1460749978-75389126-5d41-40ba-b4ba-6988b529f16d

1. A back support for a seat the back support comprising a first support element adapted to be mounted on a seat back, and a second support element adapted to be mounted to the back of a user, the arrangement being such that, in use, the first support element supports the second support element so that the back of the user is in traction, wherein the first support element is movably mounted on the seat back, the back support further comprising a winch mechanism to which the first support element is attached, the winch mechanism being operative to move the first support element relative to the seat back to increase or decrease the traction applied to the back of the user, whilst the user is sat on the seat.
2. A back support according to claim 1 wherein the first and second support elements are integral.
3. A back support according to claim 1 wherein the first and second support elements are separate elements and are each provided with securing means to secure the support elements together.
4. A back support according to claim 3 wherein the means to secure the elements together comprises a hook-and-loop pad on each support element.
5. A back support according to claim 3 wherein the means to secure the elements together comprises a region on one support element formed with a plurality of horizontal grooves, and a region on the other support element formed with a plurality of horizontal lugs, the lugs in use, being received within the grooves on the other pad.
6. A back support according to claim 1 wherein the first support element comprises an oblong of material which extends, in use, across the lower part of the back of the seat.
7. A back support according to claim 1 wherein the first support element is convex so as to extend outwardly when mounted on the seat back to provide lumbar support to a user of the back support.
8. A back support according claim 1 wherein a rear face of the first support element is backed with a low friction material which, when in use, is in contact with the seat back.
9. A back support according to claim 1 wherein the first support element is mounted on the seat back using straps which extend at least partially around the seat back and which are attached to the winch mechanism.
10. A back support according to claim 9 wherein a fastening mechanism is provided by which the length of the vertically extending straps can be adjusted.
11. A back support according to claim 10 wherein the fastening mechanism comprises a hook-and-loop fastener pad on each end of each strap.
12. A back support according to claim 10 wherein the fastening mechanism comprises a buckle at one end of the strap, the other end of the strap passing through and being releasably clamped by the buckle.
13. A back support according claim 1 wherein the winch mechanism is electrically operated.
14. A back support according to claim 1 wherein the winch mechanism is manually operated.
15. A back support according claim 1 wherein the first support element is provided with at least one heating element.
16. A back support according to claim 15 wherein the first support element is adapted to be connected to a power source to power the winch mechanism andor the heating element.
17. A back support according to claim 16 wherein the power source comprises the cigarette lighter socket of a vehicle.
18. A back support according to claim 1 wherein runners are provided for mounting at the top of the seat back, the straps, in use, resting on the runners.
19. A back support according to claim 1 wherein the second support element comprises a waist strap adapted to be secured around the waist of a user.
20. A back support according to claim 19 wherein the second support element further comprises a planar portion extending from the waist strap.

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 device for programmable delivery of a predetermined dose of a fluid, the device comprising:
(a) a replaceable cartridge located in a first housing, wherein the replaceable cartridge comprises:
a reservoir comprising at least one expandable element made of resilient material, said reservoir having at least two spatially separated sections connected so that hydraulic resistance between said two sections is not less than non-zero R1 defined as a first time-independent ratio having a numerator being a first fluid pressure difference between said two sections and the denominator being the flow rate caused by said first fluid pressure difference; and
a flow passage connecting an internal volume of said reservoir with an input and at least one exit opening so that under conditions of fluid flow, hydraulic resistance to flow of said flow passage is not less than predetermined non-zero R2 defined as a second time-independent ratio having a numerator being a second fluid pressure difference between the input and exit of said flow passage and the denominator being the flow rate caused by said second fluid pressure difference;

(b) an actuating module located in a second housing, said module comprising:
a driving force system capable of both creating a propelling force and transferring said propelling force to the fluid in the reservoir of said replaceable cartridge when both first and second housings are connected to each other; and
at least part of a sensor system, wherein said part of the sensor system is capable of producing an output associated with at least one geometric parameter of said expandable element;

(c) a connector to provide a temporary connection of said replaceable cartridge and said actuating module; and
(d) a programmable processor with fluid delivery instructions stored therein, said processor capable of acquiring said output of the sensor system and capable of producing an other output, said other output controlling the driving force system; whereas
when both housings are connected to each other, the driving force system is capable of applying a force changing over time to the fluid in the reservoir.
2. The device of claim 1, wherein at least part of said processor is located in a third housing comprising:
a display; and
a system providing a exchange of data between said actuating module and said third housing.
