What is claimed is:
1. A parenterally deliverable composition comprising an aqueous medium having dispersed therein, in solid particulate form, a steroidal drug in a therapeutically effective amount, wherein:
(a) the aqueous medium comprises one or more wetting andor suspending agents in an amount effective to provide controlled flocculation of the drug, at least one of the wetting andor suspending agents being susceptible to oxidative degradation; and
(b) the composition further comprises, as a component thereof or as an adjunct there to, means for protecting the oxidative degradation susceptible agent from oxidative degradation.
2. The composition of claim 1 wherein the at least one oxidative degradation susceptible agent comprises a polyoxyethylene chain.
3. The composition of claim 1 wherein the at least one oxidative degradation susceptible agent is a polyoxyethylene surfactant.
4. The composition of claim 3 wherein the polyoxyethylene surfactant is a polysorbate.
5. The composition of claim 3 wherein the polyoxyethylene surfactant is polysorbate 80.
6. The composition of claim 5 wherein the polysorbate 80 is present in an amount of about 0.1 to about 10 mgml.
7. The composition of claim 5 wherein the polysorbate 80 is present in an amount of about 1 to about 5 mgml.
8. The composition of claim 1 wherein the steroidal drug is selected from the group consisting of clostebol, estradiol, exemestane, medroxyprogesterone, methylprednisolone, testosterone and pharmaceutically acceptable esters and salts thereof.
9. The composition of claim 1 wherein the steroidal drug is selected from the group consisting of estradiol cypionate, exemestane and medroxyprogesterone acetate.
10. The composition of claim 1 wherein the steroidal drug is medroxyprogesterone acetate.
11. The composition of claim 10 wherein the medroxyprogesterone acetate is present in an amount of about 10 to about 400 mgml.
12. The composition of claim 10 wherein the medroxyprogesterone acetate is present in an amount of about 30 to about 300 mgml.
13. The composition of claim 10 wherein the medroxyprogesterone acetate is present in an amount of about 50 to about 200 mgml.
14. The composition of claim 1 wherein said means for protecting the oxidative degradation susceptible agent from oxidative degradation comprises an antioxidant present as a component of the composition.
15. The composition of claim 1 wherein said means for protecting the oxidative degradation susceptible agent from oxidative degradation comprises a chelating agent present as a component of the composition.
16. The composition of claim 1 wherein said means for protecting the oxidative degradation susceptible agent from oxidative degradation comprises an oxygen-depleted atmosphere in headspace overlying the composition.
17. The composition of claim 16 wherein said atmosphere comprises less than about 5% oxygen.
18. The composition of claim 17 wherein said atmosphere consists essentially of nitrogen.
19. A parenterally deliverable aqueous suspension composition comprising:
(a) medroxyprogesterone acetate, 100-200 mgml;
(b) polyethylene glycol of molecular weight 3000-4000, 20-40 mgml;
(c) polysorbate 80, 2-4 mgml;
(d) sodium chloride, 6-12 mgml; and
(e) optionally at least one parenterally acceptable preservative, 0.1-5 mgml total; said composition having an oxygen-depleted atmosphere in headspace overlying the composition.
20. The composition of claim 19 comprising:
(a) medroxyprogesterone acetate, about 150 mgml;
(b) polyethylene glycol of molecular weight about 3350, about 30 mgml;
(c) polysorbate 80, about 2.5 mgml;
(d) sodium chloride, about 9 mgml;
(e) methylparaben, about 1.5 mgml;
(f) propylparaben, about 0.15 mgml; and
(g) water for injection, q.s.
21. The composition of claim 19 comprising, in a volume of about 0.65 ml:
(a) medroxyprogesterone acetate, about 104 mg;
(b) polyethylene glycol of molecular weight about 3350, about 18.7 mg;
(c) polysorbate 80, about 1.95 mg;
(d) sodium chloride, about 5.2 mg;
(e) methylparaben, about 1.04 mg;
(f) propylparaben, about 0.10 mg;
(g) monobasic sodium phosphate monohydrate, about 0.45 mg;
(h) dibasic sodium phosphate dodecahydrate, about 0.38 mg;
(i) L-methionine, about 0.98 mg;
(j) polyvinylpyrrolidone K17, about 3.25 mg; and
(k) water for injection, q.s.
22. An article of manufacture comprising a sealed vessel having substantially oxygen-impermeable walls and a substantially oxygen-impermeable seal, and having contained therewithin:
(a) a parenterally deliverable aqueous suspension that comprises (i) a steroidal drug in a therapeutically effective amount and (ii) one or more wetting andor suspending agents in an amount effective to provide controlled flocculation of the drug, at least one of the wetting andor suspending agents being susceptible to oxidative degradation; and
(b) an oxygen-depleted atmosphere in headspace overlying the composition.
