CN1726288A - Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device - Google Patents
Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device Download PDFInfo
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- CN1726288A CN1726288A CN 200380106334 CN200380106334A CN1726288A CN 1726288 A CN1726288 A CN 1726288A CN 200380106334 CN200380106334 CN 200380106334 CN 200380106334 A CN200380106334 A CN 200380106334A CN 1726288 A CN1726288 A CN 1726288A
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Abstract
The invention relates to a vessel for dissolution testing of a pharmaceutical delivery device, comprising: an inert vessel wall and an inert vessel bottom such that the vessel is able to hold a fluid medium; an inert retainer provided by or at the vessel wall or vessel bottom, for holding a pharmaceutical delivery device; and which retainer allows a passageway to the vessel bottom for a sampling tube. The invention further relates to a method for preparing such a vessel; a dissolution method using such a vessel and an apparatus comprising such a vessel.
Description
Technical field
The present invention relates to a kind of container, method and apparatus that is used for the delivery device solubility test, more particularly, relate to this container, the method and apparatus that are used to test the annular pharmaceutical delivery device solvency action, above-mentioned annular pharmaceutical delivery device floats in a kind of fluid medium.
Background technology
Above-mentioned solubility test is well-known in this technology, and " Remington shows: the science of pharmaceutics and put into practice ", the 20th edition, by editors such as Alfonso R.Gennaro, Lippincott, Williams ﹠amp; Wilkens publishes in (2000) book and has done introduction.Solubility test normally carries out during formula of medicine development, stable mensuration, analysis and research, quality control, so that determine by the consistence of criticizing or as proofreading and correct the method for medicine release characteristics in external and the body with it.
US-A-5,412,979 relate to a kind of container, method and apparatus that is used for the solubility test of swellable dosage form, and the dosage form of above-mentioned swellable floats in a kind of fluid medium.Container comprises a disk, and described disk is suitable for engaging wall of container in the about 40 millimeters position of the bottom part of distance container bottom.Disk has an annular collar assembly, and above-mentioned annular collar seals a kind of screen cloth on circumference.The dosage form of swellable remains in the space below screen cloth and the container bottom.
WO-A-9628717 also relates to a kind of solubility test container, and described container comprises an insert screen cloth or grid, in case stand the surface that the prescription of solubility test freely floats over test(ing) medium.In one embodiment, insert screen cloth or grid rest on one or more protuberances, and described protuberance inwardly stretches out from the inside of container.
The existence of screen cloth is disadvantageous when sampling.In addition, the solubility test of delivery device may require sink conditions, and in these cases, screen cloth also is disadvantageous.In order to obtain this state, at duration of test with dissolution vessel emptying and fill fresh dissolve medium more termly.When hand sampling and/or artificial emptying dissolution vessel, can before sampling and/or emptying sample, manually remove screen cloth.Yet this action is pretty troublesome.When automatic sampling and/or automatically during the emptying dissolution vessel, can not be in sampling of the bottom of dissolution vessel and bottom that can not the emptying dissolution vessel.The another one shortcoming is that the screen cloth loosely is clamped in the container, and may change the position during solubility test.The solubility test that the container that comprises screen cloth is used for the heavy dose of form of comparison also is disadvantageous, and above-mentioned more heavy dose of form may compress screen cloth and damage.
Summary of the invention
Therefore, the purpose of this invention is to provide a kind of improved container, method and apparatus that is used for the delivery device solubility test.
The invention provides a kind of container that is used for the delivery device solubility test, comprising:
An inert vessel wall and an inert vessel bottom, so container a kind of fluid medium of packing into;
An inertia retainer, described inertia retainer provides or is located at said vesse wall or container bottom by wall of container or container bottom, be used for delivery device of clamping, and above-mentioned retainer has the passage that stopple coupon leads to container bottom.
The present invention also provides a kind of method that is used to prepare this container, described method comprise with the retainer fusion be glued to wall of container or container bottom on, perhaps one or more pits are added on wall of container or the container bottom.
