Compositions comprising zoledronic acid or related compounds for relieving inflammatory pain and related conditions

A technology for zoledronic acid and inflammatory pain, which can be used in drug combinations, non-central analgesics, anti-inflammatory agents, etc., and can solve problems such as low oral bioavailability

Pending Publication Date: 2015-02-11
ANTECIP BIOVENTURES II
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Compositions comprising zoledronic acid or related compounds for relieving inflammatory pain and related conditions
  • Compositions comprising zoledronic acid or related compounds for relieving inflammatory pain and related conditions
  • Compositions comprising zoledronic acid or related compounds for relieving inflammatory pain and related conditions

Examples

Experimental program
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Effect test

Embodiment 1

[0088] Effects of Orally Administered Zoledronic Acid in a Rat Model of Inflammatory Pain

[0089] method:

[0090] The effect of orally administered zoledronic acid on inflammatory pain was examined using the complete Freund's adjuvant (CFA) model in the rat. Inflammatory pain was induced by injecting a volume of 75 [mu]L of 100% CFA into the left hind paw of Sprague-Dawley rats on day 0 and then assessed on days 1-3. Animals were orally administered vehicle (control), zoledronic acid 18 mg / m once daily on days 1-3 2 (or 3mg / kg), zoledronic acid 120mg / m 2 (or 20mg / kg) or zoledronic acid 900mg / m 2 (or 150mg / kg). Drugs were dissolved in distilled water and prepared fresh daily. Animals were fasted prior to dosing. Under current FDA guidance on extrapolating starting doses from animals to humans, it is considered 2 The indicated doses are equivalent across mammalian species. Thus, for example, 18 mg / m in rats is considered 2 Equivalent to 18mg / m in humans 2 , while 3...

Embodiment 2

[0100] Effects of Orally Administered Zoledronic Acid in a Rat Model of Arthritis Pain

[0101] method:

[0102] The effect of orally administered zoledronic acid on arthritic pain was examined in the rat Complete Freund's Adjuvant (CFA) model of arthritic pain. In this model, 100% complete Freund's adjuvant (CFA) in a volume of 75 μL was injected into the left hind paw, followed by the development of arthritic pain over a period of 10-14 days. During the first three days after CFA injection, animals were orally administered three equal daily doses of vehicle (control), zoledronic acid 54 mg / m 2 (or 9mg / kg) or zoledronic acid 360mg / m 2 (or 60mg / kg). Drugs were dissolved in distilled water and prepared fresh daily. Animals were fasted prior to dosing.

[0103] Arthritic pain (mechanical hyperalgesia) was assessed in vehicle and drug-treated animals on day 14 after CFA injection using the Randall-Selitto digital device (dRS; IITC Life Sciences, Woodland Hills, CA). Anima...

Embodiment 3

[0109] Example 3 Treatment of complex regional pain syndrome with orally administered zoledronic acid.

[0110]The effect of orally administered zoledronic acid was examined in the rat tibial fracture model of complex regional pain syndrome (CRPS). CRPS in rats was induced by fracture of the right distal tibia of the animals and casting of the fractured hind paw for 4 weeks as described by Guo TZ et al. (Pain. 2004; 108:95-107) stated. This animal model has been shown to reproduce the stimulus trauma, natural history, signs, symptoms and lesions observed in human CRPS patients (Kingery WS et al., Pain. 2003; 104:75-84).

[0111] From the day of fracture and injection, animals were treated with 18mg / m 2 Doses per day (3 mg / kg / day) were administered orally with vehicle (control) or zoledronic acid for 28 days. Drugs were dissolved in distilled water and administered by gavage. Animals were fasted 4 hours before and 2 hours after dosing. At the end of the 28 day period, th...

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Abstract

Oral dosage forms of bisphosphonate compounds, such as zoledronic acid, can be used to treat or alleviate pain or related conditions. Although an oral dosage form with enhanced bioavailability with respect to the bisphosphonate compound can be used, the treatment can also be effective using an oral dosage form that includes a bisphosphonate compound, such as zoledronic acid, wherein the bioavailability of the bisphosphonate is unenhanced, or is substantially unenhanced.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application 61 / 646,538, filed May 14, 2012; U.S. Provisional Application 61 / 647,478, filed May 15, 2012; U.S. Provisional Application 61 / 654,292, filed June 1, 2012; 2012 U.S. Provisional Application 61 / 654,383 filed June 1; U.S. Provisional Application 61 / 655,527 filed June 5, 2012; U.S. Provisional Application 61 / 655,541 filed June 5, 2012; filed February 7, 2013 U.S. Provisional Application 61 / 762,225 filed February 14, 2013; U.S. Provisional Application 61 / 767,647 filed February 21, 2013; U.S. Provisional Application 61 filed February 21, 2013 / 767,676; and the benefit of U.S. Provisional Application 61 / 803,721, filed March 20, 2013, which are hereby incorporated by reference in their entirety. Background technique [0003] Bisphosphonates are potent inhibitors of osteoclast activity and are used clinically in the treatment of bone-related disorders, such as osteoporosis and...

Claims

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Application Information

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IPC IPC(8): A61K31/663A61P19/02A61P29/00
CPCA61K31/675A61K9/0053A61K9/2004A61K31/663A61P29/00
Inventor 赫里奥特·塔布提奥
Owner ANTECIP BIOVENTURES II
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