ES2515715T3 - Formulaciones de pancreolipasa de baja potencia con recubrimiento entérico - Google Patents

Formulaciones de pancreolipasa de baja potencia con recubrimiento entérico Download PDF

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ES2515715T3
ES2515715T3 ES11788223.3T ES11788223T ES2515715T3 ES 2515715 T3 ES2515715 T3 ES 2515715T3 ES 11788223 T ES11788223 T ES 11788223T ES 2515715 T3 ES2515715 T3 ES 2515715T3
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usp
time
pancreolipase
microcrystalline cellulose
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ES2515715T5 (es
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Giovanni Ortenzi
Giuseppe De Franza
Danilo Clementi
Christian Stollberg
Luigi Boltri
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Allergan Pharmaceuticals Holdings Ireland ULC
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Aptalis Pharma Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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Abstract

Una composición que contiene al menos una enzima digestiva y al menos un portador en la que: a) la cantidad total de enzimas digestivas en la composición es entre aproximadamente 4 y aproximadamente 20% en peso, donde el portador se elige del grupo que consiste en polioles, azúcares, alcoholes de azúcar, celulosa, sales de fosfato de calcio, aminoácidos y sus mezclas; y al menos un portador de la composición tiene un tamaño de partícula mayor de 100 μm.

Description

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midiendo la densidad (tanto la aparente como la de compactación), el índice Carr (índice de compactabilidad), la fluidez (velocidad de flujo a través de un orificio se mide como la masa por tiempo que fluye desde un embudo, método USP) y la PPS. El resumen de los resultados se muestra en la Tabla 4.
Tabla 4.
Lote
Densidad % Índice Carr Flujo de masa g/s (100 g) PPS %
No compactada
Compactada Ø 10 mm g/s Ø 15 mm g/s Ø 20 mm g/s Ø 30 mm g/s T = 0 24 h/ temp. amb; vial cerrado 24 h/ temp. amb; vial abierto 72 h/ temp. amb; vial cerrado 72 h/ temp. amb; vial abierto
Muestra de referenciaA
0.657 0.781 15.88 7.1 / / / 0.96 1.51 2.69 / /
Celulosa microcristalina C3
0.438 0.561 21.93 Sin flujo Sin flujo Sin flujo 20.8 3.68 4.05 4.04 / /
Celulosa microcristalina B2
0.423 0.500 15.40 10.4 / / / 1.09 1.59 2.12 / /
Trehalosa G
0.757 0.892 15.13 5.9 / / / 6.45 6.7 2 6.52 / /
Lactosa monohidratada
0.549 0.632 13.13 7.1 / / / 0.43 0.71 0.87 / /
L-Prolina
0.512 0.581 11.88 4.5 / / / 0.43 / / 0.52 0.97
Calcio bibásico
0.694 0.806 13.90 9.1 / / / 0.70 / / 0.89 1.25
Isomalt
0.434 0.500 13.20 5.5 / / / 2.55 / / 2.57 2.84
Lactosa Anhidra
0.769 0.833 7.68 4.34 / / / 0.43 / / 0.51 0.86
Celulosa microcristalina A1
0.434 0.515 15.73 4.34 / / / 3.89 3.92 3.96 / /
Inositol
0.609 0.781 22.02 6.66 / / / 0.61 / / 0.45 0.93
Mezclas de celulosa microcristalina B2 +C3 (1:1)
0.442 0.549 19.49 Sin flujo 5.88 / / 2.72 2.8 2.91 / /
Celulosa microcristalina A1 + C3 (1:1)
0.454 0.568 20.07 Sin flujo 14.28 / / 3.36 4.17 4.17 / /
Celulosa microcristalina C3 + trehalosa G (1:1)
0.561 0.724 22.51 Sin flujo 8.33 / / 2.78 5.64 5.86 / /
Celulosa microcristalina C3 + L-prolina (1:1)
0.515 0.649 20.65 Sin flujo 12.5 / / 2.39 2.19 2.18 / /
Celulosa microcristalina C3 + lactosa anhidra (1:1)
0.555 0.684 18.86 Sin flujo 3.33 / / 2.07 2.27 2.15 / /
15
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Lote
Densidad % Índice Carr Flujo de masa g/s (100 g) PPS %
No compactada
Compactada Ø 10 mm g/s Ø 15 mm g/s Ø 20 mm g/s Ø 30 mm g/s T = 0 24 h/ temp. amb; vial cerrado 24 h/ temp. amb; vial abierto 72 h/ temp. amb; vial cerrado 72 h/ temp. amb; vial abierto
Celulosa microcristalina C3 + lactosa monohidratada (1:1)
0.521 0.657 20.70 Sin flujo 10.0 / / 1.94 2.18 2.36 / /
Celulosa microcristalina C3 + calcio bibásico (1:1)
0.561 0.704 20.31 Sin flujo 10.5 / / 2.1 2.5 2.65 /
Celulosa microcristalina C3 + Isomalt (1:1)
0.510 0.609 16.26 Sin flujo 12.5 / / 3.38 3.37 3.4 / /
Celulosa microcristalina C3 + Inositol (1:1)
0.531 0.675 21.33 Sin flujo 6.66 / / 2.29 / / 2.06 2.27