The present invention also provides a kind of method that is used for the delivery device solubility test, it is characterized in that above-mentioned e Foerderanlage comprises on the medicine and/or the effective amount of medicament of practising contraception, and described method comprises:
A kind of fluid medium and stirring mechanism are put into according to dissolution vessel of the present invention;
One delivery device is put into according to dissolution vessel retainer of the present invention;
Make the stirring mechanism rotation so that the fluid medium in the dissolution vessel is circulated; With
Utilize the fluid medium of a stopple coupon by the selected one or more pre-determined volumes of time sampling.
The present invention also provides a kind of equipment that is used for the delivery device solubility test, comprising:
One or more according to dissolution vessel of the present invention, described dissolution vessel a kind of fluid medium that is suitable for packing into;
One or more stirring mechanisms;
Sampling and/or a discharge equipment with one or more samplings and/or delivery pipe, described device are suitable for the fluid medium share of taking a sample and/or discharging one or more pre-determined volumes in the dissolution vessel; With
Randomly, a filling unit again, described filling unit again is suitable for fluid medium is added in the dissolution vessel.
Description of drawings
Following accompanying drawing is used to illustrate the present invention.Substantially the same element and the element of finishing said function basically all use same label to represent in the drawings, in the accompanying drawing:
Figure 1A is the side sectional view according to dissolution vessel first embodiment of the present invention.
Figure 1B is the top cross-sectional view according to container shown in Figure 1A.
Fig. 2 A is the side sectional view according to dissolution vessel second embodiment of the present invention.
Fig. 2 B is a kind of top cross-sectional view according to container shown in Fig. 2 A.
Fig. 3 A is the side sectional view according to dissolution vessel of the present invention.
Fig. 3 B-3D illustrates the top cross-sectional view according to container shown in Fig. 3 A respectively.
Embodiment
Referring to Figure 1A, the container 1 that is used for solubility test comprises wall of container 2 and container bottom 3, and container can be adorned a kind of fluid medium 4 like this.Wall of container 2 and a kind of inert material of container bottom 3 usefulness are made.So-called inert material refer to a kind ofly in the trial drug e Foerderanlage or with the delivery device of test, do not absorb, reaction or interferential material.In another embodiment, the material of preparation wall of container 2 and/or container bottom 3 is a kind of material transparent.Wall of container 2 and container bottom 3 can be with dissimilar inert materials or with the material manufacturing of same type.In another embodiment, wall of container 2 and container bottom 3 the two all use the inert material manufacturing of same type.In another embodiment, wall of container 2 and container bottom 3 form an integral body, and wherein wall of container 2 becomes container bottom 3 gradually.The example of some suitable materials comprises glass or a kind of inert plastic.In another embodiment, above-mentioned materials is a glass.In a further embodiment, wall of container 2 and container bottom 3 form a transparent bulk glass.
In another embodiment, dissolution vessel 1 is the round shape that has domed bottom.Here, wall of container 2 is as the round shape part of container, and container bottom 3 is as the hemisphere portion of container.The height of dissolution vessel 1 and internal diameter can in very large range change, and can revise like this, so that can pack desirable fluid medium volume into.For example, to describe to the dissolution vessel of the 1 liter of liquid medium of packing into it highly be in the 160mm-210mm scope to American Pharmacopeia and internal diameter is 98-106mm.In one embodiment, the height of dissolution vessel 1 is in the 5-30cm scope, and in another embodiment, it highly is in the 10-25cm scope and In yet another embodiment, highly is in the 10-20cm scope.In another embodiment, the internal diameter of dissolution vessel is in the 2-15cm scope, and in also having another embodiment, its internal diameter is in the 3-11cm scope, and In yet another embodiment, its internal diameter is in the 5-8cm scope.