23. The article of claim 22 wherein the at least one oxidative degradation susceptible agent comprises a polyoxyethylene chain.
24. The article of claim 22 wherein the at least one oxidative degradation susceptible agent is a polyoxyethylene surfactant.
25. The article of claim 24 wherein the polyoxyethylene surfactant is a polysorbate.
26. The article of claim 24 wherein the polyoxyethylene surfactant is polysorbate 80.
27. The article of claim 26 wherein the polysorbate 80 is present in an amount of about 0.1 to about 10 mgml.
28. The article of claim 26 wherein the polysorbate 80 is present in an amount of about 1 to about 5 mgml.
29. The article of claim 22 wherein the steroidal drug is selected from the group consisting of clostebol, estradiol, exemestane, medroxyprogesterone, methylprednisolone, testosterone and pharmaceutically acceptable esters and salts thereof.
30. The article of claim 22 wherein the steroidal drug is selected from the group consisting of estradiol cypionate, exemestane and medroxyprogesterone acetate.
31. The article of claim 22 wherein the steroidal drug is medroxyprogesterone acetate.
32. The article of claim 31 wherein the medroxyprogesterone acetate is present in an amount of about 10 to about 400 mgml.
33. The article of claim 31 wherein the medroxyprogesterone acetate is present in an amount of about 30 to about 300 mgml.
34. The article of claim 31 wherein the medroxyprogesterone acetate is present in an amount of about 50 to about 200 mgml.
35. The article of claim 22 wherein said atmosphere comprises less than about 5% oxygen.
36. The article of claim 22 wherein said atmosphere consists essentially of nitrogen.
37. The article of claim 22 wherein the parenterally deliverable aqueous suspension comprises:
(a) medroxyprogesterone acetate, 100-200 mgml;
(b) polyethylene glycol of molecular weight 3000-4000, 20-40 mgml;
(c) polysorbate 80, 2-4 mgml;
(d) sodium chloride, 6-12 mgml; and
(e) optionally at least one parenterally acceptable preservative, 0.1-5 mgml total.
38. The article of claim 22 wherein the parenterally deliverable aqueous suspension comprises:
(a) medroxyprogesterone acetate, about 150 mgml;
(b) polyethylene glycol of molecular weight about 3350, about 30 mgml;
(c) polysorbate 80, about 2.5 mgml;
(d) sodium chloride, about 9 mgml;
(e) methylparaben, about 1.5 mgml;
(f) propylparaben, about 0.15 mgml; and
(f) water for injection, q.s.
39. The article of claim 22 wherein the parenterally deliverable aqueous suspension comprises, in a volume of about 0.65 ml:
(a) medroxyprogesterone acetate, about 104 mg;
(b) polyethylene glycol of molecular weight about 3350, about 18.7 mg;
(c) polysorbate 80, about 1.95 mg;
(d) sodium chloride, about 5.2 mg;
(e) methylparaben, about 1.04 mg;
(f) propylparaben, about 0.10 mg;
(g) monobasic sodium phosphate monohydrate, about 0.45 mg;
(h) dibasic sodium phosphate dodecahydrate, about 0.38 mg;
(i) L-methionine, about 0.98 mg;
(j) polyvinylpyrrolidone K17, about 3.25 mg; and
(k) water for injection, q.s.
40. An article of manufacture comprising a vial having
(a) a first chamber that is substantially filled with a parenterally deliverable aqueous suspension that comprises (i) a steroidal drug in a therapeutically effective amount and (ii) one or more wetting andor suspending agents in an amount effective to provide controlled flocculation of the drug, at least one of the wetting andor suspending agents being susceptible to oxidative degradation,
(b) a second chamber that is substantially empty but for a gaseous medium;
(c) a septum separating the first and second chambers and impermeable to contents thereof; and
(d) actuating means effective to bring the aqueous suspension and the gaseous medium in to contact by breach of the septum such that the gaseous medium acts as an effective headspace for agitation of the aqueous suspension.
41. The article of claim 40 wherein the at least one oxidative degradation susceptible agent comprises a polyoxyethylene chain.
42. The article of claim 40 wherein the at least one oxidative degradation susceptible agent is a polyoxyethylene surfactant.
