasticizer in which the dye may be
methylcellulose and cellulose ethers. air temperature of soluble (3). It is aggravated by the use of soluble colorants as dyes, but it can
High coating temperature drying. occur with specific lacquer pigments with a low threshold "bleed", especially in
the presence of polyethylene glycols (a common plasticizer in coating
Color variation movie). In this case, the dye is desorbed from the alumina substrate.
The color variation is explained by itself, but it is very important if intrabatch is found. dissolves in the polyethylene glycol, which then migrates, producing a mottled film with
since it indicates a variation in the deposition and, therefore, the thickness of the film of areas of high dye concentration. Removal of dyes or aluminum lacquers such as
polymer. Variations in film thickness can affect both the speed Dyes would be the best way to alleviate this defect.
of the release of an active ingredient and the incidence of such defects as bridge (6). The speckling of the core of the tablet: The speckling of the core of the tablet can be
The variation of color is essentially a mixing problem that involves distribution. due to a poor mixing of the ingredients (especially if they are colored
of a coating formulation over a large surface area of the tablets active ingredients) before the formation of tablets or selective degradation of
that continuously moves in and out of a relatively small area called light from one or the other ingredient (generally the active ingredient) as a result of
spraying zone. Therefore, any process variable or formulation that affects poor opacity of the film. In both cases, especially if the film is
the frequency and duration of the appearance of the tablets in the spraying area transparent or lacking in opacity, the resulting preparation appears mottled.
or the size/shape of the spray zone itself will have an effect on the variation of The quantification of the opacity of film coatings in tablets has been
color. the object of much detailed research (12-16). It can be evaluated easily and
In lining drums, both Rowe (7) and Porter and Saracini (8) have found a quickly through a relationship of contrast, which is defined as the relationship between
decrease in color variation with drum speed, while the work the measured reflectance when the film is placed as a black substrate so that
more recent has demonstrated an effect with the change in the design of the deflector. when the film is placed on a white substrate, with values of over 98%
increase in the number of spray guns and therefore an increase in the areas they are taking to define complete opacity for the human eye. Although opacity is
Effective spray area also reduced color variation (8). is generally associated with the inclusion of titanium dioxide, due to its high index of
Significant effects can also be obtained by reducing the content of refraction, the color of a pigment can play an important role. Table 1
solids of the coating formulation with the application of more formulations of show the contrast relationships for a film formulation that contains a
diluted coating, thus improving the quality of the product at the expense of time a wide variety of pigments and filler materials, where it can be observed that, although
processing (8). Pigments with high refractive indices generally exhibit high opacity.
Infill a similar effect can be achieved by using blue color pigments with an index of
Llenura, a defect that was first described below (9), has the same effect. much lower refraction. The increase in pigment concentration also increases
final as a bridge, that is, the provision of intagliations (logos, monograms) the contrast relationship as well as the increase in film thickness (12).
indistinct and illegible. However, in this case, the intagliation is filled with a structure Therefore, it is possible, through the application of these concepts, to reduce the
of solidified foam that cannot be deformed or pushed back into the incidence of stains in the core of the tablet. However, it has been demonstrated that the
intagliation. degradation of the light of an active ingredient can still occur in a film
The main cause of this defect has been postulated as the inability of a foam, white with a very high contrast ratio (7.16), and in these cases, it can be
formed by spraying a polymer solution with air, to break. The droplets of It is necessary to add other color pigments (15,17) to alleviate the problem.
foam on the surface of the tablet break easily due to wear, but the Orange Peel/Roughness
Engravings form a protected area, allowing the foam to accumulate and 'set'. Orange peel (roughness) is purely a surface effect that results in that
Once the foam has accumulated to a level that approaches the outer contour of the movie is rough and dull, with a surface appearance similar to that of an orange
surface of the tablet, normal wear may occur, allowing the structure that Figure 2. An interesting consequence of this defect is in the visual perception of color.
it is covered with a continuous film. from the tablets with rough surfaces-a colored film with a shiny surface
It is interesting to note that the addition of conventional anti-foaming agents does not lisa will always appear darker and more saturated in color than the same film with a
it decreases the incidence of this defect. However, the addition of alcohol and the use of rough surface, less shiny. Film-coated tablets with surfaces
spraying nozzles capable of finer atomization have both been found for Very rough surfaces can also be more difficult to pack on high-speed packaging lines.
be effective (9). speed due to the increased friction in the ramp mechanisms.
