CN107913258A - A kind of levetiracetam sustained-release tablets and preparation method thereof - Google Patents
A kind of levetiracetam sustained-release tablets and preparation method thereof Download PDFInfo
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- CN107913258A CN107913258A CN201610881427.6A CN201610881427A CN107913258A CN 107913258 A CN107913258 A CN 107913258A CN 201610881427 A CN201610881427 A CN 201610881427A CN 107913258 A CN107913258 A CN 107913258A
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- levetiracetam
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
A kind of levetiracetam sustained-release tablets and preparation method thereof, the invention discloses the pharmaceutical composition containing Levetiracetam, the pharmaceutical composition includes water-soluble active ingredient Levetiracetam, the levetiracetam tablet prescription of the present invention is reasonable, stable preparation process, selection to auxiliary material reaches preferable effect, and production cost is relatively low, and technique is simply suitable for being commercialized big production.
Description
Technical field
The present invention relates to pharmaceutical technology field, more particularly, to a kind of pharmaceutical composition and its system comprising Levetiracetam
Preparation Method.
Background technology
Levetiracetam is a kind of antiepileptic that Belgian UCB. S.A. (BE) Bruxelles Belgium develops, and FDA batches are obtained in April, 2000
Accurate to be listed in the U.S., in March, 2007 is formally mainly used for adult and more than 4 years old Patients with Epilepsy in Childhood is partial in Discussion on Chinese Listed
The add-on of breaking-out.
Chinese:Levetiracetam
Chinese nickname:(S)-alpha- ethyls -2- oxygen conjunction -1- acetamide pyrrolidines
English name:Levetiracetam
English name:(s)-2-(2-oxopyrrolidin-1-yl)butanamide；(S)-1-
pyrrolidineacetamid；(+-)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide；
(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide；1-Pyrrolidineacetamide；
alpha-ethyl-2-oxo-；alpha-Ethyl-2-oxo-1-pyrrolidineacetamide；
Etiracetam；Etiracetam[INN]；Etiracetamum[INN-Latin]；Keppra；
Levetiracetam[INN]；Levetiracetamum[INN-Latin]；LEVITIRACETAM；UCB6474；
UCB-6474；UCB-L 059；Name:(S)-2-(2-Oxopyrrolidin-1-
yl)butanamide(Levetiracetam)；(2R)-2-(2-oxopyrrolidin-1-
yl)butanamide；(2S)-2-(2-oxopyrrolidin-1-yl)butanamide
CAS:102767-28-2；51052-62-1
Molecular formula:C8H14N2O2
Molecular weight:170.209
Composition：The chemical name of Levetiracetam is (S)-alpha-ethyl-2-oxo -1- pyrrolidine acetamides, molecular formula：
C8H14N2O2, molecular weight：170.21.
Structural formula：
Levetiracetam is to be extremely easy to dissolve and have high osmosis compound.Linear metabolism, it is a in vivo and individual
Between difference it is small.Multiple dosing does not influence its clearance rate.This product does not have sex, race's otherness and circadian rhythm difference.This product
Pharmacokinetic shows that the pharmacokinetic data of healthy volunteer and patient are comparable.Due to Levetiracetam
Absorption completeness and linear relationship, its blood concentration can be predicted according to oral dose mg/kg, thus be not necessarily to pair
The carry out blood concentration monitoring of Levetiracetam.Adult and the saliva of child patient and blood concentration show significant correlation
(after when taking this product tablet or small this product liquid preparation 4, saliva/blood drug concentration ratio is 1：1.7).
Currently without the data of tissue distribution.Either Levetiracetam or its main metabolites be not easy with
Plasma protein combination (<10%).Distribution volume is 0.5-0.7L/kg, close to human body water capacity.
