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Formulate What?
p
Formulate a Film Coating
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| Basic
formulation information on formulating, developing and manufacturing
film coated pharmaceutical or nutritional products. If you have
a specific question, please email us |
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| 1]
What is Film Coating? Film coating is the process whereby a
tablet, capsule, or pellet is surrounded by a thin layer of
polymeric material. |
| 2)
Reasons for film coating include: |
| Appearance |
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To
change the color, for branding purposes or other aesthetic reasons |
| Stability |
To
protect the active ingredient from moisture, light, and/or the
acidic environment of the stomach |
| Taste/odor
Masking |
To
provide an easy to swallow tablet without the bitter taste of
many actives |
| Release
characteristics |
Many
film coating materials have functional properties which enable
the creation of sustained or delayed (enteric) release dosage
forms |
3) The basic components of a film coating system are:
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optional
ingredients:
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anti-tack
agent |
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anti-foam
agent |
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colorant |
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filler/extender |
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flavorant |
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surfactant |
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4]
Film coatings are available based on the following polymeric
materials:
Most
of these materials are available as the individual powders,
but many are also available in premixed powder blends, powder
concentrates and aqueous dispersions.
Dry
powder concentrates for reconstitution combine polymer, plasticizer
and if desired, pigment in a single system for either
aqueous or organic coating procedures, which reduces inventory
handling and raw material testing.
Aqueous
based coating systems including the aqueous dispersions have
become popular in recent years since they are solvenet free
and more nutritionalsly friendly. Most polymers are now available
for reconstitution in water, or as an aqueous dispersion.
Points
to consider in the preparation and use of coating solution/dispersions:
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Ensure
complete and uniform dissolution/dispersion of all coating
ingredients throughout the coating process
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Maintain
viscosity of coating solution/dispersion throughout
the coating process
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Keep
fluid lines free of any aggregates of solid material
throughout the coating process.
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Limit
the amount of air entrapment/foam creation during coating
solution/dispersion preparation and throughout the coating
process
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Products
for Immediate Release include:
Cellulose-based
coating materials
Methacrylate-based
coating materials
Products
for Sustained Release include:
Cellulose-based
coating materials
Methacrylate-based
coating materials
Products
for Enteric coating include:
Cellulose-based
coating materials
Methacrylate-based
coating materials
Shellac
Need
a supplier of film coating products ? Submit in Excipients Express!!!
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5)
Coating Processes and Equipment
The
majority of tablet film coating is performed in perforated closed
system pans. These provide the necessary controlled conditions of
temperature and air flow which enable reproducible and efficient
application of both appearance and functional coatings. In addition,
they limit operator exposure.
In
choosing a system for film coating, the following points should
be addressed:
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Adequate
supply of process air for the volume of the pan. |
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Ability
to maintain temperature within a narrow range (typically 30
to 70ºC). |
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Ability
to maintain dew point within a narrow range (typically 10 -
20ºC). |
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Pan
and spray system designed to be easily cleaned/sanitized. |
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Spray
system fluid path should have a minimum of dead spaces, since
many coating formulations are dispersions or suspensions. |
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Spray
system atomization and fan air are easily controlled, preferably
from the exterior of the pan. |
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Air
flow bypass capability (especially if the pan is to be used
for sugar coating. |
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Explosion
prevention construction if flammable solvents are to be used. |
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Treatment
of Inlet and Exhaust Air as required by GMP and nutritionals
regulations. |
The
pan should be equipped with appropriate sensors so that the following
conditions can be monitored/controlled:
Are
you a manufacturer or supplier of pharmaceutical grade, USP grade
or food grade ingredients, chemicals, or packaging materials for
film coatings? If so , email us at pformulate@pformulate.com
to find out how to have your products listed in our film coating
supplier directories.
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| Excipient's
Express |
| Need
to find a supplier to formulate a film coating, softgel, tablet,
gluten-free or gum based pharmaceutical or nutraceutical ? Simply
submit in Excipients
Express Requests ! |
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