FIELD OF THE INVENTION
The present invention relates to novel solid oral pharmaceutical compositions of choline
fenofibrate. The invention also relates to a process for the preparation of said compositions
of choline fenofibrate.
BACKGROUND OF THE INVENTION
Fenofibrate is a well-known lipid-regulating agent, which has been commercially available
for a long time. Fenofibrate is usually orally administered. After its absorption, which is
known to take place in the duodenum and other parts of the gastrointestinal tract, fenofibrate
is metabolized in the body to fenofibric acid. Fenofibric acid represents the active ingredient
of fenofibrate, which is a prod rug and which is converted in vivo to the active molecule. After
oral administration of fenofibrate, fenofibric acid is found in plasma.
The fenofibrate products currently on the market involve a formulation compnslng a
micronized drug substance in capsules and/or tablets. Fenofibrate is known to be nearly
insoluble in water.
However the salts of fenofibric acid are highly soluble in water and are more bioavailable as
compared to the fenofibrate.
Choline fenofibrate is marketed under the brand name Trilipix ®delayed release oral
capsules containing 45mg or 135 mg of fenofibric acid.
US 7,259,186 disclose various salts of fenofibrate and pharmaceutical formulations, which
essentially have an enteric binder.
US 2008/0095851A 1 discloses nanoparticulate compositions of fenofibrate salts.
US 2008/0152714 A 1discloses modified release formulation comprising an active agent in a
hydrophilic polymer matrix.
US 2007/0026062 A 1 discloses solid dosage form comprising a solid dispersion or solid
solution of fibrate.

Although above mentioned patents and patent applications provide various dosage forms,
but production of dosage forms of these references is a lengthy, expensive process or
requires specialized equipments or techniques.
There exists a need to develop a controlled release pharmaceutical composition comprising
choline fenofibrate, which offers advantages like simple manufacturing process, compact
dosage form, use of conventional manufacturing equipment, high throughput, easy scale-up,
economic, etc.
Thus there still exists a need to develop a novel controlled release pharmaceutical
composition comprising choline fenofibrate, wherein the release rate controlling agent is in
the coating.
OBJECT OF THE INVENTION
The first object of the present invention provides controlled release pharmaceutical
compositions comprising choline fenofibrate wherein the core comprises choline fenofibrate
and auxiliary excipient and a coating layer comprising rate controlling agent(s).
Yet another object of the invention provides controlled release pharmaceutical compositions
comprising choline fenofibrate comprising an immediate release core wherein said core
comprises choline fenofibrate, water soluble inert material with one or more auxiliary
pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic
agents(s).
Yet another object of the invention provides controlled release pharmaceutical compositions
comprising choline fenofibrate comprising an immediate release core wherein said core
comprises choline fenofibrate, water soluble inert material with one or more auxiliary
pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic
agents(s) and the core is devoid of hydrophilic polymers which are capable of forming a
matrix.
Yet another object of the invention provides controlled release pharmaceutical compositions
comprising choline fenofibrate comprising an immediate release core wherein said core

comprises choline fenofibrate, water soluble inert material with one or more auxiliary
pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic
agents(s) and the core is devoid of any enteric binder.
Yet another object of the invention provides controlled release pharmaceutical compositions
comprising choline fenofibrate comprising an immediate release core wherein said core
comprises choline fenofibrate, water soluble inert material with one or more auxiliary
pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic
agents(s) and further an additional enteric coating.
Yet another object of the invention provides controlled release pharmaceutical compositions
comprising choline fenofibrate comprising an immediate release core wherein said core
comprises choline fenofibrate, water soluble inert material with one or more auxiliary
pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic
agents(s) which is bioequivalent to commercially available choline fenofibrate (Trilipix®)
formulations.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig 1 (a) shows a release profile of controlled release dosage forms of choline fenofibrate of
example 1B, in pH 3.5 buffer followed by pH 6.8 Phosphate buffer, 50 rpm, USP Paddle.
Fig 1 (b) shows a release profile of controlled release dosage forms of choline fenofibrate of
example 1B, in pH 4.5 buffer followed by pH 6.8 Phosphate buffer, 50 rpm, USP paddle.
Fig 1 (c) shows a release profile of controlled release dosage forms of choline fenofibrate of
example 1B, in pH 6.8 buffer, 900 ml, USP paddle, 50 rpm.
DETAIL DESCRIPTION OF THE INVENTION
The dosage forms of the invention typically contain 25 to 200 mg equivalent to fenofibric
acid.
The term "immediate release core" herein refers to core comprising choline fenofibrate
thereof devoid of any release-controlling agent(s).
The term "controlled release compositions" herein refers to any composition or dosage form
which comprises an active drug and which is formulated to provide a longer duration of