In a more recent work (10), it was proposed that the collapse of bubbles in the structure In most film coating processes, the formulations of
Foam can cause holes to develop (stings). film coating is applied using spraying techniques. In flight, the droplets
Mottling The aerosol loses solvent and becomes more viscous and, in some cases, dry. If the
Mottled, as its name indicates, is the perception of a non-uniform distribution of color. drops are too dry or too viscous to spread when they reach the surface of the
inside the coating movie. It can be present in all formulations tablet, rough results of a movie. Both extremes of the viscosity of a
pigmented film coating or non-pigmented, with the latter derived from the formulation of the coating will result in the diffusion of the poor and therefore
 difficult solutions surfaces - the low viscosity due to the small droplet sizes and typical bridge shows that the movie has a
high evaporation rates that cause dehydration by spraying; the high solution normal structure (23). However, there is evidence of
viscosity due to the large dimensions of droplets with low surface area for the small amounts of substrate from the tablet that is
evaporation and high internal viscosity and therefore poor diffusion. very surfaces adhere to the bottom side of the film, which indicates
rough with little shine are always found when the tablets are coated with that at some point during the process of
solutions with high polymer concentrations. coating, the film has actually followed the
Spraying properties are not the only factor that can affect roughness and gloss. contours of the intagliation. The bridge film Figure 4 photomicrography
in film-coated tablets. The roughness of a coated surface can it can be easily deformed and fit into the scanning electronics of a
being considered as the sum of three components: one due to coating formulation, intaglio through a pin head hairpin bridges in the
one due to the method of application / process conditions, and one due to the roughness of round, thus providing a simple test of recorded.
the inherent surface of the substrate. Important factors in the former are the confirmation to distinguish this defect (23) from
concentration and size of any added pigment or filler (18-20), especially of fullness.
because the increase can have a significant effect on the increase in roughness
and decreasing the brightness. Important factors in the second are the thickness of the Cracking / Splitting
the film itself (18) and the degree of mutual friction, which is dominant in the coating In this defect, the film has cracks through the crown of the tablet (like cracks,
from the movie on the drums (21) and it is a process that is activated when the so-called Figure 3B) or fractures around the edges of the tablet (division, Figure 3C). In some
Glossing solutions are applied at the end of a coating run (22). Factors of cases, the movie either flakes off, exposing the surface of the tablet (scaling),
relevance in the third is the compaction pressure and the porosity of the core of the o the back peels, exposing the surface of the tablet (peeling).
tablet (18). Unfortunately, the degree to which each one will affect the final appearance of Conventionally, peeling has been specifically associated with edge division (24).
coverage will depend on individual cases and there are no hard and fast rules. This is Cracking can also occur on the microscopic scale, both in non-
illustrated by the data provided by Rowe (18), where it was found that the film of pigmented (25) and in pigmented films, where it is usually located around
coating of a core with a very rough surface produced a compressed tablet the individual or aggregated pigment particles (3). These cracks can have a
coated with a smoother finish and vice versa. profound effect on the release of an active ingredient.
Table 1 contrasts relationships for the film tablet Figure 2 roughness Peeling
coatings based on hydroxypropyl methylcellulose that contain peel / orange. Example Both of these defects describe the situation in which there is exposure of the surface of
a number of pigments / fillings / Colorants a a from a group 2 defect that the tablet due to the film either peeling or exfoliation. Both
fixed concentration of 16% w/w it can only be remedied they are associated with cracking or delamination of the film: conventionally,
through the change both scaling with cracking and peeling with edge division. Unfortunately,
process conditions and the Porter (3) mistakenly defines peeling as an extension of picking, and this definition is
formulation of has perpetuated and in some cases extended to scaling by others (26,27).
film coating. Figure 3 Examples of group
3 defects what they are
associates with highs
internal tensions within
of the coating of
film: (A) training of
hairpin bridges in the
recorded (logos
monograms); (B) the
cracking; (C) the division of
edge and flaking.
