CN109939237A - Preparation method containing Montelukast Sodium oral disintegrating tablet - Google Patents
Preparation method containing Montelukast Sodium oral disintegrating tablet Download PDFInfo
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Abstract
This application provides contain Montelukast Sodium oral disintegrating tablet preparation method, preparation method is first to be pre-mixed Montelukast Sodium and colloidal silicon dioxide, thereafter again by the mixture and the biggish filler of specific surface area (spray drying mannitol, spray-dried lactose etc.) premixing, premix is uniformly mixed with other auxiliary materials finally, oral disintegrating tablet is prepared using powder vertical compression technique.Bulk pharmaceutical chemicals and colloidal silicon dioxide and the biggish filler premixing of specific surface area can be improved the problems such as material fluidity occurred during direct powder compression is poor, mixing uniformity is poor, tablet weight variation is big by the application, while improve the mouthfeel of oral disintegrating tablet；The stability of bulk pharmaceutical chemicals can be significantly improved using powder vertical compression technique.The Montelukast Sodium oral disintegrating tablet that a kind of absorption is fast, bioavilability is high, side effect is low and convenient to take is provided to patient.
Description
Technical field
The application belongs to pharmaceutical technology field, and in particular to the preparation method containing Montelukast Sodium oral disintegrating tablet.
Background technique
Bronchial asthma (abbreviation asthma) is a kind of tracheae allergic inflammation based on eosinophils, mast cell reaction
The disease that disease and tracheae high response are characterized.Clinical signs are recurrent exerbation and are stranded with the expiration respiratory of asthma sound
Difficult, uncomfortable in chest and cough.In recent years, ascendant trend is worldwide presented in the incidence and mortality of asthma, especially at me
State, the illness rate of asthma is about 1% at present, and children are up to 3%；It can be seen that China has huge asthmatic patient group.
Montelukast Sodium is by MSD Corp.'s development and production first, is current asthma medications best-selling in the world
One of.As a kind of oral leukotriene receptor antagonists, Montelukast Sodium specific can inhibit the cysteinyl in air flue white
Triolefin (CysLT1) receptor, to reach improvement airway inflammation, effective Control of asthma symptom, the dosage form listed at present mainly has piece
Agent, chewable tablets, granule, freeze-drying oral disintegrating tablet etc..Although freeze-drying oral disintegrating tablet has many advantages, such as rapid-action, convenient to take, preparation
It is complex process, with high costs, and technology and equipment is required high, industrialization difficulty is big.And regular dosage form when taking exist with
Lower some disadvantages: (1) asthma patient morbidity is usually at dead of night and before dawn, and when morbidity, often shortness of breath is serious, constantly cough, together
When feel vapour lock, uncomfortable in chest, serious patient understands threat to life.It needs to alleviate above-mentioned symptom in time when patient's morbidity.Common system
Agent is tablet or granule, and there are many inconvenience when taking, and especially in morbidity, patient's shortness of breath, cough, tablet or particle are easy
In tracheae, danger is caused；(2) conventional tablet needs to be disintegrated and drug-eluting, absorption work slowly, is unfavorable for the rapid slow of symptom
Solution；(3) most of asthma patient is old man and children, is swallowed to tablet relatively difficult.Therefore develop it is a kind of it is rapid-action, take
Montelukast Sodium dosage form that is convenient and being easy to industrialization production is most important for the treatment of asthma.
Oral disintegrating tablet, which refers to, to be not required to water or need to use a small amount of water, and without chewing, tablet is placed in lingual surface, chance saliva dissolve rapidly or
After disintegration, by means of power is swallowed, drug can enter the tablet of stomach action.Compared with conventional tablet, oral disintegrating tablet has rapid-action, biology
The advantages such as availability is high, convenient to take, and first pass effect is low are more suitable for the spies such as old man, children, dysphagia or drinking-water inconvenience
Patient's medication under different environment.
Based on this, therefore the application is under given conditions, uses colloidal silicon dioxide and the biggish filler of specific surface area
Premixing processing is carried out to Montelukast Sodium, and sample is prepared using powder vertical compression technique, which has easy industrialization, taste masking
The advantages that effect is good, stability is high.
Summary of the invention
Direct powder compression is after drug powder is sieved and is mixed respectively with suitable auxiliary material, (wet without pelleting
Particle or dry particl) and connect certainly tabletted.Since its technical process is simple, it is not necessary to pelletize, dry, medicine is protected in energy- and time-economizing
Object stability improves drug dissolution and industry the degree of automation height etc., just more and more by the institute, pharmaceutical manufacturer of various countries
Using.Montelukast Sodium is the sodium-salt form of montelukast, and stability is poor, unstable to strong acid, illumination, humidity, point
Containing a hydroxyl, two methyl and a phenyl ring on the terminal carbon of son, steric hindrance is very big, in storing process, meeting
Under the catalysis of temperature, it is gradually oxidized to montelukast ketone.