Container 1 a kind of fluid medium 4 of packing into.Fluid medium can be any medium that is suitable for solubility test, comprising for example organic solvent such as alkane alcohols and ester class; Water; Acidic solution is such as aqueous hydrochloric acid; And phosphate buffered saline buffer.Fluid medium can be selected based on the character and the point of destination of delivery device 8.For example, can use a kind of fluid medium 4, described fluid medium 4 is simulated gastric fluid or intestinal juice.In another embodiment, liquid medium 4 can be selected from following one group of fluid, and described this group fluid comprises: water; Diluted hydrochloric acid aqueous solution, the HCl solution in 0.001-0.5N HCl scope for example, and in also having another embodiment, be the HCl solution in the scope of 0.01-0.1N HCl; And phosphate buffered saline buffer.In yet another embodiment, fluid medium is a water.The pH value of fluid medium can in very large range change.In one embodiment, the pH value is in the 1-12 scope, and in another embodiment, the pH value is in the 1-8 scope.In another embodiment, the pH value of the pH value of fluid medium 4 simulation dissolved point of destination in human body.For example, in order to imitate the environment of stomach, can be about 1 fluid medium 4 with the pH value; With in order to imitate the pH value of enteric cavity, can use about 6.6 pH value.
Be provided with a retainer 5 (seeing Figure 1A) by wall of container 2 or container bottom 3 or at said vesse wall 2 or container bottom 3 places; 6 (Fig. 2 A); With 7 (Fig. 3 A), described retainer 5; 6; 7 are intended for clamping delivery device 8 (Figure 1A) and described retainer has the passage that leads to container bottom 3 that can be used for a stopple coupon.The size of retainer is like this, so that delivery device can keep immersing in the dissolve medium in the mode that is fit to.
In one embodiment, retainer comprises an annular plate (seeing 5 among Figure 1A and Figure 1B), and described annular plate is included in a passage 9 that is used for stopple coupon at middle part, and annular plate 5 is placed in the dissolution vessel 1, is placed on wall of container 2 places.Annular plate 5 can be made with any inert material, but it is to make with inert plastic, glass, stainless steel or their a kind of combination in another embodiment.In yet another embodiment, annular plate 5 usefulness glass are made.Annular plate 5 can comprise a plurality of holes 10, so that provide the fluid medium 4 of annular plate 5 tops to contact with the better of fluid medium 4 of annular plate 5 belows.
The width of annular plate is unimportant, and can be selected like this, so that can the desirable delivery device 8 of clamping.In one embodiment, width is in the 0.2-6cm scope, and in another embodiment, width is in the 0.5-3cm scope, and In yet another embodiment, width is in the 0.5-2cm scope.The passage 9 at annular plate 5 middle parts has a diameter, and described diameter provides a smooth passage that is used for stopple coupon.Therefore in another embodiment, the diameter of passage 9 is 1cm at least, and In yet another embodiment, and the diameter of passage 9 is 2cm at least; In yet another embodiment, the diameter of passage is 3cm at least.In another embodiment, use diameter up to 20cm; In another embodiment, use diameter up to 10cm, and In yet another embodiment, use diameter up to 6cm.Yet using the shortcoming of the annular plate 5 that separates as mentioned above is that retainer is assemblied in the dissolution vessel 1 loosely, and can change the position during solubility test.
In another embodiment, retainer itself is provided by wall of container 2 or container bottom 3, that is to say, it for good and all is fixed on wall of container 2 or the container bottom 3.In another embodiment, this retainer is provided by wall of container 2, and it is lateral that part of that wall of container 2 is regarded formation container (being vertical basically) as herein.This retainer 6 (seeing Fig. 2 A); Can have any shape that is suitable for clamping one delivery device 8 and can be used for the passage that leads to container bottom 39 of stopple coupon with 7 (Fig. 3 A).The diameter range of suitable passage 9 comprises above-mentioned those diameters.In one embodiment, retainer comprises one or more protuberances or flange 6 (seeing Fig. 2 A and 2B); One or more bumps 7 (are seen Fig. 3 A; Fig. 3 B; With Fig. 3 C); One or more uncinus (not shown) or their a kind of combination.Annular protruding portion or flange 6, bump 7 or uncinus all inwardly stretch out from wall of container 2 or container bottom 3.It is to make the contact between retainer and the tried delivery device 8 keep minimum that bump 7 and uncinus have another advantage.
