Wet Granulation Inggris

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[Music]
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hello and welcome to the world of
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Lubrizol life sciences Lubrizol life
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sciences caters to the pharmaceutical
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and medical device
market segments
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offering innovative technologies that
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improve your products and the lives of
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consumers reuse them
Wheeling science to
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life for over 50 years
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Lubrizol has been a
global producer of
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high performing experience such as Kabul
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hemulen and polycarb of filters for
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solid semi solid and liquid dosage forms
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used in oral and topical applications
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these polymers impart valuable
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functional benefits such as bio addition
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controlling drug release from tablets
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and improving flow properties in semi
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solid and liquid formulations car bobble
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polymers are synthetic high molecular
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weight cross-linked polymers of acrylic
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acid available in both powder and
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granular form in oral solid dose
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formulations carbo pol polymers can be
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processed by all three processing
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techniques wet granulation dry
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granulation and direct compression today
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we will learn the aqueous and nomack
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Lluis wet granulation processing
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techniques using carbajal polymers in
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oral solid dose formulations
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[Music]
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first let us understand the Acuras
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granulation process
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Acura's granulation process can be
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performed by two
methods the first
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method is the direct
water Edition for
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in-situ binder activation and the second
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method is the addition of prepared
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Acuras dispersion of carbon pool
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polymers carbo pool polymers have high
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affinity to water
carbo pool polymers
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also have good binding properties and
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there is no need for any additional
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binder in the formulation in the direct
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addition method water is added to the
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dry blend comprised of Carbajal polymers
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active ingredients and other Co exhibits
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during the granulation
process the
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binder activation takes place in situ
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carbo pool polymers from the dry blend
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absorb the water and
hydrate the
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hydrated polymer then binds the powder
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forming B granules
considering carbon
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pool polymers high affinity for water
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and the in time for in situ binder
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activation the following four parameters
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should be controlled
during actual
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granulation process amount of water rate
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of water addition mixing speed and
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Vettes mapping time amount of water the
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recommended amount of water is about 10
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to 20 weeks percent of the dry blend the
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amount should be optimized based on the
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dry blend composition and the mixing
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equipment efficiency components such as
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micro crystalline cellulose or other
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insoluble ingredients may need more
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water than lactose or any other water
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soluble ingredients high shear mixer is
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generally recommended over planetary or
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other low shear mixers rate of water
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addition for uniform distribution water
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should be added gradually either as a
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thin stream or as Rob lips or a spring
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water should not
be added at once mixing
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speed the impeller speed should be
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sufficiently high to
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silat ate fast and
uniform distribution
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of the added water let me emphasize here
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on the tip speed concept the impeller
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speed is a function of the equipment
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size when changing the equipment the tip
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speed rule must be used to calculate the
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impeller speed for example a linear tip
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speed of 2.5 meters
per second achieved
