CN104739809B - Film of water-insoluble drug of high drug load and preparation method thereof can be provided - Google Patents
Film of water-insoluble drug of high drug load and preparation method thereof can be provided Download PDFInfo
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- CN104739809B CN104739809B CN201310742387.3A CN201310742387A CN104739809B CN 104739809 B CN104739809 B CN 104739809B CN 201310742387 A CN201310742387 A CN 201310742387A CN 104739809 B CN104739809 B CN 104739809B
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Abstract
The present invention relates to a kind of drug film of the water-insoluble drug of high drug load, the drug film includes the water-insoluble drug for being dispersed in that content therein is 50 80%.The drug film has appropriate size and thickness, and also has the characteristics of preferable flexibility, not cracky, convenient to take, applied widely, and patient compliance is high.The present invention also provides the preparation methods of this drug film.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparations, and in particular to a kind of drug film for the water-insoluble drug for improving drugloading rate
And preparation method thereof.
Background technology
Drug film is that the chemicals of doses or the active ingredient of Chinese medical extract are dispersed in filmogen
It is made, the film-shaped drug preparation for being discharged and being absorbed by mucous membrane of mouth.Said preparation solves most of oral solid formulation at present
The shortcomings that water is needed when taking, medication time will not be delayed in the absence of water, receive the concern of pharmacy worker always
And the favor of people, drug film also have the characteristics that easy to carry, convenient to take, applied widely, absorption is fast, are particularly suitable for
Old man and child administration, thus the compliance of patient is high.
Key technology in the preparation of drug film is the selection of filmogen.Filmogen must be susceptible to processing to generate
Film, in addition, active material allows for being easily dispersed wherein, and film must have preferable flexibility, not cracky and right
There are good release characteristics in active material.
Due to water-insoluble drug, such as Tadalafei, the solvability in filmogen is relatively low, causes thus to prepare
Drug film drugloading rate it is generally relatively low, the Tadalafei film reported at present is typically only capable to reach 40% or so drugloading rate.
And for the larger drug of some single taking doses, typically only by the area or thickness for increasing drug film or once
Multi-agent is taken to realize.However, increase the area of drug film or thickness or once take multi-agent, can to patient on using band
To carry out inconvenience, be placed in mouth and have strong foreign body sensation, compliance declines, when reaching higher drugloading rate, drug film
Graininess feeling is also easy to produce in mouth, usual flexibility is also poor, is easy to fracture and shear off.
If CN 103239427 discloses a kind of film of the drug port intracavitary dispersing and dissolving including Tadalafei,
Including at least filmogen, plasticizer, diluent composition, each preparation unit ratio containing active constituent is 0.1% -30%；CN
102824333 disclose a kind of oral quick-dissolving film preparation including Tadalafei and preparation method thereof, which contains
Some active constituents are 20-40%.
In order to improve the drugloading rate of the drug film of water-insoluble drug, US2011263606 is in the preparation process of film
In, drug is dissolved with organic solvents such as methanol, acetone, acetonitriles in advance, so as to reach up to 60% drugloading rate, however,
This method can cause the organic solvent residual in film, particularly have virose organic solvent, such as acetonitrile, remain in film
In serious harm will be not only generated to human body, but also be highly detrimental to production and environmental protection.
At present, still no method can overcome the drug film drugloading rate of existing water-insoluble drug too small, finished product
Granular sensation is strong, poor flexibility, easy fracture or the shortcomings that tear.
Invention content
In order to overcome the drug film drugloading rate of existing water-insoluble drug too small, the granular sensation of finished product is strong, poor flexibility, easily
The shortcomings that fracturing and shearing off.The present inventor studies creatively find through a large number of experiments, is centainly matched by selecting
The hypromellose and hydroxypropyl cellulose of ratio can greatly improve water-insoluble drug in drug as filmogen
Drugloading rate in film, and water-insoluble drug is done micronization processes can be better achieved this effect.