Levetiracetam does not decompose extensively in human body, main metabolic pathway be by the acetyl amination of hydrolase (to
Pharmaceutical quantities 24%).Main metabolites UCB L057 are not transformed by liver pigment P450 delivery systems.It is most of in vivo
Tissue, which includes haemocyte, can measure acetamide group hydrolysate.Metabolite UCB L057 parmacodynamics-less activities.2 a small amount of metabolism
Approach have also determined that, one be hydroxylation pyrrolidines approach (the 1.6% of dosage), be in addition pyrrolidino group open loop,
Constitute about the 0.9% of dosage.The metabolite of other metabolic pathways that can not be determined accounts for the 0.6% of dosage.External examination
As shown by data is tested, either Levetiracetam or its major metabolite is without first pass effect.The left second of in vitro test as shown by data
La Xitan and its main metabolites do not suppress liver pigment P450 isomeries (CYP3A4,2A6,2X8/9/10,2C19,2D6,2E1
And 1A2) grape alditol transferase (UGT1*6, UGT1*1 and UGT [pI6.2] and epoxides hydroxyl enzymatic activity.In addition, left second
La Xitan is tested in vitro shows the glucose hydroformylation for not influencing valproic acid.In human hepatocyte organizes, Levetiracetam is not
Produce enzyme induction.Thus, this product and other materials are applied jointly, will not usually produce interaction, vice versa.
It is grown up plasma half-life:7 ± 1 it is small when, not because dosage is different, method of administration is different or repeat administration and
Change.Average total body clearance is 0.96mL/min/kg.Medicine is mainly drained from urine, about dosage 95% (about
The 93% interior excretion when 48 is small).The medicine drained out of excrement only accounts for 0.3%.It is interior when start administration 48 are small, add up a left side
The excretion rate of etiracetam and its metabolite is respectively the 66% and 24% of dosage.Levetiracetam and UCB L057 kidneys
Dirty clearance rate is respectively 0.6 and 4.2mL/min/kg, this shows Levetiracetam by being inhaled through renal tubule after glomerular filtration again
Receive heel row to remove, main metabolites are also to eliminate by tubular secretion and glomerular filtration.The elimination factor of Levetiracetam and
Flesh elderly patients：The half-life period of gerontal patient's Levetiracetam about extends 40% (when 10-11 is small).This with renal function
Drop related.(6-12 when the Levetiracetam plasma half-life of children (4-12 Sui) single dose administration (20mg/kg) is 6.0 small
Year).Its apparent clearance rate (after weight regulation) is about higher than seizures in adults by 30%.Virgin (4-12 Sui) repeats oral (20-60mg/kg/
Day) after, Levetiracetam absorbs rapidly.Cmax is reached when 0.5-1 is small after medication.Cmax and area under the curve are linear, and
With dose proportional increase.When removing half-life period is 5 small, the about 1.1mL/min/kg of apparent internal clearance rate.
Disclose that the present invention provides a kind of levetiracetam oral disintegrating tablet and its preparation side in CN201610197802
Method, levetiracetam oral disintegrating tablet of the present invention are prepared using simple and cheap common process, its active ingredient draws for left second
It is western smooth, formed in addition with filler, disintegrant, adhesive, sweetener, lubricant.Levetiracetam is a kind of new anti-insane
Epilepsy medicine, levetiracetam oral disintegrating tablet of the present invention are conducive to improve patient medication compliance, improve curative effect.
Disclose that the invention discloses a kind of levetiracetam tablet and preparation method in CN201410239114.The present invention
Levetiracetam tablet prescription rationally and stable preparation process, the selection to auxiliary material reach preferable effect, production cost compared with
It is low.
Disclosed in CN200680051606 and a kind of substantially levetiracetam composition without glidant is provided, include reality
The pharmaceutical composition of Levetiracetam combination without glidant in matter, and the method for preparing said composition.
The Levetiracetam extended release pharmaceutical composition of dosage regimen once a day is disclosed in CN200580047316
And preparation method thereof.The Levetiracetam extended release tablet has poly- comprising Levetiracetam and water dispersible rate control
The core of compound, and the tablet core is optionally included not scattered and/or aqueous dispersion polymers the combination function of water
Property coating.It provides the effective blood plasma level of extended treatment when 24 is small and by eliminating medicine in patients blood plasma in the period
The peak and valley of concentration and reduce the incidence of psychoneural adverse reaction, it includes orally administering extended release to the patient of needs
Piece when about 8 to about 16 is small in provide Levetiracetam peak plasma level.Press by wet granulation, dry granulation or directly
Piece prepares the core, and optionally described tablet core is coated in coating pan or in fluidized system.