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at 350 rpm in a 5
liter Bowl corresponds
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to 45 rpm in 250 liter
equipment Vette
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massing time it is
very important to
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allow sufficient wet
mashing time for
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equal distribution of water and for the
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in-situ binder activation process during
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the water distribution and Institute
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binder activation phases the blend may
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appear dry however more water should not
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be added at this may
lead to over
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wetting web mapping time is to be
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determined based on mixing equipment
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efficiency formulation and the choice of
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solvent based on this understanding we
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will now demonstrate
the aqueous
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granulation process by direct
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motorisation with
appropriate excessive
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and insufficient amounts of water
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in the first example we will demonstrate
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an appropriate amount of water addition
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the formulation comprises of 85% lactose
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and 15% carbon pool 9 7 1 PMF polymer
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the amount of water used represents 13%
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of the
drive land which is an
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appropriate amount of water for this
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formulation lactose and carb appalled
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971 pmf polymer are passed through 40
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mesh screen they are loaded in the high
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shear mixer the impeller is set at 100
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rpm and the chopper is
set at 300 rpm
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dry blending is continued for 10 minutes
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the impeller speed is now increased to
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350 rpm while chopper speed is
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maintained at 300 rpm 45 grams water is
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added as a thin stream the mixing is
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continued
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[Music]
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note that during the first one or one
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and a half minute the
blend is looking
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dry and now we can see that wet granules
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are forming
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the chopper speed is further increased
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to 2880 rpm and mixing
is continued for
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one minute to complete
the wet
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granulation process
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these are the resultant wet granules the
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vet granules are loaded in fluid bed
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dryer and dried to a
moisture content of
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less than 2% these are
the resultant
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dried granules the dried granules are
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milled using multi no suited with 1.5
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millimeter screens these are the
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resultant milled granules the nil
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granules are blended with beautifying
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fibers and glidin and lubricant in Vikan
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blender for five minutes the particle
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size distribution and the granule
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characters of the blended granules are
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as shown
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[Music]
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the blended granules are compressed into
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tablets at 800 milligram target weight
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the compress tablets are tested for
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physical parameters such as average
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weight thickness hardness and
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probability the tablet properties are as
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shown
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[Music]
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thus this actual granulation process has
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resulted in good granules and robust
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tablets
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[Music]
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in the next experiment we will
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demonstrate what happens when an
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excessive amount of water is added
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during actual annulation this
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formulation comprises of 85% lactose and
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15% Carbajal 971 pmf
polymer the amount
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of water used is 25
percent of the dry
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blend which is an excessive amount of
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water for this formulation sifting and
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dry blending operations are carried out
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exactly as per the
previous experiment
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the impeller speed is now increased to
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350 rpm while chopper speed is
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maintained at 300 rpm 50 grams water is
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added as a thin stream the mixing is
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continued and an additional 38 grams of
