Atropine sulfate rapidly-disintegrating sublingual tablets, methods for manufacture thereof, and methods for use thereof for treatment of acute organophosphate toxicity
AssigneeNova Southeastern University
InventorsMutasem Rawas-Qalaji, Alhussain H. Aodah
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Abstract
The invention provides atropine sulfate (AS) rapidly-disintegrating sublingual tablets (RDSTs) in a sublingual dosage form and methods for therapeutic use of the AS RDSTs for treatment of organophosphate (OP) exposure and acute toxicity. The AS RDSTs provide an alternative easy-to-use dosage form for the management of organophosphate toxicity. Additionally, the invention provides methods for formulation and quality evaluation of the atropine sulfate rapidly-disintegrating sublingual tablets.
Claims29
A pharmaceutical composition comprising atropine sulfate and at least one pharmaceutically-acceptable excipient, the composition formulated for rapid disintegration in buccal or sublingual administration.
A method for manufacturing atropine sulfate tablets formulated for rapid disintegration in buccal or sublingual administration, the method comprising:
- weighing atropine sulfate and pharmaceutically-acceptable excipients;
- sieving the atropine sulfate and pharmaceutically-acceptable excipients;
- combining and mixing the atropine sulfate and pharmaceutically-acceptable excipients to form a directly compressible formulation;
- and
- directly compressing the formulation to form the atropine sulfate tablets.
A method for treating symptoms of exposure to organophosphates (OPs) in a subject in need thereof, comprising:
- providing a composition including atropine sulfate and at least one pharmaceutically-acceptable excipient, the composition formulated for rapid disintegration in buccal or sublingual administration;
- and
- administering the composition to the subject.
A composition comprising atropine sulfate (AS) and at least one pharmaceutically-acceptable excipient for use in the manufacture of a composition for treating symptoms of exposure to organophosphates (OPs).
A composition comprising atropine sulfate (AS), a filler, a superdisintegrant, and a lubricant for use in the manufacture of a composition for treating symptoms of exposure to organophosphates (OPs).
A composition comprising atropine sulfate (AS), at least one pharmaceutically-acceptable excipient, and a cholinesterase re-activator for use in the manufacture of a composition for treating symptoms of exposure to organophosphates (OPs).
Dependencies are inferred from the claim text.