pharmacological response after administration of the dosage form than is ordinarily
experienced after administration of a corresponding immediate release composition
comprising the same drug in the same amount. Controlled release compositions include,
inter alia, those compositions described elsewhere as "extended release", "delayed
release", "sustained release", "prolonged release", "programmed release", "time release"
and/or "rate controlled" compositions or dosage forms.
The hydrophobic release controlling agents are selected from but are not limited to polyvinyl
acetate dispersion, ethyl cellulose, cellulose acetate, cellulose propionate (lower, medium or
higher molecular weight), cellulose acetate propionate, cellulose acetate butyrate, cellulose
acetate phthalate, cellulose triacetate, poly (methyl methacrylate), poly (ethyl methacrylate),
poly (butyl methacrylate), poly (isobutyl methacrylate), and poly (hexyl methacrylate), poly
(isodecyl methacrylate), poly (Iauryl methacrylate), poly (phenyl methacrylate), poly (methyl
acrylate), poly (isopropyl acrylate), poly (isobutyl acrylate), poly (octadecyl acrylate), waxes
such as beeswax, carnauba wax, paraffin wax, microcrystalline wax, and. ozokerite; fatty
alcohols such as cetostearyl alcohol, stearyl alcohol, cetyl alcohol and myristyl alcohol, and
fatty acid esters such as glyceryl monostearate; glycerol monooleate, acetylated
monoglycerides, tristearin, tripalmitin, cetyl esters wax, glyceryl palmitostearate, glyceryl
behenate, and hydrogenated vegetable oils.
The term "controlled release pharmaceutical compositions" includes a pharmaceutical
composition that encompasses one or more individual coated units. The coated units may
be a capsule or tablet or may be in form of granules, pellets, minitablets or beads.
The compositions of the present invention can also include other materials such as
dissolution enhancing agents, binders, diluents, anti-adherents, glidants and lubricants.
Diluents may be, for example, any pharmaceutically acceptable, non-toxic diluent. Particular
examples include lactose, dextrose, sucrose, maltose, starch, calcium hydrogen phosphate,
mannitol and the like.
Binders may be, for example, starch, sugars, gums, low molecular weight hydroxypropyl
methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose or the like.
Lubricants may be, for example, talc, magnesium stearate, calcium stearate, stearic acid,
sodium stearyl fumarate, sodium benzoate or the like.

