CN103933018A - Transdermal drug delivery system - Google Patents
Transdermal drug delivery system Download PDFInfo
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- CN103933018A CN103933018A CN201310018412.3A CN201310018412A CN103933018A CN 103933018 A CN103933018 A CN 103933018A CN 201310018412 A CN201310018412 A CN 201310018412A CN 103933018 A CN103933018 A CN 103933018A
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Abstract
The invention relates to a transdermal drug delivery system having a structure with two layers namely a drug storage layer and a sticking layer. The drug is stored in the drug storage layer in an over-saturated state. The matrix materials of the drug storage layer and the sticking layer are chosen from polyacrylate, polysiloxane and polyisobutylene, and are not the same material at the same time. The transdermal drug delivery system can realize the constant drug releasing.
Description
Technical field
The present invention relates to transdermal drug delivery system, particularly refer to the transdermal drug delivery system with drug storehouse layer and adhered layer.
Background technology
In passive-type transdermal drug delivery system in early days, medicine is wherein to using that Concentraton gradient is poor to be realized in human body skin and body and transport medicine as main power.Medicine dissolution, in so-called drug storehouse layer or hypothallus, has in the transdermal patch of adhered layer and drug storehouse layer at the same time, and adhered layer generally also can contain a small amount of medicine.But the medicine of such paster in being applied to human body skin bak stay will reduce gradually along with the prolongation of its service time, and its Concentraton gradient presents obvious variation, and the medicine-feeding rate of medicine will slow down, and be difficult to reach the object of constant-rate administration.
Although people have developed again initiatively transdermal drug delivery system subsequently, initiatively often cost is high for transdermal drug delivery system, manufactures difficulty, and use procedure is complicated, and price is also too high, is difficult to generally be used.
Summary of the invention
In order to make passive-type transdermal drug delivery system, realize real constant-rate administration; the inventor has developed a kind of transdermal drug delivery system of double-layer structure, and this transdermal drug delivery system is followed successively by backing layer, drug storehouse layer, adhered layer and protective layer according to the order being applied to after human body from outside to inside.Wherein the matrix binder in backing layer and drug storehouse layer is different high molecular polymer, be selected from respectively polyisobutylene, polyacrylate, polysiloxanes, be preferably drug storehouse layer host material and adopt polyacrylate, and adhered layer host material adopts polysiloxanes or polyisobutylene, especially be preferably drug storehouse layer host material and adopt polyacrylate, sticking layer host material adopts polysiloxanes.Fig. 1 is by above-mentioned 3 kinds of polymer, and the schematic diagram of the transdermal patch of the present invention that is prepared from of polyacrylate, polysiloxanes or polyisobutylene, according to the difference of drug storehouse layer-adhered layer, having 6 kinds of combinations, is respectively polyacrylate-polysiloxanes, polyacrylate-polyisobutylene, polysiloxanes-polyacrylate, polysiloxanes-polyisobutylene, polyisobutylene-polyacrylate, polyisobutylene-polysiloxanes.
One of object of the present invention is in order to realize the constant release of transdermal drug delivery system Chinese medicine, and in order to achieve this end, the medicine in the drug storehouse layer of transdermal drug delivery system of the present invention before use with use procedure in all the time in over-saturation state.Medicine in the present invention can or be partly dissolved partially crystallizable or aggregated forms and present on the whole super-saturated state and be present in drug storehouse layer with the astable over-saturation state after dissolving.For being present in the medicine in drug storehouse layer with partially crystallizable or aggregated forms, the crystallization of medicine or aggregated forms can be in use along with the minimizing of the medicine of the dissolved wherein and dissolve, and supplement and to enter drug storehouse layer substrate and to maintain its saturation, by drug storehouse layer, enter adhered layer again, then realize the release to human body.
