WO2005027940A1 - 損傷皮膚修復用貼付剤 - Google Patents
損傷皮膚修復用貼付剤 Download PDFInfo
- Publication number
- WO2005027940A1 WO2005027940A1 PCT/JP2004/013784 JP2004013784W WO2005027940A1 WO 2005027940 A1 WO2005027940 A1 WO 2005027940A1 JP 2004013784 W JP2004013784 W JP 2004013784W WO 2005027940 A1 WO2005027940 A1 WO 2005027940A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- plaster
- patch
- weight
- damaged skin
- repairing damaged
- Prior art date
Links
Classifications
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
- A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
- A61K31/79—Polymers of vinyl pyrrolidone
-
- 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
Definitions
- the present invention relates to a patch for repairing damaged skin containing sucrose and povidonodo, which has a stable iodine content over time and is excellent in releasability, flexibility and adhesion.
- sucrose has a wound healing action and a granulation action, and thus has been used as a Knutson et al.
- Formulation (Non-Patent Document 1) and a hospital preparation (Non-Patent Document 2).
- ointments and powders containing sucrose and povidone as active ingredients have been developed and are widely used in medical practice as treatments for pressure ulcers and skin ulcers.
- the ointment has a high consistency, so when it is used on a support such as gauze at a medical site, it requires complicated labor and time. Dries and easily peels off the support and spills. Powders, on the other hand, are difficult to use on the affected area because they are powders, and they also scatter and cause stains around them.
- Non-Patent Document 1 R. A. Knutson et. Al .; Southern Medical Journal, Vol. 74, No. 11, 1329-1335 (1981)
- Non Patent Literature 2 Sone Kiyokazu et al., “Hospital Pharmacy”, Vol. 10, No. 5, 315-322 (1984) Disclosure of the Invention [0004] It is an object of the present invention to provide a patch for repairing damaged skin containing sucrose and povidonodo, in which the iodine content is stably maintained over time, and which is excellent in releasability, flexibility and adhesion. It is in.
- the present inventors have conducted intensive studies in consideration of the above points, and as a result, in a patch containing sucrose and povidone chloride, methylcellulose and medium-chain fatty acid triglyceride were used as base components of the plaster. Is used to provide the plaster with the necessary shape-retaining property, releasability, flexibility and adhesiveness, and to maintain a high iodine content stably with time, and to add a sugar alcohol to the plaster And found that the stability of the iodine content and the adhesiveness of the patch were significantly improved, and the present invention was completed.
- the present invention relates to a paste containing 50 to 90% by weight of sucrose, 0.5 to 10% by weight of povidone, 0.1 to 15% by weight of water, 1 to 15% by weight of medium-chain fatty acid triglyceride and methyl cellulose.
- the present invention provides a patch for repairing damaged skin, characterized in that the patch contains 0.1 to 15% by weight.
- the present invention provides a paste containing 50-90% by weight of sucrose, 0.5-10% by weight of povidone, 0.1-15% by weight of water, 1-115% by weight of medium-chain fatty acid triglyceride, and 0.1-1% of methylcellulose. It is intended to provide a patch for repairing damaged skin, which contains 15% by weight and 0.1 to 20% by weight of sugar alcohol.
- the patch for repairing damaged skin of the present invention maintains the stability of the iodine content over time, has an appropriate hardness so that the plaster does not press on the affected part at the time of application, and has a liner plaster.
- the plaster does not adhere to the liner, has good releasability, has moderate flexibility, and has excellent adhesion to the skin when applied.
- FIG. 1 is a conceptual diagram when measuring adhesion with a rheometer. BEST MODE FOR CARRYING OUT THE INVENTION
- the sucrose used in the present invention is preferably purified sucrose.
- the content of sucrose is preferably 60-80% by weight, particularly 65-75% by weight, which is 50-90% by weight based on the total amount of the plaster, from the viewpoint of repairing damaged skin.
- Poly ((2-oxopyrrolidin-l-yl) ethyle is used in the present invention.
- the content of iodine) is preferably 0.5 to 10% by weight based on the total amount of the plaster, 17 to 17% by weight, and particularly preferably 2 to 6% by weight, based on the effect of repairing damaged skin. .
