CN114796146B - Slow-release preparation of lamotrigine and preparation method thereof - Google Patents
Slow-release preparation of lamotrigine and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a preparation method of a slow-release preparation of lamotrigine, which comprises lamotrigine, a slow-release material, a diluent, a lubricant, an enteric material, a plasticizer, an anti-sticking agent, a wetting agent and a film coating material; the sustained-release preparation is prepared by the steps of granulating, drying, dry granulating, mixing, tabletting, enteric coating, film coating, inner packaging and the like. The lamotrigine sustained-release preparation can realize the technical effect of slow release, has simple preparation process, does not need a complex punching process, and can effectively solve the technical problem of complex preparation process of the lamotrigine sustained-release tablet in the prior art.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a slow-release preparation of lamotrigine and a preparation method thereof.
Background
Lamotrigine (Lamotrigine) is a phenyl triazine antiepileptic drug, can selectively inhibit depolarization and high-frequency discharge of neurons in epileptic foci while not influencing normal electrophysiological processes of the neurons, stabilize presynaptic membranes of the neurons and inhibit glutamate, thereby playing an antiepileptic role, and the action mechanism of the Lamotrigine can generate the antiepileptic role by inhibiting the release of excitatory amino acids, namely glutamic acid and aspartic acid, in the brain.
The lamotrigine has the chemical name of 3,5-diamino-6- (2,3-dichlorophenyl) -triazine and the molecular formula of C 9 H 7 N 5 Cl 2 Molecular weight is 256.09. The lamotrigine bulk drug is white to light butter powder, and the pKa of the lamotrigine bulk drug is 5.7; slightly soluble in water (0.17 mg/mL at 25 ℃), slightly soluble in 0.1M HCl (4.1 mg/mL at 25 ℃), and the structural formula is as follows:
commercially available lamotrigine includes 25mg, 50mg, 100mg and 200mg standard orally disintegrating tablets and 25mg, 50mg, 100mg, 200mg, 250mg and 300mg standard sustained release tablets; in addition, low dose water dispersible tablets containing 2mg, 5mg, 25mg and 100mg specifications are suitable for use by children of different ages, the low dose specifications being typically given to pediatric patients. The lamotrigine sustained-release tablet is mainly used as an additional treatment drug for partial epileptic seizures (whether secondary comprehensive epileptic seizures exist or not) of epileptic patients over 13 years old, and is prepared by a novel proprietary drug release technology called Diffcore developed by GlaxoSmithKline company, and the enteric coatings on the two sides of the tablet are respectively provided with a specially designed hole, so that the drug can be slowly released in a controlled manner in a gastric acid environment.
For epileptic patients, it is necessary to maintain sufficient antiepileptic drugs in vivo for a long period of time to prevent epileptic seizures, and the lamotrigine sustained-release tablets of GSK group can maintain effective blood concentration within 24 hours, thus having significant clinical compliance. However, the lamotrigine sustained-release tablets of the GSK group need to be perforated on the surface of a coating film to control the slow release of the drug in vivo, the preparation process is complex, the cost of the drug is high, and patients face higher economic burden of drug administration after long-term use.
Disclosure of Invention
The invention mainly aims to provide a novel lamotrigine sustained-release preparation and a preparation method thereof, the sustained-release preparation can also realize the problem of slow release, and can effectively solve the technical problem of complex preparation process of lamotrigine sustained-release tablets in the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that:
the slow release preparation of lamotrigine is provided, which comprises lamotrigine, a slow release material, a diluent, a lubricant, an enteric coating material and a film coating material, wherein the enteric coating material comprises an enteric material, a plasticizer, an antisticking agent and a wetting agent, and the film coating material comprises hydroxypropyl methyl cellulose, a colorant and a wetting agent.
The sustained-release material is selected from hydroxypropyl methylcellulose, preferably from the combination of hydroxypropyl methylcellulose E4M CR and hydroxypropyl methylcellulose K100 LV, and the mass ratio of lamotrigine to the hydroxypropyl methylcellulose E4M CR to the hydroxypropyl methylcellulose K100 LV is 50: (50-80): (40-60), the preferred mass ratio of lamotrigine to hypromellose E4M CR to hypromellose K100 LV is 50: (65-75): (50:55).