Based on this, the purpose of the application is to provide a kind of preparation method of Montelukast Sodium oral disintegrating tablet, selects powder
Last direct tablet compressing technique, method are to be pre-mixed bulk pharmaceutical chemicals with colloidal silicon dioxide and filler respectively, colloidal silicon dioxide
It with porous structure and helps stream effect preferable, during premixing with Montelukast Sodium, effectively adsorbs bulk pharmaceutical chemicals, reduce in mouth
Drug concentration and achieve the purpose that taste masking, while after bulk pharmaceutical chemicals are mixed with colloidal silicon dioxide, mobility is improved, and facilitates material
Mixing uniformity.After bulk pharmaceutical chemicals and colloidal silicon dioxide premixing, then by the mixture and the biggish filler of specific surface area
Premixing, bulk pharmaceutical chemicals are sufficiently adsorbed in its aperture, improve bulk pharmaceutical chemicals mobility, and then improve mixing uniformity.This method
A kind of good mouthfeel is provided to patient, absorbs that fast, bioavilability is high, and Montelukast Sodium oral disintegrating tablet convenient to take.
The purpose of the application is solved by following scheme:
Montelukast Sodium oral disintegrating tablet, it further includes colloidal silicon dioxide and specific surface area that wherein Montelukast Sodium dosage, which is 2.5%-5%,
Biggish filler and other pharmaceutically acceptable auxiliary materials, such as disintegrating agent, corrigent, lubricant.
Preparation method is main including the following steps:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with filler to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
In Montelukast Sodium oral disintegrating tablet preparation method, the premix ratio of colloidal silicon dioxide and bulk pharmaceutical chemicals is 1:1-1:15,
It is preferred that 1:4-1:8.
Further, filler includes spray drying mannitol, spray-dried lactose, silicified microcrystalline cellulose, pregelatinated
Any one or the two or more mixtures such as starch.
The preparation method of Montelukast Sodium oral disintegrating tablet, specifically comprises the following steps:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:1-1:15 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes in such a way that equivalent is progressively increased and is uniformly mixed with mannitol is spray-dried, obtain pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
The preparation method of Montelukast Sodium oral disintegrating tablet, further includes:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:4-1:8 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
The preparation method of Montelukast Sodium oral disintegrating tablet, further includes:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:4-1:8 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with silicified microcrystalline cellulose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
Specific embodiment
In order to better understand the present invention, below by through the invention embodiment and experimental data to the present invention and its it is excellent
Gesture and beneficial effect are described in detail and illustrate, but these embodiments are not intended to limit the present invention.
Embodiment 1
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:1 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray drying mannitol to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, sodium carboxymethyl starch, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 2
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:15 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray drying mannitol to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, sodium carboxymethyl starch, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 3
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:4 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray drying mannitol to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, sodium carboxymethyl starch, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 4
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:8 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray drying mannitol to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, sodium carboxymethyl starch, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 5
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:4 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 6
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:4 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with silicified microcrystalline cellulose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 7
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:8 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Embodiment 8
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:8 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with silicified microcrystalline cellulose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Comparative example 1
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) bulk pharmaceutical chemicals are crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition I；
(3) pre-composition I is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with magnesium stearate, it is tabletted.
Comparative example 2
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:20 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Comparative example 3
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 2:1 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with pregelatinized starch, croscarmellose sodium, Sucralose, obtains pre-composition III；
(5) pre-composition III is uniformly mixed with magnesium stearate, it is tabletted.
Comparative example 4
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:4 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is uniformly mixed with spray drying mannitol, microcrystalline cellulose, sodium carboxymethyl starch, Sucralose, is obtained
Pre-composition II；
(4) pre-composition II is uniformly mixed with magnesium stearate, it is tabletted.
Comparative example 5
Preparation process:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals with 1:4 to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray drying mannitol to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with microcrystalline cellulose, sodium carboxymethyl starch, obtains pre-composition III；
(5) 30% ethanol water is added into pre-composition III, obtains softwood after mixing evenly and obtains particle after granulation is dry；
(6) additional Sucralose, magnesium stearate are uniformly mixed, tabletted.
1 Montelukast Sodium oral disintegrating tablet mouthfeel of table and disintegration time
2 influence factor test result of table (0 day sample is bare die, and 10 days samples are that double aluminium pack sample)
Experimental result and conclusion
(1) by embodiment 1-8 it is found that colloidal silicon dioxide and bulk pharmaceutical chemicals are with the premixing of 1:1-1:15 ratio, thereafter by the premix
It closes object and the biggish filler of specific surface area is pre-mixed, and using the sample of powder vertical compression technique preparation, good mouthfeel, when disintegration
Between and uniformity of dosage units it is qualified, material fluidity is preferable, 0 day, 10 days sample stabilities it is more excellent.
