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Impulse released oral medication preparation and method for preparing the same

A technology for pharmaceutical preparations and pulse release, which can be used in pharmaceutical formulations, pill delivery, medical preparations with inactive ingredients, etc., and can solve problems such as difficult industrialization and lack of practicability.

Inactive Publication Date: 2008-07-16
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Osmotic pumps and timing pulse plug capsules have great difficulties in practical application, mainly because the preparation forms require special equipment in production, and often can only be prepared manually in the laboratory, which is difficult to industrialize and lacks practicability

Method used

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  • Impulse released oral medication preparation and method for preparing the same
  • Impulse released oral medication preparation and method for preparing the same
  • Impulse released oral medication preparation and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Drug-containing core prescription:

[0066] Starch sucrose blank core 400g

[0067]Isosorbide Dinitrate 100g

[0068] water 1kg

[0069] Preparation Process:

[0070] Dissolve isosorbide dinitrate in water, apply fluidized bed coating, air inlet temperature is 50±2°C, flow rate is 5mL / min, and isosorbide dinitrate is coated on the blank pellet core to prepare drug-containing core.

[0071] Alkaline Layer Prescription:

[0072] Sodium bicarbonate 10% (w / v), add water to 100%

[0073] Preparation Process:

[0074] Sodium bicarbonate is dissolved in water, fluidized bed coating is adopted, the sodium bicarbonate is coated on the drug-containing core, and the weight of the coating is increased by 10%, so as to prepare the alkaline drug-containing core.

[0075] Hysteretic coating formulation %(w / v)

[0076] Polyacrylic resin III (Eudragit S100) 9

[0077] Talc 0.9

[0078] Add 95% ethanol to 100%, and the weight of polyacrylic resin III (Eudragit S100) is about 90 ...

Embodiment 2

[0082] According to the sample raw materials and preparation methods in Example 1, the weight gain of the alkaline layer coating was prepared respectively at 0%, 3%, 5%, 10%, 20%, and 30%, and the weight gain of the hysteresis coating layer was 100%. sample.

Embodiment 3

[0084] According to the preparation method of sample raw and auxiliary materials in Example 1, samples with a weight gain of the basic layer coating of 10%, and a weight gain of the hysteresis coating layer of 50%, 100%, and 200% were prepared, respectively.

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Abstract

The invention discloses a pulsatile release oral drug product and a preparation method thereof. The product is a multi-layered coating product which consists of a drug-containing core, an alkaline layer and a hysteretic coating; wherein, the drug-containing core contains drug in forms of granule, micro-pill, micro-tablet or troche, etc.; the alkaline layer is alkaline medicinal adjuvant and the hysteretic coating comprises a coating material, polyacrylic resin III. 2-6 hours of delayed time for dug release can be achieved by adjusting the thickness of the hysteretic coating and the proportion of the coating materials. The pulsatile release oral drug product of the invention has the active material which is released suddenly after the preset delayed time, and the pulsatile release effect is good and not affected by the pH value of alimentary canal; meanwhile, the prescription of the pulsatile release oral drug preparation is simple in prescription and mature in process, and easy in realization of mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a dosage form composition of pulse release oral pharmaceutical preparations and a preparation method thereof. technical background [0002] With the development of chronopharmacology research, it has been found that the onset of many diseases shows obvious circadian rhythm changes. If the best administration time is selected according to the biological rhythm of the onset of these diseases, the drug can be delivered when it is most needed. Maximize the therapeutic effect with the smallest therapeutic dose, while minimizing toxic and side effects. However, the morbidity and mortality of some diseases are highest in the early morning, such as hypertension, angina pectoris, myocardial infarction, asthma, Parkinson's disease, insomnia and other diseases. It has good preventive and therapeutic effects, but administration during this period will bring great inconveni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K47/32
Inventor 刘衡马滔王春龙
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH