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Tapentadol hydrochloride paracetamol orally disintegrating tablet and preparation method thereof

A technology of paracetamol and tapentadol hydrochloride is applied in the field of compound oral disintegrating tablets containing tapentadol hydrochloride and paracetamol hydrochloride and the field of preparation thereof, which can solve difficulty in swallowing, cannot fully meet the needs of patients for medication, etc. question

Inactive Publication Date: 2013-12-11
ANHUI PIOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Ordinary tablets need to be taken with water, and it will be difficult for patients who have difficulty swallowing or taking water, so these dosage forms cannot fully meet the medication needs of patients

Method used

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  • Tapentadol hydrochloride paracetamol orally disintegrating tablet and preparation method thereof
  • Tapentadol hydrochloride paracetamol orally disintegrating tablet and preparation method thereof
  • Tapentadol hydrochloride paracetamol orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 37.5mg / 325mg Tapentadol Hydrochloride Orally Disintegrating Acetaminophen Tablets

[0040] 1. Prescription

[0041] Table 1 Prescription Composition of 37.5mg / 325mg Tapentadol Hydrochloride Orally Disintegrating Acetaminophen Tablets (1000 Tablets)

[0042]

[0043] 2. Preparation process

[0044] (1) Mix 3g of the flavoring agent aspartame and 80g of the filler mannitol, add 0.5g of the binder polyvinylpyrrolidone, pass through a 20-mesh sieve to prepare wet granules, and dry at 60-65°C to obtain granules ( I);

[0045] Said binder is polyvinylpyrrolidone;

[0046] (2) Mix 37.5g tapentadol hydrochloride (calculated as tapentadol) with 380g saturated ethanol solution of coating taste-masking agent β-cyclodextrin, mix tapentadol hydrochloride and β-cyclodextrin Add to the ethanol solution respectively, stir at high speed with a high-speed mixer for 3 to 5 hours, then spread the stirred solution on a glass dish, put it in a 55°C oven for drying, take i...

Embodiment 2

[0051] Example 2 56.25mg / 325mg Tapentadol Hydrochloride Acetaminophen Orally Disintegrating Tablets

[0052] 1. Prescription

[0053] Table 2 Prescription Composition of 56.25mg / 325mg Tapentadol Hydrochloride Orally Disintegrating Acetaminophen Tablets (1000 Tablets)

[0054]

[0055] 2. Preparation process

[0056] (1) Mix 4g of flavoring agent aspartame and 95g of filler mannitol, add 0.5g of binder polyvinylpyrrolidone, pass through a 20-mesh sieve to make wet granules, and dry at 60-65°C to obtain granules ( I);

[0057] Said binder is polyvinylpyrrolidone;

[0058] (2) Mix 56.25g of tapentadol hydrochloride (calculated as tapentadol) with 570g of saturated ethanol solution of coating taste-masking agent β-cyclodextrin, mix tapentadol hydrochloride and β-cyclodextrin Add to the ethanol solution respectively, stir at high speed with a high-speed mixer for 3 to 5 hours, then spread the stirred solution on a glass dish, put it in a 55°C oven for drying, take it out...

Embodiment 3

[0063] Example 3 75mg / 325mg Tapentadol Hydrochloride Orally Disintegrating Acetaminophen Tablets

[0064] 1. Prescription

[0065] Table 3 Prescription Composition of 75mg / 325mg Tapentadol Hydrochloride Orally Disintegrating Acetaminophen Tablets (1000 Tablets)

[0066]

[0067] 2. Preparation process

[0068] (1) Mix 4g of flavoring agent aspartame and 110g of filler mannitol, add 0.5g of binder polyvinylpyrrolidone, pass through a 20-mesh sieve to prepare wet granules, and dry at 60-65°C to obtain granules ( I);

[0069] Said binder is polyvinylpyrrolidone;

[0070] (2) Mix 37.5g tapentadol hydrochloride (calculated as tapentadol) with 760g saturated ethanol solution of coating taste-masking agent β-cyclodextrin, mix tapentadol hydrochloride and β-cyclodextrin Add to the ethanol solution respectively, stir at high speed with a high-speed mixer for 3 to 5 hours, then spread the stirred solution on a glass dish, put it in a 55°C oven for drying, take it out, and crush...

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Abstract

The invention provides a tapentadol hydrochloride paracetamol orally disintegrating tablet and a preparation method thereof. According to the invention, the content of tapentadol hydrochloride is 37.5 mg-75.0 mg (by tapentadol), and the content of paracetamol is 325 mg; taste masking coating is conducted on the tapentadol hydrochloride and the paracetamol respectively to allow the tablet to be suitable for oral taking; selecting and using pharmaceutic adjuvant suitable for physicochemical properties of the tapentadol hydrochloride and the paracetamol to conduct coating; finally blending uniformly and tabletting. The fluidity of raw materials used for the prescription and the taste masking coating is good to facilitate the tabletting; the taste of the medicine is masked after being subjected to coating, and meanwhile, a corrigent is added to conduct taste adjustment for oral use. Therefore, a suitable disintegrating agent is selected and used to allow the orally disintegrating tablet to be able to achieve the requirement of quick disintegration.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a compound orally disintegrating tablet containing tapentadol hydrochloride and acetaminophen and a preparation method thereof. Background technique [0002] Tapentadol hydrochloride is a new type of strong central analgesic with dual action modes of opioid receptor agonism and norepinephrine reuptake inhibition. On January 23, 2008, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for Tapentadol Hydrochloride Immediate Release Tablets for the treatment of moderate to severe acute pain. The results of the study show that tapentadol does not rely on metabolic activation and has no active metabolites. It has good effects on acute, inflammatory and chronic neuropathic pain models, and its potency is between morphine and tramadol. Satisfactory blood drug concentration can be obtained, and it is less likely to produce analgesic tolerance and phy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K9/20A61K47/40A61K47/38A61K47/32A61P29/00A61P25/04A61K31/137
Inventor 徐奎陈正晧魏伟
Owner ANHUI PIOM PHARMA
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