, must according to the above-mentioned prior art, it is necessary to prepare the stabilizing pharmaceutical composition for including Levetiracetam for being easy to prepare
It need to ensure its stability, in addition also need to provide good uniformity of dosage units.
The content of the invention
According under existing technology, auxiliary material and working condition, ensureing with relatively low production cost and simple and practicable
Under preparation process, on the premise of having been adapted for large-scale industrial production, it is necessary to work out a kind of stabilization composition and
Preparation process, the tablet obtained by it is with good stability, including long-term stability.Also excellent content is uniform
Degree, when cumulative release 12 is small in dissolution experiment in vitro.
Technical solution is used by the present invention solves above-mentioned technical problem：A kind of preparation side of levetiracetam sustained-release tablets
Method, it is characterised in that comprise the following steps：
(1) design medicine forms：The each component and content of the levetiracetam tablet be
| Prescription content (%) | |
| Levetiracetam | 60-80 |
| Hydroxypropyl methyl cellulose | 25-35 |
| Polyethylene glycol | 0-8 |
| Silica | 0.2-5 |
| Magnesium stearate | 0.1-1.5 |
(2) bulk pharmaceutical chemicals pre-process, and 80 mesh sieves are crossed after pa Levetiracetam is crushed with high speed disintegrator, spare.
(3) premix, by Levetiracetam and hydroxypropyl methyl cellulose, polyethylene glycol, silica, is added to mixer
In, mix 10 minutes.
(4) dry granulation, uniformly mixed material 28 mesh sieve of dry granulating machine is pelletized, and granulation pressure is 50-65N,
Tabletting speed is 7 revs/min, frequency：21.90Hz, feeding speed are 15 revs/min, frequency：12.50Hz, granulation rotating speed are
200 revs/min, frequency：20.00Hz.
(5) it is total mixed, obtained particle is proportionally added into magnesium stearate (outer), is mixed 10 minutes with mixer.
(6) tabletting, more different size and piece weight, tabletting hardness are controlled between 80-180N (YD-1 type hardness testers instrument).
(7) it is coated using high-efficiency coating machine, the stomach dissolution type premixing flour that coating material is supplied using happy Kandy is blocked, its constituent
Including hydroxypropyl methylcellulose, polyethylene glycol 3350, titanium dioxide, polyvinyl alcohol, talcum powder, iron oxide black, iron oxide yellow.Coating
Weightening control is between 2-4%.Specific coating parameter is as follows：35-45 DEG C of temperature of charge, 50 DEG C of inlet air temperature, rotation speed of fan
1000rpm, engine speed 7rpm, wriggling revolution speed 5rpm.
(8) pack, registration storage.
Embodiment
It is noted that described further below is all illustrative, it is intended to further instruction is provided to the present invention, but not
Limit present disclosure.The those of ordinary skill institute of technical and scientific terms used herein and the same technical field of the present invention
The implication of understanding is identical.
Preformulation study：
First, auxiliary material compatibility test：
Whether the present inventor mainly considers auxiliary material performance when screening auxiliary material is superior.To investigate the compatible of this product and auxiliary material
Property, hydroxypropyl methyl cellulose, polyethylene glycol, silica, Opadry II, magnesium stearate are pressed with Levetiracetam respectively
1:20 ratio is put in a closed container after mixing, 5 under the conditions of 60 DEG C of high temperature and illumination (4500LX) are placed, 10,
30 days, Levetiracetam was placed do parallel control at the same time, detects its appearance character, content, related material, is put with raw material and 0 day
Putting sample relatively has unchanged, detects related material.
Conclusion：After Levetiracetam mixes in proportion with above-mentioned auxiliary material, placed under 60 DEG C of high temperature and illumination (4500LX)
5th, 10,30 days, character, in relation to material and content with placing sample at 0 day and raw material Duplicate Samples relatively have no significant change, property
Stablize, illustrate that Levetiracetam is good in the compatibility of each auxiliary material, above-mentioned any auxiliary material can be selected in prescription screening.
