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Publication Number
US-10441556-B2
Publication Date
2019-10-15
Expiration Date
Abstract
NSC antagonists are disclosed as useful in the treatment of dementia, in delaying the onset of dementia, and in the prevention of dementia. Dementia so treated may be, for example, Alzheimer's Disease (AD). NSC antagonists for treating dementia such as AD may be administered alone, a) in combination with other drugs used for treating dementia, b) in combination with drugs that stabilize or increase blood plasma glucose levels, or with both a) and b). Pharmaceutical compositions, dosage forms, and methods for using the same are disclosed, which include NSC antagonists, NSC antagonists combined with dementia drugs, NSC antagonists combined with glucose-level stabilizing or enhancing drugs, or combinations of these. Dosage forms may be designed to provide stable plasma levels for extended periods of time. Exemplary pharmaceutical compositions include compositions including glibenclamide and memantine; glibenclamide and donepezil; tolbutamide and memantine; tolbutamide and donepezil; and these compositions further including glucagon and/or glucose.
Core Innovation
The disclosed invention relates to the use of NSC antagonists for treating, delaying onset, or preventing dementia, particularly Alzheimer’s disease (AD). NSC antagonists include sulfonylurea receptor SUR1 antagonists and blockers of SUR1-associated non-selective channels NC(Ca-ATP) and TRPM4/TRPM5, with representative agents including glibenclamide and tolbutamide.
The disclosure also addresses blood glucose management while using NSC antagonists by providing combinations with AD drugs such as memantine and donepezil and/or blood glucose level stabilizers or enhancers such as glucose or glucagon. The purpose of including glucose or glucagon is to avoid hypoglycemia while maintaining effective dosing of NSC antagonists.
In addition, the disclosure includes pharmaceutical compositions for administration via multiple dosage forms and routes, including intravenous administration and transdermal administration. The disclosure further includes kit concepts that contain an NSC antagonist together with an AD drug and a glucose-elevating agent, and example patient scenarios for prophylaxis, treatment, and concurrent diabetes management.
Claims Coverage
The provided material includes one independent claim. The independent claim focuses on an intravenous composition, and dependent claims further refine additional formulation and glucose-increasing requirements.
Intravenous glibenclamide, mannitol, and carrier composition
A composition suitable for intravenous administration comprising glibenclamide or a pharmaceutically acceptable salt thereof, mannitol, and a pharmaceutically acceptable carrier.
The claim coverage centers on an intravenous pharmaceutical composition containing glibenclamide, or a pharmaceutically acceptable salt thereof, mannitol, and a pharmaceutically acceptable carrier, with dependent limitations that add optional additional constituents and require an additional compound effective at increasing blood plasma glucose levels, specified as glucose or glucagon.
Stated Advantages
Treating, delaying onset, or preventing dementia, particularly Alzheimer’s disease (AD).
Avoiding hypoglycemia while using NSC antagonists through inclusion of glucose or glucagon with AD drug combinations.
Documented Applications
Prophylaxis for dementia, particularly Alzheimer’s disease (AD), using NSC antagonists.
Treatment of dementia, particularly Alzheimer’s disease (AD), using NSC antagonists.
Concurrent diabetes management during prophylaxis or treatment, including glucose level stabilizers or enhancers such as glucose or glucagon.
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