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Simvastatin osmotic pump controlled-release tablet

A technology of simvastatin and osmotic pump, applied in the field of pharmaceutical preparations, can solve the problems of low permeability and poor effect, etc.

Active Publication Date: 2012-03-21
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The semipermeable membranes of different coating materials have different permeability to water, which is related to the permeability coefficient k of the membrane. The most commonly used is cellulose acetate (Celluloseacetate, CA), others such as ethyl cellulose (EC) etc. Although there are also literatures that can be used for film coats of osmotic pumps, pure ethylcellulose has low permeability to water, so the effect is relatively poor, and has not been used in the production of osmotic pump controlled-release tablets (S.Rose and J.F.Nelson, Aust.J.Exp.Biol.Med.Sei., 1995, 33, 415)

Method used

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  • Simvastatin osmotic pump controlled-release tablet
  • Simvastatin osmotic pump controlled-release tablet
  • Simvastatin osmotic pump controlled-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 1. Prescription

[0051] 1. Tablet core prescription

[0052] Drug-containing layer:

[0053] Simvastatin 20g

[0054] Sodium chloride 100g

[0055] Sodium Lauryl Sulfate 15g

[0056] Sodium Carboxymethyl Cellulose 20g

[0057] Microcrystalline Cellulose 10g

[0058] Contains 0.1% tert-butylanisole (BHA), 8% appropriate amount

[0059] 70% ethanol solution of povidone K30

[0060] Magnesium Stearate 3g

[0061] Povidone K30 5g

[0062] Boost layer:

[0063] Hypromellose K4M 60g

[0064] Microcrystalline Cellulose 40g

[0065] Sodium chloride 30g

[0066] Iron oxide red 0.5g

[0067] 8% povidone K30 70% ethanol solution appropriate amount

[0068] Magnesium Stearate 1g

[0069] Povidone K30 5g

[0070] Made into 1000 pieces

[0071] 2. Prescription of semi-permeable membrane coating solution:

[0072] Ethylcellulose N100 30g

[0073] Povidone K30 15g

[0074] Ethanol 1000ml

[0075] Makes 1000ml

[0076] 3. Prescrip...

Embodiment 2

[0117] 1. Prescription

[0118] 1. Tablet core prescription: with embodiment 1.

[0119] 2. Prescription of semi-permeable membrane coating solution:

[0120] Ethylcellulose N100 30g

[0121] Povidone K30 16g

[0122] Ethanol 1000ml

[0123] 3. Prescription of coating solution for film coating: same as in Example 1.

[0124] 2. Detailed preparation process

[0125] 1. The preparation process of simvastatin tablet core: the same as in Example 1.

[0126] 2. Semi-permeable membrane preparation process: Weigh the prescribed amount of povidone K30 and ethyl cellulose (N-100), add to ethanol and stir to dissolve completely, to obtain.

[0127] 3. Coating (semi-permeable membrane): put the tablet core in a multi-functional coating machine for coating, spray the liquid at a speed of 3-5ml / min, take a small amount of tablets regularly and weigh them, and calculate the weight gain of the coating. The coating weight gains were 10.0%, 10.6%, 10.8%, 11.0%, 11.4% and 12.0%, respecti...

Embodiment 3

[0139] 1. Prescription

[0140] 1. Tablet core prescription: with embodiment 1.

[0141] 2. Prescription of semi-permeable membrane coating solution:

[0142] Ethylcellulose N100 30g

[0143] Povidone K30 18g

[0144] Ethanol 1000ml

[0145] 3. Prescription of coating solution for film coating: same as in Example 1.

[0146] 2. Detailed preparation process

[0147] 1. The preparation process of simvastatin tablet core: the same as in Example 1.

[0148] 2. Semi-permeable membrane preparation process: Weigh the prescribed amount of povidone K30 and ethyl cellulose (N-100), add to ethanol and stir to dissolve completely, to obtain.

[0149] 3. Coating (semi-permeable membrane): put the tablet core in a multi-functional coating machine for coating, spray the liquid at a speed of 3-5ml / min, take a small amount of tablets regularly and weigh them, and calculate the weight gain of the coating. Coating weight gains were 14.0%, 16.0%, respectively.

[0150] 4. heat treatment: ...

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Abstract

The invention discloses a novel simvastatin osmotic pump controlled-release tablet, wherein ethyl cellulose and povidone are used as forming materials for a semipermeable membrane, and the tablet is preferably of an asymmetric tablet shape. By utilizing the simvastatin osmotic pump controlled-release tablet, the ageing phenomenon can be overcome and the drug residue can be reduced.

Description

Technical field: [0001] The invention relates to a novel simvastatin osmotic pump controlled-release tablet, in particular to a simvastatin osmotic pump controlled-release tablet using a novel semipermeable membrane material, belonging to the field of pharmaceutical preparations. Background technique: [0002] Simvastatin (Simvastatin) was first listed in Sweden by Merck & Co. in the United States in 1988. It was approved by the FDA in December 1991. It was introduced into my country by Hangzhou Merck Pharmaceuticals in 1997 (trade name: Zocor). Simvastatin is a fat-soluble substance, which can be rapidly absorbed after oral administration, reaching the peak plasma concentration within 1-2 hours, with a half-life of 2-4 hours, and its activity in the body is 4 times that of pravastatin, which can effectively prevent atherosclerosis The development of sclerosis and heart disease recurrence, reduce the risk of non-fatal myocardial infarction and myocardial revascularization su...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/24A61K9/36A61K31/366A61K47/38A61P3/06A61K47/32
Inventor 赵志全刘延奎王颖
Owner LUNAN PHARMA GROUP CORPORATION