CN106474080A - A kind of Montelukast receives oral disintegrating tablet and preparation method thereof - Google Patents
A kind of Montelukast receives oral disintegrating tablet and preparation method thereof Download PDFInfo
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- CN106474080A CN106474080A CN201610845303.2A CN201610845303A CN106474080A CN 106474080 A CN106474080 A CN 106474080A CN 201610845303 A CN201610845303 A CN 201610845303A CN 106474080 A CN106474080 A CN 106474080A
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- Prior art keywords
- montelukast
- disintegrating tablet
- oral disintegrating
- tablet
- lactose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The Montelukast that the present invention is provided receives oral disintegrating tablet being prepared using direct compression method and dry granulation method, process is simple, reproducible, it is to avoid dry run and the damp and hot impact to product quality, is improved preparation stability.The Montelukast that the present invention is provided is received oral disintegrating tablet and meets saliva rapidly disintegration is dispersed into fine particle, and drug-eluting is accelerated, big in intestines and stomach area distributions, and it is many to absorb point, can improve its bioavilability.For child, the elderly, the difficult patient for changing of some bed positions, oral disintegrating tablet medication is convenient, without the need for need not also be chewed with water, improves the compliance of patient, improve clinical treatment validity and should be acute.
Description
Technical field
The present invention relates to Montelukast is received, more particularly to a kind of with the Montelukast for improving stability receive oral disintegrating tablet and its
Preparation method.
Background technology
Asthma is a kind of chronic inflammation disease with the characteristics of tracheae high response and Reversible airway obstruction.Leukotriene
It is one of important medium of bronchial astehma, it plays key effect for the generation of asthma, development, there are some researches show no and falls
Inner or in vitro reaction caused by it exactly likes the pathological change of asthma, and no matter action period or stationary phase in asthma patient
Its level is above normal person.LTRA becomes the new way for the treatment of asthma.
Montelukast is a kind of dirty propylhomoserin LTRA of high specific half, its positive half skin ammonia phthalein leukotriene and acceptor of breaking
Between interaction, so as to block reaction of the tracheae to leukotriene, reach the purpose of Control of asthma.Biochemistry and pharmacological
Biologicall test shows that montelukast has compatibility and the selectivity of height to CysLTI acceptor.Montelukast effectively can suppress
The physiological effect of LTC4, LTD4 and LTE4 and LTC4, LTD4 and LTE4 produced by CysLTI receptor binding is acted on and is received Wu any
Body agonist activity.It is the sodium salt of montelukast that Montelukast is received, due to its unique chemical constitution, its oral bioavailability
Degree, clinical efficacy and security are superior to conventional similar drugs.Montelukast is received suitable for 15 years old and more than 15 years old
The prevention of Adults Asthma and long-term treatment, including preventing the SOA on daytime and night, treat to aspirin-sensitive
Asthmatic patient and prevention exercise induced bronchoconstriction.
It is by Merck & Co., Inc.'s Development and Production that Montelukast is received, and is current best-selling in the world asthma medications.1998 with
To list in multiple countries and regions successively, existing formulation has Film coated tablets, granule, chewable tablets.Adopt in technique more
With wet granulation, drying time is long, the bad control of baking temperature, migrates easily soluble component, cause content in dry run
Decline, relevant material increases, obtained tablet stability is poor, see that light is easy to change, decompose.
Patent CN1962467A discloses the granule that a kind of Montelukast is received, and patent CN1287792C discloses a kind of Meng Lusi
Tener dispersible tablet, patent CN101773481A disclose a kind of chewable tablets that receives containing Montelukast, and preparing for above-mentioned patent is equal
It is obtained using general technology, the same stability of obtained preparation is poor, sees light decomposition easy to change.
Content of the invention
This provides a kind of Montelukast and receives oral disintegrating tablet and preparation method thereof, oral disintegrating tablet meet saliva rapidly disintegration be dispersed into thin
Microparticle, drug-eluting are accelerated, big in intestines and stomach area distributions, and absorption point is many, can improve its bioavilability.For child,
The elderly, the difficult patient for changing of some bed positions, oral disintegrating tablet medication are convenient, without the need for need not also be chewed with water, improve patient
Compliance, improve clinical treatment validity and should be acute.