Antiadherents and Glidants may be, for example, colloidal silicon dioxide, talc or the like.
Solid oral dosage forms of the present invention may be prepared by any conventional
techniques for example dry granulation, direct compression, wet granulation, and extrusionspheronization.
Wet granulation and extrusion-spheronization are the preferred techniques.
In the wet granulation method, choline fenofibrate and other auxiliary pharmaceutical
ingredients are granulated with a granulating fluid (e.g., isopropyl alcohol, ethyl alcohol, and
water) in a planetary mixer, high shear mixer, or fluidized bed granulator. The binder and
organic acid solution is prepared in suitable vehicles, both can be mixed. Only binder or
mixed solution of binder and organic acid can be used to granulate the powder mass. The
wet granules are dried in an oven or fluidized bed dryer, and then sieved through a suitable
screen to obtain free flowing granules. The resulting granules are blended with a suitable
lubricant and glidant. These granules are compressed into solid dosage from of suitable
size. These are further coated with the one or more hydrophobic controlling agent(s)
effective for the controlled release of choline fenofibrate.
In extrusion-spheronization method, choline fenofibrate is geometrically mixed with water
soluble inert material. The binder and organic acid solution is prepared in suitable vehicles,
both can be mixed. Only binder or mixed solution of binder and organic acid is used to
granulate the blend of active material with water insoluble inert material. Then wet mass is
extrudated using suitable extruder and spheronized using spheronizer. Pellets or spheroids
thus obtained are dried and coated with release controlling hydrophobic controlling agent(s).
The so-formed multiple units may be filled into hard shell capsules or compressed into a
tablet.
The following examples illustrate various aspects of the present invention. These examples
should not be construed as limiting the scope of the invention.
Example 1 A
mgl unit dosage
Ingredients form
1 Choline fenofibrate 178.686
2 Lactose 42.914
3 Colloidal silicon dioxide 1.300
4 Hypromellose 2.800
6
5 Purified water q.s
Extra-granular
6 Lactose 13.000
7 Colloidal silicon dioxide 1.300
8 Sodium stearyl fumarate 5.000
Weight of 12 mini tablets 245.00
Ethyl Cellulose and PVP coating
9 Ethyl cellulose 25.000
10 Polyvinyl pyrrolidone 9.250
11 Di butyl sebacate 2.500
12 Ethanol: Isopropyl alcohol Iq.s
Weight of 12 mini tablets 281.750
Brief Manufacturing Process
Sifting & Dry mixing
Sift together choline fenofibrate, lactose and colloidal silicon dioxide through #30 mesh and
mix in RMG
Granulation
Dissolve Hypromellose in water and add to the above dry mix under mixing, and continue
mixing till granular mass of desired consistency is obtained
Drying
Dry the wet mass at a suitable temperature to get desired L.O.D.
Sizing
Mill the dried granules through #30 mesh.
Blending
Blend the dried granules with Lactose (extra granular), Colloidal silicon dioxide (extra
granular) for 10 min and finally lubricate with Sodium stearyl fumarate for 5 min
Compression
Compress the above lubricated blend into mini tablets using suitable tooling.
Ethyl cellulose and PVP coating
Coat the mini tablets with the solution of Ethyl cellulose and PVP to a desired weight gain.
Example 1B
The mini tablets can be prepared as per example 1A and can additionally have an enteric
coating.
Eudragit Coating
1 Eudragit 24.654
2 Talc 12.227
3 Triethyl citrate 2.564

4 Purified water q.s
Final Wt of 12 mini tablets 321.195
Eudragit coating: Above ethyl cellulose and PVP coated tablets were coated with Eudragit
dispersion to give a 14 % w/w by preparing 20 % w/w dispersion in purified water.
Example 2A
mg/ unit
dosage
Ingredients form
1 Choline Fenofibrate 178.686
2 Lactose 42.914
3 Colloidal silicon dioxide 1.3
4 Polyvinyl pyrrolidone 2.8
5 Purified water qs
Extra-granular
6 Lactose 13
7 Colloidal silicon dioxide 1.3
8 Sodium stearyl fumarate 5
Weight of 12 mini tablets 245
Ethyl cellulose and Lactose coating (15 % w/w)
9 Ethyl cellulose 25
10 Lactose 9.25
11 Di butyl sebecatae 2.5
12 Ethanol: Isopropvl alcohol q.s
Weight of 12 mini tablets 281.75
Brief Manufacturing Process
Sifting & Dry mixing
Sift together choline fenofibrate, lactose and colloidal silicon dioxide through #30 mesh and
mix in RMG
Granulation
Dissolve PVP in water and add to the above dry mix under mixing, and continue mixing till
granular mass of desired consistency is obtained
Drying
Dry the wet mass at a suitable temperature to get desired L.O.D.
Sizing
Mill the dried granules through #30 mesh.
Blending

Blend the dried granules with Lactose (extra granular), Colloidal silicon dioxide (extra
granular) for 10 min and finally lubricate with Sodium stearyl fumarate for 5 min
Compression
Compress the above lubricated blend into mini tablets using suitable tooling.
Ethyl cellulose and Lactose coating
Coat the mini tablets with the solution of Ethyl cellulose and Lactose to a desired weight
gain.
Example 2 B
The mini tablets can be prepared as per Example 2A and can have an additional enteric
coating.
Eudragit Coatina
1 Eudraqit 24.654
2 Talc 12.227
3 Triethyl citrate 2.564
4 Purified water q.S
Final Wt of 12 mini tablets 321.195
Example 3A
Ingredients mg/ unit dosaae form
1 Choline Fenofibrate 178.686
2 Lactose 37.914
3 Colloidal silicon dioxide 1.3
4 Starch 7.8
5 Purified water qs
Extra-granular
6 Lactose 13.00
7 Colloidal silicon dioxide 1.30
8 Sodium stearvl fumarate 5.00
Weiqht of 12 mini tablets 245
Ethyl cellulose and PVP coating
9 Ethyl cellulose 25
10 Polyvinyl pyrrolidone 9.25
11 Oi butyl sebecatae 2.5
12 Ethanol: Isoproovl alcohol q.S
Weight of 12 mini tablets 281.75

