Combination unit dose dispensing containers
Dosage forms containing pharmaceutical compositions for use in devices to produce a spray or mist delivery of the compositions include dosage blister compartments and a dispensing blister compartment, wherein crushing of the compartments delivers the compositions in a desired spray pattern. Certain dosage forms include a plurality of dosage chambers each containing a component or a portion of a pharmaceutical composition, the contents of which are mixed or combined just prior to or during administration.
1. A dosage form for delivery of a pharmaceutical composition, the dosage form comprising:
a first dosage blister chamber containing a first component of the pharmaceutical composition;
a second dosage blister chamber containing a second component of the pharmaceutical composition; and
a dispensing blister chamber comprising:
a piercable membrane and
a piercing device comprising:
a substantially hollow, elongate member with a base end and a piercing tip opposite the base end and providing a discharge nozzle;
one or more inlet openings on or near the base end and an internal conduit providing fluid communication between the one or more inlet ports and the discharge nozzle; and
structural features on the surface of the internal conduit to control the spray pattern and droplet size of a fluid forced through the piercing device during use;
wherein the dosage form further comprises:
a first delamination seal, wherein the first delamination seal prevents mixing of the contents of the first dosage blister chamber with the contents of the second dosage blister chamber;
a second delamination seal, wherein the second delamination seal prevents mixing of the contents of the first dosage blister chamber and the second dosage blister chamber with the dispensing chamber; and
a permanent seal, wherein the permanent seal surrounds the outer perimeter of the first dosage blister chamber, the second dosage blister chamber and the dispensing blister chamber;
wherein the first and second delamination seals have less adhesion than the permanent seal, such that the first and second delamination seals delaminate under significantly less pressure than the permanent seal.
2. The dosage form of claim 1 , wherein the structural features include contours, steps, flutes, ribs, constrictions, or a combination thereof.
3. The dosage form of claim 1 , wherein the one or more inlet openings provide a fluid path from the interior of the dispensing blister chamber into the internal conduit that comprises one or more bends in the fluid path.
4. The dosage form of claim 3 , wherein at least one of the one or more bends is a right angle bend.
5. The dosage form of claim 1 , wherein the one or more inlet ports and structural features produce a vortex in fluids forced through the piercing device during use.
6. The dosage form of claim 1 , wherein the components of the pharmaceutical composition are each in powder or liquid form, with the proviso that at least one component is in liquid form.
7. The dosage form of claim 1 , wherein at least one of the components of the pharmaceutical composition is an active agent in dry powder form.
8. The dosage form of claim 1 , wherein at least one component of the pharmaceutical composition is a lyophilized active agent.
9. The dosage form of claim 1 , wherein the pharmaceutical composition is pharmaceutically acceptable for administration to a human.
10. The dosage form of claim 1 , wherein the pharmaceutical composition is pharmaceutically acceptable for administration to a non-human animal.
11. A dosage strip comprising a plurality of dosage forms according to claim 1 arranged to be dispensed sequentially by a dispensing device.
12. The dosage form of claim 1 , wherein the dispensing blister conforms to at least the base end of the piercing device effective to support and hold the piercing device in place during manufacture and use of the dosage form.
13. The dosage form of claim 1 , wherein the piercable membrane of the dispensing chamber is weakened by scoring, effective to inhibit production of loose pieces of the membrane during use, and to promote a seal of the pierced membrane to outer walls of the piercing tip.
14. The dosage form of claim 1 , wherein the delamination seal separating at least one of the dosage blister chambers from the dispensing blister chamber includes structural features to promote mixing of the contents of the dosage blister chambers.
15. The dosage form of claim 14 , wherein the structural features comprise one or more curves, a serpentine shape, constrictions, or a combination thereof.
16. The dosage form of claim 1 , further comprising one or more additional dosage blister chambers, each containing a further component of the pharmaceutical composition, and each separated from all other dosage blister chambers by delamination seals.
17. The dosage form of claim 1 , configured for use in a dispensing device with one or more plungers that perform the steps of:
compressing at least one of the dosage blister chambers, effective to delaminate a delamination seal between the dosage blister chambers and to allow the contents of the dosage blister chambers to mix;
compressing the dispensing chamber effective to drive the piercing tip through the piercable membrane; and
further compressing the dosage blister chambers effective to delaminate the delamination seal separating the dosage blister chambers from the dispensing blister chamber and to expel the mixed pharmaceutical composition through the piercing device and out the discharge nozzle.
18. A dosage form for delivery of a pharmaceutical composition, the dosage form comprising:
a first dosage blister chamber containing a first component of the pharmaceutical composition;
a second dosage blister chamber containing a second component of the pharmaceutical composition; and
a dispensing blister chamber comprising:
a piercable membrane and
a piercing device comprising:
a substantially hollow, elongate member with a base end and a piercing tip opposite the base end and providing a discharge nozzle;
one or more inlet openings on or near the base end and an internal conduit providing fluid communication between the one or more inlet ports and the discharge nozzle, where the fluid path from the interior of the dispensing blister chamber into the internal conduit comprises one or more bends; and
structural features on the surface of the internal conduit to control the spray pattern and droplet size of a fluid forced through the piercing device during use;
wherein the dosage form further comprises:
a first delamination seal, wherein the first delamination seal prevents mixing of the contents of the first dosage blister chamber with the contents of the second dosage blister chamber;
a second delamination seal, wherein the second delamination seal prevents mixing of the contents of the first dosage blister chamber and the second dosage blister chamber with the dispensing chamber; and
a permanent seal, wherein the permanent seal surrounds the outer perimeter of the first dosage blister chamber, the second dosage blister chamber and the dispensing blister chamber;
wherein the first and second delamination seals have less adhesion than the permanent seal, such that the first and second delamination seals delaminate under significantly less pressure than the permanent seal.
19. The dosage form of claim 18 , wherein at least one of the one or more bends is a right angle bend.
20. The dosage form of claim 18 , wherein the structural features include contours, steps, flutes, ribs, constrictions, or a combination thereof.
21. The dosage form of claim 18 , wherein the one or more inlet ports and structural features produce a vortex in fluids forced through the piercing device during use.
22. The dosage form of claim 18 , wherein at least one of the components of the pharmaceutical composition is an active agent pharmaceutically in dry powder form, acceptable for administration to a human or non-human animal.
23. The dosage form of claim 18 , wherein at least one component of the pharmaceutical composition is a lyophilized active agent.
24. A dosage strip comprising a plurality of dosage forms according to claim 18 arranged to be dispensed sequentially by a dispensing device.
25. The dosage form of claim 18 , wherein the delamination seal separating at least one of the dosage blister chambers from the dispensing blister chamber includes structural features comprising one or more curves, a serpentine shape, constrictions, or a combination thereof to promote mixing of the contents of the dosage blister chambers.
26. The dosage form of claim 1 , further comprising one or more additional dosage blister chambers, each containing a further component of the pharmaceutical composition, and each separated from all other dosage blister chambers by delamination seals.