In another embodiment, two elements that provided by wall of container 2 or container bottom 3 are provided retainer, i.e. a top element and a following element.In yet another embodiment, these two elements inwardly stretch out from wall of container 2 or container bottom 3.In one embodiment, retainer comprises two annular protruding portions or flange 6a and 6b (seeing Fig. 2 A) or two groups of bump 7a and 7b (seeing Fig. 3 A); Top annular protruding portion or flange 6A or top one group of bump 7a and following protuberance or flange 6b or following one group of bump 7b.
In another embodiment, every group of bump or uncinus comprise 2-50 bump or uncinus, in another embodiment, every group comprises 2-10 bump or uncinus and comprise 3-5 bump or uncinus in also having another embodiment.In another embodiment, one group of interior bump 7 mutual equidistant setting.
This is external to also have among another embodiment, above one group of bump 7a (seeing Fig. 3 A and Fig. 3 B) be arranged on the position that becomes to interlock with following one group of bump 7b (seeing Fig. 3 A and Fig. 3 D).In another embodiment, between top annular protruding portion or flange 6a and following annular protruding portion or the flange 6b, distance perhaps between one group of bump 7a and the following one group of bump 7b is like this, so that delivery device 8 can be clamped between them by loosely.In one embodiment, this distance is in the 0.5-4cm scope, and in another embodiment, this distance is in the 1-3cm scope.
As mentioned above, delivery device 8 can be arranged between two annular protruding portions or the flange 6 (seeing Fig. 2 A); Between two groups of bumps 7 (seeing Fig. 3 A); Perhaps in one group of uncinus.The width of annular protruding portion or flange is selected like this, so that can the desirable delivery device 8 of clamping.In one embodiment, the width of this annular protruding portion or flange 6 is in the 0.05-3cm scope, and in another embodiment, this width is in the 0.1-2cm scope, and In yet another embodiment, width is in the 0.2-1.5cm scope.Equally, bump 7 or the uncinus height on the direction of inwardly stretching out perpendicular to wall of container 2 or wall of container 3 can be selected like this, so that can the desirable delivery device 8 of clamping.In one embodiment, above-mentioned height is in the 0.05-3cm scope, and in another embodiment, above-mentioned height is in the 0.1-1.5cm scope, and In yet another embodiment, above-mentioned height is in the scope of 0.2-1.0cm.
Retainer 6; 7 can be permanently attached on wall of container 2 or the container bottom 3 by for example gluing or scorification after dissolution vessel 1 itself has created.Alternatively, retainer 6; 7 can be permanently attached on wall of container 2 or the container bottom 3 during making dissolution vessel itself.In this embodiment, retainer can be and the identical or different material of material of making wall of container 2 or container bottom 3.In another embodiment, retainer and wall of container 2 or container bottom 3 identical materials manufacturing be with glass or a kind of inert plastic manufacturing in another embodiment, and material are to make with glass In yet another embodiment.
In another embodiment, retainer is the wherein part of wall of container 2 or container bottom 3, and is provided by one or more pits of wall of container or container bottom.This pit can be circular, forms a kind of annular protruding portion or flange 6 simultaneously; Or point, form a kind of bump 7 simultaneously.Above-mentioned pit or a plurality of pit apply after can or making during dissolution vessel 1 is made.
Therefore the present invention also provide a kind of by as mentioned above with the retainer fusion be glued to wall of container or container bottom on, perhaps prepare method according to dissolution vessel of the present invention by in wall of container or container bottom, adding one or more pits as mentioned above.
In another embodiment, pit is heated to a high temperature that makes the material deliquescing by the material with wall of container 2 or container bottom 3; Subsequently above-mentioned materials inwardly is pressed to enough degree and applies pit.In also having another embodiment, retainer comprises two groups by wall of container 2 or container bottom 3 formed 3 bump 7a and 7b (seeing Fig. 3 A), that is organizes above one and organize below one, and the two is in staggered position.
