# US 2018/0021485 A1 · Method for manufacturing drug-containing biodegradable fiber material by electrospinning

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- Number: US 2018/0021485 A1
- Document ID: US20180021485A1
- Status: Published application
- Kind: A1
- Application number: 15/722,924
- Filed: 2017-10-02
- Published: 2018-01-25
- Earliest claimed: 2015-03-31
- Assignees: Orthorebirth Co., Ltd.
- Applicants: Orthorebirth Co., Ltd.
- Inventors: Yasutoshi Nishikawa; Masashi Makita; Naoki Osada
- Web page: https://patentgrep.com/patent/US20180021485A1

## CPC

- A61L 31/148: {Materials at least partially resorbable by the body}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/70: Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)}
- A61K 31/282: Platinum compounds
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61L 31/00: Materials for other surgical articles {, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices (shape or structure of stent-grafts A61F2/07, of stents A61F2/82, of surgical gloves A61B42/00, of surgical drapes A61B46/00, of occluding devices A61B17/12022)}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 35/00: Antineoplastic agents
- D01D 5/0023: {the material being a polymer melt}
- D01D 5/0046: {the fibre formed by coagulation, i.e. wet electro-spinning}
- D01D 5/0076: {characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid (D01D5/0046 takes precedence)}
- D01D 7/00: Collecting the newly-spun products ({D01D5/0076 takes precedence;} collecting newly-spun products with the imparting of twist D01H)
- D01F 1/10: Other agents for modifying properties
- D01F 6/92: of polyesters
- D04H 1/42: characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
- D04H 1/728: by electro-spinning {(electro-spinning methods and apparatus D01D5/0007)}
- D04H 3/011: Polyesters
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- D01F 6/625: {derived from hydroxy-carboxylic acids, e.g. lactones}
- D10B 2331/041: derived from hydroxy-carboxylic acids, e.g. lactones
- D10B 2509/00: Medical; Hygiene
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- D01D: MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
- D01F: CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D04H: MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL (weaving D03; knitting D04B; braiding D04C; net-making D04G; sewing D05B; tufting D05C; finishing non-woven fabrics D06); FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING {; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION}(non-woven fabrics having an intermediate or external layer of a different kind, e.g. of woven fabric, B32B)
- D10B: INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES

## Abstract

The present invention addresses the problem of providing a drug formulation material with which localized sustained release of a drug at any site in the body is possible, and which has good bioabsorption and is absorbed and broken down by the body after sustained release of the drug. A drug formulation material that has an exceedingly high sustained release effect, and that solves the foregoing problem, was successfully developed by dissolving a biodegradable resin and a drug in a solvent to prepare a spinning solution, and spinning fibers from the spinning solution by electrospinning.

## Claims

### Claim 1

A bioabsorbable cotton-like material having a cotton- or nonwoven fabric-like structure, comprising a fibrous material that comprises a drug and a biodegradable resin and has an average outer diameter of 1 μm or more but 150 μm or less.

### Claim 2 (depends on 1)

The bioabsorbable cotton-like material according to claim 1, wherein the fibrous material has an average molecular weight of 50,000 or more but less than 1,000,000.

### Claim 3 (depends on 1)

The bioabsorbable cotton-like material according to claim 1, whose bulk density is 0.01 g/cm3 to 0.1 g/cm3.

### Claim 4 (depends on 1)

The bioabsorbable cotton-like material according to claim 1, wherein the biodegradable resin is PLGA or a copolymer thereof.

### Claim 5 (depends on 1)

The bioabsorbable cotton-like material according claim 1, wherein the drug is an anticancer agent.

### Claim 6 (depends on 1)

The bioabsorbable cotton-like material according to claim 1, which has been subjected to sterilization treatment.

### Claim 7

A method for manufacturing a bioabsorbable cotton-like material, comprising:
step 1) dissolving a biodegradable resin and a drug in a solvent to prepare a spinning solution; and
step 2) spinning fibers from the spinning solution by electrospinning.

### Claim 8 (depends on 7)

The method of claim 7, wherein in the step 2), the fibers are spun by electrospinning by applying a voltage between a nozzle part provided on a spinning solution extrusion side and a plate placed in an ethanol bath provided on a collector side to deposit a bioabsorbable cotton-like material in the ethanol bath to form a bioabsorbable cotton-like material having a cotton-like three-dimensional structure.

### Claim 9 (depends on 7)

The method of claim 7, further comprising step 3) sterilization treatment.

### Claim 10 (depends on 7)

The method of claim 7, wherein the biodegradable resin is PLGA or a copolymer thereof, and the solvent is chloroform or dichloromethane.

### Claim 11 (depends on 7)

The method of claim 7, wherein the drug is an anticancer agent.

### Claim 12 (depends on 6)

A method of treating or preventing a disease in the patient, comprising:
1) implanting the bioabsorbable cotton-like material according to claim 6 in a body of a patient;
2) sustainably releasing the drug from the bioabsorbable cotton-like material; and
3) treating or preventing the disease in the patient by an effect of the sustainably released drug.

### Claim 13 (depends on 6, 12)

The method according to claim 12, wherein the bioabsorbable cotton-like material according to claim 6 is implanted by laparotomy.

### Claim 14 (depends on 6, 12)

The method according to claim 12, wherein the bioabsorbable cotton-like material according to claim 6 is implanted by a minimally invasive medical procedure using an injector.

### Claim 15 (depends on 12)

The method according to claim 12, wherein the drug is an anticancer agent, and the disease is cancer.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the patient has been subjected to resection of cancer tissue or cancer cells.

### Claim 17 (depends on 15)

The method according to claim 15, wherein the cancer is malignant bone tumor.

### Claim 18 (depends on 6, 12)

A kit for use in the method according to claim 12, comprising the bioabsorbable cotton-like material according to claim 6.

### Claim 19 (depends on 6, 14)

A kit for use in the method according to claim 14, comprising an injector and the bioabsorbable cotton-like material according to claim 6.

### Claim 20 (depends on 6, 19)

The kit according to claim 19, wherein the bioabsorbable cotton-like material according to claim 6 is contained in the injector.