Accordingly, the present invention provides a kind of drug film of the water-insoluble drug of high drug load, the drug film packets
Containing be dispersed in content therein be 50-80% water-insoluble drug.The drug film has appropriate size and thickness
Degree, and also because its flexibility is without cracky.Dissolution rate is identical with same specification tablet, is not in that dissolution is too fast or excessively slow existing
As, and in the dissolution medium of different pH value, dissolution rate difference is little.The present invention also provides the preparations of this drug film
Method, and have the characteristics that simple for process, end product properties are stablized.
The present invention provides a kind of drug films of water-insoluble drug, and comprising main ingredient and filmogen, the main ingredient is
The water-insoluble drug of 50-80%；Hypromellose and 1 ~ 20% hydroxypropyl cellulose that the filmogen is 5 ~ 30%
Combination, wherein：
The hypromellose is selected from hypromellose K4M, hypromellose E5, hydroxypropyl methylcellulose
One or more combinations in plain E50, hypromellose K100；
The hydroxypropyl cellulose is selected from hydroxypropyl cellulose EF, hydroxypropyl cellulose EXF, hydroxypropyl cellulose HF, hydroxyl
One or more combinations in propyl cellulose GF.
The drug film can also include：The plasticizer of 1-10%, the surfactant of 0.5-10%, wherein,
The plasticizer is selected from glycerine, sorbierite, propylene glycol, polyethylene glycol（PEG）In one or more combinations；
The surfactant is selected from Tween-80, lauryl sodium sulfate（SDS）In one or more combinations.
The drug film can also include the corrigent of 0-10%, wherein, the corrigent is selected from Aspartame, Chinese holly
It is one or more in rafter acid, steviol glycoside, saccharin sodium, sucrose, mannitol, tartaric acid, citric acid, malic acid, peppermint oil.
Preparing the drug film can be according to conventional film preparation method, such as《National licensed pharmacist's handbook》（Building
Prosperous Zhang Minggao chief editor publishing houses of the Tsinghua University version in 2004 of phoenix）.
Terms used herein " water-insoluble drug " refer to that the solubility in the water at 25 DEG C is less than 50mg/ml's
The drug that solubility in drug, the preferably water at 25 DEG C is 8-10mg/ml, and it is molten in the water particularly preferably at 25 DEG C
Xie Du is less than the drug of 1mg/ml.Following all kinds of unrestricted compounds and drug can be selected from：Anaesthetic, ACE inhibit
Agent, anti-thrombosis drug, antiallergic, antimicrobial, antibiotic, anticoagulant, anticarcinogen, antidiabetic medicine, anti-high blood
Pressing, antifungal, antihypotensive, antiphlogistic, antifungal, antimigraine, antirheumatic, resist anti-Parkinson drug
Fibrin ferment, antiviral drugs, Beta receptor blockers, bronchial antispasmodic, calcium antagonist, cardiovascular drugs, Cardiac glycosides drug, class are recklessly
Radish element, cephalosporin, contraceptive, cytostatic agent, diuretics, enkephalins, fibrinolytic drug, growth swash
Element, immunosuppressor, insulin, interferon, antigalactic, fat-reducing medicament, lymphokine, neurologic drugs, prostate ring
Element, prostaglandin, psychotropic agent, protease inhibitors, MR diagnosis preparation, reproductive system drug, sedative, property swash
Element, somatostatin, steroid hormone agent, vaccine, vasodilator and vitamin.
The example of some preferred water-insoluble drugs include children, antemetic, antitumor agent, easing pain and diminishing inflammation agent,
Anti-epileptics, hypnotic, sedative, resisting mental disease medicine, neuroleptic, antidepressant, antianxiety agent, resist and shy anesthetic
It faints drug, drug for hypertension, sex dysfunction drug, hormone and nutrients.
