1-7. (canceled)
8. A method of treating orthopoxvirus infections andor eczema vaccinatum comprising administering to a subject in need thereof a liquid pharmaceutical formulation comprising a therapeutically effective amount of ST-246 and cyclodextrin, and further comprising one or more pharmaceutically acceptable ingredients.
9. The method of claim 8, wherein said liquid formulation is administered by parenteral administration.
10. The method of claim 8, wherein said liquid formulation is administered by oral administration.
11. The method of claim 8, wherein said liquid formulation is administered by topical administration.
12. The method of claim 8, wherein said liquid formulation is administered by intravenous administration.
13. The method of claim 12, wherein about 50 to about 500 mg of ST-246 is infused per single session of intravenous administration.
14. The method of claim 12, wherein about 200 to about 400 mg of ST-246 is infused per single session of intravenous administration.
15. The method of claim 12, wherein about 300 mg of ST-246 is infused per single session of intravenous administration.
16. The method of claim 12, wherein said treatment is carried out for a period ranging from about 7 to about 30 days.
17. The method of claim 12, wherein said treatment is carried out for a period ranging from about 7 to about 15 days.
18. The method of claim 12, wherein the duration of each session of intravenous administration is from about 2 to about 24 hours.
19. The method of claim 12, wherein said treatment is carried out continuously over the course of treatment at a dosage of about 50 to about 500 mg of ST-246 per day.
20. The method of claim 12, wherein said intravenous administration is carried out during two sessions per day.
21. The method of claim 20, wherein the duration of each session is from about 2 to about 12 hours.
22. A process of making liquid formulation according to claim 1 comprising the steps of:
a) mixing ST-246 with cyclodextrin in a pharmaceutically acceptable liquid carrier; and
b) optionally filtering the mixture of step a).
23. The process of claim 22, wherein said ST-246 is selected from a group consisting of ST-246 polymorph Form I, ST-246 polymorph Form II, ST-246 polymorph Form III, ST-246 polymorph Form IV, ST-246 polymorph Form V and ST-246 polymorph Form VI.
24. The process of claim 22, wherein said cyclodextrin is hydroxypropyl-P-cyclodextrin.
25. The process of claim 22, wherein said hydroxypropyl-13-cyclodextrin is present in amounts from about 20% to about 40% by weight.
26. The process of claim 22, wherein said liquid formulation is adjusted to a pH between about 3 and 10.
27. The process of claim 24, wherein said hydroxypropyl-P-cyclodextrin has a degree of substitution between about 4.0 to about 8.0.
28. The process of claim 22, wherein the mixture of step (a) is brought to solubility equilibrium at a temperature of about 25\xb0 C.
29. The process of claim 22, wherein the mixture of step (a) is brought to solubility equilibrium at a temperature of about 37\xb0 C.
30. The process of claim 22, wherein said ST-246 is mixed with pharmaceutically acceptable carrier for about 72 hours.
31. A unit dosage liquid formulation comprising:
a) ST-246 content ranging from about 2 mgml to about 20 mgml; and
b) hydroxypropyl-(3-cyclodextrin content ranging from about 12.5 mgml to about 40 mgml.
32. The unit dosage liquid formulation of claim 31 further comprising one or more pharmaceutically acceptable ingredients selected from the group consisting of: mannitol, trehalose dehydrate, lactose monohydrate, and purified water.
33. The unit dosage liquid formulation of claim 31 having a pH range from about 3.0 to about 10.0.
34. The unit dosage liquid formulation of claim 31 having a total volume of about 100 ml.
35. A unit dosage liquid formulation comprising:
a) ST-246 ranging from about 2 mgml to about 20 mgml; and
b) hydroxypropyl-P-cyclodextrin content ranging from about 12.5 mgml to about 40 mgml.
36. The unit dosage liquid formulation of claim 35 further comprising one or more pharmaceutically acceptable ingredients selected from the group consisting of: polyethylene glycol 400, polysorbate 80, polyethylene glycol 300, and purified water
37. The unit dosage liquid formulation of claim 35 having a total volume of about 100 ml.
38. The unit dosage liquid formulation of claim 35 having a pH range from about 3.0 to about 10.0.
39. A process for preparing a water-soluble solid ST-246 pharmaceutical formulation comprising:
a) mixing ST-246 with cyclodextrin in a pharmaceutically acceptable liquid carrier;
b) optionally filtering the mixture of step a); and
c) lyophilizing said mixture.
40. The process of claim 8, wherein said cyclodextrin is hydroxypropyl-13-cyclodextrin.
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 of setting a hollow device into a flow pipe provided with a flow of fluids flowing in it, said method comprising the following steps:
inserting at least one stop means into a position where said hollow device is to operate;
first inserting said hollow device ahead of a driving means into an end of said flow pipe located upstream of a point where said hollow device should operate;
allowing said driving means to be urged by said flow flowing in said flow pipe, thereby displacing said hollow device along said flow pipe;
allowing said at least one stop means to halt the displacement of said hollow device, thereby setting said hollow device into its operating position; and
allowing said driving means to pass through a passage into said hollow device, urged by a pressure exerted by said flow flowing in said flow pipe.
2. A method according to claim 1, wherein:
said at least one stop means comprises:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device will operate, with an internal passage of said spool being substantially in registration with said orifice;
a bonnet of a gate valve connected to a second flange of said flanged spool, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being also provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said actuating means is able to be driven in such a way that said stem provokes a movement of said gate radially inwardly of said flow pipe, causing an insertion of said gate into said flow pipe, to a desired length.
