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Lamotrigine orally disintegrating sustained release tablets

A technology for lamotrigine and sustained-release tablets, which is applied in the field of pharmaceutical preparations and can solve problems such as inconvenient administration and side effects

Inactive Publication Date: 2015-04-01
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Specifically, it is necessary to provide a drug dosage form that can be quickly dissolved in the oral cavity, and can be continuously released in the gastrointestinal tract to ensure blood drug concentration, so as to overcome the inconvenience and side effects of lamotrigine as a common tablet. question

Method used

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  • Lamotrigine orally disintegrating sustained release tablets
  • Lamotrigine orally disintegrating sustained release tablets
  • Lamotrigine orally disintegrating sustained release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The prescription quantity is 1000 tablets, and the specification is 25mg.

[0027]

[0028] Process:

[0029] Fast-dissolving microparticles: Mix appropriate amount of crospovidone, mannitol and microcrystalline cellulose evenly, granulate, and coat with hydroxypropyl cellulose;

[0030] Organic acid core: Mix appropriate amount of fumaric acid, microcrystalline cellulose and lactose, granulate, use ethyl cellulose and cellulose acetate succinate mixture as coating barrier, coating weight gain is about 6%, and prepare Coated granules with long-lasting release of organic acids;

[0031] Lamotrigine IR beads: Layer a hydroxypropyl cellulose solution containing an appropriate amount of lamotrigine on a partially barrier-coated organic acid core, and coat an ethyl cellulose coating containing hydroxypropyl cellulose Coating liquid, to carry out sealing coating to particle;

[0032] Lamotrigine SR Beads: Ethylcellulose coating at approximately 5% weight gain ba...

Embodiment 2

[0036] The prescription quantity is 1000 tablets, and the specification is 25mg.

[0037]

[0038] Process:

[0039] Fast-dissolving microparticles: Mix an appropriate amount of cross-linked povidone and mannitol evenly, granulate, and coat with methylcellulose;

[0040] Organic acid core: mix an appropriate amount of citric acid and mannitol, granulate, use a mixture of ethyl cellulose and cellulose acetate succinate as a coating barrier, and the weight gain of the coating is about 8%, and the preparation can release organic acids for a long time coated granules;

[0041] Lamotrigine IR beads: layer the methylcellulose solution containing an appropriate amount of lamotrigine on the organic acid core of the barrier coating, and coat the ethylcellulose coating solution containing methylcellulose , seal-coat the granules;

[0042] Lamotrigine SR Beads: Ethylcellulose coating at approximately 5% weight gain based on dry weight of IR uncoated seal-coated beads;

[004...

Embodiment 3

[0046] The prescription quantity is 1000 tablets, and the specification is 25mg.

[0047]

[0048] Process:

[0049] Fast-dissolving microparticles: Mix an appropriate amount of crospovidone and microcrystalline cellulose evenly, granulate, and coat with methylcellulose;

[0050] Organic acid core: Mix appropriate amount of citric acid, fumaric acid and microcrystalline cellulose, granulate, use the mixture of cellulose acetate butyrate and cellulose acetate succinate as the coating barrier, and the weight gain of the coating is about 8% , to prepare coated granules that can release organic acids for a long time;

[0051] Lamotrigine IR beads: A layer of methylcellulose solution containing an appropriate amount of lamotrigine is layered on a partially barrier-coated organic acid core and coated with a cellulose acetate butyrate coating containing methylcellulose liquid to seal coat the granules;

[0052] Lamotrigine SR beads: cellulose acetate butyrate coating at...

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Abstract

The invention relates to a method for treating CNS diseases and provides lamotrigine orally disintegrating sustained release tablets which can be rapidly disintegrated in the oral cavity and can reflect very similar release rate unrelated to the pH value of the environment in the whole gastrointestinal tract. The preparation comprises lamotrigine, organic acids, a disintegrating agent, a polymer controlling release and an enteric polymer. The compositions can be used for treating epilepsy and bipolar disorder, particularly patients suffering from dysphagia and improving the compliance of patients suffering from the bipolar disorder. The orally disintegrating tablets are prepared according to the method disclosed by the invention, the release rate of active ingredients can be controlled, and the bioequivalence and clinical safety and effectiveness of the product are guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dosage form combining oral disintegration technology with sustained and controlled release technology and a preparation method thereof. Background technique [0002] Lamotrigine, whose chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-partial-triazine, is a phenyltriazine antiepileptic drug. The drug is typically used in drug therapy and as an addition to other antiepileptic drugs for partial-onset seizures and primary and secondary generalized tonic-clonic seizures in adults and pediatric patients (children ≥ 2 years of age) adjuvant therapy. Lamotrigine is also indicated for seizures associated with myoclonic agitation petit mals and as maintenance therapy for bipolar I disorder to delay acute mood episodes (eg, depression, mania, Hypomania, mixed acute episodes). [0003] Orally disintegrating tablets, referred to as orally disintegrating tablets, are tablets ...

Claims

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Application Information

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IPC IPC(8): A61K9/26A61K31/53A61P25/08
Inventor 张庭刁媛媛马苏峰
Owner 万全万特制药(厦门)有限公司
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