CN103827666A - System and method for dissolution analysis of drug-eluting medical devices - Google Patents
System and method for dissolution analysis of drug-eluting medical devices Download PDFInfo
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- CN103827666A CN103827666A CN201280031942.5A CN201280031942A CN103827666A CN 103827666 A CN103827666 A CN 103827666A CN 201280031942 A CN201280031942 A CN 201280031942A CN 103827666 A CN103827666 A CN 103827666A
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- elongate member
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- treatment device
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L9/00—Supporting devices; Holding devices
- B01L9/50—Clamping means, tongs
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0609—Holders integrated in container to position an object
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Abstract
This disclosure is directed to systems and methods for holding a medical device such as a drug-eluting stent (100) undergoing dissolution analysis. A clip (210) retains the device in a specific, reproducible orientation and positions it within a sample cell (202) of the dissolution testing apparatus. The sample cell is a flow-through cell having an inlet (204) and an outlet (206). Preferably, the medical device is positioned away from areas having relatively greater flow turbulence.
Description
Technical field
The disclosure relates generally to the mensuration of the PK (pharmacokinetic) profile of medical treatment device, and more specifically relates to the dissolution studies of bracket for eluting medicament.
Background technology
The use of controlling in time the medical treatment device of pharmacological agent or therapeutic agent delivery has extensively various application.For example, atherosclerotic coronary artery after percutaneous transluminal coronary angioplasty (PTCA) narrow again (ISR) in 10-50% experiences the patient of this operation, occur, and need subsequently further angioplasty or coronary artery bypass graft surgery.Smooth muscle cell (SMC) in vascular wall seems to respond this operation, is considered as the event of the principal element that causes ISR.Correspondingly, many trials have been made so that suppress the aspect of SMC activity by pharmacological agent.A kind of strategy likely relates to treated or modifies to carry medicament and medicament is directly delivered to the use of the support of vascular wall.
As will be appreciated, support or other medical treatment devices need the dynamics of medicament to discharge the accurate sign of overview through the use of delivery of pharmacologically medicament after a while.American Pharmacopeia (USP) has developed into the standard of the rate of dissolution for analyzing pharmacological agent.Use USP equipment 4, dissolution solvent pumping is passed to the sample chamber containing the material that requires study.Although more solito is used for being designed for the pharmaceutical preparation discharging in time, for example tablet, capsule or pill, USP equipment 4 also discharges for studying from the medicine of for example bracket for eluting medicament of suitable medical treatment device.
In sample chamber, flox condition significantly changes conventionally.Current sample chamber is not configured to make medical treatment device to be tested in this indoor position or orientation of being consistent.Therefore, the shortage of the repeatability in the location of medical treatment device can significantly hinder release dynamics research.Therefore, being provided for locating securely the system and method that experiences the device of dissolving analysis and maintain this location in test process will be favourable.Similarly, making the medical treatment device of experience test will be favourable away from the known zone location with high variable-flow condition.The present invention realizes these and other target.
Summary of the invention
According to above-mentioned needs with below by the needs of mentioning and becoming apparent, the disclosure relates to the clamper that dissolves the medical treatment device of analyzing for experiencing, described clamper comprises clip, described clip has: the first contiguous elongate member and the second contiguous elongate member, and the described first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately; With the bridgeware of far-end that is connected this first elongate member and the second elongate member, wherein this elongate member can be placed as the open type structure that holds medical treatment device and the enclosed structure that keeps this medical treatment device.Preferably, this clip is configured to keep support.In addition preferably, elongate member and bridgeware are formed by stainless steel.As required, clip also can comprise the shank of the near-end that is fixed to the first elongate member.
Disclosed relating on the other hand for keeping experience to dissolve the system of the medical treatment device of analyzing, described system comprises clip and has the sample chamber of entrance and exit, described clip has: the first contiguous elongate member and the second contiguous elongate member, and the described first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately; With the bridgeware of far-end that is connected this first elongate member and the second elongate member.This system preferably includes the medical treatment device that keeps specific orientation by the elongate member of clip, for example support.Preferably, medical treatment device remains on the position away from the entrance of sample chamber.In addition preferably, clip is configured to remain on the specific location in sample chamber.
