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Pharmaceutical dosage forms for controlled release producing at least a timed pulse

A technology for pharmaceutical dosage forms and tablets, applied in the field of controlled release dosage forms, can solve problems such as the release speed is not fast enough and the drug cannot be released.

Inactive Publication Date: 2010-03-17
SANOFI AVENTIS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In other words, the release rate achieved is often not fast enough
Another disadvantage of this technology is that a large amount of drug cannot be released from the coated core

Method used

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  • Pharmaceutical dosage forms for controlled release producing at least a timed pulse
  • Pharmaceutical dosage forms for controlled release producing at least a timed pulse
  • Pharmaceutical dosage forms for controlled release producing at least a timed pulse

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Example 1: Capsules Containing Alfuzosin Hydrochloride and Cetylpyridinium Chloride - Slow Release After Long Time Interval

[0087] Alfuzosin hydrochloride was loaded onto 3325 g of 16 / 18 mesh non-pareil beads by coating on a GPCG3 fluid bed coater-dryer with the suspension under the following conditions.

[0088] Alfuzosin Hydrochloride

5.0％

87.5g

polyvinyl alcohol 1

5.0％

87.5g

purified water

90.0％

1575g

[0089] 1 Mowiol 5- Sold by Chimidis Hoechst

[0090] 1100 g of these alfuzosin-coated beads were then coated on a GPCG1 fluid bed coater-dryer with a suspension of the following composition:

[0091] cetylpyridinium chloride

4.3％

43.4g

Succinic acid

4.7％

46.9g

Hydroxypropylmethylcellulose 2

5.9％

59.0g

purified water

42.5％

425.0g

Isopropanol

42.5％

425.0g

[0092] 2 Pharmacoat Sold by Sh...

Embodiment 2

[0105] Embodiment 2: coated pellet

[0106] Delayed release pellets containing alfuzosin hydrochloride, tartaric acid and cetylpyridinium chloride and cationic surfactant.

[0107] Coat 1000g of 16 / 18 mesh Super Beads with a suspension composed as follows:

[0108] tartaric acid

6.0％

78.0g

Hydroxypropylmethylcellulose 1

4.0％

53.0g

cetylpyridinium chloride

3.0％

39.0g

triethyl citrate

1.4％

18.2g

purified water

43.8％

557g

Isopropanol

43.8％

557g

[0109] 1 Pharmacoat Sold by Shin-Etsu

[0110] Then in the GPCG1 fluidized bed coater-dryer, coat with the following solution to make alfuzosin hydrochloride be loaded on the pellets:

[0111] Alfuzosin Hydrochloride

8.3％

78g

povidone 2

8.3％

78g

ethanol

83.4％

784g

[0112] Sold by BASF

[0113] Finally, 1000 g of the above-mentioned pelle...

Embodiment 3

[0118] Embodiment 3: Coated pellets:

[0119] Delayed release pellets containing alfuzosin hydrochloride, succinic acid and cocamidopropyl betaine zwitterionic surfactants.

[0120] Coat 1000g of 16 / 18 mesh Super Beads with a suspension composed as follows:

[0121] Succinic acid

5.63％

78.0g

Hydroxypropylmethylcellulose 1

3.82％

53.0g

Cocamidopropyl Betaine 2

2.81％

39.0g

purified water

43.87％

608g

Isopropanol

43.87％

608g

[0122] 1 Pharmacoat Sold by Shin-Etsu

[0123] 380LC sold by Seppic

[0124] Alfuzosin hydrochloride was then loaded onto the pellets as described in Example 2:

[0125] Finally, 1000 g of the above-mentioned pellets were coated with a polymer solution of the following composition:

[0126] Type B ammonium methacrylate copolymer 3

11.40％

208.5g

Type A Ammonium Methacrylate Copolymer 4

0.93％

17g

...

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Abstract

The present invention relates to delayed release coated cores comprising an active substance in their core and a polymer coating comprising at least one or more ammonio methacrylate copolymer, characterised in that the core comprises at least a surfactant ; to monolithic or multiparticulate pharmaceutical dosage forms comprising such delayed release coated cores and to their method of manufacture.

Description

[0001] This application entered the national stage on December 26, 2001. The international application number is PCT / EP 00 / 06795, the Chinese application number is 00809565.5, and the invention title is "a controlled-release pharmaceutical dosage form that produces at least one timing pulse". Divisional application of the application. technical field [0002] The present invention relates to controlled release dosage forms that produce at least one timed pulse, which release drug rapidly and completely at a fixed time after administration. Background technique [0003] Most oral medications are provided in conventional immediate-release or rapid-release forms. Therefore, if the drug is released and absorbed rapidly, the concentration-time profile of the active substance in the blood or other body compartments depends on the kinetics of the elimination of the molecule from the body, as well as the kinetics of the distribution and distribution of the molecule in different comp...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/22A61K9/24A61K9/48A61K47/32A61K47/38A61K9/20A61K9/50A61K9/52A61K47/18A61K47/24
CPCA61K9/5015A61K9/5026A61K9/5078A61P43/00A61K9/50
Inventor F·安德烈G·刘易斯J·米龙内奥A·里巴尔迪雷
Owner SANOFI AVENTIS SA
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