A Muestra de referencia: pancreolipasa (90%), croscarmelosa sódica (3.0%), aceite de ricino hidrogenado (1.0%), dióxido de silicio coloidal (0.5%), celulosa microcristalina (5%) (Avicel® PH101); estearato de magnesio (0.5%)
Tabla 5. Tipos de celulosas microcristalinas
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Tamaño medio nominal de partícula (µm) Análisis del tamaño de partícula: PPS
imagen15
Tamaño de malla Cantidad retenida %
1Celulosa microcristalina A
160 38 ≤1 <5%
94
≤ 50
imagen16
imagen17 300 ≤ 70
2Celulosa microcristalina B
180 60 ≥ 10.0 <5%
100
≥ 50
3Celulosa microcristalina C
50 60 ≤ 1 <5%
200
≤ 30
La celulosa cristalina A se comercializa como Vivapure®12; la celulosa cristalina B se comercializa como Avicel® 5 LM200; la celulosa cristalina C se comercializa como Avicel® PH101.
De la tabla 4 anterior se evidencia que la celulosa microcristalina C (contenido de humedad menor o igual de 5%, tamaño medio nominal de partícula de 50 µm, tamaño de malla 60: cantidad retenida ≤1.0%, tamaño de malla 200: cantidad retenida ≤ 30.0%) tiene un flujo de masa bajo que es una indicación de problemas críticos durante el
10 proceso de compresión directa. Para evitar dichos problemas con portadores que tienen baja fluidez, se debería llevar a cabo un paso de tratamiento adicional (como granulación húmeda) para aumentar el flujo de masa. Sin embargo, cualquiera de dichos pasos adicionales son perjudiciales para la actividad enzimática de la formulación de pancreolipasa y por consiguiente se deben evitar para reducir el riesgo de degradación.
15 Ejemplo 3. Mediciones de la dureza de los comprimidos de las mezclas de pancreolipasa - portador
La materia prima pancreolipasa (p. ej, recibida de Nordmark) se mezcla con diferentes portadores para formar las siete mezclas distintas: mezcla 1: pancreolipasa; mezcla 2: pancreolipasa y celulosa microcristalina B; mezcla 3: pancreolipasa y trehalosa; mezcla 4: pancreolipasa e isomalt; mezcla 5: pancreolipasa y calcio bibásico; mezcla 6:
16
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Tabla 12. Estabilidad de microcomprimidos a granel de pancreolipasa diluida con recubrimiento entérico (µC); condiciones de almacenamiento: 40 °C + 75% de humedad relativa
imagen21
Actividad de lipasa unidades USP/mg
Lote
Tiempo 0 Tiempo 3 mo Dif. tiempo
µC1 (portador: celulosa microcristalina A)
11.5 11.2 97
µC2 (portador: celulosa microcristalina A y trehalosa)
11.7 11.7 100
µC3 (portador: celulosa microcristalina B y trehalosa)
11.5 11.4 99
Tabla 13. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC1 (portador: celulosa microcristalina A); condiciones de almacenamiento: 25 °C, 60% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 735 761 754 774
675-825 unidades USP/cps
% declarado en la rotulación
98 101 101 103
Dff T0 (%)
104 103 105
Actividad de proteasa (unidades USP/cps)
1250-3850 unidades USP/cps 2015 2145 2145 2210
Actividad de amilasa (unidades USP/cps)
1600-6575 unidades USP/cps 2600 2665 2665 2795
Ácido ftálico (%)
NMT 1.4% 0.1 0.1 0.1 0.1
PPS(%)
NMT 5.0% 2.4 0.5 0.1 0.3
Disolución (%)
NLT 75% 30 min 84% (RSD 3.6) 87% (RSD 2.6) 85% (RSD 2.1) 83% (RSD 3.0)
Disolución (%) x 1.125
95% (RSD 2.9) 98% (RSD 2.2) 96% (RSD 1.5) 94% (RSD 3.0)
Peso n = 10 (mg)
imagen22 65 65 65 65

Tabla 14. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC1 (portador: celulosa microcristalina A); condiciones de almacenamiento: 40 °C, 75% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 735 754 754 754
675-825 unidades USP/cps
% declarado en la rotulación
98 101 101 101
Dff T0 (%)
103 103 103
Actividad de proteasa (unidades
1250-3850 unidades USP/cps 2015 2080 2015 2015
USP/cps
imagen23
20
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Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Actividad de amilasa (unidades USP/cps)
1600-6575 unidades USP/cps 2600 2665 2600 2795
Ácido ftálico (%)
NMT 1.4% 0.1 0.1 0.1 0.1
PPS(%)
NMT 5.0% 2.4 0.4 0.1 0.2
Disolución (%)
NLT 75% 30 min 84% (RSD 3.6) 84% (RSD 2.9) 83% (RSD 2.2) 82% RD 1.8)
Disolución (%) x 1.125
imagen24 95% (RSD 2.9) 94% (RSD 2.2) 96% (RSD 2.3) 93% (RSD 1.8)
Peso n = 10 (mg)
imagen25 65 65 65 65