Origins and Theory of Internal Stresses
In order to understand how internal tensions
they are caused in polymer films, it is
Group 3 it is necessary to first consider the physical changes
The defects that require a more fundamental approach may also include that occur in the making of a film
reformulation of the compressed core, as well as changes in the conditions of from a coating formulation. In
formulation of the film and of the process. Group 3 includes bridges, cracks, peeling, first of all, the solvent evaporates until
scaling, and dividing-defects associated with high internal tensions within the that, at a certain concentration of
film coating. polymer, a gel is formed that consists of
Bridging training of pelicular bridges in engraving solvent dispersed in a polymer network
Bridging of the intagliations is a defect from which the film is removed. open. The gel structure and then it contracts
intaglio or monogram in the core of the tablet, which forms a bridge across how more solvent is lost until it
the edges of the brand (6). This makes the intagliations indistinct and unreadable, losing produce a viscoelastic film. As it measures
thus the advantage of using intagliated tablets for product identification (Fig. 3A). that the movie solidifies, only the thickness
A scanning electron micrograph (Fig. 4) of an intaglio can contract, with movement in the
other dimensions are limited by the
adhesion of the film to the substrate tablet, Figure 5 Schematic diagram of the Seconds have comparable values to polymer film formers. This is
thus creating an internal tension in the stresses in a film coating according to what is found in practice, with compressed cores based on
movie. Moreover, if there is a big difference applied to a tablet and the causes of the inorganic loading materials that have a higher incidence of cracking than
among the coefficients of expansion of formation of cracks / division and bridge of the the ones based on organic loading materials (32). (33) The measurement data of
coating and the substrate, then the engravings. direct expansion in the granules of tablet formulation that were observed
similar tensions can be created during the similar trends; that is, those formulations with a large Δα compared to
coating process due to changes hydroxypropylmethylcellulose causing most of the problems in coating.
of temperature what himselfthey produce Recent measurements on the dimensional changes that occur with the
inevitably. different core formulations compressed under temperature variations
simulated humidity experienced during a film coating process
Tensions due to a change in volume in the substrate (for example, swelling of a typical have shown significant effects (34,35). The microcrystalline cellulose tablets and
compressed during storage at high humidity) can also be a problem. Starch significantly decreased in size during heating and expanded.
Since these tensions are present in the coating plane (Fig. 5), the failure during cooling, while the dicalcium phosphate pellets showed the
it can occur either in the movie/Tablet interface, resulting in a reduction of, or opposite behavior, but to a lesser extent. The results were evaluated in terms of
within the movie itself, resulting in cracks, breaks, peeling, and flaking. of the changes in the moisture content of the tablets, especially the
In some serious cases, all defects can occur at the same time. moisture absorption at the end of the coating process (35).
Recently, it has become possible to quantify these tensions. If Ps is the tension There are also known formulations of compressed core that swell in the
internal due to the contraction of the film in the evaporation of the solvent, Pt the tension storage specifically at a high relative humidity (36). Issues with bridge
thermal due to differences in the thermal expansion of the coating film and the Intagliation can occur at this stage, especially with tablets that have
substrate of the tablet, and Pv the tension induced by volume changes in the substrate a high proportion of specific direct compression excipients (31).
de tableta en almacenamiento, a continuación, por analogía con las ecuaciones derivadas Polymer Grade
for stress in lacquers (28 to 30), it has been possible to show (25,31) that It is deduced from the equations that if the film cracking mechanism is as indicated, the
the incidence of this defect will depend on the resistance/mechanical properties
of the polymer used in the coating formulation. A particularly easy way to
One way to increase the effective resistance of a polymer is by increasing its weight.
molecular and therefore its degree of viscosity. The basis of this approach is based on the
fact that the relationship between the mechanical properties of a polymer and its weight
molecular is qualitatively the same for all polymers. weight polymers
molecular forces are generally relatively weak, but as their weight increases
molecular, its mechanical properties also increase until at some weight
critical molecular, there is no more increase. This reasoning has been successfully applied in the
where E is the modulus of elasticity of the Young's coating film, v is the
relationship of the Poisson film layer, φs is the volume fraction of the solvent in division cases y microcracks in the prepared films a starting from
the movie at its solidification point (that is, when the coating solution hydroxypropylmethylcellulose (24).
first behaves like a solid instead of a viscous liquid), φr is the fraction of It is also known that the addition of high molecular weight components to a distribution
volume of the solvent that remains in the dry film under environmental conditions, Δα is the as a result of the mixture of high and low molecular weight grades of a polymer can
difference between the cubic thermal expansion coefficient of the tablet substrate and the increase their effective strength. This has also been shown to be beneficial for the
film coating, Delta T is the temperature difference between any tablets coated with hydroxypropyl methylcellulose (24).
