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Ropinirole hydrochloride solid oral controlled release tablets and preparation method thereof

A technology of ropinirole hydrochloride and controlled-release tablets, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations of inactive ingredients, etc., can solve the problems of long time consumption and high technical difficulty, and is suitable for large-scale industrial production and promotion. Effect

Active Publication Date: 2014-12-10
OVERSEAS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The technology is time-consuming and technically difficult

Method used

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  • Ropinirole hydrochloride solid oral controlled release tablets and preparation method thereof
  • Ropinirole hydrochloride solid oral controlled release tablets and preparation method thereof
  • Ropinirole hydrochloride solid oral controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The ropinirole hydrochloride solid oral controlled-release tablet of the present embodiment, the described controlled-release tablet is made up of a tablet core containing ropinirole hydrochloride and a coating, and the area of ​​the tablet core wrapped by the coating is S 1 with chip surface area S 2 The ratio is 1:4, and the weight ratio of the tablet core to the coating is 1:7.5.

[0028] The core and coating components are as follows:

[0029] Chip:

[0030] ingredients

Content (mg) / tablet

Percent content (%) / piece

Ropinirole Hydrochloride

1.5

1.5

HPMCK100M

50

50

lactose

46.5

46.5

silica

1

1

Magnesium stearate

1

1

total

100

100

[0031] Coating:

[0032] ingredients

Content (mg) / tablet

Percent content (%) / piece

HPMCK100M

375

50

lactose

360

48

silica

7.5

1

Magnesium stearate

7....

Embodiment 2

[0043] The ropinirole hydrochloride solid oral controlled-release tablet of the present embodiment, the described controlled-release tablet is made up of a tablet core containing ropinirole hydrochloride and a coating, and the area of ​​the tablet core wrapped by the coating is S 1 with chip surface area S 2 The ratio is 1:3, and the weight ratio of tablet core to coating is 1:3.

[0044] The core and coating components are as follows:

[0045] Chip:

[0046] ingredients

Content (mg) / tablet

Percent content (%) / piece

Ropinirole Hydrochloride

2

2

HPMCK4M

75

75

lactose

21.5

21.5

silica

0.75

0.75

Magnesium stearate

0.75

0.75

total

100

100

[0047] Coating:

[0048] ingredients

Content (mg) / tablet

Percent content (%) / piece

HPMCK15M

135

45

lactose

161.25

53.75

silica

2.25

0.75

Magnesium stearate ...

Embodiment 3

[0058] Embodiment 3 A prescription composition of ropinirole hydrochloride oral controlled release tablet

[0059] The ropinirole hydrochloride solid oral controlled-release tablet of the present embodiment, the described controlled-release tablet is made up of a tablet core containing ropinirole hydrochloride and a coating, and the area of ​​the tablet core wrapped by the coating is S 1 with chip surface area S 2 The ratio is 2:3, and the weight ratio of tablet core to coating is 1:1.5.

[0060] The core and coating components are as follows:

[0061] Chip:

[0062] ingredients

Content (mg) / tablet

Percent content (%) / piece

Ropinirole Hydrochloride

1.2

1

HPMCK15M

54

45

lactose

63.6

53

silica

0.6

0.5

Magnesium stearate

0.6

0.5

total

120

100

[0063] Coating:

[0064] ingredients

Content (mg) / tablet

Percent content (%) / piece

HPMCK4M

...

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Abstract

The invention provides solid oral controlled release tablets of ropinirole hydrochloride. The controlled release tablets consist of tablet cores containing ropinirole hydrochloride and coatings, wherein a ratio (S1 to S2) of an area S1 of the tablet cores coated by the coatings to a superficial area S2 of the tablet cores is more than 0 and less than 1; and a weight ratio of the tablet cores to the coatings is 1 to (1.5-7.5). The controlled release tablets disclosed by the invention can well support an administration method of taking the medicine once per day, release of the drugs is not influenced by change of the pH value of the environment, and in-vitro release is in a zero level or close to a zero level. The method for preparing the controlled release tablets is simple and easy to operate and is suitable for large-scale industrial production and popularization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a ropinirole hydrochloride controlled-release tablet for treating Parkinson's disease and a preparation method thereof. Background technique [0002] Controlled-release preparations, that is, drugs that can be automatically released at a predetermined rate within a predetermined time, so that the blood drug concentration can be kept constant within the effective concentration range for a long time, and the drug release is mainly zero-order or Near zero order rate release. [0003] Parkinson's disease (Parkinson's disease), Parkinson's is a degenerative disease of the central nervous system, patients mainly manifest as slow movement, tremors in hands, feet or other parts of the body, and loss of flexibility and coordination of the body. At present, there is no complete cure for the disease, and long-term and continuous drug treatment is needed to inhibit the...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4045A61K47/38A61P25/16
Inventor 闻晓光
Owner OVERSEAS PHARMA
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