It is low compared with other technical costs that direct tablet compressing and dry granulation process prepare oral disintegrating tablet, is not required to special production equipment, avoids
Dry run and the damp and hot impact to product quality, stability are improved.Select has filler, adhesive, disintegration concurrently more
The MCC of agent, lubricant characteristics and good fluidity and compressibility is added flavouring in right amount, is obtained good in taste as auxiliary material
Oral disintegrating tablet.
Technical scheme is as follows:Using mannitol, lactose as filler in prescription, its mannitol consumption by weight hundred
Ratio is divided to be calculated as 35%-75%, lactose consumption is 10%-40% by weight percentage.
Montelukast receives oral disintegrating tablet formulation, and by weight percentage, specific composition is as follows:Montelukast receives 2% -10%,
Mannitol 35% -75%, lactose 10% -40%, dry adhesives 0% -10%, colouring agent 0.2%-0.5%, disintegrant
2.0% -10%, flavouring 0.1% -6%, lubricant 0.4% -3%.
In prescription provided by the present invention mannitol ratio for total weight of tablet 35%-75%, preferably 38%-
50%.The particle diameter of mannitol be preferably 90% particle diameter be less than 200 μm, using after such particle diameter can preferably with other auxiliary materials
Particularly lactose is mixed, so as to play better filling effect.
In prescription of the present invention, the ratio of lactose is the 10%-40%, preferably 25%-40% of total weight of tablet;Lactose
Model is preferably α-lactose monohydrate.
The preferred red ferric oxide of colouring agent in the prescription, may also be employed other conventional colouring agents.
Dry adhesives preferably microcrystalline cellulose in the prescription(MCC), other conventional dry adhesives may also be employed.
Disintegrant in the prescription may be selected PVPP(PVPP), low-substituted hydroxypropyl cellulose(L-HPC)、
Sodium carboxymethyl starch(CMS-Na), Ac-Di-Sol(CMC-Na)And its mixture.
Flavouring in the prescription may be selected the natural or artificial sweetening agent such as aspartame, essence and its mixture.
Lubricant in the prescription may be selected magnesium stearate, talcum powder, stearic acid, calcium stearate, zinc stearate, poly- second two
Alcohol, superfine silica gel powder, lauryl sodium sulfate, Stepanol MG and its mixture.
Above-mentioned each auxiliary material also can adopt corresponding auxiliary material commonly used in the art in addition to using preferred kind as required.
Montelukast of the present invention receive oral disintegrating tablet preparation technology as follows:For adapting to different manufacturing technique requirents, can adopt
With direct compression method and two kinds of dry-pressing granulation.
Direct compression method:
(1)Flavouring, colouring agent and main ingredient Montelukast are received and distinguishes finely ground 80 mesh sieve of mistake, mix;
(2)100 mesh sieves crossed by disintegrant, and mannitol, lactose and dry adhesives cross 40 mesh sieves respectively, weigh respectively according to quantity and sequentially add
Mix in hybrid medicine in step one;
(3)To in step 2 in gained hybrid medicine add recipe quantity lubricant, mixing of sieving, carry out intermediates content inspection
Survey, direct tablet compressing technology compressing tablet is adopted after determining piece weight, obtain final product.
Using oral disintegrating tablet obtained in the method, its disintegration time limited is 15s-30s, 15min stripping quantity in 0.1mol HCl solution
More than 85%.
Dry-pressing granulation:
(1)Main ingredient, colouring agent, flavouring, mannitol, lactose, dry adhesives and disintegrant are crossed 100 mesh sieves respectively, is divided according to quantity
Another name takes and sequentially adds by said sequence, mixing of sieving, compressing tablet, crosses 24 mesh sieve dry granulations;
(2)To in above-mentioned gained medicine, the lubricant of addition recipe quantity, mixing of sieving, carry out intermediates content detection, determine piece
After weight, compressing tablet is obtained final product.
Using oral disintegrating tablet obtained in the method, its disintegration time limited is 15s-45s, 10min dissolution in 0.1mol HCl solution
Amount is more than 85%.
Oral disintegrating tablet is received using Montelukast obtained in above two conventional method, piece weight 50-200mg, hardness 5-10KN, friability
Less than 0.5%.
