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Abrasion-resistant opioid formulations

Technology for opioids, pharmaceutical dosage forms, opioids, orally administrable dosage forms, compositions, and uses thereof for the treatment of pain, for the treatment of pain, or for prolonged release of opioids Composition, rate release, can solve the problem of ineffectiveness, interference with euphoric effect, etc.

Inactive Publication Date: 2019-07-05
RELMADA THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this case, the opioid antagonist is not expected to be orally active under normal conditions of use and would negate the euphoric effects of oral or intravenous administration interfered with by the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] The hydrogenated palm kernel oil is heated to a temperature of about 60 degrees Celsius. Add glyceryl monooleate. Once a homogeneous mixture is obtained, the remaining ingredients are added and mixed with a homogenizer to form a molten flowable mixture, which is injected into an empty dosage form (eg, a size 2 capsule shell). The mixture hardens on cooling (usually by pouring into capsule shells).

[0067] Element Content (%w / w) Quantity / capsule, mg Hydrogenated Palm Kernel Oil 72.3 235 HPMC 18.5 60 colloidal silica 3.1 10 glyceryl monooleate 3.1 10 Levorphanol 3.1 10 Total Capsule Fills 325

[0068] In this formulation and those described in other examples, Hydrokote (RTM) 112 can be used as hydrogenated palm kernel oil (which is an ADER ingredient); "HPMC" is hydroxypropyl methylcellulose (such as Methocel K15M product ); colloidal silicon dioxide can be a product such as Aerosil (RTM) 200; glyceryl monoole...

Embodiment 2

[0070] The hydrogenated palm kernel oil is heated to a temperature of about 60 degrees Celsius. Add the remaining ingredients while mixing while maintaining the temperature at about 60 degrees Celsius to form a molten flowable mixture. The mixture is filled into empty dosage forms (eg, size 1 capsule shells). The mixture hardens on cooling (usually by pouring into capsule shells).

[0071] Element Content (%w / w) Quantity / capsule, mg Hydrogenated Palm Kernel Oil 50.8 235 HPMC 18.5 60 colloidal silica 3.1 10 Dibutyl sebacate 6.2 20 xanthan gum 3.1 10 Guar Gum 15.4 50 Levorphanol 3.1 10 Total Capsule Fills 395

[0072] In this formulation, dibutyl sebacate, xanthan gum, and guar gum were each binders. In this formulation and those in other examples, dibutyl sebacate can be the Morflex (RTM) DBS product; xanthan gum can be the Vanzan (RTM) product; and guar gum can be the Edicol (RTM) product 60-70 produc...

Embodiment 3

[0074] Lactic acid was diluted in 75 ml of water to make a 10% (v / v) acid concentration, and enough chitosan was added to produce a 2% w / v chitosan / lactic acid solution. Separately heat the yellow beeswax to about 70°C. The chitosan-citric acid solution was added to the melted yellow beeswax followed by the remaining ingredients and mixed with a homogenizer to form a molten flowable mixture. The mixture is filled into an empty dosage form (eg, a size 2 capsule shell).

[0075] Element Content (%w / w) Quantity / capsule, mg yellow beeswax 49.3 165 HPMC 14.9 50 Aerosil (RTM) 3.0 10 Chitosan 1.5 5 lactic acid 7.5 25 gelatin 20.9 70 water -* -* Levorphanol 3.0 10 Total Capsule Fills 335

[0076] * Water is removed during the production process.

[0077] In this formulation, beeswax was the ADER component, and chitosan and gelatin were each the binder. Dissolution of chitosan in acid solution triggers...

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Abstract

The disclosure relates to dosage forms which include one or more cohesion agents in amounts effective to reduce the likelihood and ease of extraction of an opioid agonist therefrom. The dosage forms exhibit improved resistance to abuse and lesser likelihood of accidental overdosing than similar dosage forms lacking a cohesion agent. Dosage forms including multiple cohesion agents capable of inhibiting or reducing extraction, abuse, or overdose over a broad range of temperatures.

Description

Background technique [0001] The present disclosure relates generally to the field of abuse-deterrent pharmaceutical compositions of opioid agonists, including orally administrable dosage forms. [0002] The present disclosure also relates to pharmaceutical compositions of opioids and their use for the treatment of pain, including compositions formulated for extended release of opioids (eg, over a period of 8-48 hours). The techniques disclosed herein can inhibit, reduce, prevent or minimize the potential for intentional tampering or unintentional disruption of opioid-containing dosage forms of opioid abuse or opioid toxicity. [0003] Physicians seeking to relieve and / or prevent pain can choose from several well-accepted classes of agents, including opioid analgesics. An important goal of labor pain management is to achieve sustained pain relief. Analgesics are often given periodically to ensure that the next dose is given before the effects of previous doses wear off. [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/00A61K31/485
CPCA61K31/135A61K31/137A61K9/4808A61K9/485A61K9/4858A61K9/4866A61K9/4875A61K31/485A61K9/0053
Inventor 詹辉郭怀宏
Owner RELMADA THERAPEUTICS