3. The device of claim 1, wherein the driving force system comprises at least one a mediatory element which, when said first and second housings are connected, said mediatory element operably transmits said force changing over time to a force receiving element of said reservoir in said replaceable cartridge.
4. The device of claim 3, wherein both said mediatory element and said force receiving element are at least partially made of a ferromagnetic material.
5. The device of claim 3, wherein both said mediatory element and said force receiving element each comprises a permanent magnet.
6. The device of claim 5, wherein said magnets have an orientation such that the mediatory element applies said driving force remotely to said force receiving element.
7. The device of claim 1, wherein said driving force system comprises a latch capable of switching between two stable states;
whereas in a first stable state the driving force applied to a force receiving element is a continuous compressive force applied to the fluid in said reservoir to urge said fluid out of said reservoir; and
whereas in a second stable state the driving force is a decompressive force applied to said fluid in the reservoir.
8. The device of claim 7, wherein said latch comprises:
a permanently stressed spring to create said continuous compressive force;
at least one permanent magnet;
at least one electromagnet; and
a mechanism capable of switching a distance between two said magnets so that one stable state occurs at greater distance between said magnets, and
whereas said second stable state occurs at shorter distance between said magnets.
9. The device of claim 7, wherein the actuating module further comprises a manual switch between said two stable states of said latch; and wherein said processor is programmed to initiate at least one signal to a patient.
10. The device of claim 9, wherein said signal is at least one of visual, mechanical, and auditory.
11. The device of claim 1, wherein said reservoir further comprises an additional section connected to said other two sections of said reservoir by a hydraulic element providing a resistance R0 so that R0 exceeds R1 when a compressive force is applied to a fluid in said reservoir, and more preferably R0 exceeds R1 at least one order of magnitude, and most preferably more than two orders of magnitude.
12. The device of claim 11, wherein said hydraulic element is a pressure-dependent static hydraulic resistor capable of switching its resistance R0 so that R0 does not exceed R1 when a decompressive force is applied to the fluid.
13. The device of claim 1, wherein said reservoir comprises an additional element made of resilient material, said element separating a movable piston from the internal volume of said reservoir, wherein said movable piston is adapted to transmit said driving force to said fluid.
14. The device of claim 13, wherein said additional element is capable of expanding into a cavity made in said movable piston when fluid in said reservoir is subjected to an internal pressure exceeding external pressure.
15. The device of claim 14, wherein said additional element is adapted to eliminate direct correspondence between displacement of said movable piston and a dose of the fluid delivered to said exit opening.
16. The device of claim 1, wherein a ratio of R1R2 is greater than 0.05 and less than 200.
17. The device of claim 1, wherein said flow passage connecting said internal volume of said reservoir with at least one exit opening further comprises a pressure-dependent valve capable of switching to an open state under conditions of fluid flow so that hydraulic resistance of said open valve is less than R2 at least by one order of magnitude when a pressure drop applied to said valve is equal or exceeds a predetermined value Popen (\u201cPop\u201d), and wherein said pressure dependent valve is capable of switching into a closed state when said pressure drop is below a predetermined value Pclosed (\u201cPcl\u201d), which is either equal or less than said Pop, whereas the hydraulic resistance of said closed valve exceeds R2 by at least one order of magnitude, and most desirable it exceeds R2 by more than two orders of magnitude.
18. The device of claim 1, wherein at least one element of said sensor system comprises a piezoelectric sensor, and when said first and said second housings are connected, the device further comprises a direct or an indirect mechanical connection of said piezoelectric sensor with an external surface of said reservoir.
19. The device of claim 1, wherein when said first and said second housings are connected together, the sensor system comprises at least one such electrically conducting area which is capable of forming a non-contact capacitor sensor so that said electrically conducting area is located in proximity to at least one other electrically conducting area which is attached to said reservoir and capable of relocating in response to deformation of said expandable element.
20. The device of claim 1, wherein said sensor system comprises a magnetic detector adapted to form a non-contact magnetic sensor when said first and said second housings are connected, so that said magnetic detector is located in proximity to either a magnetic substance or a magnetized substance attached to said reservoir and capable of relocating in response to deformation of said expandable element.
21. The device of claim 1, wherein at least one element of said sensor system is housed in said actuating module, said one element of said sensor system comprising a non-contact optical sensor comprising:
a light emitter directed onto said replaceable cartridge when said first and said second housings are connected together, and
at least one detector adapted to receive light emitted by said light emitter, either reflected by said replaceable cartridge or transmitted through said reservoir.