- the content of water used in the present invention is 0.1 to 15% by weight based on the total amount of the plaster 0.3 to 12 in view of the stability, flexibility and adhesion of iodine. %, Especially 0.5-10% by weight.
- the medium-chain fatty acid triglyceride used in the present invention is a triglyceride in which a saturated fatty acid having 6 to 12 carbon atoms, preferably 6 to 10 carbon atoms, and glycerin are ester-bonded.
- examples of the saturated fatty acid having 6 to 12 carbon atoms include caproic acid, enanthic acid, caprylic acid, pelargonic acid, and capric acid.
- the medium-chain fatty acid triglyceride triglyceride of glycerin with force prillic acid or force phosphoric acid is particularly preferable. Further, two or more medium-chain fatty acid triglycerides may be used in combination.
- medium-chain fatty acid triglycerides include Militol 888, Militonoré 325, Militonoré 318, Militonoré 318-R (Koku, Nisjiyano, Inc.), No, ° Nassate 800, Panassate 810, Panassate 875 (Nippon Oil & Fats Co., Ltd.) ), Miglyol (Mitsuba Trading Co., Ltd.), Coconard (Kao Co., Ltd.), ODO (Nissin Oil Co., Ltd.), TCG (Higher Alcohol Industry Co., Ltd.), Sun Fat MCT-6 (Taiyo Chemical Co., Ltd.), Actor (RIKEN Vitamin) Corporation).
- the content of the medium-chain triglyceride in the present invention is 11 to 15% by weight with respect to the total amount of the plaster in view of the stability of the iodine content with time, adhesiveness, flexibility, and the like. It is preferably 3% by weight, especially 3-10% by weight.
- Methylcellulose used in the present invention is a methyl mixed ether of cellulose, and commercially available products such as Metrolose SM-100, Metrolose SM_400, Metrolose SM-1500, Metrolose SM_4000, Metrolose SM_8000, (Shin-Etsu Chemical Co., Ltd.) )), Methocel A (Dow 'Chemical Co., Ltd.), Marporose M (Matsumoto Yushi Seiyaku Co., Ltd.), etc.
- the viscosity of methylcellulose (based on the viscosity measurement method described in the Japanese Pharmacopoeia General Test Method) is 80- A power of 10,000 mPa's, especially 350-mOOmPa's, is preferred in terms of flexibility, adhesion and the like.
- the content of methylcellulose in the present invention is the stability of iodine content, releasability, flexibility From the viewpoints of properties and adhesion, the amount is 0.1 to 15% by weight, preferably 0.2 to 10% by weight, and particularly preferably 0.3 to 5% by weight based on the total amount of the plaster.
- sugar alcohol is obtained by reducing the carboxyl group of a sugar molecule, and includes, for example, sorbitol (D-sorbitol, etc.), mannitol (D-mannitol, etc.), xylitol, erythritol, etc., and particularly sorbitol. But preferred.
- the content of the sugar alcohol in the present invention is 0.1 to 20% by weight, more preferably 11 to 15% by weight, especially 3 to 10% by weight based on the total amount of the plaster, in view of the stability of the iodine content and the adhesion. % Is preferred.
- the pH of the plaster used in the patch of the present invention is preferably in the range of 3.5-6 from the viewpoint of the temporal stability of the sucrose and iodine contents.
- scrape 2 g of the paste on the support add to 18 g of water, shake well, and use a pH meter (for example, F-24, Horiba, Ltd.) at 25 ° C. Do.
- the pH adjusting agent used for adjusting the pH include sodium hydroxide, potassium hydroxide, hydrochloric acid, sulfuric acid, citric acid, tartaric acid, lactic acid and the like.
- the patch of the present invention may contain, as long as the effects of the present invention are not impaired, various optional ingredients that are acceptable as additives to other drugs or pharmaceuticals, such as solubilizers, surfactants, and thickeners.
- solubilizers such as solubilizers, surfactants, and thickeners.
- the adsorbent, the absorption promoter, the stabilizing agent, the wetting agent, the filler and the like can be appropriately added as required, if necessary.
- Other agents include growth factors such as bFGF, EGF, HGF, and IGF, and proteins such as silk-fiber mouth.
