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Fixed dose combination therapy of parkinson's disease

A fixed-dose, dose-based technology for neurodegenerative diseases that addresses issues such as reduced side effects, impulse control disorders, and limited utility

Active Publication Date: 2014-11-26
图必制药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pramipexole (and several other DA agonists) also cause impulse control impairment, peripheral edema, psychosis, and sedation, which can be difficult to control and thus limit the utility of this drug
Rasagiline, another drug used to treat Parkinson's disease, is largely well tolerated but has some safety concerns, particularly related to the risks of Problems: cheese reaction (hypertensive crisis) with tyramine-rich foods and when combined with selective serotonin reuptake inhibitors and other antidepressants commonly prescribed in Parkinson's disease Serotonin reactions (excess serotonin activity) when used
Given the relatively troublesome adverse event profile associated with initiating treatment with dopamine agonists, current treatment consists of titration regimens of low doses that are not expected to be therapeutic but allow for less adverse side effects from immediate initiation of effective doses. to a minimum
In addition, adverse effects were associated with long-term treatment with higher doses of dopamine agonists

Method used

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  • Fixed dose combination therapy of parkinson's disease
  • Fixed dose combination therapy of parkinson's disease
  • Fixed dose combination therapy of parkinson's disease

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0051] The preparation of these capsules or tablets may be carried out using any suitable technique known in the art.

[0052] Examples of suitable excipients that may be used in the preparation of oral pharmaceutical compositions include, without limitation, silicon dioxide and other glidants known in the art as defined above.

[0053] Tablet fillers fill the dimensions of a tablet or capsule, making them practical for manufacture and convenient for the consumer. Fillers make it possible for the final product to have the proper volume for the patient to hold by increasing the overall volume. A good filler must be inert, compatible with the other components of the formulation, non-hygroscopic, relatively inexpensive, compactable, and preferably odorless or have a pleasant taste. Vegetable cellulose (pure vegetable filler) is a common filler in tablets or hard gelatin capsules. Dicalcium phosphate is another generic tablet filler. A variety of vegetable fats and oils can be ...

Embodiment 1

[0063] Example 1: Formulation and dissolution profile of the combination product.

[0064] Each component (Tables 1 and 2) was formulated separately and the beads were packaged in respective weights to give doses of 0.6 mg pramipexole and 0.75 mg rasagiline.

[0065] Analytical Method - Dissolution Test on the Combination Product

[0066] The method quantifies the active pharmaceutical ingredient (API), pramipexole ( PPX) and the dissolution profiles of rasagiline (RAS) were evaluated.

[0067] A sample of the contents of a capsule or a dose of beads (pellets) is placed in a basket which is rotated inside a vessel containing the medium at a constant specified rate and temperature. The sample dissolves in the vehicle solution over time at a rate that reflects the release profile of the formulation, so the solution contains different concentrations of API at different time points. At designated time points, samples were taken automatically or manually at designated time int...

Embodiment 2

[0084] Example 2: Drug in vivo studies in the MPTP model of Parkinson's disease.

[0085] Materials and Methods

[0086] Models: Experimental models of Parkinson's disease (PD) are needed to gain insight into possible pathological mechanisms of the disease. In addition to this function, they are also essential in the development and testing of new therapeutic strategies, whether pharmacological or otherwise.

[0087] MPTP mouse model: Extensive biochemical data from anatomical studies of the human brain and from animal models suggest ongoing oxidative stress processes in the substantia nigra that trigger dopaminergic neurodegeneration. It is unclear whether oxidative stress is a primary or secondary event. However, oxidative stress induced by the neurotoxin MPTP (N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) has been used in animal models to study neurodegenerative processes for the purpose of developing Antioxidant neuroprotective drugs.

[0088] Table 4: Group assign...

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Abstract

A pharmaceutical composition for use in treatment of Parkinson's disease is provided comprising a pharmaceutically acceptable carrier and a fixed dose combination of pramipexole and rasagiline, wherein the fixed dose combination contains a subtherapeutic dose of pramipexole and a subtherapeutic dose of rasagiline, and the dose of pramipexole is lower than or equal to the dose of rasagiline.

Description

technical field [0001] The present invention relates to the field of neurodegenerative diseases, and in particular, to compositions and methods for the treatment of Parkinson's disease. Background technique [0002] Dopamine agonists are commonly used to treat Parkinson's disease; however, their use may be limited by adverse events of varying levels of severity. Initiation of dopamine agonists typically causes nausea, vomiting, and orthostatic hypotension. These side effects are more pronounced at higher doses, but can usually be alleviated using a slow and complex titration regimen. Pramipexole (and several other DA agonists) also cause impulse control disturbances, peripheral edema, psychosis, and sedation, which can be difficult to control and thus limit the utility of this drug. Rasagiline, another drug used to treat Parkinson's disease, is largely well tolerated but has some safety concerns, particularly related to the risks of Problems: cheese reaction (hypertensive...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K31/4045A61K45/06A61K9/22A61K9/48A61P25/16
CPCA61K31/135A61K9/2081A61K9/5078A61K31/428A61K9/5084A61K31/136A61P25/16A61P43/00A61K2300/00A61K2121/00A61K31/137A61K8/41A61K9/006A61K9/209A61K9/0053A61K9/1676A61K9/2077A61K9/20
Inventor 纽里特·利夫纳皮尼尼特·利特曼沙立·扎克斯
Owner 图必制药公司
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