In the present invention, the medicine being stored in drug storehouse layer may exist with the form of crystallization.But a lot of medicines have multiple crystal formation, and each crystal formation has different thermodynamic parameters, shows different stability.When this kind of medicine, in drug storehouse layer, take hypersaturated state crystallization during as crystal formation, may exist with certain disadvantageous crystal formation, and this crystal formation has stronger stability, be difficult for being dissolved into again in drug storehouse layer substrate.For such medicine, can make it with the over-saturation state all dissolving, be present in drug storehouse layer and not produce crystallization.Now, just need to use crystallization inhibitor.Certainly, also can consider to use a large amount of dissolution accelerators in drug storehouse layer.Or use crystallization inhibitor and dissolution accelerator simultaneously, in fact, have some materials itself just to have the effect that suppresses crystallization and promote to dissolve simultaneously, such material is preferred object of the present invention just, as multiple polyvinylpyrrolidone.
Another object of the present invention is to realize the controllability of drug release.In order to achieve this end, the adhered layer thickness in the present invention can be adjusted as required.Generally speaking, when adhered layer thinner, the time that medicine is transported to human body from drug storehouse layer is just shorter, and on the contrary when adhered layer is thicker, the time that medicine is transported to human body from drug storehouse layer is just longer, the length of adhered layer and transhipment time is proportional relation in the ideal situation, some and binding agent is had to interactional medicine and just present positive correlation, and its magnitude relationship curve needs by experiment could Accurate Determining.Adhered layer in the present invention and the drug storehouse layer of medicine in over-saturation state laminating rear closely stick on together with, for the speed under the prerequisite realizing medicine constant release controlled, can be by regulating the thickness of adhered layer realize the control of medicine-feeding rate.
Active component in Percutaneously administrable preparation of the present invention is the medicine that medicine preferred small-molecule substance, especially pharmacodynamics effect are strong or potency is high, as medicine for central nervous system.
Active component in the present invention includes but not limited to following medicine:
Beta-adrenaline excitant, as albuterol, carbuterol, clenbuterol, clorprenaline, denopamine, dopexamine, ephedrine, epinephrine, l-.alpha.-[1-(ethylmethylamino)ethyl, ethylnorephinephrine, fenoterol, formoterol, Mabuterol, metaproterenol, methoxyl group phenylpropyl alcohol methylamine, pirbuterol, prenalterol, xamoterol, terbutaline, MJ-1992; MJ-1992, protokylol, procaterol, prenalterol.
Beta adrenergic blocker, as acebutolol, alprenolol, amosulalol, arotinolol, befunolol, betaxolol, bevantolol, bisoprolol, bucumolol.
Analgesic, as methaform, alfentanil, anileridine, benzylmorphine, Lepetan, butorphanol, codeine, dihydrodesoxymorphine, paracodin, paramorphane, ethylmorphine, fentanyl, morphine, acetaminophen, acetyl salicyl salicylic acid etc.
Cardiovascular drugs, as amlodipine, isosorbide, isradipine, limaprost, Betagon, nifedipine, Impeasel, nitroglycerin, Oxyfedrine, ozagrel.
Antihypertensive, as: clonidine, amosulalol.
Androgen, as: clausterone, dromostanolone propionate, epitiostanol, mepitiostane, testolactone.
Androgen antagonist, as: flutamide, nilutamide, tamoxifen, toremifene, finasteride etc.
Estrogen: benzestrol, chlorotrianisene, dienestrol, diethylstilbestrol, dimestrol, fosfestrol, hexestrol, methallenestril, promethestrol, 16.alpha.-hydroxyestrone diacetate, (.+-.)-Equilenin., horse alkene female (steroid) ketone, estradiol, estradiol benzoate, estriol, estrone, ethinylestradiol, norquen mestranol, moxestrol, mytatrienediol, quinestradol, alkynes are female.
Estrogen antagonist: zitazonium, toremifene
Antiparkinsonism drug, as: Buddha's warrior attendant (alkane) amine, benserazide, bietanautine, akineton, bromocriptine, Budipine, carbidopa, selegiline, dexamfetamine, diethazine, droxidopa, ethylbenzhydramine, levodopa, naxagolide, pergolide, piroheptine, pridinol, prodipine.