glass transition temperature of the film coating Tg or the temperature of Plasticizer type and concentration
process and the ambient temperature, whichever is the smallest, ? V is the change of Plasticizers are often added to polymers in order to improve their
volume, and V is the volume before the storage of the substrate tablet. characteristics of film formation. The plasticizers act by interposing between the
It is supposed that before solidification and/or above the transition temperature polymer chains, which extend in this way and the softening of the matrix,
the film's vitreous, the polymer chains are mobile so that they can decreasing the glass transition temperature of the polymer, and the decrease of the
effectively minimize the created tensions, but that after solidification and/or internal tension. However, the extent to which this occurs depends on compatibility
of the plasticizer with the polymer, with the most compatible plasticizers being the most
below the glass transition temperature, the mobility of the polymer chain is
restricted and tensions become 'frozen in.' these equations are efficient.
particularly important because they highlight those factors in the process of The beneficial effect of plasticizers on the incidence of bridge intagliations.
formulation and will affect the incidence of these defects and provide options for it has been demonstrated (37). In this sense, the curves are similar in shape to those that
relieve them. they show the effect of the same plasticizer on the glass transition temperature of
Core of the tablet formulation hydroxypropylmethylcellulose, with the plasticizers that cause a significant decrease
The only factor in the equations directly affected by the formulation of the core of of the glass transition temperature (that is, the most compatible) being the most efficient
the tablet is Δa. Unfortunately, the data on the thermal expansion coefficients of the in reducing the incidence of the defect.
relevant materials for tablet formulation and film coating Pigment / dye type and concentration
they are generally not available. Rowe (32) compiled a list of data for some A lot of work has been done on the effect of pigments and fillers on the incidence of
representative materials, showing the differences between different inorganic loads cracking film / division (38-41). In general, the addition of most pigments
it exacerbates the problem in proportion to its concentration. However, it has been found that
of tablets (that is, calcium carbonate, magnesium carbonate) and the materials of
loading of the organic tablet (i.e., the sugars). The former have very values the addition of materials such as calcium carbonate, magnesium carbonate, and talc
low compared to polymer film formers while the the so-called extension pigments had either little or no effect or were beneficial
in reducing the incidence of the defect. In fact, the addition of talc has been
demonstrated to eliminate the problem in one case, while in another, where it
added to a movie already colored with aluminum lake pigment, it reduces the
incidence of the defect in proportion to its concentration in the film (40). These effects
they have generally been interpreted in terms of the differences in the morphology of the
different pigment particles (41).
An additional factor to consider is the magnitude of the localized stress at the interface of
pigment / polymer (PL) caused by the differences in thermal expansion of the
pigment particle and the polymer film (Δα) over the temperature range? T,
given by

where Ep and vp are the Young's modulus of elasticity and the Poisson's ratio of the pigment,
respectively.
In the case where the thermal expansion coefficient of the polymer film is higher
to the pigment as in the coating of films in tablets, this equation
predice que las grietas, si se produce, siempre procederá radialmente desde el pigmento,
a fact is seen in the photomicrographs of cracked film coatings (3).
Recently, this approach has extended the use of modeling and simulation by
computer (42-44). Using the simulation (Fig. 6), the authors have investigated variables.
specific formulations that have been difficult to investigate experimentally until now, such as the
particle size of the pigment / distribution and the addition of a second pigment over
el agrietamiento. Una característica interesante de la obra es el hallazgo de que la adición
from a second population of a pigment with a larger particle size and the
expansion of the pigment size distribution as a result of a
decrease in crack speed, thus providing an alternative, although as yet Figure 6 Example of a computer simulation of crack formation in a
not tested, the method to relieve crack formation. pigmented film coating. The small circles represent particles of
Film Thickness Form / Intagliation pigment, concentric circles represent the new periphery for each step in the
Two factors that have been shown to have a dramatic effect on the reduction of growth, the straight lines between the circles represent the crack that emanates
intagliation its thickness of the film, where the incidence of defects increases with the radially from the starting pigment particles at point A and ending at the
increase in film thickness (6.45), and the intagliation shape, where the incidence of point B.
The defect can be minimized by using an intaglio with a large and deep profile. The conditions of the process
opposition to a small profile, of little depth (46). It is believed that both effects to be In stress equations, the most relevant factor regarding processing
related to the magnitude of the adhesion between the film and the substrate of the tablet. Is it? T, and therefore, the factors that are known to have some effect on temperature
from the tablet bed, that is, spraying speed and air temperature of
entry will have an effect on the incidence of both the intagliations bridge and film
of cracking / division (45,47).
