Patent application EP19179950A (EP), filed 2019-06-13
Publication number: EP3750523A1
Title: ACTIVE SUBSTANCE DELIVERY SYSTEM
Abstract: [0001]    The present invention relates to an active substance delivery system, preferably an anti-cancer agent delivery system, comprising one or more active substances included in nanoparticles and a method for producing such a delivery system.
IPC codes: A61K  47/    34            A I
A61K   9/    00            A I
A61K   9/    51            A I
Claims: number: 1
text: Active substance delivery system comprising or consisting of
number: 2
text: Active substance delivery system for use according to claim 1, wherein the weight ratio of a2) to a1) is in a range of from 2 : 1 to 150 : 1.
number: 3
text: Active substance delivery system for use according to one of the preceding claims, wherein the, one or more further pharmaceutically acceptable components is/are selected from the group consisting of carriers, polymers, surfactants, stabilizers, wetting agents, emulsifiers, antioxidants, pH influencing agents, disintegrants, recrystallization agents, fluxing agents, preservatives, solvents, salts fillers, binders, foamers, defoamers, lubricants, adsorbents for adjusting the osmotic pressure and buffers.
number: 4
text: Active substance delivery system for use according to one of the preceding claims, wherein the delivery system or the nanoparticles are preparable or prepared by a method comprising or consisting of the following steps:
number: 5
text: Active substance delivery system for use according to one of the preceding claims, wherein the solvent used in step i) and/or the solvent used in step ii) comprises or consists of one or more substances selected from the group consisting of acetone ethyl acetate, chlorinated solvents, DMSO, methylated solvents, tetrahydrofuran, halogenated hydrocarbons such as chloroform and dichloromethane, dioxanes and acetonitrile,
and/or
wherein the solvent used in step iv) for providing a PVA solution comprises or consists of one or more substances selected from the group consisting of water, ethanol and saline,
and/or
wherein the dispersant used in step vii) comprises or consists of one or more substances selected from the group consisting of saline, glucose, surfactants, pH modifiers and water.
number: 6
text: Active substance delivery system for use according to one of the preceding claims, wherein the, one or all active substance(s) is/are (a)
number: 7
text: Active substance delivery system for use according to one of the preceding claims, wherein the treatment is directed to a cancer type selected from the group consisting of gastrointestinal cancer, gynaecological cancer, prostate cancer, peritoneal metastasis, leukaemia, lymphoma, soft-tissue sarcoma, multiple myeloma, breast cancer, bladder cancer, lung cancer, thyroid cancer, Kaposi's sarcoma, particularly preferably ovarian cancer, peritoneal metastasis colorectal cancer or stomach cancer.
number: 8
text: Active substance delivery system for use according to one of the preceding claims, wherein the, one or all administration(s) of the active substance delivery system is/are performed with an assisting tool selected from the group consisting of microneedles, spray devices, angio-injectors, or any combination thereof, preferably with a nebulizer, spraying gun or spray catheter.
number: 9
text: Active substance delivery system for use according to one of the preceding claims, wherein in the treatment, the total amount of active substance(s), preferably chemotherapeutic agent(s), administered during one application is in a range of from
120 mg to 2500 mg, preferably of from 150 mg to 2000 mg, particularly preferably of from 150 mg to 1500 mg, especially preferably of from 150 mg to 800 mg
and/or
30 mg/m<2> body surface to 250 mg/m<2> body surface, preferably of from 40 mg/m<2> body surface to 200 mg/m<2> body surface, particularly preferably of from 50 mg/m<2> body surface to 180 mg/m<2> body surface, especially preferably of from 50 mg/m<2> body surface to 150 mg/m<2> body surface of the treated human subject.
number: 10
text: Method for producing an active substance delivery system, preferably according to one of the preceding claims, or nanoparticles as defined in any one of the preceding claims, comprising or consisting of the following steps
number: 11
text: Method according to claim 10, wherein the solvent used in step i) and/or the solvent used in step ii) comprises or consists of one or more substances selected from the group consisting of acetone ethyl acetate, chlorinated solvents, DMSO, methylated solvents, tetrahydrofuran, halogenated hydrocarbons such as chloroform and dichloromethane, dioxanes, acetonitrile,
and/or
wherein the solvent used in step iv) for providing a PVA solution comprises or consists of one or more substances selected from the group consisting of water, ethanol and saline,
and/or
wherein the dispersant used in step vii) comprises or consists of one or more substances selected from the group consisting of saline, glucose, surfactants, pH modifiers and water.
number: 12
text: Method according to one of claims 10 or 11, wherein the, one or all active substance(s) is/are (a)
number: 13
text: Method according to one of claims 10 to 12, wherein the one or further pharmaceutically acceptable components is/are selected from the group consisting of carriers, polymers, surfactants, stabilizers, wetting agents, emulsifiers, antioxidants, pH influencing agents, disintegrants, recrystallization agents, fluxing agents, preservatives, solvents, salts fillers, binders, foamers, defoamers, lubricants, adsorbents for adjusting the osmotic pressure and buffers.
Office action: search_report, dated 2020-12-16
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: US9511197B2
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severity: novelty_destroying
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severity: novelty_destroying
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ref_type: npl
severity: novelty_destroying
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ref_type: npl
severity: background
Final disposition: pending (2020-12-16)