- solubilizer examples include potassium iodide, sodium iodide, concentrated glycerin, polyethylene dali cone 400, polyethylene glycol 1500, polyethylene glycol 4000, polyethylene glycol 6000, polypropylene glycol, propylene glycol and the like.
- the solubilizing agent is preferably contained in an amount of 1 to 25% by weight, more preferably 5 to 20% by weight based on the total amount of the plaster.
- the surfactant examples include polyoxyethylene (average addition mole number: 4-1250, preferably 120-200) polyoxypropylene (average addition mole number: 2-100, preferably 30-70) glycol, Polyoxyethylene (average number of moles added: 2 to 200, preferably 40 to 120) such as castor oil and sucrose fatty acid ester.
- the surfactant is preferably contained in an amount of 0.5 to 10% by weight, more preferably 18 to 18% by weight based on the total amount of the plaster, from the viewpoint of suppressing separation of oil in the plaster.
- Examples of the thickener include pullulan, sodium carboxymethylcellulose, sodium alginate, hydroxypropylmethylcellulose, agar, gelatin and the like. ⁇
- the viscosity agent is preferably 0.1 to 10% by weight, more preferably 115% by weight, based on the total amount of the plaster.
- Examples of the adsorbent include bentonite, colloidal hydrous aluminum silicate, light anhydrous silicic acid, hydrous silicon dioxide, medicinal charcoal, kaolin and the like.
- the adsorbent is preferably contained in an amount of 0.1 to 10% by weight, more preferably 0.5 to 8% by weight, based on the total amount of the plaster.
- the plaster may be produced by kneading each component, or may be produced by preparing an aqueous phase and an oil phase separately, and then kneading them.
- the aqueous phase to be preliminarily prepared is prepared by adding povidonodo, methylcellulose, water and, if necessary, sugar alcohol, optional components such as a pH adjuster, a solubilizing agent such as concentrated glycerin and potassium iodide, and a thickener.
- the oil phase is produced by adding a solubilizing agent such as a medium-chain fatty acid triglyceride and an optional component such as polyethylene glycol, an adsorbent, and a surfactant. Next, it is preferable to add the oil phase to the aqueous phase, knead the mixture, and further produce sucrose by heating.
- the patch for repairing damaged skin of the present invention is prepared by kneading the above-mentioned raw materials by a usual method to produce a plaster, and then spreading and applying the mixture on a support, and then to a desired size. To manufacture.
- Examples of the base of the plaster used in the patch of the present invention include paper, woven fabric, nonwoven fabric, knitted fabric, plastic film, moisture-permeable film and the like.
- Materials other than paper include polyester, polyethylene, polypropylene, polybutadiene, polyethylene terephthalate, ethylene monoacetate copolymer, nylon, polyurethane, alkoxyalkyl (meta) acrylate copolymer, polyamide, rayon, Polyether urethane, polyester urethane And synthetic resins such as tan and polyether polyamide block polymers.
- the thickness of these supports is not particularly limited, but is preferably 0.5 to 2.5 mm, particularly preferably 0.5 to 2 mm in terms of ease of use, convenience in manufacturing, and the like.
- the basis weight of the support, 80- 150 g / m 2, further 90- 130 g / m 2, particularly preferably 100- 120 g / m in terms of ⁇ IJ flights of the force produced in is 2.
- a usual production method can be used.
- a transfer method, a knife coating method and the like can be mentioned.
- the thickness of the plaster layer is a force that varies depending on the plaster composition, ie, 1 to 4 mm, and more preferably 2 to 4 mm, particularly 2 to 3 mm, in terms of the effect of sufficiently absorbing exudate from the damaged part. preferable.
- the patch may, if necessary, cover the surface of the plaster coated on the support with a release liner for the purpose of preventing the evaporation of water and protecting the plaster.
- the release liner may be made of a synthetic resin film such as polypropylene, polyethylene terephthalate, polyethylene, polyester, polyurethane, polychlorinated vinyl, polystyrene, etc .; And laminated paper.
- the patch for repairing damaged skin of the present invention has a stable iodine content and is excellent in peelability, flexibility and adhesion.
- the releasability refers to the presence or absence of plaster on the release liner when the release liner is peeled off
- the flexibility refers to whether the plaster collapses when the patch from which the release liner is peeled is bent.
- adheresiveness means the adhesive strength of a patch to an affected area.