2nd, tablet formulation and technical study：
In order to make tablet beautiful, easy to identify, levetiracetam tablet of the invention can also be prepared as coated tablet, bag
Clothing prescription and technical study are as follows：Coating material selects gastric solubility coating powder Opadry II, is coated prescription and technique is as follows：It is excellent
The coating prescription of choosing is：Opadry II 30g purified waters add to more than 170g for 1000g label dosages coating weight gain 2.0~
5.0%.Preferable coating liquid making method and art for coating are：Coating solution is prepared：Coating powder is added to the pure of stirring
Change in water, fully dissolving, persistently stir 45 minutes, be sufficiently mixed uniformly, cross 100 mesh sieves, it is spare.Label is added into coating pan
In, pot rotating speed is adjusted, starts hot-air system, preheating, opens spray gun and spray into prepared coating powder solution, check plain piece bag at any time
Clothing degree, control plain piece gain in weight (piece increase weight again about 2.0~5.0%), is all wrapped to tablet and when surface colors are uniform,
Stop hydrojet, blowing a cold wind over makes tablet be cooled to 30 DEG C, is completely dried to unilateral.
3rd, influence factor is tested：
Levetiracetam tablet of the present invention is taken, according to bulk pharmaceutical chemicals and medicine stability test guideline, respectively by sample
It is placed under the conditions of high temperature (60 DEG C), high humidity 1 (RH75%), high humidity 2 (RH92.5%), strong light (4500LX) and places 5,10,30 days,
Sampled respectively at the 5th, 10,30 day, detect indices, and compared with 0 day result, investigate levetiracetam tablet of the present invention
Stability under the conditions of each.Measurement result is shown in Table 1.
The levetiracetam tablet influence factor result of the test of the present invention of table 1
Conclusion：Levetiracetam tablet of the present invention is placed under high temperature, high humidity, illumination condition, indices and 0 day result phase
Compare and have no significant change, property is stablized.
Embodiment 1：The each component and content of the levetiracetam tablet be
| Prescription content mg/ pieces | |
| Levetiracetam | 500 |
| Hydroxypropyl methyl cellulose | 200 |
| Polyethylene glycol | 10 |
| Silica | 5 |
| Magnesium stearate | 1 |
(1) bulk pharmaceutical chemicals pre-process, and 80 mesh sieves are crossed after pa Levetiracetam is crushed with high speed disintegrator, spare.
(2) premix, pa is moored into former times cloth Levetiracetam and hydroxypropyl methyl cellulose, polyethylene glycol, silica, adds
Into mixer, mix 10 minutes.
(3) dry granulation, uniformly mixed material 28 mesh sieve of dry granulating machine is pelletized, and granulation pressure is 50-65N,
Tabletting speed is 7 revs/min, frequency：21.90Hz, feeding speed are 15 revs/min, frequency：12.50Hz, granulation rotating speed are
200 revs/min, frequency：20.00Hz.
(4) it is total mixed, obtained particle is proportionally added into magnesium stearate (outer), is mixed 10 minutes with mixer.
(5) tabletting, more different size and piece weight, tabletting hardness are controlled between 80-180N (YD-1 type hardness testers instrument).
(6) it is coated using high-efficiency coating machine, the stomach dissolution type premixing flour that coating material is supplied using happy Kandy is blocked, its constituent
Including hydroxypropyl methylcellulose, polyethylene glycol 3350, titanium dioxide, polyvinyl alcohol, talcum powder, iron oxide black, iron oxide yellow.Coating
Weightening control is between 2-4%.Specific coating parameter is as follows：35-45 DEG C of temperature of charge, 50 DEG C of inlet air temperature, rotation speed of fan
1000rpm, engine speed 7rpm, wriggling revolution speed 5rpm.
(7) pack, registration storage.
