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Quetiapine fumarate pharmaceutical composition

A technology of quetiapine fumarate and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of complex preparation process of sustained-release tablets, slow disintegration speed of ordinary tablets, inconvenient taking of ordinary tablets, etc., and achieve good taste and prescription composition Simple, less fine powder effect

Inactive Publication Date: 2015-05-27
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

[0004] At present, the dosage forms of quetiapine fumarate in the domestic market are ordinary tablets and sustained-release tablets. The preparation process of sustained-release tablets is complicated and the cost is high.
Ordinary tablets disintegrate slowly, resulting in slow drug absorption and low bioavailability, and it is inconvenient to take ordinary tablets. It is not suitable for the elderly and children with weak swallowing ability, and patients in special morbid environments (such as lack of water). The granules with the characteristics of convenient taking and fast absorption solve these problems well.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: the preparation of quetiapine fumarate pharmaceutical composition (granule)

[0020] Quetiapine fumarate (calculated as quetiapine) 25g, mannitol 50g, lactose 60g, cross-linked polyvinylpyrrolidone 4g, acesulfame potassium 1g.

[0021] Preparation method: co-grind quetiapine fumarate and mannitol according to the weight ratio of 1:1, pass through an 80-mesh sieve, and pass the rest of the auxiliary materials through a 60-mesh sieve, and set aside; mix the crushed mixture with lactose, cross-linked polyvinylpyrrolidone and Acesulfame K is mixed evenly according to the principle of equal volume increase, and then granulated with 10% povidone K30 solution as binder by wet granulation process and 20 mesh sieve. The solid content of the binder accounts for about the total amount of the prescription. The wet granules are then dried at 50°C, and when the moisture is less than 2.0%, the granules can be sized with a 20-mesh sieve. The taste is cool and slightly sw...

Embodiment 2

[0022] Embodiment 2: the preparation of quetiapine fumarate pharmaceutical composition (granule)

[0023] Quetiapine fumarate (calculated as quetiapine) 25g, mannitol 25g, lactose 75g, carboxymethyl starch sodium 3g, aspartame 1g.

[0024] Preparation method: co-grind quetiapine fumarate and mannitol according to the weight ratio of 1:1, pass through an 80-mesh sieve, and pass the rest of the auxiliary materials through a 60-mesh sieve, and set aside; mix the crushed mixture with lactose, sodium carboxymethyl starch and Aspartame was mixed uniformly in accordance with the principle of equal incremental addition, and then 3% HPMC solution was used as a binder to granulate with a 20-mesh sieve through a wet granulation process. The solid content of the binder accounted for about 3.34% of the total amount of the formula. %, the wet granules are then dried at 50°C, and when the moisture is less than 2.0%, the granules can be sized with a 20-mesh sieve. The taste is cool and sligh...

Embodiment 3

[0025] Embodiment 3: the preparation of quetiapine fumarate pharmaceutical composition (granule)

[0026] Quetiapine fumarate (calculated as quetiapine) 25g, mannitol 50g, lactose 50g, low-substituted hydroxypropyl cellulose 4g, aspartame 1g.

[0027] Preparation method: co-grind quetiapine fumarate and mannitol according to the weight ratio of 1:1, pass through an 80-mesh sieve, and pass the rest of the auxiliary materials through a 60-mesh sieve, and set aside; mix the crushed mixture with lactose, low-substituted hydroxypropyl fiber Su and aspartame were mixed evenly according to the principle of equal increase, and then 3% HPC was used as the binder to granulate with a 20-mesh sieve through a wet granulation process. The solid content of the binder accounted for about 10% of the total amount 4.12%, the wet granules are then dried at 50°C, and when the moisture is less than 2.0%, the granules can be sized with a 20-mesh sieve. The taste is cool and slightly sweet, and the ...

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PUM

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Abstract

The invention discloses a quetiapine fumarate pharmaceutical composition. The dosage form of the pharmaceutical composition is a granule; the pharmaceutical composition is prepared from the following raw materials in percentage by weight: 15%-30% of quetiapine fumarate (based on quetiapine), 1%-8% of a disintegrating agent, 60-90% of filling agent, 1%-10% of an adhesive and 0.5%-3% of a flavoring agent, wherein the disintegrating agent is one or a mixture of more of crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium and sodium carboxymethyl starch; the filling agent is one or combination of mannitol, lactose and sucrose; and the adhesive is one or more of polyvinylpyrrolidone K-30, starch, hydroxy propyl cellulose or hydroxypropyl methylcellulose, purified water and ethyl alcohol. According to the prescription, dissolution of active components of the pharmaceutical composition does not need to be adjusted by auxiliary materials, such as a surfactant, with interaction property; and the effects that the obtained granulated powder is less and is good in taste can be achieved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a solid pharmaceutical composition of quetiapine fumarate, in particular to quetiapine fumarate granules. Background technique [0002] Schizophrenia is a psychiatric disease, a persistent, usually chronic, major mental illness, and the most serious of all mental illnesses, characterized by splits in basic personality, thinking, emotion, and behavior, and differences in mental activity and the environment. Coordination is the most common type of mental illness, and it usually occurs in young and middle-aged adults, which in turn affects behavior and emotion. Its etiology has not been fully elucidated. The course of schizophrenia is often protracted and develops progressively. If it is found early, it should be given reasonable treatment as soon as possible. The prognosis of most patients is relatively optimistic. A small number of patients are delayed due to untimely a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/554A61K9/16A61P25/20
Inventor 殷小芳刁媛媛马苏峰
Owner 万全万特制药(厦门)有限公司