Aspect another, the disclosure relates to for keeping experience to dissolve the method for the medical treatment device of analyzing, said method comprising the steps of: clip is provided, described clip has: the first contiguous elongate member and the second contiguous elongate member, described the first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately, with the bridgeware of far-end that is connected this first elongate member and the second elongate member; When this clip is in the time that open type is constructed, medical treatment device is positioned to the orientation reproduced in this clip; By described clip being placed as to enclosed structure, make elongate member engage described medical treatment device, this medical treatment device is remained on and can reproduce orientation; And this clip is positioned in sample chamber.Preferably, the step of location medical treatment device comprises locating support.In addition preferably, clip being positioned to step in sample chamber comprises and makes medical treatment device away from the entrance location of sample chamber or clip is limited to ad-hoc location.
Accompanying drawing explanation
As shown in the drawing, more feature and advantage are following according to the preferred embodiment of the invention and describe and will become apparent more specifically, and wherein similar reference character generally refers to view same parts or element from start to finish, and wherein:
Fig. 1 is the axonometric drawing that waits that is applicable to support of the present invention;
Fig. 2 is according to the schematic diagram of a part for dissolution test equipment of the present invention;
Fig. 3 is according to the present invention, for making medical treatment device remain on the axonometric drawing such as grade of the clip of open type structure at dissolving test process; And
Fig. 4 is according to the present invention, the axonometric drawing such as grade of the clip in enclosed structure shown in Fig. 3.
Embodiment
At first, be to be understood that the disclosure is not limited to the material of particular instantiation, structure, routine, method or structure, because these can change certainly.Therefore,, although this paper describes preferred material and method, can be used in the practice of embodiment of the present disclosure to those many these Class Options similar or of equal value described herein.
It should be noted additionally that, term used herein, just in order to describe the object of specific embodiment of the present disclosure, is not intended to limit.
Unless otherwise defined, otherwise all technology used herein and scientific terminology have with disclosure those of ordinary skill in the field and conventionally understand identical implication.
In addition no matter be to be all incorporated to way of reference in full at this above or in all patent publication, patents and patent applications of below quoting herein.
Finally, as this specification and the appended claims, unless content separately clearly states, otherwise singulative " ", " one " and " described " comprise plural reference.
As mentioned above, for example support of medical treatment device can be configured to realize the control of therapeutic agent in time and discharges.There is remarkable advantage by support local delivery medicine or drug regimen; , bounce back and reinvent by the supporting role prevention blood vessel of support, and preventing multiple factors of new intima hyperplasia or ISR, and reducing inflammation and thrombosis.The topical that carries out medicine, medicament or compound at the coronary artery place of proping can also have other useful results for the treatment of.For example, utilize local delivery but not whole body administration can realize the high tissue concentration of medicine, medicament or compound.In addition, utilize local delivery but not whole body administration can reduce general toxicity in keeping high tissue concentration.Equally, utilize from support local delivery but not whole body administration, single operation can achieve the goal, and therefore can improve patient's biddability.Another beneficial effect of medicine, medicament and/or compound combination therapy is the dosage that can reduce every kind of curative drug, medicament or compound, thereby limits its toxicity, can reach again and reduce ISR, inflammation and thrombotic object simultaneously.Therefore, the topical therapeutic based on support is to improve the treatment of anti-ISR, anti-inflammatory, anti-thrombosis drug, medicament or compound than the method for (effect/toxicity).
The multiple different support that existence can utilize after PTCA.Although can utilize the support of any amount according to the present invention, for simplicity's sake, will describe single support in exemplary embodiment of the present invention.One skilled in the art will appreciate that the present invention can utilize the support of any amount.In addition, as mentioned above, also can utilize other medical treatment devices.
Support is usually as staying tubular structure in the chamber of pipeline for reducing embolism.Conventionally, support inserts in chamber with unexpansive form, and then Self-expanding or the auxiliary lower original position at the second device expand.Typical expanding method is by realizing with the angioplasty sacculus that conduit is installed, and this sacculus can expand in narrow blood vessel or body passage, to shear the embolism relevant to vascular wall composition with destruction, and obtains the tube chamber expanding.
Fig. 1 shows the illustrative drug FirebirdTM 100 that can utilize according to exemplary embodiment of the present invention.The cylindrical stent 100 that can expand has reticulate texture, can put into blood vessel, pipeline or chamber so that blood vessel, pipeline or chamber keep unimpeded, more specifically, can prevent that artery segment is at postangioplasty restenosis.Support 100 can circumferential expansion and is maintained circumferentially or the expanded configuration of radial rigidity.Support 100 is axial elasticity, and when bending at band place, support 100 is avoided to any components of outer process.