Water-insoluble drug of the present invention in particular selected from silaenafil, sildenafil citrate, Tadalafei, cut down ground
That non-, avanaphil, udenafil, sieve that non-, sieve that non-carbonic ester, edenaphy, thio edenaphy, it is red ground that
It is one or more in non-, excellent Ke Nafei, meter Luo Nafei, Nitrosoprodenafil.
Present invention particularly provides a kind of avanaphil drug films, consist of the following compositions：
Avanaphil 50-80%, hypromellose K100 5 ~ 30%, hydroxypropylcellulose GF 1 ~ 20%, plasticizer 1 ~
10%th, surfactant 0.5 ~ 10%, corrigent 0 ~ 10%.
The present invention also particularly provides a kind of Tadalafei drug film, consists of the following compositions：
Tadalafei 50-80%, hypromellose 5 ~ 30%, hydroxypropylcellulose 1 ~ 20%, plasticizer 1 ~ 10%, surface
Activating agent 0.5 ~ 10% and corrigent 0 ~ 10%.
The Tadalafei drug film preferably consists of the following compositions：
Tadalafei 60-70%, hypromellose K4M 5-10%, hydroxypropylcellulose EF 5-10%, plasticizer 5-
10%th, surfactant 5-10% and corrigent 0-1%.Wherein, Tadalafei can reach better effect after micronization processes.
A kind of method for preparing the Tadalafei drug film, includes the following steps：
1) each material is weighed by formula ratio；
2) Tadalafei, HPMC K4M, hydroxypropylcellulose EF and corrigent are mixed, obtains mixed-powder；
3) plasticizer and surfactant are added in purified water and dissolved, be heated to 60-80 DEG C, obtain heated solvent；
4) by step 2）Gained mixed-powder adds in step 3）In the heated solvent of gained, homogeneous 5-10min；
5) 4 are removed）In bubble；
6) room temperature is cooled to, with film applicator film；
7) by step 6）The film that gained coats is in 50-60 DEG C of drying, demoulding；
8) single dose fritter is cut into, is then packed.
Advantageous effect：Water-insoluble drug drug film provided by the invention overcomes the pharmaceutical film of existing water-insoluble drug
Agent drugloading rate is too small, and the granular sensation of finished product is strong, poor flexibility, easy fracture or the shortcomings that tear.Provide a kind of water of high drug load
The drug film of insoluble drugs, the drug film include the water insoluble drugs for being dispersed in that content therein is 50-80%
Object.The drug film has appropriate size and thickness, and also because its flexibility is without cracky.Dissolution rate and same specification
Tablet is identical, is not in dissolve out too fast or excessively slow phenomenon, and in the dissolution medium of different pH value, dissolution rate difference is not
Greatly.The present invention also provides the preparation method of this drug film, and have the characteristics that simple for process, end product properties are stablized.
Description of the drawings
Fig. 1 Tadalafei film samples 5 provided by the invention and sample 6 and the dissolution of reference preparation compare.
Dissolution phenomenon of Fig. 2 Tadalafei films provided by the invention in different pH medium.
Specific embodiment
According to following embodiments, the present invention may be better understood.It is however, as it will be easily appreciated by one skilled in the art that real
It applies the described content of example and is merely to illustrate the present invention, without sheet described in detail in claims should will not be limited
Invention.
The preparation of 1 Ondansetron film of embodiment
1 embodiment of table, 1 formula composition
1 preparation method of embodiment：
1) each material is weighed by formula ratio；
2) main ingredient, hydroxypropyl methylcellulose, hydroxypropylcellulose and required corrigent are mixed, obtains mixed-powder；
3) plasticizer and surfactant are added in purified water and dissolved, be heated to 60-80 DEG C, obtain heated solvent；
4) by step 2）Gained mixed-powder adds in step 3）In the heated solvent of gained, homogeneous 5-10min；
5) removing 4 is vacuumized）In bubble；
6) room temperature is cooled to, with film applicator film；
7) by step 6）The film that gained coats is in 50-60 DEG C of drying, demoulding；
8) single dose fritter is cut into, is then packed.
