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Anti-abuse opioid oral sustained-release tablet and preparation method thereof

A technology for opioids and sustained-release tablets, which can be used in pharmaceutical formulations, drug combinations, drug delivery and other directions, and can solve the problems of difficult extraction, easy oxidation of polymers, and high production costs

Active Publication Date: 2021-02-26
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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  • Anti-abuse opioid oral sustained-release tablet and preparation method thereof
  • Anti-abuse opioid oral sustained-release tablet and preparation method thereof
  • Anti-abuse opioid oral sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Embodiment 1 Modified polyammonium methacrylate Ⅰ

[0072] 1) Preparation method

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

[0074] 2) Main performance

[0075] The performance of the synthesized polymer body is similar to that of polyammonium methacrylate Ⅰ, which is soluble in ethanol, but the modified polyammonium methacrylate Ⅰ is not only soluble in ethanol, but also has the property of being swellable or even soluble in water, such as figure 2 shown.

[0076] Modified polyammonium methacrylate Ⅰ with a content of trimethylammonium ethyl methacrylate chloride of 11%-14% can swell in water, and the dissolution rate increases with the increase of ammonium-based mon...

Embodiment 2

[0078] The process flow chart for the preparation of mesh nanocellulose is shown in image 3 , and the preparation method is detailed in Example 3 of CN110452305A. from Figure 4 It can be seen that the particle size of homemade cellulose is between 500-5000nm, the average particle size is about 2025nm, and the overall size is still in the micron range; it does not have the potential toxicity and inflammatory risk of nanocellulose (≤100nm) to the human body, and can be directly used as medicine Use with excipients. from Image 6 It can be seen from the atomic force microscope that some grooves have been engraved on the surface of the cotton fiber after gas-solid acid hydrolysis, and the surface roughness is increased after enzymatic hydrolysis, and the engraved grooves are more and deeper. from Figure 7 It can be seen from the scanning electron microscope that the surface of cotton fiber is roughened after gas-solid acid hydrolysis, and cellulase is further used to degrad...

Embodiment 3

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

[0081]

[0082]

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

[0084] (1) Prepare modified polyammonium methacrylate I solution (11%) ethanol solution for later use.

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

[0086] (3) Mix the prescribed amount 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 prescribed amount of metformin saturated aqueous solution, metformin saturated alcohol solution and cellulosic alcohol solution with mesh structure into the reaction kettle and mix evenly.

[0089] (2) The mixture in step (1) is dried by spray drying method, the spray drying parameters are inle...

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Abstract

The invention discloses an anti-abuse opioid oral sustained-release tablet and a preparation method thereof. The anti-abuse opioid oral sustained-release tablet at least comprises the following components in parts by weight: (1) 2-9 parts of cellulose which is loaded with an opioid active component and has a nano reticular structure; and (2) 5-13 parts of a polymer with swelling properties in alcohol and water, wherein the opioid active component is dispersed on the surface of the cellulose with the nano reticular structure. The opioid oral sustained-release tablet is obvious in sustained-release effect, does not have obvious burst release, and has excellent anti-abuse characteristic.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an anti-abuse oral slow-release tablet of opioids and a preparation method thereof. Background technique [0002] Since 1995, James Campbell, chairman 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 preparations containing active ingredients are often used for long-term treatment, for example, for the treatment of chronic pain or pain caused by tumors. It is especially important to enable patients to enjoy a good quality of life during long-term treatment. Measures to improve patient quality of life include dosage forms that allow 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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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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