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Zolpidem tartrate oral pulse controlled release drug delivery system and preparation method thereof

A zolpidem tartrate, drug delivery system technology, applied in the pulse controlled release composition and its tablet, the field of time-selected controlled release preparations for the treatment of early awakening and sleep disorders, can solve the problem of large batch-to-batch differences, no oral pulse controlled release preparation literature and patent reports, difficulty in process control, etc.

Active Publication Date: 2017-09-12
NHWA PHARMA CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN101574328A discloses a time-selected pulse release pellet of zolpidem salt. The pellet is composed of a blank pellet core, a drug layer, an organic acid layer, and a time-lag layer. The time-lag is 4 hours. The preparation process of the blank pellet core adhered to the organic acid, the process control is difficult due to the large batch-to-batch variation
According to the latest novelty search report, there have been no literature and patent reports on this type of oral pulse-controlled release preparation

Method used

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  • Zolpidem tartrate oral pulse controlled release drug delivery system and preparation method thereof
  • Zolpidem tartrate oral pulse controlled release drug delivery system and preparation method thereof
  • Zolpidem tartrate oral pulse controlled release drug delivery system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] R 1 Tablet prescription:

[0042]

[0043] Preparation Process:

[0044] (1) Preparation of Submicron Solid Dispersion Drugs

[0045] A. Preparation of micronized medicine: take 55g zolpidem tartrate raw material, put in jet mill, set powder delivery pressure as 4bar, grinding pressure 2bar, powder delivery speed 0.5g / min, pulverization time is 30min, particle is carried out Micronized pulverization, continuous pulverization twice to obtain micronized drug (average particle size 0.5-3 μm), the yield is 91%;

[0046] B. the preparation of submicron solid dispersion medicine: take by weighing 50g micronized medicine, and 290g solid dispersion carrier lactose ( 200) Place a cube mixer at a rotational speed of 180rpm, and mix for 10 minutes; take the solid dispersion mixed drug and put it in a small ball mill, add zirconia balls, and grind for 2 hours to obtain a submicron solid dispersed drug. Its scanning electron microscope picture is shown in figure 1 .

[004...

Embodiment 2

[0055] R 2 Tablet prescription:

[0056]

[0057] Preparation Process:

[0058] (1) Preparation of Submicron Solid Dispersion Drugs

[0059] A. Preparation of micronized medicine: take 53g zolpidem tartrate raw material, put in the jet mill, set the powder conveying pressure as 5bar, grinding pressure 3bar, powder conveying speed 0.6g / min, crushing time is 35min, the particle is carried out Micronized pulverization, continuous pulverization twice to obtain micronized drug (average particle size 0.2-5 μm), the yield is 94%;

[0060] B. Preparation of submicron solid dispersion drug: Weigh 50g of micronized drug, put it in a cube mixer with 250g of solid dispersion carrier compressible starch, and mix it for 15min at a speed of 150rpm; take the solid dispersion mixed drug and put it in a small ball mill, add Zirconia grinding balls, grind for 3 hours to obtain submicron solid-dispersed drugs.

[0061] (2) Preparation of drug-containing tablet core in solubilization system...

Embodiment 3

[0069] R 3 Tablet prescription:

[0070]

[0071] Preparation Process:

[0072] (1) Preparation of Submicron Solid Dispersion Drugs

[0073] Preparation of micronized drug: Weigh 54g zolpidem tartrate raw material, put it in the jet mill, set the powder delivery pressure to 6bar, the grinding pressure to 3bar, the powder delivery speed to 0.3g / min, and the pulverization time to 35min, and the particles are micronized Pulverize, pulverize twice in a row to obtain micronized drug (average particle size 0.5-8 μm), yield is 92.5%;

[0074] Preparation of submicron solid-dispersed drug: Weigh an appropriate amount of micronized drug, put it in a cube mixer with solid dispersion carrier lactose (Tablettose80), and mix it for 20 minutes at a speed of 150 rpm; take the solid-dispersed mixed drug and put it in a small ball mill, add zirconia mill balls, and grind for 4 hours to obtain submicron solid-dispersed drugs.

[0075] (2) Preparation of solubilizing system drug-containin...

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Abstract

The invention belongs to the field of slow / controlled-release preparations, and particularly relates to a novel zolpidem tartrate oral timed pulse controlled-release delivery system and a preparation process thereof. The pulse controlled-release delivery system and a composition thereof comprise (A) a submicron solid dispersed medicament, (B) a solubilizing system tablet-containing core, and (C) a pulse controlled-release part, wherein the controlled-release part consists of a hydrophilic isolation coating, a hydrophobic controlled-release coating and an enteric coating. By adopting novel micronization and solid dispersion submicron solubilizing technologies, the problem of bioavailability of medicaments in enteral absorption, particularly in small intestine mid-segment absorption is solved; the pulse controlled-release delivery system is dissolved rapidly in intestines and is efficiently transferred through a biological film, so that a pulse blood concentration peak can be formed, the bioavailability is increased, and the pulse release delay time is 2-3 hours. The zolpidem tartrate oral pulse controlled-release delivery system is mainly used for treating early awakening disease of middle aged and elderly people.

Description

technical field [0001] The invention belongs to the field of sustained / controlled release preparations, and specifically relates to a novel oral timed pulse controlled release drug delivery system for zolpidem tartrate and a preparation process thereof. Further provided are the pulse controlled-release composition with multi-layer fully aqueous film coating and the tablet thereof. Background technique [0002] The incidence of insomnia diseases in my country has been increasing year by year in recent years. The number of people with sleep disorders due to the rapid acceleration of work and mental stress is increasing. According to the survey results: the prevalence of sleep disorders in my country is 42.7%, of which about There are 300 million middle-aged and elderly people suffering from sleep disorders, and the total sales of the global hypnotics market reached 1.3 billion US dollars. Middle-aged and elderly patients often have symptoms of difficulty falling asleep, early ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/437A61K47/38A61K47/32A61P25/20
Inventor 李娟王广基朱正辉
Owner NHWA PHARMA CORPORATION
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