Delivery of oral drugs

A device for delivery of a drug comprising a housing and an actuator, said device capable of containing multiple doses of multiparticulates comprising drug particles, said device upon actuation capable of delivering a unit dose of said multiparticulates wherein said drug particles have a mean diameter of greater than 10 μm to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

A method for delivery of a drug comprising delivering multiparticulates comprising drug particles via the use of a multiple unit dosing device comprising a housing and an actuator, said device upon actuation delivering a unit dose of said multiparticulates, and thereafter re-using said device to deliver additional unit doses of said drug at appropriate dosing intervals, said drug particles having a mean particle size of greater than 10 μm to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

A mouthpiece of a drug delivery device for administering a drug in multiparticulate form into the oral cavity of a patient, said mouthpiece having an outlet for delivering said multiparticulates and an inlet for receiving said multiparticulates, the improvement being that the mouthpiece protrudes downward from the drug delivery device at an angle greater than about 15 degrees measured from a horizontal baseline when the drug device is in an upright position, in order to direct the multiparticulates onto the tongue of said patient.

A method of administering a drug to a human patient for gastrointestinal deposition comprising

• formulating said drug in multiparticulate form;
• containing said multiparticulates in a drug delivery device capable of administering multiple unit doses of said multiparticulates into the oral cavity;
• administering a unit dose of the multiparticulates to the oral cavity wherein greater than about 80% of the unit dose is deposited in the gastrointestinal tract.

A device for delivering multiple unit doses of a drug in multiparticulate form comprising

• a housing for containing multiple unit doses of multiparticulates comprising drug particles, said housing having an opening for delivering a unit dose of said multiparticulates;
• a metering component operable between a first position in which it receives a unit dose from said housing and a second position in which it delivers said unit dose to said opening in said housing;
• said unit dose being delivered from said metering component to the exterior of the device through said opening of said housing with an air flow of less than about 20 liters/min.

A method of preparing a drug delivery system for delivering multiple doses of a drug for gastrointestinal deposition comprising

• preparing multiparticulates comprising drug particles in a manner wherein said drug particles, when placed in the oral cavity and swallowed are deposited to the gastrointestinal tract and not deposited in any substantial amount to the lungs;
• and
• placing multiple unit doses of said multiparticulates in a device which meters a single unit dose for delivery.

A drug formulation for gastrointestinal deposition comprising

• a non-compressed free flowing plurality of particles comprising a drug and a pharmaceutically acceptable excipient, said drug particles having a mean diameter of greater than 10 μm to about 1 mm, said particles comprising at least about 80% drug.

A method of preparing a drug formulation for gastrointestinal deposition comprising preparing a non-compressed free flowing plurality of particles comprising a drug and a pharmaceutically acceptable excipient, said particles having a mean diameter of greater than 10 μm to about 1 mm, said particles comprising at least about 80% drug.