ES2579857T3 - Composiciones de plasma rico en plaquetas - Google Patents

Composiciones de plasma rico en plaquetas Download PDF

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Publication number
ES2579857T3
ES2579857T3 ES12155924.9T ES12155924T ES2579857T3 ES 2579857 T3 ES2579857 T3 ES 2579857T3 ES 12155924 T ES12155924 T ES 12155924T ES 2579857 T3 ES2579857 T3 ES 2579857T3
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visit
rich plasma
platelet rich
prp
plasma compositions
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Inventor
Julián Agut Sánchez
Carlos Fernández Navarro
Joan Cos Trullas
Laura Ocaña Safont
Elsa Genove Corominas
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Opko Lab Europe Sl
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Opko Lab Europe Sl
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/19—Platelets; Megacaryocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/16—Blood plasma; Blood serum
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1808—Epidermal growth factor [EGF] urogastrone
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1833—Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1841—Transforming growth factor [TGF]
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1858—Platelet-derived growth factor [PDGF]
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1858—Platelet-derived growth factor [PDGF]
    • A61K38/1866—Vascular endothelial growth factor [VEGF]
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biotechnology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Composición farmacéutica que comprende plasma rico en plaquetas (PRP) obtenido de una fuente heteróloga para su uso en el tratamiento o en la prevención del dolor asociado con enfermedades, trastornos o lesiones de las articulaciones y de los tendones, en la que la composición se administrará por vía oral.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
Ejemplo 2. Composición oral
El PRP obtenido se formuló de acuerdo con la siguiente composición para obtenerse un polvo para su uso en forma de una formulación sólida que se puede suspender en agua.
PRP
10,2 %
Fructosa
76,0 %
Manitol
10,2 %
Aroma de piña
2,5 %
Ascorbato de sodio
0,9 %
Aerosil 200
0,15 %
Ejemplo 3. Composición oral en comprimidos
El PRP liofilizado obtenido como se describe en el Ejemplo 1 se formuló de acuerdo con la siguiente composición 10 para obtenerse un comprimido.
PRP
25,0 %
Hidroxipropilcelulosa
2,0 %
Almidón de sodio
4,0 %
Sílice coloidal
0,5 %
Lactosa monohidratada
15,0 %
Estearato de magnesio
1,2 %
Celulosa microcristalina
52,3 %
Ejemplo 4. Cápsulas
15 El PRP obtenido como se describe en el Ejemplo 1 se formuló de acuerdo con la siguiente composición para obtenerse una cápsula.
PRP
15,0 %
Manitol
15,0 %
Croscarmelosa de sodio
4,5 %
Sílice coloidal
0,5 %
Celulosa microcristalina
25,0 %
Fosfato tricálcico
40,0 %
20 Ejemplo 5. Evaluación del tratamiento
Se administró la composición descrita en el Ejemplo 2 por vía oral a 8 pacientes con artrosis de rodilla de clase II-III (puntuación ACR). Los pacientes recibieron una dosis diaria durante un mes. Los resultados clínicos relacionados con la función y el dolor de las articulaciones se midieron usando las escalas VAS y WOMAC. Además, se analizó la
25 opinión subjetiva en términos de eficacia y tolerabilidad del médico y del paciente. Todos los resultados clínicos se midieron los días 0, 15 y 30.
Se calcularon los datos estadísticos descriptivos, la media, la desviación estándar y el intervalo de confianza del 95 % para todas las variables cuantitativas. Las variables cualitativas se analizaron mediante tablas de contingencia 30 y diagramas de barras.
Las diferencias entre los grupos se analizaron por ANOVA para medidas repetidas con la corrección de Bonferroni, adoptando la primera visita como el control de las escalas VAS y WOMAC.
9
Se observó una disminución estadísticamente significativa de la puntuación del dolor de VAS desde la visita 2 (día 15) en adelante (Figura 1). De igual manera, el índice de WOMAC total (Figura 2), que está relacionado con el empeoramiento de la calidad de vida debido a la artrosis, se reduce significativamente de la visita 2 (día 15) en adelante.
5 El estudio de los componentes individuales de la escala WOMAC (dolor, rigidez y función) revela una disminución de las puntuaciones del dolor (Figura 3), de la rigidez (Figura 4) y de la incapacidad funcional (Figura 5), siendo significativamente diferentes de las puntuaciones basales en la visita 3, en la visita 2 y de la visita 3 en adelante, respectivamente.
10 La eficacia subjetiva de acuerdo con el médico fue de poca eficacia de acuerdo con el 62,5 % de los médicos, y de buena o poca eficacia para el 75 % de los pacientes en la visita 2 (día 15). Tras 30 días, el 100 % de los médicos consideró el tratamiento de buena o poca eficacia, y el 66,7 % de los pacientes consideró el tratamiento bueno o ideal (Tabla 3 y 4, Figura 6 y 7).
15 En la evaluación de la tolerabilidad durante todo el estudio, el 100 % de los médicos y de los pacientes consideró la tolerabilidad excelente. No se registraron acontecimientos adversos (Tabla 5 y 6).
Tabla 3. Eficacia subjetiva de acuerdo con el médico
Ningún efecto
Poca eficacia Buena eficacia N total
N
% en la visita N % en la visita N % en la visita
Visita
2 3 3 37,5 % 5 62,5 % 0 0,0 % 8
0
0,0 % 3 50,0 % 3 50,0 % 6
Tabla 4. Eficacia subjetiva de acuerdo con el paciente
Ningún efecto
Poca eficacia Buena eficacia Eficacia ideal N total
N
% en la visita N % en la visita N % en la visita N % en la visita
Visita
2 3 2 25,0 % 2 25,0 % 4 50,0 % 0 0,0 % 8
0
0,0 % 2 33,3 % 3 50,0 % 1 16,7 % 6
Tabla 5. Evaluación subjetiva de la tolerabilidad de acuerdo con el médico
Excelente
N total
N
% en la visita
Visita 2 3
8 100 % 8
6
100 %
6
Tabla 6. Evaluación subjetiva de la tolerabilidad de acuerdo con el paciente
Buena eficacia
N total
N
% en la visita
Visita 2 3
8 100 % 8
6
100 %
6
10