Be suitable for testing the solvency action of wide region delivery device 8 according to container of the present invention.Yet, especially be suitable for the solvency action that test has the delivery device of an annular shape (that is a kind of ring device) according to container of the present invention.The external diameter of annular pharmaceutical delivery device and thickness can in very large range change.In one embodiment, external diameter is in the 3-10cm scope, and in another embodiment, external diameter is in the 4-8cm scope; And in another embodiment, thickness is in the 0.1cm-1cm scope and in another embodiment, and thickness is in the 0.2cm-0.7cm scope.In another embodiment, a kind of flexible material of annular pharmaceutical delivery device 8 usefulness is made, so they can be easy to be placed in retainer 5; 6; 7 inside.In one embodiment, when testing the solvency action of this annular pharmaceutical delivery device, the internal diameter that uses according to container of the present invention is bigger slightly than the external diameter of annular pharmaceutical delivery device, be 1.0001 wherein: 1-1.5: in 1 the scope according to the two ratio of the external diameter of the internal diameter of dissolution vessel of the present invention and annular pharmaceutical delivery device, and in another embodiment, above-mentioned ratio is 1.005: 1-1.1: in 1 the scope.
Also especially be suitable for the solubility test of annular pharmaceutical delivery device according to dissolution vessel of the present invention, above-mentioned annular pharmaceutical delivery device floats in the fluid medium.This unsteady trend may for example be because the composition of used non-activity causes.In one embodiment, annular pharmaceutical delivery device is a kind of flexible circular delivery device that comprises at least one compartment, this compartment comprises a thermoplastic polymer core and a thermoplastic polymer crust that covers above-mentioned core, above-mentioned core comprises the mixture of a kind of progestogenic compounds and estrogen compound, and permeable above-mentioned progestogenic compounds of above-mentioned crust and estrogen compound.
Especially some examples of the annular pharmaceutical delivery device that is fit to according to dissolution vessel of the present invention are included in the annular pharmaceutical delivery device of introducing among for example US-A-5989581, WO-A-97/02015, US-A-4237885, EP-A-0876815, EP-A-0050867, US-A-4292965, the US-A-4596576 etc., and their are in conjunction with as reference of the present invention.
Except above-mentioned situation, one or more stirring mechanisms 11 can be arranged.These stirring mechanisms 11 can be known any stirring mechanisms in this technology, are used for the fluid medium of stirring and dissolving container, and comprise for example agitating vane and magnetic stirring apparatus.In a specific embodiment, use magnetic stirring apparatus.
The present invention also provides a kind of method that is used for the delivery device solubility test, and above-mentioned e Foerderanlage is equipped with a kind of medicine and/or the effective amount of medicament of practising contraception, and described method comprises:
A kind of fluid medium and stirring mechanism are placed in one according in the dissolution vessel of the present invention;
A delivery device is placed in the retainer according to dissolution vessel of the present invention;
Make the stirring mechanism rotation so that the fluid medium in the dissolution vessel is circulated;
With the fluid medium of a stopple coupon with the selected one or more pre-determined volumes of time sampling.
Delivery device can be known any e Foerderanlage in this technology, but in a specific embodiment, it is aforesaid a kind of circular conveyor.In another embodiment, delivery device is a kind of circular conveyor described in US-A-5989581.
Fluid medium can be any fluid medium that is suitable for solubility test.Yet in another embodiment, it is aforesaid a kind of fluid medium.In another embodiment, the fluid medium that uses water as.The amount of used fluid medium can be selected like this, measures so that can carry out the dissolving of concrete drug concentration in delivery device.In one embodiment, volume is in the 25-1000ml scope, and in another embodiment, volume is in the 50-500ml scope.In also having another embodiment, use volume to be 100ml or 200ml.The temperature of fluid medium can in very large range change, but in another embodiment, and the body temperature class Sihe of it and human body is in 36 ℃ of-38 ℃ of scopes, and In yet another embodiment, temperature is in 36.5 ℃ of-37.5 ℃ of scopes.The temperature of fluid medium can keep with known any method in this technology, and aforesaid method comprises and for example utilizes water-bath or utilize heating jacket.
