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Zolpidem composition and process for preparing the same

A technology of composition and zolpidem, which is applied in the field of zolpidem composition and its preparation, can solve the problems of complex, time-consuming method of masking zolpidem composition, etc.

Active Publication Date: 2018-04-17
PHARMATHEN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Additionally, the preparation of conventional taste-masked zolpidem compositions requires several steps and requires the use of one or more mucoadhesives
Due to these problems, the process of manufacturing taste-masked zolpidem compositions has become time consuming and complicated

Method used

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  • Zolpidem composition and process for preparing the same
  • Zolpidem composition and process for preparing the same
  • Zolpidem composition and process for preparing the same

Examples

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Embodiment 1

[0044] In Example 1, a method for preparing a 5 milligram (mg) zolpidem composition is described. The process for preparing the zolpidem composition of the present invention begins by physically mixing 5 mg zolpidem tartrate with 40 mg polacrilin potassium. The mixture formed above was sieved / screened through a 36 mesh screen equipped with a shaker to obtain Zolpidem Tartrate and Polacrilin Potassium in screened quality. Additionally, Zolpidem Tartrate and Potassium Polacrilin Potassium in screening quality were charged into an internal mixer (rotary mixer) and mixed to form a taste-masked dry blend. Mixing was accomplished in a 120 liter internal mixer at a mixer speed of 8 revolutions per minute (RPM) for 60 minutes. The taste-masked dry blend was then unloaded into a double polyethylene bag lined with HDPE container and appropriately labeled from the inside and outside of the container.

[0045] Next, 85.75 mg of drug B2, 13 mg of lactose monohydrate, 1.5 mg of anhydrous ...

Embodiment 2

[0075] In Example 2, a method for preparing a 10 milligram (mg) zolpidem composition is described. The process for preparing the zolpidem composition of the present invention begins by physically mixing 10 mg zolpidem tartrate with 80 mg polacrilin potassium. The mixture formed above was sieved / screened through a 36 mesh screen equipped with a vibrating sieve to obtain Zolpidem Tartrate and Polacrilin Potassium in screened quality. Additionally, Zolpidem Tartrate and Potassium Polacrilin Potassium in screening quality were charged into an internal mixer (rotary mixer) and mixed to form a taste-masked dry blend. Mixing was accomplished in a 120 liter internal mixer at a mixer speed of 8 revolutions per minute (RPM) for 60 minutes. The taste-masked dry blend was then unloaded into a double polyethylene bag lined with HDPE container and appropriately labeled from the inside and outside of the container.

[0076] Next, 171.5 mg of drug B2, 26 mg of lactose monohydrate, 3 mg of a...

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Abstract

Disclosed is a zolpidem composition and a process for preparing the same. The zolpidem composition comprises: zolpidem tartrate and polacrillin potassium in a weight ratio of 1:8. The process for preparation of a zolpidem composition comprises: mixing zolpidem tartrate and polacrillin potassium in a weight ratio of 1:8 to form a taste masked dry mix; mixing the pharmaburst B2, lactose monohydrate,colloidal silicon dioxide anhydrous, a sweetener, and a flavorant to form a flavor blend; blending of the taste masked dry mix and the flavor blend to form an intermediate blend; mixing of intermediate blend with magnesium stearate to form ready to compress granules of the zolpidem composition; and compressing the ready to compress granules of the zolpidem composition to form a sublingual oral disintegrating tablet.

Description

technical field [0001] The invention relates to a zolpidem composition and a preparation method thereof. Background technique [0002] Zolpidem is a sedative used in the treatment of insomnia. It has been shown to reduce sleep latency, increase sleep duration, and reduce nighttime awakenings. Zolpidem tablets and drugs have been around for a long time, however, the regular tablet disintegrates much more slowly, making the drug less effective. Also, due to the bitter taste of regular tablets, administration by patients may be problematic, especially in the elderly, patients with impaired swallowing, or patients with reduced saliva production. Therefore, oral intake of conventional tablets is a troublesome process. [0003] In addition, orally disintegrating tablets (ODTs) are also available. ODTs differ from regular tablets in that they are designed to dissolve or disintegrate in the mouth rather than being swallowed whole. Therefore, ODTs have been developed so that chi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519
CPCA61K31/437A61K9/0056A61K9/2027A61K9/006A61P25/20A61K31/4375A61K47/12A61K47/36
Inventor 马亨德拉·B·乔杜里贾格迪什·S·瓦德瓦尼阿莫勒·Y·乔杜里苏查塔·S·凯特
Owner PHARMATHEN
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