The diluent is selected from lactose, and the preferable mass ratio of the lamotrigine to the filler is 50:100-150, preferably the mass ratio of lamotrigine to filler is 50:110-140, or 50:120-135, or 50:130.
the lubricant of the invention is selected from stearic acid or pharmaceutically acceptable salts thereof, preferably magnesium stearate, and the mass ratio of lamotrigine to the lubricant is 50:1-1.4, preferably 50:1.1-1.3, most preferably 50:1.2.
the enteric material in the enteric coating material is selected from methacrylic acid-ethyl acrylate copolymer, and the mass ratio of lamotrigine to the enteric material is 50:6-12, preferably 50:7-11, more preferably 50:8-10, most preferably 50:9.
the plasticizer is selected from triethyl citrate, and the mass ratio of lamotrigine to the plasticizer is 50:0.6-1.2, preferably 50:0.7-1.1, more preferably 50:0.8-1.0, most preferably 50:0.9.
the anti-sticking agent is selected from glyceryl mono-distearate and the mass ratio of lamotrigine to glyceryl mono-distearate to glyceryl distearate is 50:0.3 to 0.6, preferably 50:0.35-0.55, more preferably 50:0.4-0.5, most preferably 50:0.45.
the wetting agent is selected from polysorbate 80, and the mass ratio of lamotrigine to polysorbate 80 is 50:0.12-0.24, preferably 50:0.15-0.20, more preferably 50:0.17:0.19, most preferably 50:0.18.
the film coating material or the film coating premixed powder is a combination of hydroxypropyl methylcellulose, titanium dioxide, tween 80, polyethylene glycol and yellow ferric oxide or a combination of hydroxypropyl methylcellulose, titanium dioxide, tween 80, polyethylene glycol and black ferric oxide, and the mass ratio of lamotrigine to the film coating premixed powder is 50:5-10, preferably 50:6-9, more preferably 50:7-8, most preferably 50:7.40.
further, the film coating material or film coating premix powder of the present invention comprises: 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and yellow ferric oxide or 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and black ferric oxide.
The invention further provides a preparation method of the lamotrigine sustained-release preparation, which comprises the following steps:
1. and (3) granulating: adding the hydroxypropyl methylcellulose E4M CR, the hydroxypropyl methylcellulose K100 LV, the lamotrigine and the lactose in the prescription amount into equipment in sequence, uniformly mixing, adding purified water, and granulating.
2. And (3) drying: the granules are fed into a fluidized bed for drying through vacuum feeding.
3. Dry granulation: the dried granules are transferred to a granulator for dry granulation.
4. Mixing: collecting the dry granules, weighing magnesium stearate according to the yield of the dry granules, and adding the magnesium stearate into the dry granules for mixing to obtain the total mixed granules.
5. Tabletting: the total blended granules were tabletted.
6. Enteric coating: and (4) performing enteric coating by using the enteric coating solution after tabletting. The enteric coating liquid consists of: methacrylic acid-ethyl acrylate copolymer and aqueous dispersion thereof (mass concentration is 25-35%, preferably 30%), triethyl citrate, glyceryl monostearate and polysorbate 80.
7. And (3) film coating, namely performing a film coating process by using film coating liquid. The film coating liquid consists of: and mixing the water and the film coating material uniformly to obtain the coating. The coating material comprises: 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and yellow ferric oxide or 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and black ferric oxide.
8. And (4) inner packaging, namely performing inner packaging on the film-coated tablets.
The terms of the present invention:
glyceryl mono-bis-stearate: the monoglyceride content is in the range of 40.0% -55.0%, and the diglyceride content is in the range of 30.0% -45.0%. The Chinese pharmacopoeia corresponding to the Chinese pharmacopoeia has the name: glyceryl mono-bis-stearate; eur name is: glycerol Monoostearate 40-55; USP name of load: mono-and Di-saccharides;
lactose in the present invention refers to lactose anhydride or lactose monohydrate.