Suitable stirring mechanism as mentioned above.
Fluid medium is taken a sample with stopple coupon.Sample time can be selected like this, so that take out the sample of q.s at medicine from delivery device process time of releasing.Precise time will depend at interval the time of releasing of medicine from delivery device.For example, if test abrupt release e Foerderanlage, then the timed interval can for example be in 1 minute to 1 hour scope.If the e Foerderanlage that test slowly discharges, then these timed intervals can for example be in 0.5 hour to 48 hours scope.According to the purpose of solubility test, sampling can only be carried out once or often carry out repeatedly.In one embodiment, fluid medium is only taken a sample once, and it is to take a sample afterwards in medicine has discharged the 50-100% scope.In another embodiment, fluid medium be at medicine during delivery device time of releasing in the sampling 1-30 underrange, in another embodiment, the fluid medium sampling is in the 3-20 underrange, and the fluid medium sampling is in the 4-15 underrange In yet another embodiment.
Obtain the crust state if desired, then in another embodiment, add the step of after sampling, discharging in the dissolution vessel whole fluid mediums and refilling full dissolution vessel with the fresh fluid medium.Fluid medium can be discharged from dissolution vessel by a delivery pipe.Equally, dissolution vessel can fill pipe again by one and fill the fresh liquid medium.In another embodiment, when needs, aforesaid stopple coupon can be used as delivery pipe and/or tubulature again.
The sample of being got is analyzed, so that determine at sampling drug concentration constantly.Can after having got all samples, analyze, but in another embodiment, be the analysis of after sampling, directly carrying out sample sample.Can be with known any suitable methods analyst sample in this technology.Some examples of possible analytical technology comprise fluorescent method, indirect or direct ultraviolet (UV) method, infrared (IR) method, refractometry, scattering technology, near infrared (NIR) method, electrochemical techniques and/or Raman (Raman) spectrography technology.
In addition, the invention provides a kind of equipment that is used for the delivery device solubility test, described equipment comprises:
One or more according to dissolution vessel of the present invention, described dissolution vessel is suitable for the fluid medium of packing into;
One or more stirring mechanisms;
The fluid medium share that sampling and/or discharge equipment with one or more samplings and/or delivery pipe, described device are suitable for from dissolution vessel sampling and/or discharge one or more pre-determined volumes; With
Preferably, a kind of filling unit again, described filling unit again is suitable for fluid medium is added in the dissolution vessel.
The fluid medium share that sampling and/or discharge equipment can be used for taking out a pre-determined volume is used for analysis purposes, and the share that perhaps is used for taking out a series of pre-determined volumes is used for the whole fluid mediums of discharging from dissolution vessel.In another embodiment, discharge equipment and again filling unit be same device, this device can just be transferred to fluid medium predetermined exhaust position and fluid medium is transferred to dissolution vessel from a predetermined storage location from dissolution vessel towards two opposite direction operations.
Can be used for comprising equipment except analytical equipment according to equipment of the present invention.Analytical equipment can be a kind of device that is used for measuring by fluorescent method, ultraviolet (UV) method, infrared (IR) method, near infrared (NIR) method, electrochemical process and/or raman spectroscopy fluid medium sample drug concentration.
Aforesaid device can manually or automatically be operated.Yet in another embodiment of the present invention, aforesaid device is automatic operation, motor operation stirring mechanism, sampling and/or discharge equipment that one of them is controlled by computer installation and/or filling unit again.In another embodiment, any sample is all further transferred to analytical equipment automatically, herein they is analyzed automatically.In yet another embodiment, analytical data is collected automatically by computer installation subsequently, and In yet another embodiment, analytical data is observed automatically by same computer installation.
