Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Composition and method for treating neurological disease

a neurological disease and composition technology, applied in the direction of drug compositions, osmotic delivery, nervous disorders, etc., can solve the problems of motor and psychiatric side effects, troublesome and disabling, and the majority of patients develop other health problems, so as to increase the number of awake on hours without dyskinesia, and increase the number of awake on hours

Inactive Publication Date: 2019-08-15
ADAMAS PHARMA INC
View PDF2 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a method that can improve the symptoms of patients with levodopa-induced dyskinesia (LID) by reducing the level of dysfunction and increasing the amount of time awake without dyskinesia. This method can result in more effective treatment and improved quality of life for patients with LID.

Problems solved by technology

In addition to the motor symptoms, most patients develop other health problems related to PD.
These symptoms are diverse but are collectively known as non-motor symptoms and can likewise be troublesome and disabling.
However, it is associated with motor and psychiatric side-effects.
Levodopa has been previously tested for use in the treatment of drug-induced extrapyramidal syndrome but with a disappointing therapeutic response.
Administration of the IR form raised issues with patient compliance, because of the number of dosages required per day, and the negative side effects from use of the IR dosage form throughout the day.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Composition and method for treating neurological disease
  • Composition and method for treating neurological disease
  • Composition and method for treating neurological disease

Examples

Experimental program
Comparison scheme
Effect test

example 1

Amantadine Tablet Formulation

[0270]Amantadine HCl Extended Release (ER) Tablets, 160, 240 and 320 mg (each tablet contains 129 mg, 193 mg, or 258 mg amantadine fee base equivalent, respectively) were manufactured as described herein. The tablets contain an extended release core and an immediate release layer.

[0271]Amantadine release from the extended release core is controlled by an osmotic pump system. The osmotic pump system consists of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules but not to the drug with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are ...

example 2

Biopharmaceutic Studies and Associated Analytical Methods

2.1 Background and Overview.

[0274]Three clinical studies were conducted to compare relative bioavailability of Amantadine HCl ER Tablets, 160 mg, 240 mg and 320 mg, and an immediate release amantadine oral syrup formulation, Amantadine ER Tablets were manufactured as described in Example 1. Amantadine HCl syrup, 50 mg / 5 mL (amantadine HCl oral solution, USP), ANDA 075060, was the approved immediate-release product (Reference Listed Drug, RLD) and used as reference product in the comparative bioavailability studies.

[0275]The three bioavailability studies were carried out in healthy volunteers:[0276]1. Study 1 compared the steady-state bioavailability of amantadine from one Amantadine HCl ER 320 mg Tablet administered orally once daily to 160 mg amantadine HCl syrup, 50 mg / 5 mL administered orally twice daily for 7 days;[0277]2. Study II compared the single-dose bioavailability and pharmacokinetics of Amantadine MCI ER Tablets, ...

example 3

In Vitro Dissolution

[0309]Amantadine HCl ER Tablets were analyzed in various media to confirm the extended release of amantadine HCl from Amantadine HCl ER Tablets. Three Amantadine HCl ER Tablets were manufactured as described in Example 1 and the dissolution profile data are presented in FIGS. 5-7. The dissolution profiles of extended release cores for each of the three strengths (160 mg, 240 mg, and 320 mg) have also been characterized in the following four dissolution media: 1) water (drug product test method) 2) 0.1 N HCl, 3) pH 4.5 acetate buffer and 4) pH 6.8 phosphate buffer.

[0310]All 3 strengths (160 mg, 240 mg, and 320 mg of amantadine HCl) are soluble in 250 mL water, and sink conditions (concentration is less than 20% of solubility of amantadine HCl).

3.1 Dissolution in Water

[0311]The dissolution test method for Amantadine MCI ER Tablets is summarized in Table 5.

[0312]In vitro dissolution data revealed slow release of amantadine HCl from Amantadine HCl ER Tablets, 160 mg,...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
volumeaaaaaaaaaa
volumeaaaaaaaaaa
heightaaaaaaaaaa
Login to View More

Abstract

The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and / or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

Description

FIELD OF THE INVENTION[0001]This invention relates to compositions and methods for treating neurological disorders, such as Parkinson's disease, drug-induced extrapyramidal reactions, and levodopa-induced dyskinesia.BACKGROUND OF THE INVENTION[0002]A neurological disorder is any disorder of the nervous system, which can be categorized according to the primary location affected, the primary type of dysfunction involved, or the primary type of cause. The broadest division is between central nervous system disorders and peripheral nervous system disorders. Movement disorder is one of the sub-categories that involves the disorder of the central and / or peripheral nervous system such as Parkinson's disease, secondary Parkinsonism, essential tremor, amyotrophic lateral sclerosis. Tourette's Syndrome, multiple sclerosis, extrapyramidal movement disorders, and various types of Peripheral Neuropathy.[0003]Among the various neurological disorders, Parkinson's Disease (PD) is a progressive, chr...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/13A61K9/00A61P25/16A61K9/20A61K45/06
CPCA61K31/13A61K9/0004A61P25/16A61K9/20A61K45/06A61K9/2886
Inventor MEYER, GLENN A.FAOUR, JOAQUINAPASTINI, ANA CRISTINABEFUMO, MARCELO FERNANDO
Owner ADAMAS PHARMA INC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com