- the patch for repairing damaged skin of the present invention can be occupied by shellfish on the affected area only by peeling off the release liner, and therefore requires less labor than conventional ointment preparations. It is also possible to cut the patch with scissors or the like according to the size of the affected area. In addition, since it has excellent adhesive strength, it does not require any special fixtures, and even if it is used to fix it to the affected part daringly, it also has excellent effects such as improving blood circulation without pressing the affected part with a simple object. Have.
- the resulting plaster is applied to a nonwoven fabric (EW6090: Nippon Vilene Co., Ltd.) and a liner for release (polypropylene TS-30: Okura Kogyo Co., Ltd.) using an plastering machine (model C-140 Ikeda Machinery Co., Ltd.).
- the patch was spread to a size of 14 ⁇ 10 cm to produce a patch having a plaster layer thickness of 2.2 mm.
- the pH (25 ° C) of the plaster was 5.3.
- aqueous phase As an aqueous phase, 2.4 g of citric acid and 1.6 g of sodium hydroxide were dissolved in 60 g of purified water, and 14 g of potassium iodide, 160 g of concentrated glycerin, 60 g of povidone oxide and 10 g of methylcellulose (Metroze SM4000) were added and dispersed.
- 400 120 g of polyethylene glycol was heated to 50 ° C. as an oil phase, and 90 g of polyethylene glycol 4000 and 42 g of sucrose luster fatty acid ester were uniformly dispersed in kagami.
- aqueous phase 2.4 g of citric acid and 1.6 g of sodium hydroxide were dissolved in 62 g of purified water, and 14 g of potassium iodide, 160 g of concentrated glycerin and 60 g of povidone were added and dispersed.
- 400 g of polyethylene glycol 400 as an oil phase was heated to 50 ° C., 4000 77 g of polyethylene glycol was dissolved, and 42 g of sucrose fatty acid ester was uniformly dispersed in kagami.
- the iodine content in the plaster of the patch was measured.
- the iodine residual ratio (%) with respect to the iodine content immediately after the production was calculated.
- scrape 3 g of the plaster from the patch add 35 mL of purified water, shake for 60 minutes, add 65 mL of purified water, and titrate with 0.01 N sodium thiosulfate solution (Hiranuma automatic titrator: COMTITE-900 Hiranuma) Sangyo Co., Ltd.)
- the patch was stored at 25 ° C. for 14 days, and when the release liner was peeled from the patch, it was visually observed whether or not the plaster adhered to the release liner. Those that were cleanly peeled without adhesion were rated as ⁇ , those that slightly adhered but were peeled off, and those that adhered and were not peeled were rated as X.
- the patch was stored at 25 ° C for 14 days, and the release liner was peeled off and bent The collapse of the plaster at the time was visually observed. Those that did not collapse were rated as ⁇ , those that slightly collapsed were rated ⁇ , and those that collapsed were rated X on a three-point scale.
- the patch was stored at 25 ° C. for 14 days, cut into 35 ⁇ 80 mm, and the peeling liner was peeled off and attached to a jig of a rheometer. Apply a 2 kg load to the adhesive patch surface of 35 ⁇ 30 mm for 30 seconds, attach it to a rheometer (NRM-3002D-L Fudo Kogyo Co., Ltd.), and hold the adhesive patch surface of 35 ⁇ 10 mm with a jig. Fixed ( Figure 1). The numbers in FIG. 1 indicate the length (mm).
- the measurement conditions were as follows: the sample stage was lowered at a speed of 6 cm / min, and the maximum load when peeling off from the adhered part was measured.
- Table 1 shows the results of measurements on the patches manufactured in Examples and Comparative Examples.
