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A explosive core composition of controlled release administer drug and controlled release preparation as well as its preparing method

A composition and drug core technology, which is applied in pharmaceutical formulations, drug delivery, medical preparations with inactive ingredients, etc., can solve the problem that PEO is prone to sticking, PEO does not have thermal stability, preparation quality and adverse effects on release, etc. question

Active Publication Date: 2008-04-16
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 explosive core composition of controlled release administer drug and controlled release preparation as well as its preparing method
  • A explosive core composition of controlled release administer drug and controlled release preparation as well as its preparing method
  • A explosive core composition of controlled release administer drug 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]

[0069] Single tablet weight gain 38mg

[0070] (4) Composition of moisture-proof coating solution:

[0071] Color blue pink (CM-0317)

[0072] Preparation Process:

[0073] 1...

Embodiment 2

[0086] 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.

[0087] The results are shown in Table 1.

[0088] (1) 1% hydrochloric acid solution (pH1.2) of sodium lauryl sulfate;

[0089] (2) acetic acid-sodium acetate buffer (pH4.5) of 1% sodium lauryl sulfate;

[0090] (3) Phosphate-citrate buffer solution (pH 6.8) of 1% sodium lauryl sulfate.

[0091] Table 1 The release degree of self-made tablets and commercially available products

[0092]

[0093] 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 se...

Embodiment 3

[0095] The prescription is as follows:

[0096] (1) Drug-containing layer (per tablet):

[0097] Nifedipine 33mg

[0098] Povidone (Plasdone K-90D) 30mg

[0099] Copovidone (Plasdone S630) 91mg

[0100] Magnesium Stearate 1.5mg

[0101] Micronized silica gel 0.5mg

[0102] (2) Booster layer (per piece):

[0103] Low-substituted hydroxypropyl cellulose 150mg

[0104] Hypromellose (K15M) 30mg

[0105] Carbomer (971PNF) 10mg

[0106] Sodium chloride 33mg

[0107] Copovidone (Plasdone S630) 30mg

[0108] Red Iron Oxide 1.1mg

[0109] Magnesium stearate 0.6mg

[0110] Micronized silica gel 0.4mg

[0111] (3) Composition of semi-permeable membrane coating solution (for every 1000 tablets)

[0112] Cellulose acetate 59.5g

[0113] Diethyl phthalate 3g

[0114] Acetone 1500ml

[0115] Single tablet weight gain 38mg

[0116] (4) Composition of moisture-proof coating solution:

[0117] Color blue pink (CM-0317) Appropriate amount

[0118] The preparation process is the ...

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Abstract

A medicine core composition used for low solubility active medicine controlling release administration is provided in the present invention, wherein, at least comprising medicine-containing layer and boosting layer, the medicine-containing layer comprises low solubility active medicine and hydrophilic polymer carrier, the boosting layer at least comprises penetration enhancing polymer, insoluble polymer and osmotic pressure promoter; a osmotic pump containing the medicine core composition is also provided in the present invention, wherein also comprising semi-transparent material film coating outer of the medicine core; the medicine core composition of the present invention can controlled speed release medicine, leading the preparation containing the medicine core to achieve aim of administration one time every day, that is about in 24 hours to release active medicine.

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 Applications(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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