Psychosis: bromperidol, benperidol, droperidol, haloperidol, moperone, pipamperone, timiperone, psychoperidol, acephenazine, chlorproethazine, chlorpromazine, 8-［3-(2-chloro-10-phenothiazinyl)propyl］-3-oxo-1-thia-4,8-diazaspiro［4.5］decane., cyamemazine, dixyrazine, fluphenazine, imiclopazine, mepazine, mesoridazine, oxaflumazine, perazine, periciazine, perphenazine, pipenzolate bromide, promazine, sulforidazine, thiopropazate, thioridazine, chlorprothixene, clopenthixol, thiothixene, benzquinamide, carbadipimidine, clocapramine, clomacrane, clotiapine, clozapine, opipramol, prothipendyl, tetrabenaine.
Local anesthetic, as lignocaine, procaine, tetracaine, bupivacaine.
Other also can be used for medicine of the present invention also has: huperzine A, Rivastigmine, granisetron, galantamine.
In the preparation process of transdermal patch of the present invention, medicine is with hypersaturated state, dissolve or be uniformly distributed in drug storehouse layer substrate in advance.According to the character of medicine, medicine is dissolved in drug storehouse layer and can adopts the conventional technology in this area with hypersaturated state.As thermosol technology, cold cut technology, by adding cosolvent to system, carries out ultra fine to medicine, solid compacting etc.The present invention preferably completes the preparation of medicine supersaturation drug storehouse layer by thermosol or hydrotropy.
The matrix binder of drug storehouse layer of the present invention and adhered layer is selected from polyacrylate, polysiloxanes, polyisobutylene, and preferred version is that drug storehouse layer is polyacrylate, and adhered layer is polysiloxanes.Because polyacrylate all has larger drug loading to multi-medicament, be particularly suitable for drug storehouse layer of the present invention.The polyacrylate can be used in the present invention can select the Duro-tak of commercially available prod serial, as Duro-tak87-2287, and Duro-tak87-8252, Duro-tak87-2677, Duro-tak87-2051, Duro-tak87-2052, Duro-tak87-2054, Duro-tak87-2510, Duro-tak87-2516, Duro-tak87-2515, Duro-tak87-2825, the models such as Duro-tak87-200A, but be not limited to above-mentioned model.Palyacrylate binder in drug storehouse layer of the present invention also can be synthetic voluntarily by those skilled in that art, and monomer wherein can be selected from ethyl acrylate, 2-EHA, Isooctyl acrylate monomer, butyl acrylate, vinyl acetate, acrylic acid methyl ester., styrene, ethylene nitrile, methacrylic acid C
1-10arrcostab, also can add monomer, as (Yang Yu Definition such as (methyl) acrylic acid, (methyl) acrylamide, (methyl) propenoic acid beta-hydroxy ethyl ester, (methyl) propenoic acid beta-hydroxy propyl ester, (methyl) glycidyl acrylate, N hydroxymethyl acrylamide, divinylbenzene, maleic acid, maleic anhydrides, < < pressure-sensitive adhesive > >, Science Press, publish in June, 1994,149-150 page).The polyacrylate using in the present invention is particularly preferably formed by butyl acrylate, Isooctyl acrylate monomer, vinyl acetate, acrylamide and α-methacrylic acid monomer copolymerization.
Polysiloxanes generally has less drug loading, is preferred in the present invention adhered layer.Polysiloxanes in the present invention is selected from but is not limited to following commercially available prod:
BI0-PSA X7-3027, X7-4919, X7-2685, X7-3122, X7-4603, X7-4301, X7-4303, X7-4603, X7-4919, Q7-4503, Q7-4501, Q7-4502 etc.
Polyisobutylene in the present invention can be selected from the commercially available product that can be used for transdermal patch, as the PIB Oppanol B1 of BASF AG, and PIB Oppanol B10, PIB Oppanol B100, the Vistanex PIB LM-MH of Exxon chemical Co. etc.
The present invention can increase the dissolubility of medicine in above-mentioned polyacrylate by the mode of heating, make the substrate coating mixture that contains supersaturation medicine, then carry out heat coating, coating mixture is coated on backing layer, then through suitably dry laminating on backing layer, make drug storehouse layer.Supersaturation medicine in drug storehouse layer may keep hypersaturated state and non-crystallizable under the effect of crystallization inhibitor, also may some medicine at drug storehouse layer, be cooled to crystallization in normal storage process in the process of normal storage temperature or thereafter.