Claims (1)

  1. imagen1
ES12155924.9T 2012-02-17 2012-02-17 Composiciones de plasma rico en plaquetas Active ES2579857T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12155924.9A EP2628484B9 (en) 2012-02-17 2012-02-17 Platelet-rich plasma compositions

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ES2579857T3 true ES2579857T3 (es) 2016-08-17

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US (1) US9233126B2 (es)
EP (1) EP2628484B9 (es)
BR (1) BR102013003570A8 (es)
CL (1) CL2013000426A1 (es)
CO (1) CO7030201A1 (es)
DK (1) DK2628484T3 (es)
ES (1) ES2579857T3 (es)
HR (1) HRP20160719T1 (es)
HU (1) HUE030322T2 (es)
MX (1) MX341202B (es)
PL (1) PL2628484T3 (es)
RS (1) RS54845B1 (es)
SI (1) SI2628484T1 (es)

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BR112019001052A2 (pt) 2016-07-21 2019-04-30 F Khorakiwala Habil composição farmacêutica tópica para promover crescimento capilar e/ou reduzir perda de cabelo
RU2644934C1 (ru) * 2016-12-29 2018-02-14 Руслан Расулжанович Шеров Способ эндоскопического лечения гастродуоденальных язв
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JP7175055B1 (ja) * 2021-05-14 2022-11-18 セルソース株式会社 血液由来成長因子含有組成物及びその調製方法
CN114272359A (zh) * 2021-12-21 2022-04-05 青岛恩普生物技术有限公司 一种重组人血小板衍生生长因子pdgf治疗急性伤害性疼痛的新应用

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BR102013003570A8 (pt) 2017-03-21
RS54845B1 (sr) 2016-10-31
HRP20160719T1 (hr) 2016-09-23
SI2628484T1 (sl) 2016-07-29
CO7030201A1 (es) 2014-08-21
BR102013003570A2 (pt) 2013-12-17
DK2628484T3 (en) 2016-08-01
PL2628484T3 (pl) 2016-10-31
US9233126B2 (en) 2016-01-12
EP2628484A1 (en) 2013-08-21
MX2013001842A (es) 2013-08-27
EP2628484B9 (en) 2016-08-17
CL2013000426A1 (es) 2014-02-14
US20130216626A1 (en) 2013-08-22
HUE030322T2 (en) 2017-05-29
EP2628484B1 (en) 2016-04-20
MX341202B (es) 2016-08-09

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