Compared with the prior art, the invention has the following beneficial effects: the sustained-release preparation can also realize the technical effect of slow release, has simple preparation process, and can effectively solve the technical problem of complex preparation process of the lamotrigine sustained-release tablet in the prior art.
Drawings
Fig. 1 is an overall flow chart of a process for preparing a lamotrigine sustained-release preparation of the present invention.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific embodiments.
General preparation examples:
weighing the components of the lamotrigine sustained-release preparation and purified water according to the material ratio for later use.
The preparation method comprises the following steps of adding the hydroxypropyl methylcellulose E4M CR, the hydroxypropyl methylcellulose K100 LV, the lamotrigine and the lactose (monohydrate) in the prescribed amount into equipment in sequence, uniformly mixing, and granulating by using purified water (the ratio of lamotrigine to purified water is 1.5-1.5). The main parameters of granulation were: rotating speed of the stirring knife: 170rpm, chopper speed: 1200rpm.
The granules are fed into a fluidized bed for drying through vacuum feeding. The main parameters of drying were: air inlet temperature: 60 ℃, air volume: front 1200m 3 H, late stage 800m 3 /h。
Transferring the dried granules to a granulating machine for dry granulating, wherein the main parameters of the dry granulating are as follows: rotating speed: 40Hz (corresponding to a rotation speed of 1200 rpm).
Collecting the dry granules, weighing magnesium stearate according to the yield of the dry granules, and adding the magnesium stearate into the dry granules for mixing to obtain the total mixed granules. The main parameters of mixing were: rotating speed: 10r/min, time setting: for 10min.
Tabletting the total mixed granules, wherein the main parameters of tabletting are as follows: the production speed is as follows: 30-70 thousand tablets/hour, the main pressure is controlled to be 17.8-37.8KN, and the filler is controlled to be 20-70rpm.
Performing enteric coating after tabletting, preparing the methacrylic acid-ethyl acrylate copolymer into aqueous dispersion with the mass concentration of about 30%, adding triethyl citrate, glyceryl monostearate and polysorbate, uniformly mixing, and spraying the aqueous dispersion to the material obtained in the above step, wherein the main parameters are as follows: the rotating speed of the main machine is as follows: 2-12rpm, inlet air temperature: 60 ℃, guniting speed: initial 20rpm, late 60rpm, atomization pressure: 0.3bar, actual temperature of the material: 25-35 ℃.
Then, a film coating process is carried out, and the film coating liquid comprises the following components: and mixing the water and the film coating material uniformly to obtain the coating. The coating material comprises: 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and yellow ferric oxide or 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of tween 80 and black ferric oxide.
The main parameters are as follows: the rotating speed of the main machine is as follows: 2-12rpm, inlet air temperature: 60 ℃, guniting speed: initial 40rpm, late 90rpm, atomization pressure: 0.3bar, actual temperature of the material: 35-45 ℃.
And (4) carrying out inner packaging on the film-coated tablets. The main parameters are as follows: 30 bottles/min.
Specific examples (50 mg scale, table 1)
Test example 1 (stability experiment):
the lamotrigine sustained-release tablets obtained in example 1 were subjected to stability test tests under accelerated test conditions (temperature 40 ℃. + -. 2 ℃ C., humidity 75%. + -. 5%) and under prolonged conditions for 3 months, and the results are shown in Table 2:
impurity C: 3-amino-6- (2,3-dichlorophenyl) -1,2,4-triazin-5 (4H) -one, dimer of impurities: n5, N5' -methylenebis (6- (2,3-dichlorophenyl) -1,2,4-triazine-3,5-diamine
Test example 2 (dissolution test)
Dissolution comparisons of 3 media using 50mg of the self-ground product (example 1) with commercially available Lamitl XR 50mg at 50rpm by Paddle method gave F2 results exceeding 50, indicating similar in vitro dissolution results.