Should be appreciated that according to support 100 of the present invention and can specifically adopt shape-memory material, comprise for example suitable Nitinol or stainless steel.By stainless steel being configured in a predefined manner for example by being twisted into pigtail columnar structure, the structure that stainless steel can be formed be made self-expansion type.In this embodiment, can after support 100 is shaped, be compressed, thereby occupy enough little space, to allow being inserted into blood vessel or its hetero-organization by insertion apparatus, wherein insertion apparatus comprises suitable conduit or rods.After exposing from conduit, support 100 can be configured to expand into required structure, and wherein expansion is automatically or triggers by change or the electro photoluminescence of pressure, temperature.
In addition, support 100 can be characterised in that one or more reservoirs 102.Each in reservoir 102 can be opened as required or be closed.These reservoirs 102 can be become to keep one or more medicaments to be delivered by specialized designs.No matter which kind of design support 100 takes, preferably allow applied dosage there is enough specificitys and enough concentration, to provide effect dosage in focus region.In this, the size of reservoir, shape, position and number can be used for controlling the pharmaceutical quantities discharging, and therefore control the dosage of sending.In addition, the coating of biocompatible materials or film can be applied on reservoir as required, so that the other control to the medicament diffusion from reservoir to arterial wall to be provided.The character that an advantage of this system is coating can optimization for realizing good biocompatibility and sticking property, containing the other demand that can load and discharge medicine.In alternative exemplary embodiment, the inside surface of support 100 and outside surface all or part of can be by the film coating of one or more medicaments that comprise therapeutic dose, cover or bombard with one or more medicaments of therapeutic dose.
Therapeutic agent and the pharmacological agent that preferably can be used alone or in combination at present comprise: antiproliferative/antimitotic agent, for example vinca alkaloids is (to comprise natural products, vincaleukoblastinum, vincristine and vinorelbine), taxol, epipodophyllotoxin (, Etoposide, Teniposide), microbiotic (dactinomycin D (actinomycin D), daunorubicin, Doxorubicin and idarubicin), anthracycline antibiotic, mitoxantrone, bleomycin, plicamycin (mithramycin) and mitomycin, enzyme (L-ASP, it makes the metabolism of altheine systematicness and makes not have the cell inactivation of the ability of synthetic himself asparagine), anti-platelet agents, for example G (GP)
llbl lllainhibitor and vitronectin receptor antagonist, antiproliferative/antimitotic alkylating agent, for example mustargen (chlormethine, endoxan and analog, melphalan, Chlorambucil), Ethylenimine and methylmelamine (altretamine and thio-tepa), alkyl sulfonic ester-busulfan, nitroso ureas (BCNU (BCNU) and analog, streptozotocin), triazenes-Dacarbazine (DTIC), antiproliferative/antimitotic antimetabolite, for example folacin (methotrexate (MTX)), pyrimidine analogue (fluorouracil, floxuridine and cytarabine), purine analogue and relevant inhibitor (mercaptopurine, thioguanine, Pentostatin and 2-chlorodeoxyadenosine { Cladribine }), platinum coordination complex (cis-platinum, carboplatin), procarbazine, hydroxycarbamide, mitotane, aminoglutethimide, hormone (being estrogen), anti-agglomerating agent (heparin, synthetic heparinate and other thrombin inhibitors), fibrinolytic agent (for example tissue plasminogen activator, streptokinase and urokinase), aspirin, Dipyridamole, Ticlopidine, clopidogrel, Abciximab, migration inhibitor, anti-secrete pharmaceutical (brefeldin), antiinflammatory: for example adrenocorticotro (cortisol, cortisone, fludrocortison, metacortandracin, prednisolone, 6a-methylprednisolone, fluoxyprednisolone, betamethasone and dexamethasone), nonsteroidal medicament (salicyclic acid derivatives, i.e. aspirin, P-aminophenol derivatives, i.e. paracetamol, indoles and indeneacetic acid (indocin, sulindac and Etodolac), heteroaryl acetic acid (tolmetin, Diclofenac and ketorolac), arylpropionic acid (brufen and derivant thereof), ortho-aminobenzoic acid (mefenamic acid and Meclofenamic Acid), bmap acid (piroxicam, tenoxicam, phenylbutazone and crovaril (oxyphenthatrazone)), Nabumetone, gold compound (Anranofin, aurothioglucose, disodium aurothiomalate), immunodepressant: (cyclosporin, tacrolimus (FK-506), sirolimus (rapamycin), imuran, mycophenolate mofetil), antiplatelet drug: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), ARB, nitric oxide donors, antisense oligonucleotides and their combination, cell cycle inhibitor, mTOR inhibitors and growth factor receptors signal transduction inhibitors of kinases, retinoids, cyclin/CDK inhibitor, HMG coenzyme reductase inhibitor (statins), and protease inhibitors.