Tabla 15. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC2 (portador: celulosa microcristalina A y trehalosa); condiciones de almacenamiento: 25 °C, 76% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 736 755 762 755
675-825 unidades USP/cps
imagen26 imagen27 imagen28
% declarado en la rotulación
98 101 102 101
Dff T0 (%)
imagen29 103 104 103
Actividad de proteasa (unidades USP/cps)
1250-3850 unidades USP/cps 1984 2048 1984 2112
Actividad de amilasa (unidades USP/cps)
1600-6575 U USP/cps 2496 2688 2880 2816
Ácido ftálico (%)
NMT 1.4% 0.1 0.1 0.1 0.1
PPS(%)
NMT 5.0% 1.6 0.2 0.2 0.3
Disolución (%)
NLT 75% 30 min 84% (RSD 2.0) 91% (RSD 3.6) 87% (RSD 2.4) 86% RD 12.2)
Disolución (%) x 1.125
imagen30 94% (RSD 2.3) 103% (RSD 3.6) 98% (RSD 2.5) 96% (RSD 1.7)
Peso n = 10 (mg)
imagen31 64 64 64 64

Tabla 16. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC2 (portador: celulosa microcristalina A y trehalosa); condiciones de almacenamiento: 40 °C, 75% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 736 755 781 742
imagen32
675-825 unidades USP/cps imagen33 imagen34 imagen35
imagen36
% declarado en la rotulación 98 101 104 199
imagen37
Dff T0 (%) imagen38 103 106 101
Actividad de proteasa (unidades USP/cps)
1250-3850 unidades USP/cps 1984 2240 2048 1984
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Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Actividad de amilasa (unidades USP/cps)
1600-6575 unidades USP/cps 2496 2688 2880 2688
Ácido ftálico (%)
NMT 1.4% 0.1 0.1 0.1 0.1
PPS(%)
NMT 5.0% 1.6 0.5 0.2 0.3
Disolución (%)
NLT 75% 30 min 84% (RSD 2.0) 91% (RSD 2.6) 87% (RSD 3.7) 84% RD 1.4)
Disolución (%) x 1.125
imagen39 94% (RSD 2.3) 103% (RSD 2.7) 98% (RSD 4.0) 94% (RSD 1.7)
Peso n = 10 (mg)
imagen40 64 64 64 64

Tabla 17. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC3 (portador: celulosa microcristalina B y trehalosa); condiciones de almacenamiento: 25 °C, 60% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 746 770 779 792
675-825 unidades USP/cps
imagen41 imagen42 imagen43
% declarado en la rotulación
99 104 104 106
Dff T0 (%)
imagen44 104 104 106
Actividad de proteasa (unidades USP/cps)
1250-3850 unidades USP/cps 1980 2112 2112 2112
Actividad de amilasa (unidades USP/cps)
1600-6575 unidades USP/cps 2640 2838 2772 2838
Ácido Ftáltico (%)
NMT 1.4% 0.1 0.1 0.1 0.1
PPS(%)
NMT 5.0% 1.6 0.5 0.2 0.3
Disolución (%)
NLT 75% 30 min 87% (RSD 2.4) 91% (RSD 2.6) 89% (RSD 1.4) 91% RD 3.4)
Disolución (%) x 1.125
imagen45 98% (RSD 2.1) 102% (RSD 2.7) 100% (RSD 1.2) 103% (RSD 3.4)
Peso n = 10 (mg)
imagen46 66 66 66 66

Tabla 18. Análisis de microcomprimidos de pancreolipasa diluida con recubrimiento entérico, µC3 (portador: celulosa microcristalina B y trehalosa); condiciones de almacenamiento: 40 °C, 75% de humedad relativa
Prueba
Especificación Tiempo 0 Tiempo 1 mo Tiempo 2 mo Tiempo 3 mo
Aspecto
Perlas livianas pequeñas marrones corresp corresp corresp corresp
Actividad de lipasa (unidades USP/cps)
90-110% de lo declarado en la rotulación 746 766 766 766
imagen47
675-825 unidades USP/cps imagen48 imagen49 imagen50
imagen51
% declarado en la rotulación 99 102 102 102
imagen52
Dif T0 (%) imagen53 103 103 103
Actividad de proteasa (unidades USP/cps)
1250-3850 unidades USP/cps 1980 1980 2046 2046
22
imagen54

Claims (1)

  1. imagen1
    imagen2
ES11788223T 2010-10-01 2011-09-30 Formulaciones de pancreolipasa de baja potencia con recubrimiento entérico Active ES2515715T5 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
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US389037P 2010-10-01
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