US 10,894,023 B2Granted

Oral pH independent dosage formulation for treating neurodegenerative disorders

AssigneeCenter Laboratories, Inc.

InventorsMeng-Ju Lee, Shu-Hsien Chang, Chih-Chiang Yang, Yuan-Chih Le, Tse-Ching Lin, Ko-Chiang Chen, Lai-Cheng Chin, Tai-Yin Ke, Pei-Ying Liao

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Abstract

Disclosed herein is an oral dosage formulation suitable for treating a neurodegenerative disorder. The oral dosage formulation contains both sustained-release and immediate-release drugs. The sustained-release drug in the oral dosage formulation is memantine, and the immediate-release drug in the oral dosage formulation is donepezil and/or memantine, and the formulation is characterized in having a pH-independent dissolution profile of memantine at a pH range from about 1.0 to about 7.0.

Claims3

Dependent claims

An oral dosage formulation comprising a sustained-release portion of memantine;

and an immediate-release portion of donepezil and/or memantine, in which the oral dosage formulation is characterized in having a pH-independent dissolution profile of memantine from about pH 1.0 to 7.2;
and the oral dosage formulation has ingredients as set forth below:
Weight
Percentage
Ingredients
(mg)
(%)
donepezil/memantine
Donepezil HCl
5
4.5
IR granules
Memantine HCl
8
7.3
Microcrystalline
85.9
78.1
cellulose
Pregelatinized Starch
10.0
9.1
Magnesium stearate
1.1
1
Subtotal
110
100
memantine SR
Memantine HCl
12
13.06
granules
Sugar sphere
60
65.29
Hydroxypropyl methyl
6
6.53
cellulose (HPMC)
Polyethylene glycol
1.2
1.31
Ethyl cellulose
12.7
13.82
Subtotal
91.9
100.

46 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/446,634Filed 20 Jun 2019 · us provisional application
Priority: 20 Jun 2018
Published: US 2019/0388340 A126 Dec 2019
Granted: 19 Jan 2021
Term ends: Not estimatedThe source records don’t support an estimate.

Classification13 codes

A61K 31/13
Medicinal preparations containing organic active ingredients: amines
A61K 9/0053
Galenical forms characterised by the site of application: mouth and digestive tract, i.e. intraoral and peroral administration
A61K 9/1652
Organic macromolecular compounds: polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
A61K 9/1676
With an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface: having a drug-free core…