Although exemplary embodiment of the present invention will be with respect to using stent in the treatment ISR and related complication to be described after PTCA, but it should be noted that, the local delivery of one or more medicaments can be used for utilizing extensively various illness of medical treatment device treatment of any amount, or promotes function and/or the life-span of this device.For example, the intraocular lens that being used for of putting into after cataract operation recovered eyesight tends to cause secondary cataract, and therefore curative effect reduces.Secondary cataract is the result of lens surface cell transition growth often, and can be by one or more medicines and device combination are minimized as much as possible.Usually because device is inner, raw or protein material accumulate other medical treatment devices for example hydrocephalus isocon, dialyse transplantation device, colostomy bag attachment arrangement, ear drainage tubes, pacemaker wires and the implantable defibrillator that lost efficacy and also can be benefited from device-drug regimen method in surface or tissue around.In the time being used in combination with one or more suitable medicaments, also can show beneficial effect for the device that improves tissue or organ structure and function.For example, by orthopedic device is combined with for example medicament of bomeplasty albumen and so on, the bone of orthopedic device is integrated the stability that can improve strengthening implanted device.Similarly, utilize this medicine-device combined method, other surgical devices, suture line, staple, stapling apparatus, interverbebral disc, spicule, stitching holdfast, tourniquet, fixture, screw, plate, clip, blood vessel implant, organize bonding agent and sealant, organization bracket, various bandage, bone substitute, pipe intracavitary unit and vessel support part also to can be patient to provide the beneficial effect of enhancing.Perivascular wraps is especially favourable, and it can be used alone or uses together with other medical treatment devices.Perivascular wraps can be therapentic part extra medicine is provided.Substantially, the medical treatment device of any type can pass through certain mode painting medicine or drug regimen, can have better curative effect than independent operative installations or medicament like this.
The dissolution characteristics that those skilled in the art will recognize that pharmacological agent depends on its chemical property and concrete preparation thereof.Like this, these characteristics must be fully understood, to predict the effect of medicine and to guarantee the consistance of product in manufacture process.The dissolving standard of the pharmaceutical preparation preferably discharging for analysis and Control is at present USP equipment 4 system for the distribution of commoditiess.Therefore, significantly dirigibility is relevant to these systems, the ability that is included in for example open type of different condition or enclosed structure and operates at different in flow rate and temperature.Extensively various sample chamber with clamper is configured to multiple formulation, comprises and controls the oral powder, particle and the solid dispersions that discharge.4 type equipment also can allow the variation of medium volume, allow reduced volume to improve detection limit, or increase volume is used for maintaining sink condition.
The part of the assembly of the schematically illustrated USP equipment 4 of Fig. 2.Circulation sample chamber 200 comprises the mobile chamber 202 that is configured to instruct dissolution solvent.Like this, solvent pumping, through chamber 200, is entered at entrance 204 places and left by exporting 206.In enclosed structure, make the solvent recycled of fixed amount, and the dissolving of medicine is by relevant to the concentration increasing in solvent.Alternatively, in open type structure, fresh solvent uninterrupted pumping is passed to entrance 204, and analyze the solvent that leaves outlet 206 to measure the amount of dissolved substance.
Consider that solvent is pumped through sample chamber 202, will be appreciated that hydrodynamic is in the interior change in chamber 202.Particularly, compare with the region of for example contiguous outlet 206, the region of neighboring entry 204 is by the turbulent flow of the relative higher degree of experience.In certain embodiments, multiple beaded glasses 208 are deposited on to entrance 204 places, to minimize turbulent flow and to produce more multi-layered stream.
As discussed above, conventional sample chamber does not have for medical treatment device being reproducibly positioned to given position in sample chamber and particular organization or the structure of orientation.Therefore, depend on its position and orientation, use conventional sample chamber experience to dissolve the medical treatment device of analyzing and there are the potentiality that experience various flows dynamic characteristic.Correspondingly, the identical medical treatment device with same medicine preparation still can demonstrate different solubility characteristics, reduces and dissolves the degree of accuracy of analyzing.
