Pharmaceutical composition for neuropathic pain

Pending Publication Date: 2019-01-10
FRIMLINE PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent describes a new pharmaceutical composition that combines Palmitoylethanolamide (PEA) and one or more naturally occurring Fatty Acid Amide Hydrolase (FAAH) inhibitors. This combination has been found to have a synergistic effect, meaning that the two ingredients work together to provide better results than either one alone. The composition may also include additional ingredients such as vitamins, coenzymes, or other substances. The patent also describes a process for preparing the composition, involving mixing the ingredients, adding a binder solution, and optionally adding a second natural FAAH inhibitor. The result is a synergistic pharmaceutical composition that can provide improved results in the treatment of certain medical conditions.

Problems solved by technology

However, no biological effects or further technical results of such hypothetical combination comprising PEA have been shown in such document.
However, these chemically synthesized FAAH inhibitors may have side effects upon administration in human or animals.
These side effects decrease the Quality of Life of patient and reduce active working life.
Moreover using these drugs for long-term causes de-sensitization of receptors.
Therefore, the requirement of increase in the dose of these drugs is required to elicit the desired response and that leads to more number of side effects.
In conclusion, the current treatment paradigm has some gaps and requires some new arsenal to fight against Neuropathic Pain.
The above-mentioned documents disclosing use of FAAH inhibitors are chemically synthesized, and there can be side effects due to synthetic ingredients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0078]

Std. Qty.S. NoIngredientsmg / unit% w / wIntragranular Ingredients1Micronized PEA30066.672Natural FAAH Inhibitor (Daidzein)5011.113MCC pH 10145.510.114Croscarmellose Sodium153.33Binder Solution5PVP K-3051.116Polysorbate 80102.227IPAQS8WaterQSExtragranular Ingredients9Magnesium Stearate102.2210Talc40.8911Zinc Stearate61.3312Colloidal silicon dioxide4.51.00Average Wt.450100.00

example 2

[0079]

Std. Qty.S. NoIngredientsmg / unit% w / wIntragranular Ingredients1Micronized PEA30060.002Natural FAAH Inhibitor (Myricetin)10020.003Lactose Monohydrate45.59.104Crospovidone153.00Binder Solution5Hypromellose51.006Polysorbate 80102.007IPAQS8WaterQSExtragranular Ingredients9Magnesium Stearate102.0010Talc40.8011Zinc Stearate61.2012Colloidal silicon dioxide4.50.90Average Wt.500100.00

example 3

[0080]

Std. Qty.S. NoIngredientsmg / unit% w / wIntragranular Ingredients1Micronized PEA30066.672Natural FAAH Inhibitor (Isorhamnetin)5011.113MCC pH 10245.510.114Croscarmellose Sodium153.33Binder Solution5PVP K-3051.116Sodium Lauryl Sulfate102.227IPAQS8WaterQSExtragranular Ingredients9Magnesium Stearate102.2210Talc40.8911Zinc Stearate61.3312Colloidal silicon dioxide4.51.00Average Wt.450100.00

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Abstract

The present application describes a pharmaceutical composition / formulation for use in controlling neuropathic pain. The composition / formulation includes Palmitoylethanolamide (PEA) and one or more natural ingredients. The application also provides various formulations and methods of preparing the same.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a pharmaceutical composition / formulation for use in controlling neuropathic pain. More particularly, the invention relates to a composition / formulation comprising a synergistic combination of Palmitoylethanolamide (PEA) and one or more natural ingredients.BACKGROUND OF THE INVENTION[0002]Humans and animals suffering from chronic and severe pain require good clinical management. Multiple pharmacological agents are generally employed to treat diverse pathological pain states. Specifically, these pharmacological agents include opiates, nonsteroidal anti-inflammatory drugs, anticonvulsants, antidepressants, ketamine and others (Guindon et al., 2007). However, adverse side effects from these pharmacological agents constrain therapeutic dosing ultimately limiting therapeutic efficacy.[0003]Improvements have been made in understanding pathophysiological mechanisms underlying chronic pain states. In addition, efforts have been mad...

Claims

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Application Information

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IPC IPC(8): A61K31/16A61K31/352A61P25/00A61K9/48A61K31/56A61K31/714A61K31/122A61K31/685
CPCA61K31/16A61K31/352A61P25/00A61K9/4866A61K9/4858A61K9/4816A61K31/56A61K31/714A61K31/122A61K31/685A61K9/485A61P25/04A61K31/164A61K31/215A61P25/02A61K2300/00
InventorSINGH, ANKIT SHYAMMISHRA, VEDPRAKASHTONGRA, NEELIMA
OwnerFRIMLINE PTE LTD