(2) by comparative example 1-2 it is found that being premixed when in prescription without silica or silica and bulk pharmaceutical chemicals with 1:20
The sample of preparation is closed, hardship sense is obvious, and when bulk pharmaceutical chemicals and filler are pre-mixed, mobility is poor, possible cause are as follows: titanium dioxide
The too low taste masking of silicon dosage and help stream effect it is bad；By comparative example 3 it is found that when silica and bulk pharmaceutical chemicals are pre-mixed with 2:1
The sample of preparation, entrance have obvious paste sense, therefore the premix ratio of silica and bulk pharmaceutical chemicals should be within the scope of 1:1-1:15.
(3) it is only pre-mixed with colloidal silicon dioxide by comparative example 4 it is found that working as bulk pharmaceutical chemicals, and uses powder vertical compression work
The sample of skill preparation, the uniformity of dosage units of sample is unqualified, and mobility is poor, and possible cause is the flowing of Montelukast Sodium
Property poor and shared in composition ratio it is smaller (2.5%-5.0%), be difficult to be mixed directly with other auxiliary materials, therefore
Select premixing process.
(4) by comparative example 5 it is found that the sample prepared using wet granulation, 0 day related substance of bare die and double aluminium packaging
10 days related substances of sample are larger, therefore prepare sample using powder vertical compression technique.
Claims (7)
1. Montelukast Sodium oral disintegrating tablet, preparation method are main including the following steps:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is crossed 60 meshes with bulk pharmaceutical chemicals to be uniformly mixed, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with filler to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
2. Montelukast Sodium oral disintegrating tablet described in claim 1, it further includes colloidal state that wherein Montelukast Sodium dosage, which is 2.5%-5%,
Silica and the biggish filler of specific surface area and other pharmaceutically acceptable auxiliary materials, such as disintegrating agent, corrigent, lubricant
Deng.
3. in Montelukast Sodium oral disintegrating tablet preparation method as described in claim 1, the premix of colloidal silicon dioxide and bulk pharmaceutical chemicals
Ratio is 1:1-1:15, preferably 1:4-1:8.
4. Montelukast Sodium oral disintegrating tablet as claimed in claim 2, the biggish filler of specific surface area includes spray drying sweet dew
Any one or the two or more mixtures such as alcohol, spray-dried lactose, silicified microcrystalline cellulose, pregelatinized starch.
5. the preparation method of Montelukast Sodium oral disintegrating tablet as described in claim 1, specifically comprises the following steps:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:1-1:15 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes in such a way that equivalent is progressively increased and is uniformly mixed with mannitol is spray-dried, obtain pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
6. the preparation method of Montelukast Sodium oral disintegrating tablet as described in claim 5, further includes:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:4-1:8 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with spray-dried lactose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
7. the preparation method of Montelukast Sodium oral disintegrating tablet as described in claim 6, further includes:
(1) Montelukast Sodium crosses 80-100 mesh, remaining auxiliary material crosses 80 meshes, spare；
(2) colloidal silicon dioxide is uniformly mixed with bulk pharmaceutical chemicals with 1:4-1:8 sieving, obtains pre-composition I；
(3) pre-composition I is crossed 60 meshes with silicified microcrystalline cellulose to be uniformly mixed in such a way that equivalent is progressively increased, obtains pre-composition II；
(4) pre-composition II is uniformly mixed with filler, disintegrating agent, corrigent, obtains pre-composition III；
(5) pre-composition III and mix lubricant is uniform, tabletting.
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| CN201711398031.7A CN109939237A (en) | 2017-12-21 | 2017-12-21 | Preparation method containing Montelukast Sodium oral disintegrating tablet |
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| CN201711398031.7A CN109939237A (en) | 2017-12-21 | 2017-12-21 | Preparation method containing Montelukast Sodium oral disintegrating tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115337276A (en) * | 2021-05-14 | 2022-11-15 | 南京科默生物医药有限公司 | Novel sildenafil citrate orally disintegrating composition |
-
2017
- 2017-12-21 CN CN201711398031.7A patent/CN109939237A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115337276A (en) * | 2021-05-14 | 2022-11-15 | 南京科默生物医药有限公司 | Novel sildenafil citrate orally disintegrating composition |
| CN115337276B (en) * | 2021-05-14 | 2024-02-09 | 南京科默生物医药有限公司 | Preparation method of sildenafil citrate orally disintegrating tablet |
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