22. The device of claim 1, where the replaceable cartridge comprises:
at least a portion of a connector to at least temporarily operably connect said cartridge with a housing containing an actuator; wherein said connector provides that relative locations of said reservoir and said housing containing said actuator to permit transfer a force from said actuator to internal surface of a second section of said two sections of said reservoir.
23. The device of claim 22, wherein under flow conditions, the ratio R1R2 exceeds 0.05 and is less than 200, more desirably said ratio is in between 0.25 and 40, and most desirably said ratio is in between 1 and 10.
24. The device of claim 22,
wherein when said actuator and said replaceable cartridge are connected to each other, said driving force system is capable of applying a force changing over time to a fluid in the reservoir.
25. The device of claim 24, wherein said sensor system comprises at least one such electrically conducting area which is capable of forming a non-contact capacitor sensor when said actuator and a replaceable cartridge comprising a reservoir having an expandable element made of resilient material are connected, so that said electrically conducting area is located in proximity to at least one other electrically conducting area which is attached to said reservoir and capable of relocating in response to deformation of said expandable element.
26. The device of claim 24, wherein said sensor system comprises a magnetic detector adapted to form a non-contact magnetic sensor when said actuator and a replaceable cartridge comprising a reservoir having an expandable element made of resilient material are connected, so that said magnetic detector is located in proximity to either a magnetic substance or a magnetized substance attached to said reservoir and capable of relocating in response to deformation of said expandable element.
27. The device of claim 24, wherein at least one element of said sensor system is housed in said actuating module, said one element of said sensor system comprising a non-contact optical sensor comprising:
a light emitter directed onto said replaceable cartridge when said actuator and said replaceable cartridge are connected together, and
at least one detector, wherein said detector is adapted to receive light emitted by said light emitter, either reflected by said replaceable cartridge or transmitted through said reservoir.
28. A method for a delivering of a dose of a fluid, comprising the steps:
(a) providing a device of claim 1;
(b) introducing said fluid into said reservoir;
(c) initiating a non-zero force urging said fluid out of the reservoir;
(d) acquiring at least one output from said sensor system associated with at least one geometric parameter of said resilient element;
(e) calculating a time to stop (\u201ctend\u201d) providing said force urging said fluid out of the reservoir comprising treating said acquired output by a processor executing commands based upon instructions stored in said processor; and
(f) terminating said force at tend.
29. The method of claim 28, further comprising the steps:
(i) before step (c) subjecting said fluid in the reservoir to a sufficiently low pressure to prevent said fluid from flowing out of said exit opening, said pressure in the reservoir close to an external pressure Pext;
(ii) the step (c) further comprising producing at least one starting electric output at a predetermined moment tst, said starting output resulting in producing:
said force urging said fluid out of said reservoir; and
subjecting said expandable element to a pressure Pind(t) within the range defined by the expression:
Pmax+Pext>Pind(t)>Pmin+Pext, wherein Pmax and Pmin are correspondingly a maximum and a minimum pressure increase caused in the reservoir by the driving force system which obey condition 25>PmaxPmin>1;

(iii) treating said output of said sensor, comprising determining a pressure difference Pind(t)\u2212Pext, and further comprising determining a period Tc satisfying the condition Tc=tend\u2212tst, wherein Tc is of such duration of said force urging said fluid out of said reservoir to provide an equality of said predetermined dose and an actual dose delivered, said actual dose being an integral found by integrating over time from time tst of a ratio having a numerator being said pressure difference, and a denominator being a parameter expressing hydraulic resistance Rexit of said flow passage connecting the reservoir with said exit opening;
(iv) the step (f) comprises producing at least one ending electric output at tend=Tc+tst, wherein said ending output results in either decreasing the force or changing a direction of the force or both so that the pressure of the fluid in said first section can relax in time up to about its initial value before step (c).
30. The method of claim 29, wherein under flow conditions, hydraulic communication between said two spatially separated sections of the reservoir has a resistance R1\u22670.05R2;
wherein step (d) comprises acquiring at least two outputs from said sensor system;
wherein said step (e) further comprises:
determining an actual hydraulic resistance Rexit of said flow passage connecting the reservoir with said exit opening;
setting said denominator equal to said actual Rexit;
producing an alarm signal if said actual Rexit exceeds a predetermined level; or
substituting said actual Rexit into an analytic expression of said integral if said actual Rexit does not exceed said predetermined level.
