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In-situ channel time formation for controlling penetrating pressure pump system

A technology of osmotic pressure pump and osmotic pressure activity, applied in the field of dosage forms that control the initial time of drug release and drug release rate, can solve the problems of low film coating, poor isolation, drug release variability, etc., and achieve cost reduction Effect

Inactive Publication Date: 2010-07-21
TWI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the method disclosed in US4,016,880 uses the internal pressure of the tablet to push the film coat after absorbing water in the internal environment to generate drug channels, which adds substances that increase the fragility of the film coat to form channels, but also increases the film coating. The danger of the clothing being squeezed by gastrointestinal peristalsis and releasing a large amount of drugs
In addition, according to US5,736,159, generally there is a thinner coverage on the edge of the tablet during film coating, and the channel can be generated by using the relative weakness of internal pressure pushing; however, the coating amount of the film coating of the present invention must be relatively Lower to cooperate with the lower internal pressure application, because the larger internal pressure will make the channel formed expand into large cracks along the edge of the tablet; Potential drug release variability issues in the GI tract

Method used

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  • In-situ channel time formation for controlling penetrating pressure pump system
  • In-situ channel time formation for controlling penetrating pressure pump system
  • In-situ channel time formation for controlling penetrating pressure pump system

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0058] Example 1, the osmotic pressure pump controlled-release dosage form containing glipizide (Glipizide), which is prepared with the following prescription:

[0059] Element

weight%

mg

Drug Layer

Glipizide

Polyox N-80

PVP K29-32

Sodium chloride (NaCl)

Magnesium Stearate (Mg Stearate)

7.9

43.2

2.9

5.7

0.5

20.0

110.0

7.5

14.5

1.4

Push Layer

Polyox 303

Sodium chloride

Magnesium stearate

27.8

11.8

0.2

71.0

30.0

0.5

Semi-permeable membrane coat

[0060] Element

weight%

mg

Cellulose acetate

Hydroxypropyl Cellulose

(Hydroxypropylcellulose)

Polyethylene glycol 4000 (Polyethylene

glycol-4000)

Acetone: water

75

20

5

9∶1

[0061] *Polyox N-80 is polyethylene oxide (PEO) with a molecular weight of 200,000, Polyox 303 is PEO with a molecul...

example 2

[0067] f) Example 2, an osmotic pressure pump controlled release dosage form containing oxybutynin chloride (Oxybutynin Chloride), which is prepared with the following prescription:

[0068] Element

weight%

mg

Drug Layer

[0069] Element

weight%

mg

Oxybutynin chloride (Oxybutynin

Chloride)

Polyox N-80

PVP K29-32

Sodium chloride

Magnesium stearate

6.0

44.0

3.0

5.8

0.6

15.0

110.0

7.5

14.5

1.4

Push Layer

Polyox 303

Sodium chloride

Magnesium stearate

28.4

12.0

0.2

71.0

30.0

0.5

Semi-permeable membrane coat

Cellulose acetate

Hydroxypropyl Cellulose

polyethylene glycol 4000

Acetone: water

75

20

5

9∶1

[0070] *Polyox N-80 is polyethylene oxide with a molecular weight of 200,000, Polyox 303 is the numerator. Polyethylene oxide in an amoun...

example 3

[0076] Example 3, osmotic pressure pump controlled release dosage form containing glipizide (Glipizide):

[0077] Except changing the following preparation methods, all the other are the same as Example 1: the diameter of the filling mold is changed to 8.5mm, and the diameter of the circular protrusion on the surface of the lower filling mold is changed to 1.0mm; meanwhile, the composition of the film coat is changed to 93% by weight of acetic acid Cellulose (containing 39.8% of acetyl groups in the molecular structure), 7% by weight of polyethylene glycol 4000, and the coating weight is about 14% of the weight of the bare ingot. Tested with the elution method of Example 1, the delay time (lag time) of drug channel formation and release can be extended to 5 hours (as shown in Figure 8), and the graph of the elution rate and time after that still presents a similar zero Level of release rate (as shown in Figure 9).

[0078] Comparing the results obtained by the osmotic pressur...

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Abstract

A tablet with a osmotic pressure pump system for controlling release, a method for generating a medicine channel and a method for controlling the time when said medicine channel is generated are disclosed. Said tablet is composed of a solid medicine core with a shallow recess and a coated film with a thin position relative to said shallow recess. When the liquid or water is introduced to inside of said tablet to generate pressure, a medicine channel is generated at said recess for releasing medicine.

Description

technical field [0001] The present invention relates to a dosage form and method for controlling drug release initiation time and drug release rate, in particular to a dosage form of an osmotic pressure pump controlled release system and a method for controlling drug channel formation position and time. Background technique [0002] Controlling the release rate of drugs in the absorption site of the body is another important research topic besides the development of new drugs in the recent pharmaceutical industry. Because this type of dosage form can reduce side effects, prolong the effective time of action, reduce the frequency of dosing, improve the compliance of patients with medication by maintaining a constant drug concentration in the blood, and thus increase the effectiveness of treating patients with chronic diseases. [0003] At present, the most convenient controlled-release dosage form on the market is oral administration, which can be classified into three system...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M31/00A61M37/00A61K9/22
Inventor 吴振森林意毅陈守琼黄逸斌詹惠如郭姵君林君郁
Owner TWI PHARMA