Table 2 shows the data for two tablet formulations, one knows that they are
prone to the bridge of intagliation and the other is known to be prone to division
border. It can be observed that at higher temperatures the tablet bed, of bridge
of the intagliations was reduced but the edge division increased. This discrepancy is
explain by reference to the stress equations. It is known that the films prepared under
spraying conditions where the evaporation of the solvent increases (that is,
similarly to the temperature conditions of the high tablet bed in Table 2)
tend to show a progressive decrease in Young's modulus of elasticity. This
it will lead to lower induced tension and therefore less bridging. However, the
the same conditions can cause a decrease in tensile strength of the
movie, and if this is the dominant effect, then the cracking/spitting movie will be
exacerbated.
Table 2 Effect of process conditions on the incidence of bridging
of the Intagliations and the incidence of Edge Fragmentation
 simple and the user is asked to select an appropriate answer. If the user is not
Sure of the terminology, a hypertext system is used to define and expand on the
terms. The routine is repeated until sufficient data is available for a decision
to be made through the decision tree (Fig. 8). At this point, the decision is shown with
a brief description of the identified defect. In addition, the user is asked to confirm
the decision by comparing the defect with stored images and photographs
in the database. If the answer is negative, the question and answer routine will
run it again, since it is supposed that an incorrect answer was given at some point
moment. If the answer is positive, the system proceeds to the next stage.

Expert System Development

It can be observed that it is now possible to use a rational scientific approach to the solution.
of a series of defects found in film-coated tablets
watery. It is obvious that in problem-solving, compromises have to be made and
that these can give rise to imbalances in the process / formulation, which in turn
It can create more problems (26). Judging by the overall effect of any commitment is
field of expertise and does not require specific knowledge and extensive experience.
Experience and knowledge in this way are not easily documented and therefore
Stage II: Defect Resolution
general knowledge is passed from mouth to mouth; therefore, experts often spend a
In stage II, the user is asked to enter relevant conditions of the process
considerable time for the formation of new staff. In addition, early retirement may
used in the coating machine, formulation details, and the incidence of
lead to the irreplaceable loss of consciousness, and personal preferences to
defect. As in stage I, hypertext is used to amplify or define terms.
They often result in inconsistencies in focus.
The system allows for two cases: first, a solution by only changing the conditions of the
Expert system technology provides an affordable means of capturing this
process, as in the case of defects that occur with a formulation already
knowledge and experience in a documented form that is available to everyone. By
registered, and second, when changing one or both process and formulation conditions,
on the other hand, expert systems can combine the expertise of more than one expert or
como en el caso de los defectos que ocurren en una etapa de desarrollo. Esto se indica por
make use of theory or complementary data, which leads to greater consistency
the selection of the answer to the question 'Change Formulation?', which occurs in case
of the decision-making process, which can in turn be consulted, examined and
necessary.
easily update.
Después de que todos los datos han sido introducidos, se muestra el asesoramiento
Recently, this concept has been applied to the identification and solution of defects in
pertinent. At this stage, the user can enter the third stage of the system, which
film-coated tablets (48). The expert system is based on a shell
gives advice, information, and references.
available on the market in a PC microcomputer. A flowchart of the system
Stage III: Information and References
It is fully shown in Figure 7. Basically, the system is divided into three stages:
The system contains comprehensive information about each effect in the form of notes, images.
identification, solution, and information / references.
additional photographs, and the bibliographic references. Furthermore, the hypertext can
to be used to link to other associated defects.
The system is easy and quick to use, combining all the knowledge in the area.
a permanent and easily accessible format. It is obvious that a system of this type could be
easily combined with the computer program to simulate the propagation of
cracks in pigmented films (44), as mentioned earlier, to function
within a more advanced expert system, such as the expert formulation system
product (ZFPs, Logica, Cambridge, United Kingdom) as described by Skingle (49) and
Turner (50). This would provide an expert system for the development of the formulation/process.
integral for film coatings in tablets comparable to the one already described
Stage I: Identification and confirmation of the Defect
for the cores of the tablets (51).
The correct identification of the defect is essential, and in this part of the system, a
question and answer routine. The questions are displayed on the screen in a format