31. The method of claim 28, wherein said flow passage connecting the reservoir with said exit opening is further supplied with an element switching hydraulic resistance at a predetermined pressure drop Pop;
wherein step (d) comprises acquiring at least five outputs and desirably more than five outputs from said sensor system;
said treating of step (e) further comprising:
calibrating said device delivering the fluid;
checking current performance of components of said device;
determining the amount of the fluid remaining in the reservoir; and
producing one or more of a report and an alarm signal to inform a user if said amount of remaining fluid is below a predetermined amount or a malfunction is detected that cannot be self-compensated by said steps determining of the time tend.
32. The method of claim 28, wherein step (c) further comprises creating a first emergency signal if after said starting electric output said force urging the fluid out of said reservoir is not produced, said first emergency signal resulting in the at least one of:
(i) prompting a patient to initiate a manual application of said force to said reservoir;
(ii) determining an actual starting time tst, when an appearance of manually created non-zero force urging the fluid out of said reservoir is detected by said sensor system;
(iii) said ending electric output of step (e) results in creating such second emergency signal at the moment tend which recommends the patient to terminate manually said application of said force, whereas both said first and second emergency signals are visual, mechanical or acoustic signals.
33. The method of claim 29, wherein said predetermined R2 is substituted into said denominator in order to fulfill the role of said parameter expressing said Rexit, and said integral is proportional to a sum of all said outputs of said sensor system acquired since the time tst.
34. The method of claim 28, further comprising:
transmitting at least one output of at least one bio-medical device analyzing a physiological feature of a patient to a control system, and
correcting the predetermined dose delivered by said device according to said transmitted output of said bio-medical device.
35. A method for a delivery of a predetermined dose of a fluid, comprising the steps:
(a) providing a device of claim 1;
(b) switching said module into a stable state which results in producing of a continuous compressive force applied to the fluid in said reservoir;
(c) acquiring at least one output from a sensor system associated with at least one geometric parameter of said resilient element;
(d) calculating a time tend, comprising treating said acquired output by a processor capable of executing commands stored in said processor; and
(e) switching said module into said other stable state at tend.

1460749970-4463aeae-cd7d-4097-b629-a53bbe153ee8

1. A sheet feeding apparatus, comprising:
a sheet stacking portion which rises and lowers while sheets are stacked on the sheet stacking portion;
a feed roller which is attached to a feed shaft and rotates from a feed initial position in association with rotation in one direction of the feed shaft to send out each of the sheets stacked on the sheet stacking portion;
an urging member which urges the sheet stacking portion to press the stacked sheets toward the feed roller;
a cam member which rotates in association with the rotation of the feed shaft to raise and lower the sheet stacking portion;
a predetermined idle zone provided between the feed roller and the feed shaft, for preventing the feed roller from being associated with the rotation of the feed shaft; and
a return mechanism which returns the feed roller to the feed initial position after the feed roller finishes feeding of each of the sheets on the sheet stacking portion,
wherein at a start of sheet feeding operation, the cam member starts to rotate in association with the rotation of the feed shaft and the feed roller starts to rotate from a time when the feed shaft has passed the predetermined idle zone, so as to send out each of the sheets on the sheet stacking portion, and thereafter the feed roller is returned to the feed initial position by the return mechanism.
2. A sheet feeding apparatus according to claim 1, wherein the feed roller is supported on the feed shaft through a feed roller holder, and
wherein the predetermined idle zone is formed by a recessed portion and a protruding portion, the recessed portion being provided on one of the feed roller holder and the feed shaft, and the protruding portion being provided on the other of the feed roller holder and the feed shaft.
3. A sheet feeding apparatus according to claim 1, wherein the return mechanism comprises:
a feed rotatable member which is supported on the feed shaft coaxially with the feed roller and is associated with the feed roller within a predetermined torque in the one direction; and
a conveyance roller which conveys each of the sheets sent out from the sheet stacking portion to a downstream side, and
wherein the feed roller comprises a roller formed over a range of a predetermined angle centered on the feed shaft, and after the feed roller starts to rotate from the feed initial position and causes a rotation-downstream-side end portion of the feed roller to abut the sheets on the sheet stacking portion to send out each of the sheets with a rotation-upstream-side end portion of the feed roller, the feed roller is returned to the feed initial position by the feed rotatable member which is rotated in association with each of the sheets conveyed to the downstream side by the conveyance roller.
4. A sheet feeding apparatus according to claim 1, further comprising an engagement portion which temporarily engages the feed roller and the feed shaft with each other,
wherein the engagement portion inhibits the feed roller from rotating from the feed initial position.