Embodiment 2：Prepare Film coated tablets
(1) coating solution is prepared：The purified water calculated is added in liquid dispensing container, starts blender, stirring blade is from appearance
Device bottom level is the 1/3 of liquid height, liquid is stirred completely, liquid level just forms vortex and not spatter liquid, will wrap
Clothing powder is constantly sprinkling upon on vortex liquid level with stable speed, is persistently stirred 45 minutes and is leached completely to coating agent, crosses 100 mesh sieves,
It is spare；
(2) it is coated：The label obtained in embodiment 1 is added in coating pan, adjusts pot rotating speed, starts hot-air system, in advance
Heat, opens spray gun and sprays into prepared coating powder solution, checks plain piece coating degree at any time, (piece increases control plain piece gain in weight again
Weigh about 2.0%~4.0%), when all wrapped and surface color is uniform to tablet, stop hydrojet, blowing a cold wind over cools down tablet
To 30 DEG C, it is completely dried to unilateral.
Testing result：
Conclusion：Using the prescription and preparation process, on In Vitro Dissolution without influence after coating, when 12 is small, the interior sustained release that reaches is released
Put effect.This product is using dry granulation, tabletting, art for coating, and simple process is controllable, and coating material is aqueous coatings material, nothing
Pollution, no organic residue, is suitable for industrialized production.By the application of new sustained release material, using dry granulation process, show
The productibility for improving preparation is write, midbody particle size uniform flow is preferable, ensures the uniformity of sample during total mix,
Reduce the unfavorable aspect such as tablet weight variation in tableting processes.
Claims (7)
1. a kind of pharmaceutical composition for including Levetiracetam, it is characterised in that the pharmaceutical composition is by Levetiracetam
Formed with pharmaceutically acceptable pharmaceutic adjuvant, the pharmaceutic adjuvant include filler, including but not limited to microcrystalline cellulose,
One or more in lactose, starch, mannitol, polyethylene glycol；The pharmaceutic adjuvant includes adhesive, includes but not limited to
One or more in hydroxypropyl cellulose, hydroxypropyl methyl cellulose, povidone；The medicine auxiliary material includes suitably anti-help
Agent is flowed, includes but not limited to talcum powder, silica, magnesium stearate；The auxiliary material also includes the coating with humidity resistance
Material；50%-90% of its its content of Levetiracetam as active component equivalent to tablet weight.
2. Levetiracetam according to claim 1, the particle diameter of the Levetiracetam be 40um≤Dv (90)≤
200um, 5um≤Dv (50)≤30um.
3. pharmaceutical composition according to claim 1, the adhesive can be hydroxypropyl cellulose, hydroxypropyl methyl
One or more in cellulose, povidone；It is more than 4% to the adhesive no more than 40% with equivalent to total weight of tablet.
4. pharmaceutical composition according to claim 1, can also include pharmaceutically acceptable carrier, such as filler,
Glidant and lubricant etc..
5. pharmaceutical composition according to claim 4, the medicine include Levetiracetam as effective active components with
Relative to the pharmaceutical composition gross weight：50% to 90% Levetiracetam, more than 4% to the bonding no more than 40%
Agent, 0% to 20% filler, 0.1% to 4.0% glidant, lubricant 0.1% to 2.0%.
6. pharmaceutical composition according to claim 5, including quite with total weight of tablet：60% to 80% left second is drawn
It is western smooth, 25.0% to 35.0% adhesive, 0.0% to 8.0% filler, 1.0% to 4.0% disintegrant, 0.2% to
5.0% glidant, 0.1% to 1.5% lubricant.
7. a kind of preparation method of levetiracetam medicinal composition as claimed in claim 1, this method include：
(1) Levetiracetam pulverization process, the sieving pretreatment of other auxiliary materials are removed into caking, control particle size range 40um≤Dv
(90)≤200um.5um≤Dv(50)≤30um；
(2) by Levetiracetam and adhesive, and pharmaceutically acceptable filler, glidant mixing；
(3) recipe quantity Levetiracetam, polyethylene glycol, hypromellose, silica is taken to be placed in dry granulating machine；
(4) in mixer, magnesium stearate, total mixed rear tabletting are added；
Coating, is packed, storage.
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Application publication date: 20180417 |