- Example 1 Comparative Example 1 Comparative Example 2 Purified water 3 1 33.1 Citric acid 0.12 0.11 2 0.12 0.12 Sodium hydroxide 0.08 0.08 08 0.08 0.08 ® ⁇ of Kariumu 0.7 0.7 0.7 0.7 concentrated glycerin 6 4 8 8 Pobidonyodo 3 3 3 3 Mechinoresenore opening one scan ⁇ 0. 5 0. 5 0. 5 -
- caprylic triglyceride 85% by weight of caprylic triglyceride, 15% by weight of capric triglyceride
- Example 1 in which the methylcellulose of the present invention and the medium-chain fatty acid triglyceride were blended, the stability of the iodine content was maintained over time, the flexibility was moderate, and the adhesion was excellent. was gotten. Further, Example 2 containing sorbitol is a preparation in which the stability of the iodine content is maintained over time, has an appropriate flexibility, and has further improved adhesion without impairing the excellent liner peelability. there were. In contrast, in Comparative Example 1, the plaster adhered to the force liner where the stability of the iodine content was maintained over time. The liner had poor releasability, poor flexibility, and poor adhesion.
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Abstract
Description
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Priority Applications (1)
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JP2005514097A JP4575881B2 (ja) | 2003-09-22 | 2004-09-22 | 損傷皮膚修復用貼付剤 |
Applications Claiming Priority (2)
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JP2003-329583 | 2003-09-22 | ||
JP2003329583 | 2003-09-22 |
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WO2005027940A1 true WO2005027940A1 (ja) | 2005-03-31 |
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PCT/JP2004/013784 WO2005027940A1 (ja) | 2003-09-22 | 2004-09-22 | 損傷皮膚修復用貼付剤 |
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WO (1) | WO2005027940A1 (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005306808A (ja) * | 2004-04-23 | 2005-11-04 | Kowa Co | 損傷皮膚修復用組成物 |
JP2007277135A (ja) * | 2006-04-05 | 2007-10-25 | Mie Univ | 創傷治療用外用剤 |
WO2012086760A1 (ja) * | 2010-12-24 | 2012-06-28 | Meiji Seikaファルマ株式会社 | 消毒剤 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001017533A (ja) * | 1999-07-02 | 2001-01-23 | Terumo Corp | 皮膚潰瘍補填修復材料 |
JP2002104974A (ja) * | 2000-09-29 | 2002-04-10 | Nichiban Co Ltd | ハイドロゲル損傷皮膚治療剤 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6310731A (ja) * | 1986-03-12 | 1988-01-18 | Kowa Co | 安定な損傷皮膚修復用製剤 |
JPH07103016B2 (ja) * | 1988-03-11 | 1995-11-08 | 積水化学工業株式会社 | 貼付剤およびその製造方法 |
JP3583166B2 (ja) * | 1994-06-27 | 2004-10-27 | 興和株式会社 | 損傷皮膚修復用粉末製剤 |
JPH11343248A (ja) * | 1998-03-30 | 1999-12-14 | Taisho Pharmaceut Co Ltd | 局所タ―ゲティング用組成物 |
JP2002193810A (ja) * | 2000-12-22 | 2002-07-10 | Kyowa Yakuhin Kogyo Kk | 褥瘡・損傷皮膚修復用製剤 |
-
2004
- 2004-09-22 JP JP2005514097A patent/JP4575881B2/ja not_active Expired - Fee Related
- 2004-09-22 WO PCT/JP2004/013784 patent/WO2005027940A1/ja active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001017533A (ja) * | 1999-07-02 | 2001-01-23 | Terumo Corp | 皮膚潰瘍補填修復材料 |
JP2002104974A (ja) * | 2000-09-29 | 2002-04-10 | Nichiban Co Ltd | ハイドロゲル損傷皮膚治療剤 |
Non-Patent Citations (1)
Title |
---|
KNUTSON R.A. ET AL.: "Use of sugar and povidone-iodine to enhance wound healing: fi ve years' experience", SOUTHERN MEDICAL JOURNAL, vol. 74, no. 11, 1981, pages 1329 - 1335, XP002903644 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005306808A (ja) * | 2004-04-23 | 2005-11-04 | Kowa Co | 損傷皮膚修復用組成物 |
JP4575705B2 (ja) * | 2004-04-23 | 2010-11-04 | 興和株式会社 | 損傷皮膚修復用組成物 |
JP2007277135A (ja) * | 2006-04-05 | 2007-10-25 | Mie Univ | 創傷治療用外用剤 |
WO2012086760A1 (ja) * | 2010-12-24 | 2012-06-28 | Meiji Seikaファルマ株式会社 | 消毒剤 |
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JPWO2005027940A1 (ja) | 2007-11-15 |
JP4575881B2 (ja) | 2010-11-04 |
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