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Osmotic pump type controlled release tablets and preparation method thereof

A technology of osmotic pumps and controlled-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, drug delivery, etc., can solve problems such as undiscovered, and achieve the effects of avoiding superposition, precise release control, and strong toughness

Inactive Publication Date: 2011-09-28
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] In addition, there is no report on the application of acrylic resin RL alone or in combination with other semipermeable membrane materials such as cellulose acetate in the semipermeable membrane of osmotic pump controlled release tablets

Method used

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  • Osmotic pump type controlled release tablets and preparation method thereof
  • Osmotic pump type controlled release tablets and preparation method thereof
  • Osmotic pump type controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Example 1 Venlafaxine hydrochloride immediate release + controlled release osmotic pump tablet formulation, preparation method and release characteristics prepared by common semipermeable membrane material

[0060] 1. Prescription

[0061] 1. Tablet core prescription (1000 tablets) (specification 37.5mg)

[0062]

[0063] 2. Semi-permeable membrane prescription (1000 tablets)

[0064]

[0065] 3. Immediate release layer prescription

[0066]

[0067] 2. Preparation process

[0068] 1. Tablet core preparation process

[0069] Weigh venlafaxine hydrochloride, hypromellose K4M, lactose, and microcrystalline cellulose of the prescribed amount and mix them evenly; make soft materials with 8% PVPK30 and 80% ethanol; pass through a 24-mesh sieve for granulation, and dry at 40°C; Sieve with a 24-mesh sieve; add the prescribed amount of magnesium stearate and mix well, calculate the theoretical tablet weight, and punch the tablet with a 9mm circle.

[0070] 2. Prep...

Embodiment 2

[0086] Example 2 Venlafaxine hydrochloride immediate release-controlled release osmotic pump tablet using cellulose acetate-acrylic resin RL as semipermeable film-forming material

[0087] 1. Prescription

[0088] 1. Tablet core prescription (1000 tablets) (specification 37.5mg)

[0089]

[0090] 2. Semi-permeable membrane prescription (1000 tablets)

[0091]

[0092] 3. Immediate release layer prescription

[0093]

[0094] Second, the preparation process:

[0095] 1. The preparation process of the tablet core: pass venlafaxine hydrochloride through a 100-mesh sieve, and pass other auxiliary materials through a 60-mesh sieve for later use; weigh the main drug and other auxiliary materials (except lubricant) according to the prescription ratio; make soft with a wetting agent material; pass through a 24-mesh sieve to granulate, dry at 40°C, add the prescribed amount of lubricant, pass through a 24-mesh sieve for granulation; calculate the theoretical tablet weight, ...

Embodiment 3

[0111] Example 3 Venlafaxine hydrochloride immediate-release-controlled release osmotic pump tablet using cellulose acetate-acrylic resin RL as semipermeable film-forming material

[0112] 1. Prescription

[0113] 1. Tablet core prescription (1000 tablets) (specification 50mg)

[0114]

[0115] 2. Semi-permeable membrane prescription (1000 tablets)

[0116]

[0117] 3. Immediate release layer prescription

[0118]

[0119] 2. Preparation process: the same as in Example 2, wherein when the specifications of the controlled-release part are 50 mg, and the specifications of the immediate-release part are 12.5, 25, 37.5, and 50 mg (calculated as venlafaxine), the weight gain of each immediate-release layer coating is about 21.23 mg, 42.47mg, 63.70mg, 84.94mg.

[0120] 3. Release measurement method and results

[0121] 1, measurement method: with embodiment 2, wherein the sample measurement of specification 50mg controlled release uses 2cm absorption cell, all the other...

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Abstract

The invention provides novel osmotic pump type controlled release tablets. A semi-permeable membrane adopts the combination of cellulose acetate and acrylic resin RL as a semi-permeable membrane forming material, can overcome the ageing phenomenon, and can maintain a stable release property all the time without being limited by the storage time. In addition, the controlled release tablets have the characteristic of preliminary time release, and a preparation method provided by the invention is suitable for preparing a controlled release preparation needing the preliminary time release characteristic. The preparation method is especially suitable for quick release-controlled release osmotic pump controlled release tablets, and is particularly suitable for the quick release-controlled release osmotic pump controlled release tablets with a monolithic controlled release part.

Description

technical field [0001] The invention relates to a novel osmotic pump type controlled-release tablet and a preparation method thereof, in particular to a novel osmotic pump type quick-release-controlled release tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] There is a dose-effect relationship between the blood drug concentration of most drugs and the drug effect, and the drug must be above the effective concentration to exert its drug effect. Although immediate-release drugs have a rapid onset of action, because there is no subsequent drug release, the blood drug concentration drops rapidly, so the drug has a short action time and requires frequent administration; due to the slow release rate of slow-release drugs, it takes a long time to reach the peak in the body. Effective blood drug concentration, so the onset of the drug is slow, but due to the long duration of drug release, the blood drug con...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K47/38A61K47/32
Inventor 姜庆伟刘全志衣伟锋梁希
Owner 北京天衡药物研究院有限公司
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