3. A method according to claim 2, wherein:
said driving means is a flexible pig.
4. A method according to claim 3, wherein:
said flexible pig is a foam pig.
5. A method according to claim 4, wherein:
said flow pipe is an undersea flow pipe.
6. A method according to claim 5, wherein:
said hollow device is provided with an external sealing system to prevent fluid from passing between a fortuitous space formed between an external wall of said hollow device and an internal wall of said flow pipe.
7. A method according to claim 1, wherein:
said at least one stop means comprises:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device will operate, with an internal passage of said spool being substantially in registration with said orifice;
a first flange of a first gate valve connected to a second flange of said flanged spool;
a bonnet of a second gate valve connected to a second flange of said first gate valve, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said first gate valve can be opened and said actuating means is able to be driven in such a way that said stem provokes movement of said gate of said second gate valve radially inwardly of said flow pipe, causing an insertion of said gate into said flow pipe, to a desired length.
8. A method according to claim 7, wherein said orifice is drilled after welding of said flanged spool on an exterior of said flow pipe, by means of a drilling means passing through said flanged spool.
9. A method according to claim 8, wherein:
said driving means is a flexible pig.
10. A method according to claim 9, wherein:
said flexible pig is a foam pig.
11. A method according to claim 10, wherein:
said flow pipe is an undersea flow pipe.
12. A method according to claim 11, wherein:
said hollow device is provided with an external sealing system to prevent fluid from passing between a fortuitous space formed between an external wall of said hollow device and an internal wall of said flow pipe.
13. A method of retrieving a hollow device located in a flow pipe provided with a flow of fluids flowing into it by at least one stop means provided in said flow pipe, said method comprising the following steps:
removing said at least one stop means from an interior of said flow pipe;
inserting a driving means into a first end of said flow pipe located upstream of a point where said hollow device operates;
allowing said driving means to be urged by said flow flowing in said flow pipe; and
allowing said driving means to contact said hollow device, thereby displacing it towards a second end of said flow pipe where said driving means and said hollow device can both be retrieved.
14. A method according claim 13, wherein:
said at least one stop means comprises:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device operates, with an internal passage of said spool being substantially in registration with said orifice;
a bonnet of a gate valve connected to a second flange of said flanged spool, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being also provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said actuating means is able to be driven in such a way that said stem provokes a movement of said gate radially outwardly of said flow pipe, thereby causing a removal of said gate from an interior of said flow pipe.
15. A method according to claim 14, wherein:
said driving means is a flexible pig.
16. A method according to claim 15, wherein:
said flexible pig is a foam pig.
17. A method according to claim 16, wherein:
said flow pipe is an undersea flow pipe.
18. A method according to claim 17, wherein:
said hollow device is provided with an external sealing system to prevent fluid from passing between a fortuitous space formed between an external wall of said hollow device and an internal wall of said flow pipe.
19. A method according claim 13, wherein:
said at least one stop means comprises:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device operates, with an internal passage of said spool being substantially in registration with said orifice;
a first flange of a first gate valve connected to a second flange of said flanged spool;
a bonnet of a second gate valve connected to a second flange of said first gate valve, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said actuating means is able to be driven in such a way that said stem provokes movement of said gate of said second gate valve radially outwardly of said flow pipe, thereby causing a removal of said gate from an interior of said flow pipe.
20. A method according claim 19, wherein:
said first gate valve is closed after said gate of said second gate valve is removed from said interior of said flow pipe.
21. A method according to claim 20, wherein:
said flow pipe is an undersea flow pipe.
22. A method according to claim 21, wherein:
said hollow device is provided with an external sealing system to prevent fluid from passing between a fortuitous space formed between an external wall of said hollow device and an internal wall of said flow pipe.
23. A stop means for halting a displacement of a hollow device in a flow pipe, said stop means comprising:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device will operate, with an internal passage of said spool being substantially in registration with said orifice;
a bonnet of a gate valve connected to a second flange of said flanged spool, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being also provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said actuating means is able to be driven in a first sense to turn said stem, provoking a movement of said gate in a direction from said second end towards said first end of said flanged spool, and in a second sense, contrary to said first sense, for provoking a return movement of said gate.
24. A stop means according to claim 23, wherein:
said flow pipe is an undersea flow pipe.
25. A stop means for halting a displacement of a hollow device in a flow pipe, said stop means comprising:
a flanged spool provided with a first flange, said first flange being welded over an orifice drilled in an outer wall of said flow pipe, at a point where said hollow device will operate, with an internal passage of said spool being substantially in registration with said orifice;
a first gate valve provided with a first flange, said first flange of said first gate valve being connected to a second flange of said flanged spool;
a second gate valve provided with a bonnet, said bonnet being connected to a second flange of said first gate valve, said bonnet being provided with a stem and being also provided with a gate, said gate being connected to a first end of said stem, said bonnet being provided with a packing set to seal said stem; and
an actuating means connected to a second end of said stem, for driving said stem;
whereby said actuating means is able to be driven in a first sense, to displace said stem and to provoke a movement of said gate of said second gate valve in a direction from said second flange of said flanged spool towards said first flange thereof, and is able to be driven in a second sense, contrary to said first sense, provoking a return movement of said gate.
26. A stop means according to claim 25, wherein:
said flow pipe is an undersea flow pipe.