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Pioglitazone hydrochloride orally disintegrating tablet and preparation method thereof

A technology of pioglitazone hydrochloride and orally disintegrating tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of low dissolution rate, incomplete dissolution, and low bioavailability, etc. problems, to achieve the effects of accelerated dissolution, short disintegration time, and improved solubility

Inactive Publication Date: 2018-11-23
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pioglitazone hydrochloride is almost insoluble in water and is a poorly soluble drug. At present, pioglitazone hydrochloride is mainly administered in the form of oral tablets, which has a low dissolution rate, incomplete dissolution, and low bioavailability
[0003] Patents CN200710173648.9 and CN200710152509.8 both disclose a pioglitazone hydrochloride dispersible tablet and its preparation method. Although the disintegration time of the prepared pioglitazone hydrochloride dispersible tablet is short, the dissolution rate and bioavailability are not satisfactory

Method used

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  • Pioglitazone hydrochloride orally disintegrating tablet and preparation method thereof
  • Pioglitazone hydrochloride orally disintegrating tablet and preparation method thereof
  • Pioglitazone hydrochloride orally disintegrating tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] prescription:

[0013] Material composition

Prescription ratio (g)

Pioglitazone Hydrochloride

10

microcrystalline cellulose

25

lactose

55

Crospovidone

5

citric acid

1

Micropowder silica gel

0.5

[0014] Preparation method: pioglitazone hydrochloride is micronized by supercritical fluid recrystallization, using supercritical fluid crystallization pharmaceutical equipment (SCF PD Lab type), the steps are as follows: 1) use a pump to input CO2 through the pipeline into the heater, and heat it to become super Critical CO enters in the crystallization kettle, and the temperature in the crystallization kettle is 45 ℃, and the pressure is 11MPa, 2) the pioglitazone hydrochloride solution is input in the above-mentioned crystallization kettle through pipelines with a pump, the concentration of the pioglitazone hydrochloride solution is 2%, and the solvent is methanol: dichloro Methane (volume ratio 1:...

Embodiment 2

[0017] prescription:

[0018]

[0019]

[0020] Preparation method: pioglitazone hydrochloride is micronized by supercritical fluid recrystallization, using supercritical fluid crystallization pharmaceutical equipment (SCF PD Lab type), the steps are as follows: 1) use a pump to input CO2 through the pipeline into the heater, and heat it to become super Critical CO2 enters in the crystallization kettle, and the temperature in the crystallization kettle is 55 ℃, and the pressure is 14MPa, 2) the pioglitazone hydrochloride solution is input in the above-mentioned crystallization kettle through pipelines with a pump, the concentration of the pioglitazone hydrochloride solution is 4%, and the solvent is methanol: dichloro Methane (volume ratio 2: 1) mixed solvent; 2) in the crystallization kettle, supercritical CO2 and pioglitazone hydrochloride solution are mixed in the nozzle and sprayed out by the nozzle, and the crystallization of pioglitazone hydrochloride is separated o...

Embodiment 3

[0023] prescription:

[0024] Material composition

Prescription ratio (g)

Pioglitazone Hydrochloride

10

microcrystalline cellulose

35

lactose

55

Crospovidone

13

citric acid

5

Micropowder silica gel

2

[0025] Preparation method: pioglitazone hydrochloride is micronized by supercritical fluid recrystallization, using supercritical fluid crystallization pharmaceutical equipment (SCF PD Lab type), the steps are as follows: 1) use a pump to input CO2 through the pipeline into the heater, and heat it to become super Critical CO enters in the crystallization kettle, and the temperature in the crystallization kettle is 50 DEG C, and the pressure is 18MPa, 2) the pioglitazone hydrochloride solution is input in the above-mentioned crystallization kettle through pipelines with a pump, the concentration of the pioglitazone hydrochloride solution is 4%, and the solvent is methanol: dichloro Methane (volume ratio...

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Abstract

The invention discloses a pioglitazone hydrochloride orally disintegrating tablet. The pioglitazone hydrochloride orally disintegrating tablet is prepared by the steps: controlling the particle size of pioglitazone hydrochloride, controlling other specific ingredients including citric acid and using dry powder to be directly compressed into the tablet. The pioglitazone hydrochloride orally disintegrating tablet disclosed by the invention has the advantages of short disintegrating time, accelerated dissolving-out speed, improved solubility and higher biological degree.

Description

technical field [0001] The invention relates to a pioglitazone hydrochloride orally disintegrating tablet. Background technique [0002] Pioglitazone is an insulin sensitizer that can reduce insulin resistance in peripheral tissues and liver, increase insulin-dependent glucose processing, and reduce glycogen output; it can reduce insulin resistance due to hyperglycemia, hyperinsulinemia, and high triacylglycerol; improve Reduces the effect of circulating insulin (i.e. reduces insulin resistance). Pioglitazone hydrochloride is almost insoluble in water and belongs to insoluble drug. At present, pioglitazone hydrochloride is mainly administered in the form of oral tablets, which has low dissolution rate, incomplete dissolution and low bioavailability. [0003] Patents CN200710173648.9 and CN200710152509.8 both disclose a pioglitazone hydrochloride dispersible tablet and a preparation method thereof. Although the disintegration time of the prepared pioglitazone hydrochloride d...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61K47/12A61P5/50
CPCA61K31/4439A61K9/0056A61K9/2013A61K9/2054A61K9/2095
Inventor 洪江游凌日金刘贵金
Owner HAINAN HONZ PHARMA
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