Brief Manufacturing Process
Sifting & Dry mixing
Sift together choline fenofibrate, lactose and colloidal silicon dioxide through #30 mesh and
mix in RMG
Granulation
Prepare Starch paste in water and add to the above dry mix under mixing, and continue
mixing till granular mass of desired consistency is obtained
Drying
Dry the wet mass at a suitable temperature to get desired L.O.D.
Sizing
Mill the dried granules through #30 mesh.
Blending
Blend the dried granules with Lactose (extra granular), Colloidal silicon dioxide (extra
granular) for 10 min and finally lubricate with Sodium stearyl fumarate for 5 min
Compression
Compress the Above lubricated blend into mini tablets using suitable tooling.
Ethyl cellulose and PVP coating
Coat the mini tablets with the solution of Ethyl cellulose and PVP to a desired weight gain.
Example 3B
The mini tablets can be prepared as per example 3A and can have an additional enteric
coating.
Eudragit Coating
1 Eudragit 24.654
2 Talc 12.227
3 Triethyl citrate 2.564
4 Purified water q.S
Final Wt of 12 mini tablets 321.195
Example 4A
Ingredients mg/ unit dosage form
1 Choline Fenofibrate 178.686
2 Lactose 37.914
3 Colloidal silicon dioxide 1.3
10
4 Starch 7.8
5 Purified water q.S
Extra-granular
6 Lactose 13.00
7 Colloidal silicon dioxide 1.30
8 Sodium stearyl fumarate 5.00
Weight of 12 mini tablets 245
Ethyl acrylate methyl ethacrylate
copolymer aqueous dispersion and
HPMC coating
Ethyl acrylate methyl ethacrylate copolymer
9 aqueous dispersion 20.00
10 Hydroxypropyl methyl cellulose 14.25
11 Triethyl citrate 2.5
12 Purified water q.S
Weight of 12 mini tablets 281.75
Brief Manufacturing Process
Sifting & Dry mixing
Sift together choline fenofibrate, lactose and colloidal silicon dioxide through #30 mesh and
mix in RMG
Granulation
Prepare Starch paste in water and add to the above dry mix under mixing, and continue
mixing till granular mass of desired consistency is obtained
Drying
Dry the wet mass at a suitable temperature to get desired L.O.D.
Sizing
Mill the dried granules through #30 mesh.
Blending
Blend the dried granules with Lactose (extra granular), Colloidal silicon dioxide (extra
granular) for 10 min and finally lubricate with Sodium Stearyl Fumarate for 5 min
Compression
Compress the above lubricated blend into mini tablets using suitable tooling.
Coat the mini tablets with the solution of Ethyl acrylate methyl ethacrylate copolymer
aqueous dispersion and HPMC coating to a desired weight gain.
Example 4B
The mini tablets can be prepared as per example 4A and can have an additional enteric
coating.

EUdragit Coating
1 Eudragit 20.00
2 Talc 16.881
3 Triethyl citrate 2.564
4 Purified water q.S
Final Wt of 12 mini tablets 321.195
Example 5A
mgl unit
Ingredients dosage form
1 Choline Fenofibrate 191.922
2 Dibasic calcium phosphate 42.678
3 Colloidal silicon dioxide 2.6
4 Polyvinyl pyrrolidone 2.8
5 Purified water qs
Extra-granular
6 Sodium Stearvl Fumarate 5
Weight of 12 mini tablets 245
Ethyl cellulose and Lactose coating
7 Ethyl cellulose 25
8 Lactose 9.25
9 Di butyl sebecatae 2.5
10 Ethanol: Isopropyl alcohol q.S
Weight of 12 mini tablets 281.75
Brief Manufacturing Process
Sifting & Dry mixing
Sift together choline fenofibrate, dibasic calcium phosphate and colloidal silicon dioxide
through #30 mesh and mix in RMG
Granulation
Dissolve PVP in water and add to the above dry mix under mixing, and continue mixing till
granular mass of desired consistency is obtained
Drying
Dry the wet mass at a suitable temperature to get desired L.O.D.
Sizing
Mill the dried granules through #30 mesh.
Blending
Lubricate the dried granules with Sodium Stearyl Fumarate and mix for 5 min.
Compression
Compress the above lubricated blend into mini tablets using suitable tooling.