In sum, the invention provides a kind of preparation process is simple, low cost, avoid dry run and damp and hot to product matter
The impact of amount, stability are improved.And taking convenience, the Montelukast rapid-action to indication receive oral disintegrating tablet, the mouth collapses
After piece is oral, rapid disintegration is dispersed into fine particle or powder in the oral cavity, is particularly suited for the patient of dysphagia, and should
Preparation was present with fine particle or powder type before intestines and stomach are reached, and drug-eluting is accelerated, in intestines and stomach Line Integral
Cloth is big, and absorption point is many, can improve its bioavilability, while common press device and simple process is employed, processing step
Simply, low cost, is suitable for extensive promotion and application.
Specific embodiment:
In order to be illustrated more clearly that advantages of the present invention and feature, with reference to specific embodiment of the embodiment to the present invention
Be further described, it will be appreciated by those skilled in the art that below specifically described content be illustrative rather than restricted
, should not be limited the scope of the invention with this.
Embodiment 1:Montelukast receives the preparation of oral disintegrating tablet
Prescription is:
Montelukast receives 4%
Mannitol 48.8%
Lactose monohydrate 39.5%
PVPP (PVPP) 5%
Red ferric oxide 0.2%
Aspartame 0.5%
Fragrant citrus essence 0.5%
Magnesium stearate 1.5%.
Prepare:The formulation can be produced using conventional tablet pharmaceutical equipment and use direct tablet compressing technique to prepare, concrete preparation method
As follows:Essence, aspartame, red ferric oxide, main ingredient are distinguished finely ground 80 mesh sieve of mistake, essence, aspartame, red ferric oxide and master
Medicine is mixed;PVPP crosses 100 sieves, and mannitol and lactose cross 40 mesh sieves respectively, weigh respectively according to quantity according to
Secondary addition in the main ingredient for being mixed with essence, aspartame mixes, and adds the magnesium stearate of recipe quantity, and mixing of sieving carries out centre
Body content detection.Direct tablet compressing technology compressing tablet is adopted after determining piece weight, obtain final product.
Embodiment 2:
Prescription is:
Montelukast receives 6%
Mannitol 38%
Lactose 38.3%
Microcrystalline cellulose 10%
Red ferric oxide 0.2%
PVPP (PVPP) 5%
Aspartame 0.5%
Fragrant citrus essence 0.5%
Magnesium stearate 1.5%.
Prepare:The formulation can be produced using conventional tablet pharmaceutical equipment and use direct tablet compressing technique to prepare, concrete preparation method
As follows:Red ferric oxide, essence, aspartame, main ingredient are distinguished finely ground 80 mesh sieve of mistake, red ferric oxide, essence, aspartame and master
Medicine is mixed;PVPP crosses 100 mesh sieves, and mannitol, lactose and microcrystalline cellulose cross 40 mesh sieves respectively, press
Amount is weighed respectively to sequentially add in the main ingredient for being mixed with essence, red ferric oxide, aspartame and is mixed, and adds the stearic acid of recipe quantity
Magnesium, mixing of sieving, carry out intermediates content detection.Direct tablet compressing technology compressing tablet is adopted after determining piece weight, obtain final product.
Embodiment 3:
Prescription is:
Montelukast receives 8%
Mannitol 42.6%
Lactose monohydrate 28.7%
Microcrystalline cellulose (MCC PH101) 8%
Red ferric oxide 0.2%
Low-substituted hydroxypropyl cellulose (L-HPC) 8%
PVPP (PVPP) 2%
Aspartame 0.5%
Fragrant citrus essence 0.5%
Magnesium stearate 1.5%.
Prepare:The formulation can be produced using conventional tablet pharmaceutical equipment and use dry granulation tablet forming technique to prepare, concrete preparation
Method is as follows:By main ingredient, red ferric oxide, fragrant citrus essence, aspartame, mannitol, lactose, microcrystalline cellulose, low-substituted hydroxypropyl
Cellulose and PVPP cross 100 mesh sieves respectively, weigh respectively according to quantity and sequentially add, mixing of sieving, compressing tablet, mistake
24 mesh sieve dry granulations.The magnesium stearate of recipe quantity is added, mixing of sieving, carry out intermediates content detection.After determining piece weight
Compressing tablet, obtains final product.