In order to minimize these effects, system and method for the present invention adopts clip 210, so that for example support 100 of medical treatment device is positioned to reproduced position and the orientation in chamber 202.Clip 210 is characterised in that the elongate member 214 and 216 of two aligned adjacent, and described elongate member 214 and 216 is not attached at near-end 218 places, and by connecting at the bridgeware member 220 at far-end 222 places.Preferably, the size of bridgeware member 220 is set the natural diameter corresponding to support 210 for, allows elongate member 214 and 216 side periphery at support 210, and it is stabilized in chamber 202.In addition preferably, the diameter of elongate member 214 and 216 is enough little, with allow elongate member 214 and 216 screw threads by or slide on the opening in support 100.For example, the preferred diameter of elongate member 214 and 216 at about 39mm in the scope of 40mm.
Be shown in Fig. 3 and 4 about the more details of clip 210.In an illustrated embodiment, clip 210 forms by having enough flexible material monolithics, to allow it to present the enclosed structure shown in the open type structure shown in Fig. 3 and Fig. 4.In other embodiments, elongate member 214 and 216 can be used any suitable mechanism to be fixed to bridgeware member 220, and described suitable mechanism is characterised in that necessary dirigibility.In general, the open type of clip 210 structure allows support 100 to be loaded, wherein elongate member 214 and 216 or screw thread through the space in the framework of support 100, or just in abutting connection with the side of support 100.In certain embodiments, bridgeware 220 can be configured to the far-end of splice holder 100 in the time suitably locating.How concrete enforcement relates to structure bridgeware 220 to fit in the opening of framed structure of support 100.When clip 210 is in the time that its enclosed is constructed, the preferred clamp bracket 100 of elongate member 214 and 216, its side that is frictionally engaged is so that support 100 remains on required orientation and position.
In presently preferred embodiment, the overall length of clip 210, corresponding to the inner dimensions separately of chamber 202, allows its close fit in clip 210, and clip 210 is limited to the narrow range of the lengthwise position in chamber 202.In fact, if needed, the inside that the near-end 218 of clip 210 and far-end 222 can abutment chamber 202.Therefore support 100 can remain on the position away from far-end 222 in clip 210, guarantees that the jag of elongate member 214 and 216 makes support 100 be kept away from entrance 204.
Elongate member 214 also can be included in the shank 224 at near-end 216 places.If needed, shank 224 can be configured to one or more structure example of the contiguous sample chamber 202 that exports 204 as shoulder or container cooperation, so that clip 210 remains on the desired location place in chamber 202.As required, the far-end of elongate member 216 can be configured to be retrained by shank 224, makes clip 210 keep its enclosed structure.Subsequently the retaining clip 210 in enclosed structure that contains sample is placed in the top edge of chamber 202.Referring to appended other chart and the data of supporting claim.
In alternate embodiments, clip 210 can be configured to make support 100 to be coaxially placed on elongate member 214 and 216.The size of bridgeware 220 is set the length with the internal diameter that is slightly greater than support 100 for.Support 100 is advanced the distal position that engages the inside surface of tubular bracket 100 in its place's elongate member 214 and 216, makes support 100 constrain in desired location and orientation.
As the skilled person will recognize, sample chamber 202 can be in a usual manner for carrying out the dissolving analysis that uses USP equipment 4.Particularly, clip 210 makes support 100 remain on ad-hoc location and the orientation in chamber 202, experiences laminar with similar flox condition and improves consistance guaranteeing in each test process.In addition, clip 210 can be used for support 100 to be positioned at the desired location place away from turbulent flow, and therefore away from the variable-flow condition of neighboring entry 204.By making support 100 be kept away from the turbulent flow of entrance 204, the use that can omit beaded glass in some concrete enforcements.In this type of embodiment, this is avoided to beaded glass structure, maintains and relevant complicated of the variation in clean pearl between analyzing.Alternatively, while needs, still can adopt as discussed above pearl 208, to be created in the more multi-layered stream of the solvent in chamber 202.
Described herein is presently preferred embodiment.But those skilled in the art in the invention are to be understood that principle of the present disclosure can follow suitable modification to other applications and easily extend.
Claims (13)
1. for experiencing a clamper that dissolves the medical treatment device of analyzing, comprise clip, described clip has: the first contiguous elongate member and the second contiguous elongate member, and the described first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately; With the bridgeware of far-end that is connected described the first elongate member and the second elongate member, wherein said elongate member can be placed as the open type structure that holds medical treatment device and the enclosed structure that keeps described medical treatment device.
2. clamper according to claim 1, wherein said clip is configured to keep support.
3. clamper according to claim 1, wherein said elongate member and bridgeware are formed by stainless steel.
