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US 12,653,786 B2Granted
Preparation of solid dosage forms comprising antibodies by solutions/suspension layering
AssigneeTillotts Pharma AG
InventorsFelipe Varum, Laetitia Von Rochow, Carmen Goetz, Roberto Bravo
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Abstract
The present invention relates to a method for preparing immediate and sustained release solid dosage forms, comprising antibodies and functional fragments thereof, by solution/suspension layering, optionally coated with a delayed release coating; the solid dosage forms prepared by the method; and the use of the solid dosage forms in the topical treatment in the gastrointestinal tract of a patient.
Claims24
A method for preparing a solid dosage form comprising i) an inert core unit;
- and ii) a drug coating, said drug coating comprising at least one antibody or functional fragment thereof as active agent, a buffer and at least one polymeric binder deposited on the inert core unit by drug layering;
- said method comprising the steps of:
- a) preparing an active agent coating liquid, comprising 1-50 mg/ml of the at least one antibody or functional fragment thereof, the buffer and the at least one polymeric binder, as an aqueous solution or suspension;
- b) layering the inert core unit with the active agent coating liquid of step (a) using spray coating;
- and
- c) drying the wet drug layered inert core unit, simultaneously with step b), or after step b) has been completed, to give rise to a dried solid dosage form.
3 more elements
Dependencies are inferred from the claim text.