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water is added to the blend we can now
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see that an overweight mass is formed
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which is difficult to
process further
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thus demonstrating
negative effect of
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adding too much
water
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in the next experiment
we will
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demonstrate what happens when an
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insufficient amount of water is added
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during aqueous granulation this
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formulation comprises of 85% lactose and
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15% Carbajal nine seven one PMF polymer
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the amount of water used is slight
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percent of the dry blend which is an
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insufficient amount of water for this
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formulation sifting and drive blending
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operations are carried out exactly as
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per the previous
experiment the impeller
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speed is now increased to 350 rpm while
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chopper speed is maintained at 300 rpm
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18 grams of water is added as a thin
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stream the mixing is continued for two
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minutes
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no granule formation is observed mixing
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for an additional two minutes leads to a
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mixture of wet granules and a large
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amount of dry powder
indicating poor
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granulation thus demonstrating the
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negative effect of using an insufficient
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amount of water these
three experiments
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have shown that the amount of water 00:11:17,670
mixing speed and the vet mashing time
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are critical parameters for conducting
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aqueous granulation by direct water
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addition in formulations containing
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carbon pool polymers we will now learn
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the second method of Acuras granulation
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better by using preformed binder
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dispersion the following experiment
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demonstrates high shear granulation by
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addition of preformed binder which is an
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accuracy Carbajal dispersion this
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experiment shows actual granulation by
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the addition of a 2% accuracy of kaabah
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pol 971 TNS polymer as
a binder to
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lactose the amount of binder dispersion
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used is 15 weight percent of the dry
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blend a 2-
person act with dispersion of
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carbon pool
9 7
1 CNF polymer is
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prepared as the standard dispersion
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technique lactose is thought through 40
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mesh screen and loaded
in the high shear
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mixer the impeller speed is set at 350
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rpm and the chopper speed is set at 300
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rpm 50 2.5 grams of 2
percent accuracy
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dispersion of kaabah
Falls 971 pmf
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polymer is added as a thin stream and
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now we can see that vet granules are
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forming the chopper speed is further
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increased to 2880 rpm and the mixing is
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continued for 1 minute to complete 00:13:00,919
wet granulation process
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note that since the
binder dispersion
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was preformed the vet granule formation
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was much quicker in this example
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compared to the direct water addition
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case that required in situ binder
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activation these are the resultant red
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granules the red granules are dry to a
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moisture content of
less than 2% mils
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and lubricated exactly as seen in the
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first experiment the particle size
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distribution and the granule characters
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of the blended granules are as shown
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the blended granules are compressed into
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tablets at 800 milligrams target weight
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and the physical parameters of tablets
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are tested the tablet properties are as
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shown
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thus this Acuras granulation process of
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addition of prepared binder dispersion
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of carbajal 97 1 p NS polymer has
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resulted in good granules and robust
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tablets after having
learned the
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accuracy granulation
we will now learn
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the non accurate granulation process the
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following experiment demonstrates high
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shear granulation by non aqueous