The mini tablets were coated with the solution of Ethyl cellulose and Lactose to a desired
weight gain.
Example 58
The mini tablets can be prepared as per example 5A and can have an additional enteric
coating.
Eudragit Coating
1 Eudragit 22.224
2 Talc 14.657
3 Triethyl citrate 2.564
4 Purified water q.s
Final Wt of 12 mini tablets 321.195
The term "bioequivalent" as used herein is intended to illustrate bioequivalence of the
compositions of the present invention in comparison to the reference composition.
The term "reference composition" as used herein refers to the marketed preparation of
Choline fenofibrate which is sold under the trade name of Trilipix by Abbott.
Bioequivalence studies are conducted to demonstrate equivalence in the bioavailability of
the active ingredient in different formulations.
The U.S. Food and Drug Administration (FDA) requires ANDA filers to show bioequivalence
against the innovator's reference listed product before approval. Bioequivalence study
involves statistical analysis for pharmacokinetic measures, such as area under the curve
(AUC) and peak concentration (Cmax) for a test (T) and reference (R) drug product, where T
and R can vary, depending on the comparison to be performed (e.g., to-be-marketed
dosage form versus clinical trial material, generic drug versus reference listed drug, drug
product changed after approval versus drug product before the change).
Bioequivalence comparisons normally rely on (1) a criterion, (2) a confidence interval for the
criterion, and (3) a predetermined bioequivalence limit. According to the FDA guidance,
demonstration of bioequivalence involves the calculation of a 90% confidence interval for the
ratio of the averages of the measures for the T and R products. To establish bioequivalence,
the calculated confidence interval should fall within a limit of 80-125% for the ratio of the
product averages. For a broad range of drugs, a bioequivalence limit of 80 to 125% for the
ratio of the product averages has been adopted for use of a bioequivalence criterion.

Generally, the bioequivalence limit of 80 to 125% is based on a clinical judgment that a test
product with bioavailability measures outside this range should be denied market access.
In vivo test
A single dose, two way crossover bioequivalence studies was carried out and bioavailability
of Example 1A of the present invention was compared with the bioavailability of the
reference product (Trilipix 145 mg Capsule, Abbott) on 10 and 12 healthy subjects in
standard fasting and fed conditions respectively.
Table 1: Comparative pharmacokinetic data for composition of example 1A (T) and Trilipix ®
under fasting conditions (n=1 0)
Pharmacokinetic T/R ratio (90% Mean - Reference Mean - Test (Range)
Parameter confidence interval) (Range)
Cmax (ng/mL) 111.93 (Limit- 5873.46 (4940.604- 6603.79 (5062.392-
100.72-124.4) 6975.426) 8258.804)
AUClast (ng/mL *h) 102.82 (Limit - 112134.16 (72556.505- 11595.103 (73573.383-
97.56-108.37) 134970.834) 170959.600)
AUC.. 102.66 (Limit- 124737.23 (74717.184- 128664.67 (78492.577-
(ng/mL*h) 97.41-108.21) 150893.829) 198882.560)

