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US 9,849,097 B2Granted
Dosage forms containing terbutaline sulphate
AssigneeJagotec AG
InventorsAlain Nhamias, Nasser Beniou
Life of this patent
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Abstract
A modified release oral dosage form comprising an internal phase containing terbutaline sulphate and a pharmaceutically acceptable excipient, dispersed in an external phase comprising pharmaceutically acceptable excipients.
Claims27
An oral dosage form containing terbutaline sulphate, said dosage form comprising
- an internal phase of particles of terbutaline sulphate coated with or surrounded by particles of a single pharmaceutically acceptable excipient selected from a diluent,
- said particles being dispersed in an external phase comprising particles of one or more additional pharmaceutically acceptable excipients, and wherein the internal phase comprises less than 25% by weight of terbutaline sulphate.
A method for stabilizing an oral dosage form comprising terbutaline sulphate and pharmaceutically acceptable excipients, said method comprising the steps of:
- i) admixing 1 to 5 mg of terbutaline sulphate with a single pharmaceutically acceptable excipient selected from a diluent to form a first internal phase of particles of terbutaline sulphate and the excipient,
- ii) optionally mixing the particles of step 1 with an optional second internal phase comprising one or more additional pharmaceutically acceptable excipients but no terbutaline sulphate,
- iii) mixing the particles of the first internal phase and the optional second internal phase with an external phase comprising one or more pharmaceutically acceptable excipients but no terbutaline sulphate, and
- iv) forming the mixture resulting from step iii) into an oral dosage form.
1 more element
Dependencies are inferred from the claim text.