4. clamper according to claim 1, also comprises the shank of the near-end that is fixed to described the first elongate member.
5. one kind for keeping experience to dissolve the system of medical treatment device of analyzing, comprise clip and there is the sample chamber of entrance and exit, described clip has: the first contiguous elongate member and the second contiguous elongate member, and the described first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately; With the bridgeware of far-end that is connected described the first elongate member and the second elongate member.
6. system according to claim 5, also comprises the medical treatment device that keeps specific orientation by the elongate member of described clip.
7. system according to claim 6, wherein said medical treatment device comprises support.
8. system according to claim 6, wherein said medical treatment device remains on the position away from the entrance of described sample chamber.
9. system according to claim 6, wherein said clip is configured to remain on the specific location in described sample chamber.
10. for keeping experience to dissolve a method for the medical treatment device of analyzing, comprise the following steps:
A) provide clip, described clip has: the first contiguous elongate member and the second contiguous elongate member, and the described first contiguous elongate member and the second contiguous elongate member have near-end and far-end separately; With the bridgeware of far-end that is connected described the first elongate member and the second elongate member;
B) when described clip is in the time that open type is constructed, medical treatment device is positioned to the orientation reproduced in described clip;
C) by described clip being placed as to enclosed structure, make described elongate member engage described medical treatment device, described medical treatment device is remained on and describedly can reproduce orientation; And
D) described clip is positioned in sample chamber.
11. methods according to claim 10, the step of wherein said location medical treatment device comprises locating support.
12. methods according to claim 10, are wherein saidly positioned at step in sample chamber by described clip and comprise and make the entrance location of described medical treatment device away from described sample chamber.
13. methods according to claim 12, are wherein saidly positioned at step in sample chamber by described clip and comprise described clip is limited to ad-hoc location.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161502689P | 2011-06-29 | 2011-06-29 | |
| US61/502,689 | 2011-06-29 | ||
| US61/502689 | 2011-06-29 | ||
| US13/246,898 | 2011-09-28 | ||
| US13/246898 | 2011-09-28 | ||
| US13/246,898 US20130074587A1 (en) | 2011-09-28 | 2011-09-28 | System and method for dissolution analysis of drug-eluting medical devices |
| PCT/US2012/044501 WO2013003518A1 (en) | 2011-06-29 | 2012-06-28 | System and method for dissolution analysis of drug-eluting medical devices |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103827666A true CN103827666A (en) | 2014-05-28 |
| CN103827666B CN103827666B (en) | 2016-08-10 |
Family
ID=46584329
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201280031942.5A Active CN103827666B (en) | 2011-06-29 | 2012-06-28 | The system and method dissolving analysis for drug eluting medical device |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP2726862A1 (en) |
| CN (1) | CN103827666B (en) |
| WO (1) | WO2013003518A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050238540A1 (en) * | 2004-04-22 | 2005-10-27 | Swon James E | Apparatus and method for agitating a sample during in vitro testing |
| US20090165578A1 (en) * | 2007-12-06 | 2009-07-02 | Pain Therapeutics, Inc. | Dissolution test equipment and methods for testing |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4669771A (en) * | 1986-03-12 | 1987-06-02 | Finneran James G | Capsule holder |
-
2012
- 2012-06-28 EP EP12740764.1A patent/EP2726862A1/en not_active Withdrawn
- 2012-06-28 WO PCT/US2012/044501 patent/WO2013003518A1/en active Application Filing
- 2012-06-28 CN CN201280031942.5A patent/CN103827666B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050238540A1 (en) * | 2004-04-22 | 2005-10-27 | Swon James E | Apparatus and method for agitating a sample during in vitro testing |
| US20090165578A1 (en) * | 2007-12-06 | 2009-07-02 | Pain Therapeutics, Inc. | Dissolution test equipment and methods for testing |
Non-Patent Citations (2)
| Title |
|---|
| ANNE NEUBERT: "Development of a vessel-simulating flow-through cell method for the in vitro evaluation of release and distribution from drug-eluting stents", 《JOURNAL OF CONTROLLED RELEASE》 * |
| ANNE NEUBERT: "Development of a vessel-simulating flow-through cell method for the in vitro evaluation of release and distribution from drug-eluting stents", 《JOURNAL OF CONTROLLED RELEASE》, no. 130, 19 May 2008 (2008-05-19) * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2726862A1 (en) | 2014-05-07 |
| WO2013003518A1 (en) | 2013-01-03 |
| CN103827666B (en) | 2016-08-10 |
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