The preparation of 2 donepezil film of embodiment
2 embodiment of table, 2 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Donepezil | 15.22 | 50.00% |
| Hydroxypropyl methylcellulose | Hydroxypropyl methylcellulose K100 | 9.133 | 30.00% |
| Hydroxypropylcellulose | Hydroxypropyl cellulose EXF | 6.087 | 20.00% |
| Plasticizer | 0 | 0.00% | |
| Surfactant | 0 | 0.00% | |
| Corrigent | 0 | 0.00% | |
| It is total | 30.44 | 100.00% |
2 preparation method of embodiment：
1) each material is weighed by formula ratio；
2) main ingredient, hydroxypropyl methylcellulose, hydroxypropylcellulose are mixed, obtains mixed-powder；
3) by step 2）Gained mixed-powder, which is added in purified water, to be dissolved, and is heated to 60-80 DEG C, homogeneous 5-10min；
4) 3 are removed）In bubble；
5) room temperature is cooled to, with film applicator film；
6) by step 5）The film that gained coats is in 50-60 DEG C of drying, demoulding；
7) single dose fritter is cut into, is then packed.
The preparation of 3 Mitiglinide film of embodiment
3 embodiment of table, 3 formula composition
The preparation method is the same as that of Example 1.
The preparation of 4 Tadalafei film sample 1 of embodiment
4 embodiment of table, 4 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 24.352 | 80.00% |
| Hydroxypropyl methylcellulose | Hydroxypropyl methylcellulose E5 | 1.522 | 5.00% |
| Hydroxypropylcellulose | Hydroxypropylcellulose GF | 1.522 | 5.00% |
| Plasticizer | Glycerine | 1.522 | 5.00% |
| Surfactant | Tween-80 | 1.522 | 5.00% |
| Corrigent | Aspartame | 0 | 0.00% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
The preparation of 5 Tadalafei film sample 2 of embodiment
5 embodiment of table, 5 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 15.22 | 50.00% |
| Hydroxypropyl methylcellulose | Hydroxypropyl methylcellulose E50 | 9.133 | 30.00% |
| Hydroxypropylcellulose | Hydroxypropyl cellulose HF | 0.304 | 1.00% |
| Plasticizer | Propylene glycol | 0.305 | 1.00% |
| Surfactant | SDS | 2.434 | 8.00% |
| Corrigent | Citric acid | 3.044 | 10.00% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
The preparation of 6 Tadalafei film sample 3 of embodiment
6 embodiment of table, 6 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 18.264 | 60.00% |
| Hydroxypropyl methylcellulose | HPMC K4M | 2.588 | 8.50% |
| Hydroxypropylcellulose | Hydroxypropylcellulose EF | 6.088 | 20.00% |
| Plasticizer | PEG | 3.044 | 10.00% |
| Surfactant | Tween-80 | 0.152 | 0.50% |
| Corrigent | Aspartame | 0.304 | 1.00% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
The preparation of 7 Tadalafei film sample 4 of embodiment
7 embodiment of table, 7 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 21.308 | 70.00% |
| Hydroxypropyl methylcellulose | HPMC K4M | 3.044 | 10.00% |
| Hydroxypropylcellulose | Hydroxypropylcellulose EF | 3.044 | 10.00% |
| Plasticizer | Glycerine | 0.305 | 1.00% |
| Surfactant | Tween-80 | 1.522 | 5.00% |
| Corrigent | Steviol glycoside | 1.217 | 4.00% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
The preparation of 8 Tadalafei film sample 5 of embodiment
8 embodiment of table, 8 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 21.296 | 69.96% |
| Hydroxypropyl methylcellulose | HPMC K4M | 2 | 6.57% |
| Hydroxypropylcellulose | Hydroxypropylcellulose EF | 2 | 6.57% |
| Plasticizer | PEG | 2 | 6.57% |
| Surfactant | SDS | 3.044 | 10.00% |
| Corrigent | Malic acid | 0.1 | 0.33% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
The preparation of 9 Tadalafei film sample 6 of embodiment
9 embodiment of table, 9 formula composition
| Classification | Ingredient | Inventory（g） | Percentage |
| Main ingredient | Tadalafei | 20 | 65.70% |
| Hydroxypropyl methylcellulose | HPMC K4M | 2.4 | 7.88% |
| Hydroxypropylcellulose | Hydroxypropylcellulose EF | 2.94 | 9.66% |
| Plasticizer | Glycerine | 3 | 9.86% |
| Surfactant | Tween-80 | 2 | 6.57% |
| Corrigent | Aspartame | 0.1 | 0.33% |
| It is total | 30.44 | 100.00% |
The preparation method is the same as that of Example 1.
