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Combined osmotic pump preparation and preparation method thereof

An osmotic pump and combined technology, which is applied in the field of combined osmotic pump preparations and its preparation, can solve problems such as difficult product quality control, residues, and large drug residues, achieve flexible and diverse drug delivery methods, reduce production requirements, and reduce drug production. small residual effect

Active Publication Date: 2013-12-04
吉林天衡药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the dual-chamber osmotic pump also has defects, such as a large amount of drug residue, and the content of most of the dual-chamber osmotic pumps that have been listed is in the range of 105-115%. Core
However, the entire tablet core is a three-layer tablet, and the tablet compression process is extremely cumbersome, making product quality control difficult. Due to the cumbersome preparation process of the three-chamber osmotic pump controlled-release tablet, product development is limited.

Method used

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  • Combined osmotic pump preparation and preparation method thereof
  • Combined osmotic pump preparation and preparation method thereof
  • Combined osmotic pump preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1 Pariperidone Controlled-Release Capsules

[0063]

[0064]

[0065] Preparation Process

[0066] 1. Chip

[0067] 1. Drug-containing tablet core (1) / drug-containing tablet core (2)

[0068] (1) Pretreatment of raw and auxiliary materials: pass the raw material medicine through a 100-mesh sieve, and pulverize the sucrose through an 80-mesh sieve, for subsequent use;

[0069] (2) Mixing: Weigh 3000 pieces of raw and auxiliary materials in the recipe, and mix them evenly in a wet granulator;

[0070] (3) Granulation: The peristaltic pump feeding speed is set to 15 rpm, and the atomization pressure is 0.1 bar. Spray in the right amount of adhesive to make granules with moderate humidity.

[0071] (4) Drying: place the wet granules in a fluidized bed to dry at 45°C for 1 hour;

[0072] (5) Granulation: pass the dry granules through a 30-mesh stainless steel screen to granulate;

[0073] (6) total mixing: adding magnesium stearate, placing in a three-d...

Embodiment 2

[0101] Embodiment 2 Pariperidone controlled-release capsules

[0102]

[0103]

[0104] Preparation Process

[0105] 1. Chip

[0106] 1. Drug-containing tablet core (1) / drug-containing tablet core (2)

[0107] (1) Pretreatment of raw and auxiliary materials: pass the raw material medicine through a 100-mesh sieve, and pulverize the sucrose through an 80-mesh sieve, for subsequent use;

[0108] (2) Mixing: Weigh 3000 pieces of raw and auxiliary materials in the recipe, and mix them evenly in a wet granulator;

[0109] (3) Granulation: The peristaltic pump feeding speed is set to 10 rpm, and the atomization pressure is 0.1 bar. Spray in the right amount of adhesive to make granules with moderate humidity.

[0110] (4) Drying: place the wet granules in a fluidized bed to dry at 45°C for 1 hour;

[0111] (5) Granulation: pass the dry granules through a 30-mesh stainless steel screen to granulate;

[0112] (6) total mixing: adding magnesium stearate, placing in a thre...

Embodiment 3

[0141] Embodiment 3 Pariperidone controlled-release capsules

[0142]

[0143]

[0144] Preparation Process

[0145] 1. Chip

[0146] 1. Drug-containing tablet core (1) / drug-containing tablet core (2)

[0147] (1) Pretreatment of raw and auxiliary materials: pass the raw material medicine through a 100-mesh sieve, and pulverize the sodium chloride through an 80-mesh sieve, for subsequent use;

[0148] (2) Mixing: Weigh 3000 pieces of raw and auxiliary materials in the recipe, and mix them evenly in a wet granulator;

[0149] (3) Granulation: The peristaltic pump feeding speed is set to 15 rpm, and the atomization pressure is 0.1 bar. Spray in the right amount of adhesive to make granules with moderate humidity.

[0150] (4) Drying: place the wet granules in a fluidized bed to dry at 45°C for 1 hour;

[0151] (5) Granulation: pass the dry granules through a 30-mesh stainless steel screen to granulate;

[0152] (6) total mixing: adding magnesium stearate, placing i...

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Abstract

The invention discloses combined osmotic pump preparation. The combined osmotic pump preparation is characterized by comprising a capsule, contents, a slow release coating, and a release hole, wherein the capsule which is hollow is filled with the contents and comprises at least two parts which can be separated and combined, the contents include at least one medicated sheet core and at least one boost sheet core, the slow release coating covers the capsule to form a semipermeable membrane, and the capsule covered with the slow release coating is provided with the release hole which is 0.1-1.0mm, preferably 0.3-0.7mm, in diameter.

Description

technical field [0001] The invention relates to a combined osmotic pump preparation and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Osmotic pump type controlled-release preparations, as a typical representative of sustained-controlled release preparations, are a preparation technology characterized by osmotic pressure as the release power and zero-order release kinetics. Among them, osmotic pump controlled-release tablets are the most common dosage form in oral osmotic pump controlled-release preparations. [0003] From the perspective of the development of osmotic pumps, it can be roughly divided into three generations: single-chamber osmotic pumps, double-chamber osmotic pumps, and longitudinal multi-layer osmotic pumps. The vast majority of products are developed and marketed by A1ZA. [0004] Single-chamber osmotic pumps are generally used for readily soluble drugs. They are composed of a tablet cor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/42A61K47/38A61K47/34
Inventor 于景敏刘光权
Owner 吉林天衡药业有限公司
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