Embodiment 4:
Prescription is:
Montelukast receives 10%
Mannitol 42.8%
Lactose monohydrate 26.5%
Microcrystalline cellulose (MCC PH101) 10.5%
Low-substituted hydroxypropyl cellulose (L-HPC) 2.5%
Red ferric oxide 0.2%
PVPP (PVPP) 5%
Aspartame 0.5%
Fragrant citrus essence 0.5%
Magnesium stearate 1.5%.
Prepare:The formulation can be produced using conventional tablet pharmaceutical equipment and use dry granulation tablet forming technique to prepare, concrete preparation
Method is as follows:By main ingredient, red ferric oxide, fragrant citrus essence, aspartame, mannitol, lactose, microcrystalline cellulose, low-substituted hydroxypropyl
Cellulose and PVPP are crossed 100 respectively and are sieved, and weigh respectively according to quantity and sequentially add, mixing of sieving, and compressing tablet crosses 24
Mesh sieve dry granulation.The magnesium stearate of recipe quantity is added, mixing of sieving, carry out intermediates content detection.Press after determining piece weight
Piece is obtained final product.
Comparative example:
Prescription is:
Montelukast receives 5%
Microcrystalline cellulose (MCC PH101) 35%
Lactose monohydrate 48.1%
Ac-Di-Sol(Interior)5%
Red ferric oxide 0.2%
Ac-Di-Sol(Outward)5%
Hydroxypropylcellulose 0.2%
Silica 0.5%
Magnesium stearate 1%.
Prepare:Weigh recipe quantity microcrystalline cellulose, lactose monohydrate, red ferric oxide, the mixing of interior plus Ac-Di-Sol all
Even you, then the Montelukast of recipe quantity is received progressively increase 3 times with said mixture equivalent and mixes, plus 2% hydroxypropylcellulose water
Solution softwood, 24 mesh sieves are pelletized, and particle is dry under the conditions of 50 DEG C, particle moisture control within 3.0%, 24 mesh sieve whole grains,
With additional Ac-Di-Sol and silica and magnesium stearate are mixed, determine Montelukast in particle and receive and contain
Amount, determines piece weight, and compressing tablet is obtained final product.
According to influence factor test method(Chinese Pharmacopoeia 2015 four)Compare the embodiment of the present invention and comparative example is made
Standby Montelukast receive preparation place 10 days after relevant material growth pattern, respectively in 60 DEG C ± 2 DEG C of high temperature, high humidity RH92.5%
And each placement 10 days under the conditions of illumination 5000lx ± 500lx, investigate relevant material growth pattern.As a result see the table below:
.
From influence factor result:Each under the conditions of 60 DEG C ± 2 DEG C of high temperature, high humidity RH92.5% and illumination 5000lx ± 500lx
After placing 10 days, Montelukast prepared by the present invention is received oral disintegrating tablet and compares comparative example(Montelukast receives tablet)Relevant material increases
Long slow, and the present invention is without wet granulation, preparation process is simple, improve Montelukast and receive and the stability of preparation save
Cost.
Claims (8)
1. a kind of Montelukast receives oral disintegrating tablet, it is characterised in that:Using mannitol and lactose as filler in prescription, its consumption
It is mannitol 35%-75%, lactose 10%-40% by weight percentage.
2. the Montelukast according to claim 1 receives oral disintegrating tablet, it is characterised in that:By weight percentage, specifically become
Part is as follows:
Montelukast receives 2.5%-10%,
Mannitol 35%-75%,
Lactose monohydrate 10%-40%,
Colouring agent 0.2%-0.5%,
Dry adhesives 0%-10%,
Disintegrant 2.0%-10%,
Flavouring 0.1%-6%,
Lubricant 0.5%-3%.
3. Montelukast according to claim 1 and 2 receives oral disintegrating tablet, it is characterised in that:Described mannitol consumption is by weight
Amount percentage is 38%-50%, and lactose is 25%-40%.
4. Montelukast according to claim 1 and 2 receives oral disintegrating tablet, it is characterised in that:The lactose is a α-water and milk
Sugar.