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granulation process in the case of
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formulations containing high levels of
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Carbajal polymers such as 20% or 25% the
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non active granulation process may be
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adopted appropriate precautions should
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be taken while handling the solvents the
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same principle of institute binder
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activation seen in Acuras granulation
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applies in this also carbo pol polymers
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swell in polar
solvents during the non
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aqueous granulation process carbo pool
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polymers absorb the added solvent
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solvent swell and bind
the powders
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forming the granules
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the solvents recommended for non aqueous
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granulation are ethanol and high super
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pile alcohol nonpolar solvents such as
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methylene chloride and chloroform can
280
00:15:31,290 --> 00:15:34,290
also be used but only in combination
281
00:15:34,290 --> 00:15:36,870
with polar solvents typically greater
282
00:15:36,870 --> 00:15:39,120
amount of solvent and a longer wet
283
00:15:39,120 --> 00:15:41,640
mashing time are necessary for non
284
00:15:41,640 --> 00:15:43,770
aqueous granulation due to the
285
00:15:43,770 --> 00:15:45,900
difference in salvation compared to
286
00:15:45,900 --> 00:15:48,200
water
287
00:15:52,470 --> 00:15:55,749
we now demonstrate the non a queue is
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00:15:55,749 --> 00:15:59,079
granulation with isopropyl alcohol for a
289
00:15:59,079 --> 00:16:03,369
blend comprising 75% of lactose and 25%
290
00:16:03,369 --> 00:16:07,989
of Carbajal 971 PMF
polymer the amount
291
00:16:07,989 --> 00:16:10,779
of isopropyl alcohol used is 30 percent
292
00:16:10,779 --> 00:16:16,959
of the dry blend shifting and dry
293
00:16:16,959 --> 00:16:18,970
blending operations are carried out
294
00:16:18,970 --> 00:16:22,269
exactly as per the first experiment the
295
00:16:22,269 --> 00:16:25,089
impeller speed is now increased to 350
296
00:16:25,089 --> 00:16:28,059
rpm while chopper
speed is maintained at
297
00:16:28,059 --> 00:16:33,579
300 rpm 105 ml of isopropyl alcohol is
298
00:16:33,579 --> 00:16:37,600
added as a thin stream wet massing is
299
00:16:37,600 --> 00:16:40,410
continued for about
six to seven minutes
300
00:16:40,410 --> 00:16:46,449
and now you can see that granules are
301
00:16:46,449 --> 00:16:49,720
being formed note the longer wet massing
302
00:16:49,720 --> 00:16:52,419
time required for non Acuras granulation
303
00:16:52,419 --> 00:16:55,600
compared to Acuras granulation the
304
00:16:55,600 --> 00:16:58,379
chopper speed is further increased to
305
00:16:58,379 --> 00:17:03,789
2880 RPM and mixing is
continued for one
306
00:17:03,789 --> 00:17:06,250
minute to complete the vet granulation
307
00:17:06,250 --> 00:17:13,148
process these are the
resultant wet
308
00:17:13,148 --> 00:17:15,970
granules that are dried in fluid bed
309
00:17:15,970 --> 00:17:18,909
drier milled and
blended with lubricants
310
00:17:18,909 --> 00:17:21,519
exactly as per the process seen in the
311
00:17:21,519 --> 00:17:22,730
first experiment
312
00:17:22,730 --> 00:17:25,849
[Music]
313
00:17:26,640 --> 00:17:29,710
the particle size distribution and the
314
00:17:29,710 --> 00:17:31,570
granule characters of the blended
315
00:17:31,570 --> 00:17:43,150
granules are as shown the blended
316
00:17:43,150 --> 00:17:45,460
granules are compressed into tablets at
317
00:17:45,460 --> 00:17:48,280
800 milligrams target weight and the
318
00:17:48,280 --> 00:17:50,170
physical parameters of tablets are
319
00:17:50,170 --> 00:17:52,930
tested the tablet properties are as
320
00:17:52,930 --> 00:18:01,720
shown thus non-active granulation
321
00:18:01,720 --> 00:18:04,570
process has resulted in good granules
322
00:18:04,570 --> 00:18:07,450
and robust tablets note that in the case
323
00:18:07,450 --> 00:18:10,630
of aqueous granulation only about 13
324
00:18:10,630 --> 00:18:12,640
weight percent of water was required and
325
00:18:12,640 --> 00:18:15,010
the vet mapping time was short of about
326
00:18:15,010 --> 00:18:18,280
three minutes
however in the case of non
327
00:18:18,280 --> 00:18:20,920
accurate granulation a higher proportion
328
00:18:20,920 --> 00:18:24,400
of isopropyl alcohol that is 38 percent
329
00:18:24,400 --> 00:18:27,970
and a longer wet mashing time of seven
330
00:18:27,970 --> 00:18:30,040
minutes was required extended-release
331
00:18:30,040 --> 00:18:32,410
tablet formulations of
metformin
332
00:18:32,410 --> 00:18:35,080
hydrochloride that low Finnick sodium
333
00:18:35,080 --> 00:18:37,810
the Vera pommel
hydrochloride and others
334
00:18:37,810 --> 00:18:40,090
have been successfully
developed in
335
00:18:40,090 --> 00:18:42,910
various Lubrizol laboratories using 00:18:44,980
three different granulation techniques
337
00:18:44,980 --> 00:18:48,100
you can access these formulations from
338
00:18:48,100 --> 00:18:51,400
the Lubrizol
Life Sciences website to
339
00:18:51,400 --> 00:18:54,010
summarize we have seen the demonstration
340
00:18:54,010 --> 00:18:56,530
of Acuras and non
acuse granulation
341
00:18:56,530 --> 00:18:58,810
techniques in the case
of Acuras
342
00:18:58,810 --> 00:19:01,120
granulation we have demonstrated the
343
00:19:01,120 --> 00:19:03,940
appropriate accesses
and insufficient
344
00:19:03,940 --> 00:19:06,400
amounts of water as well as granulation
345
00:19:06,400 --> 00:19:08,920
using preformed binder dispersion of
346
00:19:08,920 --> 00:19:12,310
carbo pol polymer we have also seen the
347
00:19:12,310 --> 00:19:14,200
known activist granulation technique
348
00:19:14,200 --> 00:19:17,500
using isopropyl alcohol in all cases
349
00:19:17,500 --> 00:19:19,240
were the appropriate
amount of water
350
00:19:19,240 --> 00:19:21,580
proper liquid addition techniques and
351
00:19:21,580 --> 00:19:24,190
wet massing were used
we were able to
352
00:19:24,190 --> 00:19:26,530
demonstrate that
Carbajal polymers
353
00:19:26,530 --> 00:19:29,050
produced good granules and robust
354
00:19:29,050 --> 00:19:31,530
tablets
355
00:19:44,950 --> 00:19:49,959
[Music]
356
00:19:56,710 --> 00:19:58,990
we hope that you enjoyed learning the
357
00:19:58,990 --> 00:20:01,600
granulation techniques using your Brazil
358
00:20:01,600 --> 00:20:04,600
scar before polymers
we encourage you to
359
00:20:04,600 --> 00:20:06,279
contact your local you Brazil
360
00:20:06,279 --> 00:20:08,830
representatives to
find out how you
361
00:20:08,830 --> 00:20:11,350
resolved life sciences can enhance the
362
00:20:11,350 --> 00:20:14,200
performance of your formulations and be
363
00:20:14,200 --> 00:20:18,200
the link to help you improve lives
364
00:20:18,200 --> 00:20:26,419
[Music]
365
00:20:26,419 --> 00:20:27,300
you
366
00:20:27,300 --> 00:00:00,000
[Music]

Wet Granulation Inggris

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