Table 3:
TABLE 4
TABLE 5
The foregoing shows and describes the general principles and features of the present invention, together with the advantages thereof. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (2)
1. The preparation method of the slow-release preparation of lamotrigine comprises lamotrigine, a slow-release material, a diluent, a lubricant, an enteric coating material and a film coating material, wherein the enteric coating material comprises an enteric material, a plasticizer, an anti-sticking agent and a wetting agent, and the film coating material comprises hydroxypropyl methyl cellulose, a colorant and a wetting agent, and is characterized in that the slow-release material is selected from the combination of hydroxypropyl methylcellulose E4M CR and hydroxypropyl methylcellulose K100 LV, and the mass ratio of lamotrigine to hydroxypropyl methylcellulose E4M CR to hydroxypropyl methylcellulose K100 LV is 50: (65-75): 50; the diluent is selected from lactose, and the mass ratio of lamotrigine to the diluent is 50:130, 130;
the method comprises the following steps:
(1) And (3) granulating: sequentially adding the slow-release material, the lamotrigine and the diluent in the prescription amount into equipment, uniformly mixing, adding purified water, and granulating;
(2) And (3) drying: feeding the granules into a fluidized bed for drying through vacuum feeding;
(3) Dry granulation: transferring the dried particles to a granulating machine for dry granulation;
(4) Mixing: collecting dry particles, weighing the lubricant according to the yield conversion of the dry particles, and adding the lubricant into the dry particles for mixing to obtain total mixed particles;
(5) Tabletting: tabletting the total mixed particles;
(6) Enteric coating: performing enteric coating process by using enteric coating liquid after tabletting, wherein the enteric coating liquid is a dispersion of enteric coating materials and water, and the mass concentration is 25-35%; the enteric material is selected from methacrylic acid-ethyl acrylate copolymer, and the mass ratio of lamotrigine to the enteric material is 50:9;
(7) Film coating, namely performing a film coating process by using film coating liquid, wherein the film coating liquid is obtained by uniformly mixing water and film coating materials;
the film coating material is a combination of hydroxypropyl methylcellulose, titanium dioxide, tween 80, polyethylene glycol and yellow ferric oxide or a combination of hydroxypropyl methylcellulose, titanium dioxide, tween 80, polyethylene glycol and black ferric oxide, and the mass ratio of lamotrigine to film coating premixed powder is 50:7-8;
the film coating material comprises: 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of Tween 80 and yellow ferric oxide;
or the film coating material comprises: 30-50% of hydroxypropyl methylcellulose, 10-30% of titanium dioxide, 5-10% of polyethylene glycol and the balance of Tween 80 and black iron oxide;
the lubricant is selected from stearic acid or pharmaceutically acceptable salts thereof, and the mass ratio of lamotrigine to the lubricant is 50:1-1.4;
the plasticizer is selected from triethyl citrate, and the mass ratio of lamotrigine to the plasticizer is 50:0.6 to 1.2;
the anti-sticking agent is selected from glyceryl monostearate and glyceryl distearate, and the mass ratio of the lamotrigine to the glyceryl monostearate to the glyceryl distearate is 50:0.3-0.6;
the wetting agent in the enteric coating material is selected from polysorbate 80, and the mass ratio of lamotrigine to polysorbate 80 is 50:0.12-0.24.
2. The sustained-release preparation of lamotrigine produced by the process for producing a sustained-release preparation of lamotrigine according to claim 1.
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| GB9726987D0 (en) * | 1997-12-22 | 1998-02-18 | Glaxo Group Ltd | Compounds |
| GB0217493D0 (en) * | 2002-07-29 | 2002-09-04 | Glaxo Group Ltd | Novel methods of treatment |
| US20090196924A1 (en) * | 2008-02-04 | 2009-08-06 | Pramod Kharwade | Controlled-release lamotrigine formulations |
| CN103948553A (en) * | 2014-04-22 | 2014-07-30 | 青岛市中心医院 | Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet |
| CN104721163A (en) * | 2015-04-09 | 2015-06-24 | 海南华益泰康药业有限公司 | Sustained release tablet containing lamotrigine and preparing method thereof |
| CN112843012B (en) * | 2019-11-12 | 2023-06-02 | 石家庄以岭药业股份有限公司 | Lamotrigine-containing preparation composition and preparation method thereof |
| KR20220110759A (en) * | 2019-12-06 | 2022-08-09 | 나넥사 에이비 | novel composition |
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