10 Tadalafei film provided by the invention of embodiment dissolves out phenomenon.
The release for testing 1 Tadalafei film provided by the invention and Tadalafei tablet (Xi Aili) compares.
Experiment purpose：Pass through the difference of experimental verification Tadalafei film provided by the invention and Tadalafei tablet.
Experimental preparation：Reference preparation is the tadalafil tablet researched and developed by company of Li Lai companies of the U.S., and trade name wishes love
Power（Cialis）；Every 20mg containing Tadalafei；Test preparation for through the embodiment of the present invention 8 and embodiment 9 prepare he reach
Draw non-film sample 5 and sample 6.
Experimental method：This product is taken, according to drug release determination method [Chinese Pharmacopoeia two annex X the second methods of D of version in 2010
（Two）], using drug release determination method（Chinese Pharmacopoeia two annex X the second methods of C of version in 2010）Device experiment.
Experimental result is shown in Figure of description 1.
This experiment proves that Tadalafei film dissolution rate provided by the invention is identical with same specification tablet, is not in dissolution
Too fast or excessively slow phenomenon.
Test dissolution phenomenon of the 2 Tadalafei films provided by the invention in different PH media.
Experiment purpose：Showed by dissolution of the experimental verification Tadalafei film provided by the invention in different PH media
As.
Experimental preparation：The 9 Tadalafei film sample 6 prepared through the embodiment of the present invention.
For experimental method with experiment 1, dissolution medium is respectively water, pH4.5 buffer solutions and pH6.8 buffer solutions.
Experimental result is shown in Figure of description 2.
This experiment proves Tadalafei film provided by the invention in the dissolution medium of different pH value, and dissolution rate is basic
Unanimously.This product is with good stability.
It is verified by above example, water-insoluble drug drug film provided by the invention overcomes existing water-insoluble
The drug film drugloading rate of drug is too small, and the granular sensation of finished product is strong, poor flexibility, easy fracture or the shortcomings that tear.Provide one kind
The drug film of the water-insoluble drug of high drug load, the drug film, which includes, is dispersed in content therein as 50-80%
Water-insoluble drug.The drug film has appropriate size and thickness, and also because its flexibility is without cracky.This
The preparation method of invention drug film is simple for process, end product properties are stablized.
Claims (5)
1. a kind of drug film of water-insoluble drug, includes main ingredient and filmogen, it is characterised in that：The main ingredient is 50-
80% water-insoluble drug；Hypromellose and 1~20% hydroxy propyl cellulose that the filmogen is 5~30%
The combination of element, wherein：
The drug that the water-insoluble drug is 0.001-50mg/ml for solubility in 25 DEG C of water, selected from silaenafil,
Tadalafei, Vardenafil, avanaphil, udenafil, sieve that non-, sieve that non-carbonic ester, edenaphy, it is thio love ground
It is one or more in that non-, Acctildenafil, excellent Ke Nafei, meter Luo Nafei, Nitrosoprodenafil；The hydroxypropyl
Cellulose is selected from hypromellose K4M, hypromellose E5, hypromellose E50, hypromellose
One or more combinations in K100；The hydroxypropyl cellulose be selected from hydroxypropyl cellulose EF, hydroxypropyl cellulose EXF,
One or more combinations in hydroxypropyl cellulose HF, hydroxypropyl cellulose GF；
The drug film includes：The plasticizer of 1-10%, the surfactant of 0.5-10%, wherein, the plasticizer is selected from sweet
One or more combinations in oil, sorbierite, propylene glycol, polyethylene glycol；The surfactant is selected from Tween-80,12
One or more combinations in sodium alkyl sulfate；
The drug film includes the corrigent of 0-10%, wherein, the corrigent be selected from Aspartame, citric acid, steviol glycoside,
It is one or more in saccharin sodium, sucrose, mannitol, tartaric acid, citric acid, malic acid, peppermint oil.