The present invention also can be by conventional coating method in cold coating or other this areas, and the difference of itself and heat coating is just that medicine for the initial mixing substrate of drug storehouse layer coating is in hypersaturated state.
The transdermal patch that drug storehouse layer of the present invention contains supersaturation medicine, it also contains adhered layer, the matrix binder material of adhered layer is different with the matrix binder material of drug storehouse layer, but be to be selected from a kind of in polyacrylate, polysiloxanes and polyisobutylene equally, it selects the scope of host material is the same with drug storehouse layer.If the matrix binder material selection of drug storehouse layer polyacrylate, the matrix binder material of adhered layer just can not re-use polyacrylate, but selects polysiloxanes or polyisobutylene, by that analogy.This is in order to prevent that this transdermal patch from the excessive migration of medicine occurring in storage process, destroys the hypersaturated state of drug storehouse layer Chinese medicine.And, for being become, the transdermal process of medicine is easy to carry out, and generally adhered layer is difficult for blocked uply, and its thickness can be 1/4～1/2 of drug storehouse layer.And preferably do not add wherein in the preparation medicine, but also can add a small amount of primary quantity medicine.
The inventor has drawn the cumulative release curve chart of medicine with the release data of specific embodiment of the invention embodiment 4, see Fig. 2, the parabola of the open semi to the right form manifesting with respect to the cumulative release Curves of common passive-type transdermal drug delivery system, release profiles of the present invention is more tending towards straight line.
Accompanying drawing explanation
A in accompanying drawing 1 refers to drug storehouse layer, and B refers to adhered layer.Below the rectangle of three kinds of different shadings represent that respectively drug storehouse layer or hypothallus substrate are polyacrylate, polysiloxanes, polyisobutylene.
Accompanying drawing 2 is the cumulative release curve with respect to common passive-type transdermal drug delivery system, the drug accumulation releasing curve diagram (being tending towards straight line) of the embodiment of the present invention 4
the specific embodiment
Table 1. embodiment 1～4 formula (every 1000)
Note: the unit of above-mentioned each amounts of components be " gram ".
Embodiment 1
According to the 1 drug-reservoir layer of embodiment in table 1 and adhered layer each component weight fraction another name, measure each component.Each component of drug-reservoir layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on backing layer material with 0.65mm thickness, and it is standby that 40 ℃ of temperature lucifuge oven dry are cooled to room temperature in 2 hours; Each component of adhered layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on antiseized protective layer material with 0.30mm thickness, and it is standby that 40 ℃ of temperature lucifuge oven dry are cooled to room temperature in 2 hours; By above-mentioned, prepare the two-part adhered layer of gained and drug storehouse layer is compound through mould, is die-cut into 2.5cm
2specification embodiment 1 percutaneous plaster, with aluminum plastic film pack keep in Dark Place standby.
Embodiment 2:
According to the 2 drug-reservoir layers of embodiment in table 1 and adhered layer each component weight fraction another name, measure each component.Each component of drug-reservoir layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on backing layer material with 0.45mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; Each component of adhered layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on antiseized protective layer material with 0.20mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; By above-mentioned, prepare the two-part adhered layer of gained and drug storehouse layer is compound through mould, is die-cut into 2.5cm
2specification embodiment 2 percutaneous plasters, with aluminum plastic film pack keep in Dark Place standby.
Embodiment 3:
According to the 3 drug-reservoir layers of embodiment in table 1 and adhered layer each component weight fraction another name, measure each component.Each component of drug-reservoir layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on backing layer material with 0.70mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; Each component of adhered layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on antiseized protective layer material with 0.20mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; By above-mentioned, prepare the two-part adhered layer of gained and drug storehouse layer is compound through mould, is die-cut into 2.5cm
2specification embodiment 3 percutaneous plasters, with aluminum plastic film pack keep in Dark Place standby.