43. The article of claim 42 wherein the polyoxyethylene surfactant is a polysorbate.
44. The article of claim 42 wherein the polyoxyethylene surfactant is polysorbate 80.
45. The article of claim 44 wherein the polysorbate 80 is present in an amount of about 0.1 to about 10 mgml.
46. The article of claim 44 wherein the polysorbate 80 is present in an amount of about 1 to about 5 mgml.
47. The article of claim 40 wherein the steroidal drug is selected from the group consisting of clostebol, estradiol, exemestane, medroxyprogesterone, methylprednisolone, testosterone and pharmaceutically acceptable esters and salts thereof.
48. The article of claim 40 wherein the steroidal drug is selected from the group consisting of estradiol cypionate, exemestane and medroxyprogesterone acetate.
49. The article of claim 40 wherein the steroidal drug is medroxyprogesterone acetate.
50. The article of claim 49 wherein the medroxyprogesterone acetate is present in an amount of about 10 to about 400 mgml.
51. The article of claim 49 wherein the medroxyprogesterone acetate is present in an amount of about 30 to about 300 mgml.
52. The article of claim 49 wherein the medroxyprogesterone acetate is present in an amount of about 50 to about 200 mgml.
53. The article of claim 40 wherein the parenterally deliverable aqueous suspension comprises:
(a) medroxyprogesterone acetate, 100-200 mgml;
(b) polyethylene glycol of molecular weight 3000-4000, 20-40 mgml;
(c) polysorbate 80, 2-4 mgml;
(d) sodium chloride, 6-12 mgml; and
(e) optionally at least one parenterally acceptable preservative, 0.1-5 mgml total.
54. The article of claim 40 wherein the parenterally deliverable aqueous suspension comprises:
(a) medroxyprogesterone acetate, about 150 mgml;
(b) polyethylene glycol of molecular weight about 3350, about 30 mgml;
(c) polysorbate 80, about 2.5 mgml;
(d) sodium chloride, about 9 mgml;
(e) methylparaben, about 1.5 mgml;
(f) propylparaben, about 0.15 mgml; and
(g) water for injection, q.s.
55. The article of claim 40 wherein the parenterally deliverable aqueous suspension comprises, in a volume of about 0.65 ml:
(a) medroxyprogesterone acetate, about 104 mg;
(b) polyethylene glycol of molecular weight about 3350, about 18.7 mg;
(c) polysorbate 80, about 1.95 mg;
(d) sodium chloride, about 5.2 mg;
(e) methylparaben, about 1.04 mg;
(f) propylparaben, about 0.10 mg;
(g) monobasic sodium phosphate monohydrate, about 0.45 mg;
(h) dibasic sodium phosphate dodecahydrate, about 0.38 mg;
(i) L-methionine, about 0.98 mg;
(j) polyvinylpyrrolidone K17, about 3.25 mg; and
(k) water for injection, q.s.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A method for allocating seat space, the method comprising:
identifying a seating space requirement in a passenger cabin to form an identified seating space requirement;
detecting positions of a plurality of armrests located between a first seat and a second seat and connected to at least one of the first seat and the second seat using a sensor; and
deploying, using a data processing system, a number of armrests in the plurality of armrests separating the first seat and the second seat based on the identified seating space requirement and the positions of the plurality of armrests.
2. The method of claim 1, wherein the identifying step comprises:
identifying the seating space requirement for a passenger assigned to the first seat in the passenger cabin to form the identified seating space requirement.
3. The method of claim 1, wherein the identifying step comprises:
identifying the seating space requirement based on a size of a passenger assigned to the first seat in the passenger cabin to form the identified seating space requirement.
4. The method of claim 1, wherein the identifying step comprises:
identifying the seating space requirement based on a class of service for a passenger assigned to the first seat in the passenger cabin to form the identified seating space requirement.
5. The method of claim 1, wherein the deploying step comprises:
unlocking the number of armrests separating the first seat and the second seat based on the identified seating space requirement.
6. The method of claim 1, wherein the deploying step comprises:
moving the number of armrests into an unfolded position.
7. The method of claim 1, wherein the deploying step comprises:
unlocking the number of armrests separating the first seat and the second seat based on the identified seating space requirement; and
moving the number of armrests into an unfolded position.
8. A method for allocating seat space, the method comprising:
identifying a seating space requirement for a passenger assigned to a first seat in a row in a passenger cabin based on one of a size of the passenger and a class of service to form an identified seating space requirement, the row having a plurality of seats including the first seat, the plurality of seats supported by a frame, and the row having a plurality of armrests between the first seat and a second seat in the plurality of seats and connected to at least one of the first seat and the second seat, in which the first seat is adjacent to the second seat; and
deploying, using a data processing system, a number of armrests in the plurality of armrests between the first seat and a second seat based on the identified seating space requirement by unlocking the number of armrests based on the identified seating space requirement and moving the number of armrests into an unfolded position to change a seating space for the first seat.