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Lyophobic matrix sustained-release tablet for pH independence drugs and preparation method thereof

A technology of dependent, sustained-release tablets, applied in the directions of drug delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve the problems of incomplete pH-dependent drug release, etc., and achieve easy industrial scale-up and actual production, promotion Dissolving and improving the effect of in vitro release

Active Publication Date: 2019-05-03
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the present invention is to solve the technical problem of incomplete release of existing pH-dependent drugs in sustained-release matrix tablets, and provide a pH-dependent drug hydrophobic matrix sustained-release tablet and its preparation method

Method used

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  • Lyophobic matrix sustained-release tablet for pH independence drugs and preparation method thereof
  • Lyophobic matrix sustained-release tablet for pH independence drugs and preparation method thereof
  • Lyophobic matrix sustained-release tablet for pH independence drugs and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Preparation method of diclofenac sodium sustained-release tablets (100 mg specification)

[0038]Tablet weight 291.3mg, diclofenac sodium 100mg, cetyl alcohol (Cetyl alcohol) 60.56mg, sucrose 121.09mg, povidone (PVPK30) 4.69mg, magnesium stearate 2.48mg, silicon dioxide 2.48mg. (1) Weigh the prescribed amount of cetyl alcohol in a water bath at 70°C to melt it completely, and set aside; (2) Weigh the prescribed amount of diclofenac sodium, sucrose, and povidone (PVPK30), mix well, and set aside; (3) Pour the uniformly mixed raw and auxiliary materials in (2) into the completely melted cetyl alcohol, hot-melt, mix and stir to granulate, pass through a 18-mesh sieve, let the granules cool at room temperature, add the prescribed amount of silicon dioxide and magnesium stearate, press piece.

[0039] Such as figure 1 As shown, the in vitro release performance test results show that the preparation of this embodiment presents a slow drug release within 24 hours.

Embodiment 2

[0041] Preparation method of diclofenac sodium sustained-release tablets (100 mg specification)

[0042] Tablet weight 291.3mg, diclofenac sodium 100mg, cetyl alcohol 80.57mg, sucrose 101.08mg, povidone (PVPK30) 4.69mg, magnesium stearate 2.48mg, silicon dioxide 2.48mg. (1) Weigh the prescribed amount of cetyl alcohol in a water bath at 70°C to melt it completely, and set aside; (2) Weigh the prescribed amount of diclofenac sodium, sucrose, and povidone (PVPK30), mix well, and set aside; (3) Pour the uniformly mixed raw and auxiliary materials in (2) into the completely melted cetyl alcohol, hot-melt, mix and stir to granulate, pass through a 18-mesh sieve, let the granules cool at room temperature, add the prescribed amount of silicon dioxide and magnesium stearate, press piece.

[0043] Such as figure 1 As shown, the in vitro release performance test results show that the preparation of this embodiment presents a slow drug release within 24 hours.

Embodiment 3

[0045] Preparation method of diclofenac sodium sustained-release tablets (100 mg specification)

[0046] Tablet weight 291.3mg, diclofenac sodium 100mg, cetyl alcohol 58.76mg, stearyl alcohol (Stearyl alcohol) 1.81mg, sucrose 121.10mg, povidone (PVPK30) 4.69mg, magnesium stearate 2.48mg, silicon dioxide 2.48mg . (1) Weigh the prescribed amount of cetyl alcohol and stearyl alcohol in a water bath and heat them at 70°C to melt them completely, and set aside; (2) Weigh the prescribed amount of diclofenac sodium, sucrose, and povidone (PVPK30), mix them evenly, and set aside (3) Pour the uniformly mixed raw and auxiliary materials in (2) into completely melted cetyl alcohol and stearyl alcohol, heat-melt, mix and stir to granulate, pass through a 18-mesh sieve, let the granules cool at room temperature, add the prescribed amount of carbon dioxide Silicon and magnesium stearate, compressed tablet.

[0047] Such as figure 1 As shown, the in vitro release performance test results ...

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Abstract

The invention discloses a lyophobic matrix sustained-release tablet for pH independence drugs and a preparation method thereof. The sustained-release tablet is prepared from the following raw materials: a main drug, a wax matrix material, a local pH regulating agent, an adhesive, a filler, a lubricating agent and a glidant, wherein the local pH regulating agent is selected from calcium hydrogen phosphate dihydrate, disodium hydrogen phosphate or calcium silicate. The preparation method of the lyophobic matrix sustained-release tablet comprises the following steps: heating and melting the wax matrix material; uniformly mixing the main drug, the local pH regulating agent, the adhesive and the filler; melting and pelletizing the matrix material and the uniformly mixed materials; screening when the mixture is hot, granulating the mixture, performing standing to cool the mixture, adding the lubricating agent and the glidant into the mixture, and performing tableting to obtain the lyophobicmatrix sustained-release tablets. According to the lyophobic matrix sustained-release tablet, the local pH regulating agent is added into the existing prescription of diclofenac sodium sustained-release tablets, the pH value of a micro-environment can be maintained to promote solubility of drugs, and release in vitro of pH independence drugs can be improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pH-dependent drug hydrophobic matrix sustained-release tablet and a preparation method thereof. Background technique [0002] Oral sustained-release and controlled-release preparations are a very important direction for the development of the pharmaceutical industry at home and abroad. Compared with ordinary oral preparations, oral sustained-release preparations have the following characteristics: ① For drugs with short half-lives or frequent administration, it can reduce the number of administrations, improve patient compliance, and be easy to use; ② Make blood drug concentrations stable and avoid The peak-valley phenomenon is beneficial to reduce the adverse reaction of the drug; ③ it can reduce the total dose of the drug, so the minimum dose can be used to achieve the maximum drug effect. And because of its short research and development cycl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61K31/196A61K47/10A61K47/14
Inventor 涂家生吴涓沈雁
Owner CHINA PHARM UNIV
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