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Compositions for promoting healing of bone fracture

a technology for fracture healing and compositions, applied in the direction of drug compositions, prosthesis, transportation and packaging, etc., can solve the problems of limiting the patient's daily life, and affecting the healing effect of bone fractures, so as to accelerate the healing of bone fractures and accelerate the healing of fractures. , the effect of efficient fracture healing

Inactive Publication Date: 2004-07-29
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012] One of purposes of the present invention is to provide a novel pharmaceutical composition for accelerating bone fracture healing, which accelerates the healing of a fracture in the early stage. Another purpose of the present invention is to provide a novel pharmaceutical composition for local administration which, when applied to a fracture region, exerts efficiently the fracture healing accelerating activity only at an intended site while avoiding the manifestation of systemic action of an active ingredient. Yet another purpose of the present invention is to provide a sustained release depot preparation for accelerating bone fracture healing, which, when applied locally, can release an active ingredient gradually and exert the drug efficacy over a long term by one time dosage.

Problems solved by technology

Generally, it takes a considerable time until a bone fracture heals, which can be an obstacle in daily life.
In particular, the transcervical fracture requires a long-term hospitalization and often develops internal complication including dementia due to a long-term hospitalization, which is becoming a major social and economic issue.
The new bone formed during the re-molding phase has intensity of certain degree, and one's daily life is less hampered; however, the reparative phase takes a long term and restricts patient's daily life greatly.

Method used

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  • Compositions for promoting healing of bone fracture
  • Compositions for promoting healing of bone fracture
  • Compositions for promoting healing of bone fracture

Examples

Experimental program
Comparison scheme
Effect test

experimental example 1

Acceleration of Fracture Healing in Normal Rat

[0108] (Acclimation)

[0109] CD (SD) IGS rats (Charles River Japan, Inc.; male; 7-week-old) were housed for seven days at room temperature (23.+-.2.degree. C.) and 40-70% humidity. During the housing period, the rats were free to access commercially available food (from Oriental Bio; CE-2).

[0110] (Fracture Healing)

[0111] Under ether anesthesia, the left-lower legs of rats were shaved and sterilized with 70% aqueous ethanol, fibulas were exposed with scissors and cut with nail scissors (Natsume Seisakusyo; B17). The cut sections of the fibula were re-matched with tweezers. For the test groups (20 rats / group), the drug-containing microspheres prepared in Example 2-(1), which contains 0.1 or 0.5 mg of Compound (1), were placed around the cutting site of each rat using spatula followed by suturing with silk thread. For the control group (20 rats / group), the same amount of drug-free microspheres prepared in Control Example 1-(1) were placed aro...

experimental example 2

Acceleration of Fracture Healing in Normal Rats

[0127] (Acclimation)

[0128] CD (SD) IGS rats (Charles River Japan, Inc.; male; 7-week-old) were housed for seven days at room temperature (23+2.degree. C.) and 50.+-.20% humidity. During the housing period, the rats were free to access commercially available food (from Oriental Bio; CE-2).

[0129] (Fracture Healing)

[0130] Under ether anesthesia, the left-lower legs of rats were shaved and sterilized with 70% aqueous ethanol; fibulas were exposed with scissors and cut with nail scissors (Natsume Seisakusyo; B17). The cut sections of the fibula were re-matched with tweezers. For the test groups (15 rats / group), the drug-containing microspheres prepared in Example 7, which contains 0.004, 0.02, 0.1 or 0.5 mg of Compound (2), were placed around the cutting site using spatula followed by suturing with silk thread. For the control group (15 rats / group), the same amount of drug-free microspheres prepared in Control Example 2 were placed around th...

experimental example 3

In Vitro Test

[0144] (Isolation of Costicartilage Cell)

[0145] Costicartilages were isolated from NZ line rabbit (Kitayama Labes., Co Ltd.; male; 4-week-old) and soaked into Hank's balanced salt solution (calcium- and magnesium-free; LifeTech Co., Ltd.; hereinafter, referred to as HBSS"). One costicartilage and one costa were excised together, the adipose tissue and the muscle tissue were removed and then, the proliferating chondrocyte layer of costicartilage was excised. The collected proliferating chondrocyte layer was cut into sections with a surgical knife (FEATHER Safety Razor Co., Ltd.) and the all proliferating chondrocyte layer sections from 4 rabbits were combined in a centrifuge tube. To the centrifuge tube was added 40 ml of HBSS (pH 7.2) supplied with 0.1% tetrasodium ethylenediamine tetraacetate to obtain suspension of the proliferating chondrocyte layer sections, which was shaken at 37.degree. C. for 20 minutes and centrifuged (1500 rpm, 10 minutes). The supernatant was ...

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Abstract

A composition for accelerating fracture healing, which comprises a PDE4 inhibitor as an active ingredient, specifically a composition comprising a PDE4 inhibitor and a biocompatible and biodegradable polymer is provided, which composition, when formulated into a form suitable for local administration such as microsphere preparation, can provide a pharmaceutical composition showing an excellent effect in the early healing of bone fracture. The said composition is useful in the healing of refractory fracture of elderly people and diabetic or osteoporosis patients.

Description

[0001] The present invention relates to a composition for accelerating bone fracture healing, specifically, to a pharmaceutical composition for accelerating bone fracture healing, which comprises as an active ingredient a PDE4 inhibitor, preferably a PDE4 inhibitor together with a biocompatible and biodegradable polymer, which is especially in the form of microsphere preparation, more preferably, microsphere-containing injectable preparation, and which is able to promote bone fracture healing when locally administered.[0002] Bone fracture is a condition where a physiological continuity of bone tissue is partially or completely broken off and generally classified on the basis of the outbreak mechanism into (a) fracture by external force, (b) pathological fracture, and (c) fatigue fracture. In addition, the state of bone fracture is classified on the basis of the fracture line (the line tracing the epiphysis generated by bone transection), into fissure fracture, greenstick fracture, t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/16A61K31/27A61K31/277A61K31/343A61K31/381A61K31/40A61K31/4166A61K31/42A61K31/423A61K31/44A61K31/4409A61K31/4418A61K31/4425A61K31/4453A61K31/4709A61K31/4985A61K31/50A61K31/501A61K31/502A61K31/5025A61K31/519A61K31/522A61K31/5377A61K31/551A61L27/22A61L27/58A61P19/02C09K23/42C09K23/48C09K23/56
CPCA61K9/1647A61L2430/02A61K31/277A61K31/343A61K31/381A61K31/40A61K31/4166A61K31/42A61K31/423A61K31/44A61K31/4409A61K31/4418A61K31/4425A61K31/4453A61K31/4709A61K31/4985A61K31/50A61K31/501A61K31/502A61K31/5025A61K31/519A61K31/522A61K31/5377A61K31/551A61L27/227A61L27/58A61K31/27A61P19/00A61P19/02A61P19/08A61P43/00
Inventor SAKURAI, NAOKITAKAGI, TOSHIKIYANAKA, NORIYUKIHORIKIRI, YUJITAMURA, TAKASHI
Owner MITSUBISHI TANABE PHARMA CORP
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