Table 2: Comparative pharmacokinetic data for composition of example 1A (T) and Trilipix ®
under fed conditions (n=12)
Pharmacokinetic T/R ratio (90% Mean - Reference Mean - Test
Parameter confidence (Range) (Range)
interval)
Cmax (ng/mL) 94.60 (Limit - 5912.06 (4474.195- 5545.50 (4432.864-
82.29-108.76) 8731.203) 7738.208)
AUClast (ng/mL *h) 86.74 (Limit - 124668.99 (87538.725- 108024.56
79.29-94.91 ) 190320.857) (70844.844-
168518.265)
AUC .. (ng/mL*h) 88.16 (Limit - 138896.89 (93529.859- 121733.56
82.24-94.51) 229450.664) (79225.257 -
196085.664)
Cmax = Maximum plasma concentration
AUClast = Area under the plasma concentration vs. time curve from 0 hours to the time of last
sample collected
AUC .. = Area under the plasma concentration vs. time curve from 0 hours to infinity
As is evident from Table 1 and Table 2, the composition of Example 1A is bioequivalent to
the reference product under both fasting and fed conditions.
1. A controlled release pharmaceutical composition(s) comprising choline fenofibrate
wherein the core comprises choline fenofibrate and auxiliary excipient and a coating
layer comprising rate controlling agent(s).
2. A controlled release pharmaceutical composition(s) of claim 1 comprise(s) choline
fenofibrate comprising an immediate release core, wherein the core is devoid of
hydrophilic polymers which are capable of forming a matrix.
3. A controlled release pharmaceutical composition(s) of claim 1 comprise(s) choline
fenofibrate comprising an immediate release core, wherein the core is devoid of any
enteric binder.
4. A controlled release pharmaceutical composition(s) comprising choline fenofibrate
comprising an immediate release core wherein said core comprises choline
fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical
excipient and a coating layer comprising rate controlling hydrophobic agent(s).
5. A controlled release pharmaceutical composition(s) comprising choline fenofibrate of
claim 4, wherein the hydrophobic rate controlling agent(s) are selected from the
group consisting of polyvinyl acetate dispersion, ethyl cellulose, cellulose acetate,
cellulose propionate (lower, medium or higher molecular weight), cellulose acetate
propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose
triacetate, poly (methyl methacrylate), poly (ethyl methacrylate), poly (butyl
methacrylate), poly (isobutyl methacrylate), and poly (hexyl methacrylate), poly
(isodecyl methacrylate), poly (lauryl methacrylate), poly (phenyl methacrylate), poly
(methyl acrylate), poly (isopropyl acrylate), poly (isobutyl acrylate), poly (octadecyl
acrylate), waxes such as beeswax, carnauba wax, paraffin wax, microcrystalline
wax, and. ozokerite; fatty alcohols such as cetostearyl alcohol, stearyl alcohol, cetyl
alcohol and myristyl alcohol, and fatty acid esters such as glyceryl monostearate;
glycerol monooleate, acetylated monoglycerides, tristearin, tripalmitin, cetyl esters
wax, glyceryl palmitostearate, glyceryl behenate, and hydrogenated vegetable oils.
6. A controlled release pharmaceutical composition(s) comprising choline fenofibrate
comprising an immediate release core wherein said core comprises choline
fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical
excipient and a coating layer comprising rate controlling hydrophobic agents(s) which
is bioequivalent to commercially available choline fenofibrate (Trilipix®) formulations.

7. A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fasting conditions to the commercially
available choline fenofibrate capsule formulation, marketed under the brand name
Trilipix® and exhibits a mean Cmaxfrom about 5062.392 to about 8258.804 ng/ml.
8. A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fed conditions to the commercially available
choline fenofibrate capsule formulation, marketed under the brand name Trilipix®
and exhibits a mean Cmaxfrom about 4432.864 to about 7738.208 ng/ml.
9. A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fasting conditions to the commercially
available choline fenofibrate capsule formulation, marketed under the brand name
Trilipix® and exhibits a mean AUC'astfrom about 73573.383 to about 170959.600
ng/mL*h.
10.A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fed conditions to the commercially available
choline fenofibrate capsule formulation, marketed under the brand name Trilipix®
and exhibits a mean AUClastfromabout 70844.844 to about 168518.265 ng/mL*h.
11.A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fasting conditions to the commercially
available choline fenofibrate capsule formulation, marketed under the brand name
Trilipix® and exhibits a mean AUCo.oofrom about 78492.577 to about 198882.560
ng/mL*h.
12.A controlled release pharmaceutical composition(s) of claim 6 comprising choline
fenofibrate which is bioequivalent under fed conditions to the commercially available
choline fenofibrate capsule formulation, marketed under the brand name Trilipix®
and exhibits a mean AUCo.oofrom about 79225.257 to about 196085.664 ng/mL*h.