Top some examples that provide do not mean it is unique.Many changes of the present invention all are very conspicuous concerning those skilled in the art, and above-mentioned many variations are planned all to be included in the appending claims.
Claims (11)
1. container that is used for the delivery device solubility test comprises:
An inert vessel wall and an inert vessel bottom, so container a kind of fluid medium of packing into;
An inertia retainer, described inertia retainer provides or is located at said vesse wall or container bottom by wall of container or container bottom, be used for delivery device of clamping, and above-mentioned retainer has the passage that stopple coupon leads to container bottom.
2. according to the described container of claim 1, it is characterized in that wall of container and container bottom form a transparent bulk glass part together.
3. according to claim 1 or 2 described containers, it is characterized in that retainer comprises an annular plate, described annular plate is included in a passage that is used for stopple coupon at middle part, and annular plate is placed in internal tank wall of container place.
4. according to claim 1 or 2 described containers, it is characterized in that retainer is permanently attached on wall of container or the container bottom.
5. according to claim 1 or 2 described containers, it is characterized in that retainer comprises one or more annular protruding portions or flange; One or more bumps; And above-mentioned annular protruding portion or flange or bump inwardly stretch out from wall of container or container bottom.
6. according to claim 1 or 2 described containers, its feature comprises two groups of bumps at retainer, and described two groups of bumps are formed by the inside pit of wall of container or container bottom.
7. according to claim 1 or 2 described containers, it is characterized in that comprising that one is provided or be located at the retainer of wall of container or container bottom by wall of container or container bottom, can flexible annular pharmaceutical delivery device of clamping with above-mentioned retainer.
8. according to the described container of claim 8, it is characterized in that the flexible circular delivery device comprises at least one compartment, described compartment comprises a thermoplastic polymer core and covers the thermoplastic polymer crust of above-mentioned core, above-mentioned core comprises the mixture of a kind of progestogenic compounds and estrogen compound, and above-mentioned outer micromicro is used for infiltration progestogenic compounds and estrogen compound.
9. method that is used to prepare according to one of them described container of claim 4-6, it is characterized in that comprising with a retainer fusion be glued to wall of container or container bottom on, perhaps one or more pits are added on wall of container or the container bottom.
10. a method that is used for the delivery device solubility test is characterized in that above-mentioned e Foerderanlage comprises on the medicine and/or the effective amount of medicament of practising contraception, and described method comprises:
A kind of fluid medium and stirring mechanism are put into one of them described dissolution vessel according to claim 1-9;
One delivery device is put into one of them described dissolution vessel retainer according to claim 1-9;
Make the stirring mechanism rotation so that the fluid medium in the dissolution vessel is circulated; With
Utilize the fluid medium of a stopple coupon by the selected one or more pre-determined volumes of time sampling.
11. an equipment that is used for the delivery device solubility test comprises:
One or more according to one of them described dissolution vessel of claim 1-9, described dissolution vessel a kind of fluid medium that is appropriate to pack into;
One or more stirring mechanisms;
Sampling and/or a discharge equipment with one or more samplings and/or delivery pipe, described device are suitable for the fluid medium share of taking a sample and/or discharging one or more pre-determined volumes in the dissolution vessel; With
Randomly, a filling unit again, described filling unit again is suitable for fluid medium is added in the dissolution vessel.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US43367602P | 2002-12-16 | 2002-12-16 | |
| EP02102772.7 | 2002-12-16 | ||
| US60/433,676 | 2002-12-16 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1726288A true CN1726288A (en) | 2006-01-25 |
| CN100482804C CN100482804C (en) | 2009-04-29 |
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| CNB2003801063347A Expired - Fee Related CN100482804C (en) | 2002-12-16 | 2003-12-09 | Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device |
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| CN106770957A (en) * | 2016-12-26 | 2017-05-31 | 重庆中烟工业有限责任公司 | One tobacco articles oral cavity dissolving-out analog device |
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| US3801280A (en) * | 1971-11-11 | 1974-04-02 | Upjohn Co | Solubility-dissolution test apparatus and method |
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