2. a kind of drug film according to claim 1, which is characterized in that consist of the following compositions：Avanaphil 50-
1~10% surfactant 0.5 of the hydroxypropylcellulose GF1 of 80% hypromellose K1005~30%~20% plasticizer~
10% corrigent 0~10%.
3. a kind of drug film according to claim 1, which is characterized in that consist of the following compositions：Tadalafei 50-
80% hypromellose, 5~30% hydroxypropylcellulose, 1~20% plasticizer, 1~10% surfactant 0.5~10% is rectified
Taste agent 0~10%.
4. drug film according to claim 3, which is characterized in that consist of the following compositions：Tadalafei 60-70% hydroxyls
Third methylcellulose K4M5-10% hydroxypropylcellulose EF5-10% plasticizer 5-10% surfactant 5-10% corrigents 0-
1%.
5. a kind of preparation method of drug film as claimed in claim 4, includes the following steps：1) by formula ratio weigh it is each into
Point；2) Tadalafei, HPMC K4M, hydroxypropylcellulose EF and corrigent are mixed, obtains mixed-powder；It 3) will plasticising
Agent and surfactant, which are added in purified water, to be dissolved, and is heated to 60-80 DEG C, is obtained heated solvent；It 4) will be mixed obtained by step 2)
It closes powder to add in solvent heated obtained by step 3), homogeneous 5-10min；5) bubble in removing 4)；6) room temperature is cooled to,
With film applicator film；7) by the film coated obtained by step 6) in 50-60 DEG C of drying, demoulding；8) single dose fritter is cut into, then
It is packed.
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|---|---|---|---|
| CN201310742387.3A CN104739809B (en) | 2013-12-30 | 2013-12-30 | Film of water-insoluble drug of high drug load and preparation method thereof can be provided |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106333953A (en) * | 2015-07-08 | 2017-01-18 | 珠海津之敦医药科技有限公司 | Novel application of yonkenafil |
| CN105878219B (en) * | 2016-05-19 | 2019-10-18 | 广州迈达康医药科技有限公司 | A kind of Li Gelieting pelliculae pro cavo oris and preparation method thereof |
| CN109010324B (en) * | 2018-08-30 | 2021-07-02 | 南京康川济医药科技有限公司 | Sildenafil oral dissolving film agent and preparation method thereof |
| CN116270553B (en) * | 2023-02-01 | 2024-05-07 | 北京悦康科创医药科技股份有限公司 | Aidinafil oral film-dissolving agent and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005016321A1 (en) * | 2003-08-15 | 2005-02-24 | Qlt Usa, Inc. | Adhesive bioerodible transmucosal drug delivery system |
| CN102824333A (en) * | 2012-09-26 | 2012-12-19 | 苏州大学 | Oral quick-dissolving film preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102010049708A1 (en) * | 2010-10-28 | 2012-05-03 | Hexal Ag | Oral pharmaceutical film formulation for bitter-tasting drugs |
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2013
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005016321A1 (en) * | 2003-08-15 | 2005-02-24 | Qlt Usa, Inc. | Adhesive bioerodible transmucosal drug delivery system |
| CN102824333A (en) * | 2012-09-26 | 2012-12-19 | 苏州大学 | Oral quick-dissolving film preparation and preparation method thereof |
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