A kind of anti-abuse oral sustained-release opioid tablet and preparation method thereof

A technology for opioid drugs and sustained-release tablets, which is applied in drug combination, drug delivery, and pharmaceutical formulations. It can solve the problems of polymers being easily oxidized, difficult to extract, and high production costs, and achieve obvious sustained-release effects.

Active Publication Date: 2022-06-28
NHWA PHARMA CORPORATION +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the anti-abuse preparations of narcotic drugs on the market are mainly PEOs. The anti-abuse preparations prepared by this type of polymer have the advantages of high hardness and difficult extraction. However, this type of polymer is easy to oxidize, and vitamins need to be added during the preparation process. Antioxidants such as E, and the current anti-abuse preparations require high-end preparation equipment and high production costs

Method used

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  • A kind of anti-abuse oral sustained-release opioid tablet and preparation method thereof
  • A kind of anti-abuse oral sustained-release opioid tablet and preparation method thereof
  • A kind of anti-abuse oral sustained-release opioid tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Example 1 Modified Ammonium Polymethacrylate I

[0072] 1) Preparation method

[0073] The same as "Chinese Pharmacopoeia 2015 Edition" polyammonium methacrylate I, but the ratio of the three monomers is changed from the original: methyl methacrylate: ethyl acrylate: trimethylammonium ethyl methacrylate = 60:30 : 10, changed to methyl methacrylate:ethyl acrylate:trimethylammonium ethyl methacrylate == 55:30:15.

[0074] 2) Main performance

[0075] The main properties of the synthesized polymer are similar to those of polyammonium methacrylate I and are soluble in ethanol, but the modified polyammonium methacrylate I is not only soluble in ethanol, but also swellable and even soluble in water. figure 2 shown.

[0076] Modified polyammonium methacrylate I with a content of 11%-14% trimethylammonium chloride methacrylate can swell in water, and the dissolution rate increases with the increase of ammonium monomer content, and the swelling is slower in cold water. In ho...

Embodiment 2

[0078] The flow chart of the preparation process of mesh nanocellulose is shown in image 3 , the preparation method is detailed in Example 3 of CN110452305A. from Figure 4 It can be seen that the particle size of the self-made cellulose is between 500-5000nm, the average particle size is about 2025nm, and the overall size is still in the micrometer range; it has no potential poisoning and inflammatory risks of nanocellulose (≤100nm) to the human body, and can be directly used as medicine Use with excipients. from Image 6 The atomic force microscope picture shows that some grooves have been carved on the surface of the cotton fiber after gas-solid acid hydrolysis. After enzymatic hydrolysis, the surface roughness is increased, and the grooves are more and deeper. from Figure 7 It can be seen from the scanning electron microscope that the surface of the cotton fiber is roughened after gas-solid acid hydrolysis, and further degraded by cellulase to make the cellulose form...

Embodiment 3

[0080] Since oxycodone hydrochloride is a controlled drug, metformin was used instead of oxycodone hydrochloride in formula screening.

[0081]

[0082]

[0083] Prescription A, B, C preparation method:

[0084] (1) Prepare modified ammonium polymethacrylate I solution (11%) ethanol solution for use.

[0085] (2) Mix the prescribed amount of sodium carboxymethyl cellulose (CMC-Na) with ammonium polymethacrylate I solution (11%) ethanol solution, and dry in an oven at 50° C. for 1 hour.

[0086] (3) Mix the recipe quantities of metformin, vinyl acetate, PVP K30 and the mixture in (3) evenly, and press into tablets.

[0087] Prescription D, E preparation method:

[0088] (1) Add the metformin saturated aqueous solution, the metformin saturated alcohol solution and the cellulosic alcohol solution of the mesh structure of the recipe quantity into the reaction kettle and mix uniformly.

[0089] (2) the mixture in the step (1) is dried by spray drying method, and the spray ...

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Abstract

The invention discloses an anti-abuse oral slow-release tablet of opioids and a preparation method thereof. An anti-abuse oral sustained-release tablet for opioids, comprising at least: 1) 2-9 parts by weight of cellulose with a nano-network structure loaded with active components of opioids; 5-13 parts by weight; wherein, the active component of the opioid drug is dispersed on the surface of the cellulose with a nano-network structure. The opioid oral sustained-release tablet of the invention has obvious slow-release effect, no obvious burst release, and excellent abuse-preventing properties.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an anti-abuse opioid oral sustained-release tablet and a preparation method thereof. Background technique [0002] Since 1995, James Campbell, president of the American Pain Society, first proposed that pain is the fifth vital sign. Today, the World Health Organization has identified pain as the "fifth vital sign" after blood pressure, respiration, pulse, and body temperature. Research is getting more and more attention. Opioid formulations containing the active ingredient are often used for long-term treatment, eg, for the treatment of chronic pain or pain caused by tumors. During long-term treatment, it is particularly important that patients enjoy a good quality of life. Measures to improve the patient's quality of life include dosage forms that allow for once-daily dosing. However, due to the relatively large amount of active ingredient required, these dosage forms...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K31/485A61K31/137A61P25/04C08B15/02C12P19/14C12P19/04
CPCA61K9/2054A61K9/2027A61K31/485A61K31/137A61P25/04C08B15/02C12P19/14C12P19/04C12P2201/00
Inventor 高梓真郑欢李效文李凤和许向阳
Owner NHWA PHARMA CORPORATION
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