5. Montelukast according to claim 2 receives oral disintegrating tablet, it is characterised in that:The preferably red oxidation of described colouring agent
Iron;Described dry adhesives preferably microcrystalline cellulose (MCC);Disintegrant is that PVPP or low-substituted hydroxypropyl are fine
Dimension element or sodium carboxymethyl starch or Ac-Di-Sol or its mixture;Flavouring is aspartame or essence or which is mixed
Compound;Lubricant is magnesium stearate or talcum powder or stearic acid or calcium stearate or zinc stearate or polyethylene glycol or superfine silica gel powder
Or lauryl sodium sulfate or Stepanol MG or its mixture.
6. oral disintegrating tablet according to claim 1 and 2, it is characterised in that:Described Montelukast receives oral disintegrating tablet, piece weight 50-
250mg, hardness 5-10KN, friability < 0.5%, the disintegration time determined using oral disintegrating tablet disintegration time mensuration method are 15-
45 seconds.
7. oral disintegrating tablet preparation method as claimed in claim 1 is prepared, it is characterised in that:Direct compression method step is:
Flavouring, colouring agent and main ingredient Montelukast are received and distinguishes finely ground 80 mesh sieve of mistake, the two is mixed;Disintegrant mistake
100 mesh sieves, mannitol, lactose and dry adhesives cross 40 mesh sieves respectively, weigh respectively according to quantity and sequentially add step by said sequence
Mix in hybrid medicine in rapid one;To in step 2 in gained hybrid medicine add recipe quantity lubricant, mixing of sieving, enter
Row intermediates content detects, adopts direct tablet compressing technology compressing tablet, obtain final product after determining piece weight.
8. oral disintegrating tablet preparation method as claimed in claim 1 is prepared, it is characterised in that:Dry-pressing granulation step is:
Main ingredient, colouring agent, flavouring, mannitol, lactose, dry adhesives and disintegrant are crossed 100 mesh sieves respectively, is claimed respectively according to quantity
Take and sequentially add, mixing of sieving, compressing tablet, cross 24 mesh sieve dry granulations;The lubricant of recipe quantity is added in above-mentioned gained medicine,
Sieve mixing, intermediates content detection is carried out, compressing tablet is obtained final product after determining piece weight.
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CN201610845303.2A CN106474080A (en) | 2016-09-24 | 2016-09-24 | A kind of Montelukast receives oral disintegrating tablet and preparation method thereof |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110711179A (en) * | 2018-07-11 | 2020-01-21 | 北京万全德众医药生物技术有限公司 | Orally disintegrating tablet containing montelukast sodium and preparation method thereof |
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CN102973532A (en) * | 2012-12-28 | 2013-03-20 | 南京瑞尔医药有限公司 | Stable montelukast sodium tablet and preparation method thereof |
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CN103239450A (en) * | 2012-02-07 | 2013-08-14 | 齐鲁制药有限公司 | Rapidly-dissolving and stabile montelukast oral solid preparation and preparation method thereof |
CN103494781A (en) * | 2013-08-30 | 2014-01-08 | 哈药集团技术中心 | Montelukast sodium chewing tablet prescription and preparation process thereof |
CN104055741A (en) * | 2013-03-18 | 2014-09-24 | 青岛大学 | Montelukast sodium tablet and preparation method thereof |
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2016
- 2016-09-24 CN CN201610845303.2A patent/CN106474080A/en active Pending
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Publication number | Priority date | Publication date | Assignee | Title |
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EP1818057A1 (en) * | 2006-02-09 | 2007-08-15 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical formulations of montelukast sodium |
KR20090074716A (en) * | 2007-02-14 | 2009-07-07 | 한미약품 주식회사 | Method for preparing rapidly disintegrating formulation for oral administration and medicine packing machine for the same |
CN101732268A (en) * | 2010-01-09 | 2010-06-16 | 鲁南制药集团股份有限公司 | Montelukast sodium tablet and preparation method thereof |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110711179A (en) * | 2018-07-11 | 2020-01-21 | 北京万全德众医药生物技术有限公司 | Orally disintegrating tablet containing montelukast sodium and preparation method thereof |
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