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A medicine core composition of controlled release drug delivery and controlled release preparation as well as its preparing method

一种组合物、药芯的技术，应用在医药配方、药物输送、非有效成分的医用配制品等方向，能够解决吸水速度和水合速度慢、有机溶剂残留量高、药物释放时滞长等问题

Active Publication Date: 2009-12-02
OCEAN STAR INT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the osmotic pump controlled-release tablet prepared by the drug core composition with PEO as the main auxiliary material has some inherent disadvantages: (1) the water absorption rate and the hydration rate of polyoxyethylene are all slow, so the time lag of drug release is longer; ( 2) The typical glass transition temperature range of polyoxyethylene is 65°C to 67°C, so PEO does not have ideal thermal stability, which may cause problems in the preparation and storage of osmotic pump tablets
For example, it is difficult to dry the solvent during the granulation process, because the drying temperature should not exceed 40°C due to the glass transition temperature of polyoxyethylene, which will easily cause a high residual amount of organic solvent; if the drying is to be relatively complete, a relatively long time is required Drying time will have adverse effects on the quality and release of the preparation; in the process of high-speed tablet compression, if the die is used repeatedly to generate heat and the temperature reaches about 50°C, if PEO is used, adverse phenomena such as sticking and punching are prone to occur, so special special equipment is required. The cooling facility controls the temperature of the die or reduces the tableting speed

Method used

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  • A medicine core composition of controlled release drug delivery and controlled release preparation as well as its preparing method
  • A medicine core composition of controlled release drug delivery and controlled release preparation as well as its preparing method
  • A medicine core composition of controlled release drug delivery and controlled release preparation as well as its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription:

[0049] (1) Drug-containing layer (per tablet):

[0050] Nifedipine 33mg

[0051] Povidone (Plasdone K-90D) 30mg

[0052] Copovidone (Plasdone S630) 91mg

[0053] Magnesium Stearate 1.5mg

[0054] Micronized silica gel 0.5mg

[0055] (2) Booster layer (per piece):

[0056] Sodium starch glycolate 37mg

[0057] Hypromellose (K15M) 30mg

[0058] Carbomer (971PNF) 8mg

[0059] Sodium chloride 21mg

[0060] Copovidone (Plasdone S630) 15mg

[0061] Red Iron Oxide 1.1mg

[0062] Magnesium stearate 0.6mg

[0063] Micronized silica gel 0.4mg

[0064] (3) Composition of semi-permeable membrane coating solution (for every 1000 tablets)

[0065] Cellulose acetate 59.5g

[0066] Diethyl phthalate 3g

[0067] Acetone 1500ml

[0068] Single tablet weight gain 38mg

[0069] (4) Composition of moisture-proof coating solution:

[0070] Color blue pink (CM-0317)

[0071] Preparation Process:

[0072] 1. Preparation of drug-containing layer particles:

...

Embodiment 2

[0085] Under the conditions of dissolution media of different pH, the tablet prepared in Example 1 and the commercially available product (trade name Baixintong, produced by Bayer, Germany) were respectively tested for release rate, wherein, according to the usual practice, the dosage was 110% , for example, the theoretical value is 30 mg, and the actual dosage is 33 mg.

[0086] The results are shown in Table 1.

[0087] (1) 1% hydrochloric acid solution (pH1.2) of sodium lauryl sulfate;

[0088] (2) acetic acid-sodium acetate buffer (pH4.5) of 1% sodium lauryl sulfate;

[0089] (3) Phosphate-citrate buffer solution (pH 6.8) of 1% sodium lauryl sulfate.

[0090] Table 1 The release rate of self-made tablets and commercial products

[0091]

[0092] The test results show that the release rate of the sample prepared in Example 1 and the commercially available product all meet the standard requirements. Compared with the commercially available product, the self-made sample...

Embodiment 3

[0094] The prescription is as follows:

[0095] (1) Drug-containing layer (per tablet):

[0096] Nifedipine 33mg

[0097] Povidone (Plasdone K-90D) 30mg

[0098] Copovidone (Plasdone S630) 91mg

[0099] Magnesium Stearate 1.5mg

[0100] Micronized silica gel 0.5mg

[0101] (2) Booster layer (per piece):

[0102]Low-substituted hydroxypropyl cellulose 150mg

[0103] Hypromellose (K15M) 30mg

[0104] Carbomer (971PNF) 10mg

[0105] Sodium chloride 33mg

[0106] Copovidone (Plasdone S630) 30mg

[0107] Red Iron Oxide 1.1mg

[0108] Magnesium stearate 0.6mg

[0109] Micronized silica gel 0.4mg

[0110] (3) Composition of semi-permeable membrane coating solution (for every 1000 tablets)

[0111] Cellulose acetate 59.5g

[0112] Diethyl phthalate 3g

[0113] Acetone 1500ml

[0114] Single tablet weight gain 38mg

[0115] (4) Composition of moisture-proof coating solution:

[0116] Color blue pink (CM-0317) Appropriate amount

[0117] The preparation process is the...

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Abstract

The present invention provides a drug core composition for controlled-release administration of active drugs with low solubility, which at least includes a drug-containing layer and a booster layer, and the drug-containing layer includes active drugs with low solubility and hydrophilic A polymer carrier, the booster layer at least includes a permeation-promoting polymer, an insoluble polymer and an osmotic pressure enhancer; the present invention also provides an osmotic pump preparation containing the drug core composition, which also includes The thin film of semipermeable material; drug core composition of the present invention can release drug at a controlled rate, so that the formulation containing the drug core composition can release the active drug in about 24 hours once a day. .

Description

technical field [0001] The present invention relates to the field of pharmaceutical preparations, including providing a drug core composition for controlled release administration and a controlled release pharmaceutical preparation containing the drug core, especially a drug core composition for controlled release administration of low solubility drugs. The invention also provides a method for preparing the drug core composition by using a hydrophilic polymer, an insoluble polymer and an osmotic pressure enhancer, and thereby forming an osmotic release system, so that the controlled-release preparation of the drug with low solubility can control the active ingredient The release method releases the drug. Background technique [0002] In the prior art in this field, oral osmotic pump tablets (capsules) and osmotic implants can be made by using the principle of osmotic pressure, which can release drugs uniformly and at a constant rate in the body. ALZA Corporation of the Unit...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K47/02A61K47/10A61K47/12A61K47/22A61K47/26
CPCA61K9/0004
Inventor 甘勇周新腾
Owner OCEAN STAR INT
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