Embodiment 4:
According to the 4 drug-reservoir layers of embodiment in form 1 and adhered layer each component weight fraction another name amount.Each component of drug-reservoir layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on backing layer material with 0.50mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; Each component of adhered layer weighing is through fully mixing after homogenizing, and colloid mixture is coated on antiseized protective layer material with 0.20mm thickness, and it is standby that 60 ℃ of temperature oven dry are cooled to room temperature in 2 hours; By above-mentioned, prepare the two-part adhered layer of gained and drug storehouse layer is compound through mould, is die-cut into 2.5cm
2specification embodiment 4 percutaneous plasters, with aluminum plastic film pack keep in Dark Place standby.
Experimental example:
Complete above-described embodiment 1～4 percutaneous plaster and prepare after 1 month, from above-mentioned four kinds of percutaneous plasters, randomly draw respectively 10.Remove wherein the 4 antiseized protective layers of putting up sheet, in 400 times of optical microphotograph Microscopic observation pasters, whether adhered layer Chinese medicine occurs that crystal separates out phenomenon.
Claims (8)
1. a transdermal drug delivery system; by its hierarchical structure; comprise backing layer, drug storehouse layer, adhered layer and protective layer; it is characterized in that storing and use procedure in active component with hypersaturated state, be present in drug storehouse layer, and its drug storehouse layer and adhered layer are to be selected from but one of binding agent of mutually different following three kinds of polymer: polyacrylate, polysiloxanes, polyisobutylene.
2. the transdermal drug delivery system of claim 1, is characterized in that this transdermal drug delivery system does not contain active component or only contains a small amount of active component in its adhered layer in the preparation.
3. the transdermal drug delivery system of claim 1, it is characterized in that the crystal or other accumulation shapes that contain active component in the drug storehouse layer of this transdermal drug delivery system, and dissolved substance exists with hypersaturated state.
4. the arbitrary transdermal drug delivery system of claim 1～3, it is characterized in that the drug storehouse layer of this transdermal drug delivery system is usingd polyacrylate as host material, and adhered layer is usingd polysiloxanes as host material.
5. the arbitrary transdermal drug delivery system of claim 1～3, it is characterized in that the drug storehouse layer of this transdermal drug delivery system is usingd polyacrylate as host material, and adhered layer is usingd polyisobutylene as host material.
6. the arbitrary transdermal drug delivery system of claim 1～3, it is characterized in that the drug storehouse layer of transdermal drug delivery system is usingd polyisobutylene as host material, and adhered layer is usingd polysiloxanes as host material.
7. the arbitrary transdermal drug delivery system of claim 1～3, wherein the ratio of the thickness of drug storehouse layer and adhered layer is 2: 1～4: 1.
8. the arbitrary transdermal drug delivery system of claim 1～7, active component is wherein selected from clonidine, Lepetan, granisetron, Rivastigmine.
Priority Applications (1)
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| CN201310018412.3A CN103933018A (en) | 2013-01-18 | 2013-01-18 | Transdermal drug delivery system |
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| CN201310018412.3A CN103933018A (en) | 2013-01-18 | 2013-01-18 | Transdermal drug delivery system |
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| CN103933018A true CN103933018A (en) | 2014-07-23 |
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| CN201310018412.3A Pending CN103933018A (en) | 2013-01-18 | 2013-01-18 | Transdermal drug delivery system |
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Cited By (2)
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| CN108738309A (en) * | 2015-11-23 | 2018-11-02 | 诺迪克控股公司 | Form the spray of localized membrane |
| CN110441302A (en) * | 2018-05-03 | 2019-11-12 | 中国医学科学院药物研究所 | A kind of tulobuterol transdermal patch non-destructive quality control method |
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| CN110441302A (en) * | 2018-05-03 | 2019-11-12 | 中国医学科学院药物研究所 | A kind of tulobuterol transdermal patch non-destructive quality control method |
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Address after: Zhongshan science and Technology Park, Zhongxin road along the Yangtze River Industrial Development Zone in Nanjing City, Jiangsu Province, No. 709 211500 Applicant after: Jiangsu Kang times pharmaceutical Limited by Share Ltd Address before: Zhongshan science and Technology Park, Zhongxin road along the Yangtze River Industrial Development Zone in Nanjing City, Jiangsu Province, No. 709 211500 Applicant before: JIANGSU KBD PHARMACEUTICAL CO., LTD. |
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Application publication date: 20140723 |
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