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1. EP2509620 - NANOPARTICLE CARRIER SYSTEMS BASED ON HUMAN SERUM ALBUMIN FOR PHOTODYNAMIC THERAPY

Office
European Patent Office
Application Number 10836582
Application Date 08.12.2010
Publication Number 2509620
Publication Date 17.10.2012
Publication Kind A4
IPC
A61K 38/38
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
38Albumins
A61K 9/51
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules
51Nanocapsules
A61K 31/409
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
409having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
A61K 31/54
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
54having six-membered rings with at least one nitrogen and at least one sulfur as the ring hetero atoms, e.g. sulthiame
A61K 38/18
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
18Growth factors; Growth regulators
A61K 41/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
41Medicinal preparations obtained by treating materials with wave energy or particle radiation
CPC
A61K 9/5169
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules ; 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
51Nanocapsules; Nanoparticles;
5107Excipients; Inactive ingredients
513Organic macromolecular compounds; Dendrimers
5169Proteins, e.g. albumin, gelatin
A61K 31/409
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
409having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
A61K 41/0071
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
41Medicinal preparations obtained by treating materials with wave energy or particle radiation ; ; Therapies using these preparations
0057Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
0071PDT with porphyrins having exactly 20 ring atoms, i.e. based on the non-expanded tetrapyrrolic ring system, e.g. bacteriochlorin, chlorin-e6, or phthalocyanines
A61P 13/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13Drugs for disorders of the urinary system
A61P 17/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
17Drugs for dermatological disorders
A61P 19/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19Drugs for skeletal disorders
02for joint disorders, e.g. arthritis, arthrosis
Applicants BIOLITEC PHARMA IP & INVEST LTD
Inventors LANGER KLAUS
WACKER MATTHIAS
RÖDER BEATE
PRUESS ANNEGRET
ALBRECHT VOLKER
GRÄFE SUSANNA
WIEHE ARNO
VON BRIESEN HAGEN
WAGNER SYLVIA
Designated States
Priority Data 28590209 11.12.2009 US
12941350 08.11.2010 US
Title
(DE) NANOPARTIKEL-TRÄGERSYSTEM AUF BASIS VON MENSCHLICHEM SERUMSALBUMIN FÜR PHOTODYNAMISCHE THERAPIEN
(EN) NANOPARTICLE CARRIER SYSTEMS BASED ON HUMAN SERUM ALBUMIN FOR PHOTODYNAMIC THERAPY
(FR) SYSTÈMES DE TRANSPORT DE NANOPARTICULES À BASE DE SÉRUM-ALBUMINE HUMAINE DESTINÉS À UNE THÉRAPIE PHOTODYNAMIQUE
Abstract
(EN) Compositions, which are stable in storage, and a method of production of pharmaceutical based nanoparticulate formulations for photodynamic therapy comprising a hydrophobic photosensitizer, human serum albumin (HSA) and stabilizing agent are provided. These nanoparticulate formulations provide therapeutically effective amounts of photosensitizer (PS) for parenteral administration. In particular, tetrapyrrole derivatives can be used as photosensitizers whose efficacy and safety are enhanced by such nanoparticulate formulations. A method of preparing the HSA-based nanoparϋcles under sterile conditions is also provided. In one of the preferred embodiments of the present invention temoporfin, a hydrophobic PS, is formulated as a nanoparticle for parenteral administration. The formulations are useful for treating hyperplasic and neoplasic conditions, inflammatory problems, and more specifically to target tumor cells.
(FR) La présente invention concerne des compositions, qui sont stables au stockage, et un procédé de production de formulations nanoparticulaires à base pharmaceutique destinés à une thérapie photodynamique comprenant un photosensibilisateur hydrophobe, de sérum-albumine humaine (HSA) et un agent stabilisant. Ces formulations nanoparticulaires fournissent des quantités thérapeutiquement efficaces d'un photosensibilisateur (PS) destinées à être administrées par voie parentérale. En particulier, des dérivés tétrapyrrole peuvent être utilisés comme photosensibilisateurs dont l'efficacité et la sûreté sont améliorées par de telles formulations nanoparticulaires. L'invention concerne également un procédé de préparation des nanoparticules à base de HSA dans des conditions stériles. Dans un des modes de réalisation préférés de la présente invention, la témoporfine, un PS hydrophobe, est formulée sous la forme d'une composition nanoparticulaire destinée à une administration par voie parentérale. Les formulations sont utiles pour traiter des états pathologiques hyperplasiques et néoplasiques, des problèmes inflammatoires, et plus particulièrement pour cibler des cellules tumorales.