Process for preparing solid dosage forms of very low-dose drugs
AssigneeSmithKline Beecham Corporation
InventorsJames Albert Napper, Karen Triona O'Brien, Sultan James Manek, Rajinder Kumar, Julia Mary Loudon, Michael Sydney George Clark, Neil Mortimer
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Abstract
A drug formulation process which comprises admixing carrier particles with a solution of drug in water in a quantity of 1-3% by weight of solution to total mix and a method of treatment and/or prophylaxis of dementia, which method comprises administering to the patient [R-(Z)]-α-(methoxyimino)-α-(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride at a daily dose below 0.01 mg/kg and pharmaceutical compositions used therein.
Claims31
A drug formulation process which comprises admixing carrier particles with a solution of drug in water in a quantity of 1-3% by weight of solution to total mix.
A process according to any preceding claim which further comprises blending the mixture with further carrier and/or one or more additives selected from a disintegrant;
- an acidic or a alkaline excipient to improve chemical stability of the drug in the formulation, a lubricant and a glidant.
A process according to any preceding claim wherein the mire is formulated into a unit dose presentation.
A process according to any preceding claim for formulating [R-(Z)]-α-(methoxyimino)-α -(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride.
A pharmaceutical composition comprising a drug, obtainable by the process of any preceding claim.
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and [R-(Z)]-α-(methoxyimo)-α-(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride at a level of up to 0.1% by weight of drug to carrier, 0% volatile organic solvent and 0% binder.
A method of treatment and/or prophylaxis of dementia, which method comprises administering to the patient [R-(Z)]-α-(methoxyimino)-α-(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride at a daily dose below 0.01 mg/kg.
The use of [R-(Z)]-α-(methoxyimino)-α-(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride in the manufacture of a medicament for the treatment and/or prophylaxis of dementia at a daily dose below 0.01 mg/kg.
A pharmaceutical composition for the treatment and/or prophylaxis of dementia which comprises [R-(Z)]-α-(methoxyimino)-α-(1-azabicyclo [2.2.2]oct-3-yl)acetonitrile monohydrochloride at a unit dose suitable for administration at a daily dose below 0.01 mg/kg, and a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.