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Fixed dose composition of paracetamol: amitriptyline and method for treatment of mixed cancer pain

A technology of acetaminophen and amitriptyline, applied in the field of treatment of fixed-dose acetaminophen: amitriptyline combination and mixed cancer pain, which can solve the problem of no description

Inactive Publication Date: 2020-12-08
CENT DE INVESTIGACION & DESARROLLO DE MEDICAMENTOS CIDEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The examples do not describe clinical efficacy trials of the proposed combination of drug treatments versus the individual drugs

Method used

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  • Fixed dose composition of paracetamol: amitriptyline and method for treatment of mixed cancer pain
  • Fixed dose composition of paracetamol: amitriptyline and method for treatment of mixed cancer pain
  • Fixed dose composition of paracetamol: amitriptyline and method for treatment of mixed cancer pain

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Persistent pain model (formalin test, acute spontaneous behavior)

[0048] Rats were placed individually in an open cylindrical glass chamber (34×30×28 cm). Animals were given 20 min to acclimatize to the camera before injection and were returned for observation immediately after injection. Animals were gently immobilized for oral dosing one hour prior to formalin injection, and various doses of the drug or its vehicle were administered by gavage depending on the group to which they were assigned. Formalin (50 μL, s.c.) was injected into the plantar region of the rat's right hind paw using a microsyringe with a 26G gauge needle. After the formalin injection, the licking / biting behavior of the injected paw was recorded using a digital timer, with 5 minutes as the observation period, and the total licking / biting time was recorded for 45 minutes. Response curves for formalin-induced licking / biting behavior were generated by recording the following phases: early (0-5 min)...

Embodiment 2

[0050] Sciatic nerve chronic contraction injury model (neuropathic surgery). Behavioral assessment of mechanical allodynia and mechanical supranociception

[0051] Animals were anesthetized with sodium thiopental (50 mg / kg, i.p.). Ligation of the common sciatic nerve on the left produced a chronic compressive injury (CCI) (Bennett and Xie, 1988). Briefly, the sciatic nerve was exposed at the mid-thigh level through blunt dissection of the biceps femoris. Near its bifurcation, approximately 7 mm of the nerve had no adherent tissue, and three ligatures (using 4.0 chromic gut) were loosely tied around it at 1-1.5 mm intervals. When viewed at 40X magnification, the ligature has barely the diameter of the constricted nerve. This degree of constriction slows but does not prevent circulation through the superficial epineural vasculature and produces a small transient twitch in the exposed surrounding muscles. The incision is closed in layers. In the sham control group, the same ...

Embodiment 3

[0055] Behavioral Safety Pharmacological Testing

[0056]To rule out signs of worsening movement, sedation, or stiffness. Spin-rod or spin-rod tests were performed. The device consists of a rod with a diameter of 2.5 cm, divided into 4 compartments. The rod was rotated at a constant speed of 22 rpm and the time it took for the animal to fall from the rod was assessed. Animals were assessed 1 hour after dosing. The cutoff time used is 60 seconds. Additionally, the animals were studied for tone of voice, posture, righting reflex, cornea, vital signs and general status 30 minutes to 3 hours after separate and combined dosing, respectively. Probe the corneal and tympanic reflexes by stimulating the cornea or auditory canal with a tissue tip, and observe rapid responses of eye opening and closing or ear mobilization in normal animals. Posture and righting reflex assessments were based on Devor and Zalkind's measurements. Postural measure: 0 = normal posture, grooming supporte...

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Abstract

The present application to an invention describes a pharmaceutical composition with a fixed dose of paracetamol and specifically amitriptyline supported by the pharmacological interaction and safety studies that show its synergy for the anti-allodynic and the mechanical anti-hypernociceptive effects and for the reduction of persistent pain, proportions, safety and neuroprotective capacity. This isaimed to the treatment of mixed pain due to cancer that can be incorporated as another option in the strategy of the WHO analgesic ladder at step 1 for the treatment of mild pain. However, it can also be included in higher steps associated with opioids for the treatment of pain of greater intensity and potentially decrease dose escalation and adverse effects such as tolerance and hyperalgesia.

Description

Background technique [0001] Despite major advances in cancer knowledge and improved patient survival, morbidity and mortality continue to rise worldwide. In 2008, 12.7 million new cases and a total of 7.6 million cancer deaths were reported worldwide, and this number is expected to double to 21.4 million new cases and 13.2 million deaths by 2030. Regardless of the advances in tumor-specific treatments and the use of analgesics, typically 70% of cancer patients experience pain, 48% in early stages and 64-75% in advanced stages. Its incidence varies according to the site and is very high at 70% in head and neck tumors, 55% in lung and bronchi, 54% in breast, 60% in gynecology, 52% in genitourinary tract, and 59% in gastrointestinal tract %. In addition, pain from cancer may be directly related to primary and / or metastatic tumors infiltrating and compressing visceral, somatic, and neural structures, but also to their treatment, whether surgery, radiation, or chemotherapy. Chem...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K31/167
CPCA61K31/167A61K31/135A61K45/06A61P25/00A61K2300/00A61P25/04A61P29/00A61K9/0053
Inventor B·B·加里多萨莱兹A·贝尔玛梅门德斯A·冈萨雷斯寇特左恩N·德拉帕斯马丁维亚那P·G·巴萨迦费尔南德斯R·佩尔多莫莫拉雷斯A·S·帕德龙雅奎斯
Owner CENT DE INVESTIGACION & DESARROLLO DE MEDICAMENTOS CIDEM
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