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Respiratory tract delivery of levodopa and dopa decarboxylase inhibitor for treatment of parkinson's disease

A technology of dopa decarboxylase and levodopa, which is applied in the directions of nebulizers for treatment, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of dysphagia, levodopa, etc. difficulties, etc.

Pending Publication Date: 2021-06-11
IMPEL NEUROPHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, PD patients experience dysphagia as motor function deteriorates with disease progression; in these patients, dysphagia makes oral intake of levodopa increasingly difficult

Method used

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  • Respiratory tract delivery of levodopa and dopa decarboxylase inhibitor for treatment of parkinson's disease
  • Respiratory tract delivery of levodopa and dopa decarboxylase inhibitor for treatment of parkinson's disease
  • Respiratory tract delivery of levodopa and dopa decarboxylase inhibitor for treatment of parkinson's disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0164] Powder capsule

[0165] In one embodiment, a device is constructed and tested. Test the residual powder in the compound container after actuation. When 2 or more but less than 6 grooves are used on the inlet interface, the apparatus has a relatively powder delivery performance, as measured by the actuated residue. In this example, the groove is combined with a 63mg HFA propellant and a nozzle. The aperture is combined. Four grooves (90 degrees) are found to provide a homogeneous gas delivery.

[0166] Dose quality

[0167] Perform dose quality reproducibility test. The standard deviation of the dose delivery indicates that the device can deliver a consistent dose quality. The average dosage residue remaining in the device <5%, indicating that the dose in the device is very small.

[0168]

[0169] Table 0: Quality reproducibility of the final molding device, value in milliga

[0170] 5.5.3.4. Nasal devices with multiple filter

[0171] Figure 9A Another example of the ...

Embodiment 1

[0180] 5.6.1. Example 1: Non-human primate PK research

[0181]Developing and manufacturing a series of L-DOPA (L-dopa) powder formulation with or without the DDI (benserazide or carbidopa) levodopa to assess non-human primates ( "NHP" Pharmacokinetics in the Nasal Nasal Division. Formulation development target is to obtain a powder using a nasal delivery precision non-human primate ( "nhpPOD") after intranasal delivery device leads to a rapid increase in plasma concentrations Formulation> 200-400ng / mL of the formulation such that It is expected to actively affect the "OFF" on Parkinson's disease.

[0182] Six single dose PK studies were carried out in the cynomolus monkeys to examine the PK after administration of the poly powder L-DOPA formulation delivered by the NHPPOD device through the intranasal pathway. Check unmodified formulation comprising crystalline powder (median particle size of about 50μm), sieved formulation crystalline L-DOPA-containing particles to determine t...

Embodiment 2

[0306] 5.6.2. Example 2: Rethinking PK Research

[0307] 5.6.2.1. Single dose of intranasal pharmacokinetics in rats (Research No. PBI-18-057)

[0308] Single dose PK studies were carried out in Sprague-Dawley rats (weight of 226-250 g), in which to use or without benzyl hydrazine pretreatment, the intranasal administration ("RPOD") is administered in nasal administration ("RPOD"). DOPA drying powder (spray dry) formulation. The RPOD used in this experiment is an intranasal delivery device for rats, which is described in U.S. Patent Publication No. 2015 / 0100042, which is incorporated herein by reference. Twenty male rats were divided into five groups. According to the description summarized in Table 19, different L-DOPA spray drying preparations were administered each group.

[0309] Pre-administration of each animal in the first group 1-4 was preprocessed using 3 mg / k oral benzyl hydrazine using 3 mg / K orally. Animals in the 5th group do not use oral benzyl hydrazine pretreat...

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Abstract

A dry pharmaceutical composition is provided that is suitable for respiratory tract delivery of levodopa and DDI for treatment of Parkinson's disease or Parkinson syndrome. The dry pharmaceutical composition comprises levodopa, a dopa decarboxylase inhibitor (DDI) and at least one excipient. A unit dosage form of the dry pharmaceutical composition and a method of treating a patient with Parkinson's disease or Parkinson syndrome by administering the dry pharmaceutical composition are also provided.

Description

[0001] 1. Cross-reference related application [0002] The present application claims priority to US Temporary Application No. 62 / 700, 584, filed on July 19, 2018, filed on March 18, 2019, which is incorporated herein by reference. . [0003] 2. Background [0004] Parkinson's disease (PD) is a neurodegenerative disease, characterized in that the dopamine neurons in the black quality are missing. Patients show sporty symptoms in early disease, including tremor or shaking, stiffness, slow motion and difficult walking. Sport symptoms are called Parkinson syndrome. Although Parkinson's disease is the most common cause of Parkinson's syndrome, Parkinson syndrome may also be caused by various toxic injuries. [0005] The oral treatment of Dopa Detection Inhibitor ("DDI") in the peripheral effect is the cornerstone of PD early treatment and Parkinson syndrome. However, the absorption changes after oral administration, causing changes in plasma and brain. According to the volatility of the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/133A61K31/198A61K47/18
CPCA61K31/198A61P25/16A61K9/0075A61K9/48A61K9/14A61K9/0043A61K31/165A61K9/1623A61K9/1652A61M15/0036A61M11/02A61M15/009A61M15/003A61M15/08A61M15/0035A61M2202/04A61M2202/064A61M2206/20A61M2205/8225A61K9/0053
Inventor J·D·赫克曼K·H·萨特利I·达舍夫斯基A·R·达斯S·B·什雷斯布里G·J·戴维斯B·Y·加杰拉
Owner IMPEL NEUROPHARMA INC
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