5. A sheet feeding apparatus according to claim 4, further comprising:
a feed roller holder which supports the feed roller on the feed shaft; and
a feed rotatable member which is supported on the feed shaft coaxially with the feed roller and is associated with the feed roller within a predetermined torque in the one direction,
wherein the engagement portion comprises engagement teeth on the feed roller holder and engagement teeth on the feed rotatable member, and the engagement portion engages the engagement teeth on the feed roller holder and the engagement teeth on the feed rotatable member with each other to couple the feed roller holder and the feed rotatable member to each other, to thereby inhibit the feed roller from rotating from the feed initial position.
6. A sheet feeding apparatus according to claim 4, further comprising a feed roller holder which supports the feed roller on the feed shaft,
wherein the engagement portion comprises:
a lever member which is attached to the feed roller holder and is movable depending on presence and absence of the feed roller; and
a lever urging member which urges the lever member toward the feed roller, and
wherein in a case where the feed roller is detached, the engagement portion engages an engagement protruding portion of the lever member with the feed shaft to couple the feed roller holder and the feed shaft to each other, to thereby inhibit the feed roller from rotating from the feed initial position.
7. An image forming apparatus, comprising:
a sheet feeding apparatus which feeds a sheet;
an image forming portion which forms an image on the sheet fed by the sheet feeding apparatus;
a sheet stacking portion which rises and lowers while sheets are stacked on the sheet stacking portion;
a feed roller which is attached to a feed shaft and rotates from a feed initial position in association with rotation in one direction of the feed shaft to send out each of the sheets stacked on the sheet stacking portion;
an urging member which urges the sheet stacking portion to press the stacked sheets toward the feed roller;
a cam member which rotates in association with the rotation of the feed shaft to raise and lower the sheet stacking portion;
a predetermined idle zone provided between the feed roller and the feed shaft, for preventing the feed roller from being associated with the rotation of the feed shaft; and
a return mechanism which returns the feed roller to the feed initial position after the feed roller finishes feeding of each of the sheets on the sheet stacking portion,
wherein at a start of sheet feeding operation, the cam member starts to rotate in association with the rotation of the feed shaft and feed roller starts to rotate from a time when the feed shaft has passed the predetermined idle zone, so as to send out each of the sheets on the sheet stacking portion, and thereafter the feed roller is returned to the feed initial position by the return mechanism.
8. An image forming apparatus according to claim 7, wherein the feed roller is supported on the feed shaft through a feed roller holder, and
wherein the predetermined idle zone is formed by a recessed portion and a protruding portion, the recessed portion being provided on one of the feed roller holder and the feed shaft, the protruding portion being provided on the other of the feed roller holder and the feed shaft.
9. An image forming apparatus according to claim 7, wherein the return mechanism comprises:
a feed rotatable member which is supported on the feed shaft coaxially with the feed roller and is associated with the feed roller within a predetermined torque in the one direction; and
a conveyance roller which conveys each of the sheets sent out from the sheet stacking portion to a downstream side, and
wherein the feed roller comprises a roller formed over a range of a predetermined angle centered on the feed shaft, and after the feed roller starts to rotate from the feed initial position and causes a rotation-downstream-side end portion of the feed roller to abut the sheets on the sheet stacking portion to send out each of the sheets with a rotation-upstream-side end portion of the feed roller, the feed roller is returned to the feed initial position by the feed rotatable member which is rotated in association with each of the sheets conveyed to the downstream side by the conveyance roller.
10. An image forming apparatus according to claim 7, further comprising an engagement portion which temporarily engages the feed roller and the feed shaft with each other,
wherein the engagement portion inhibits the feed roller from rotating from the feed initial position.
11. An image forming apparatus according to claim 10, further comprising:
a feed roller holder which supports the feed roller on the feed shaft; and
a feed rotatable member which is supported on the feed shaft coaxially with the feed roller and is associated with the feed roller within a predetermined torque in the one direction,
wherein the engagement portion comprises engagement teeth on the feed roller holder and engagement teeth on the feed rotatable member, and the engagement portion engages the engagement teeth on the feed roller holder and the engagement teeth on the feed rotatable member with each other to couple the feed roller holder and the feed rotatable member to each other, to thereby inhibit the feed roller from rotating from the feed initial position.
12. An image forming apparatus according to claim 10, further comprising a feed roller holder which supports the feed roller on the feed shaft,
wherein the engagement portion comprises:
a lever member which is attached to the feed roller holder and is movable depending on presence and absence of the feed roller; and
a lever urging member which urges the lever member toward the feed roller, and

wherein in a case where the feed roller is detached, the engagement portion engages an engagement protruding portion of the lever member with the feed shaft to couple the feed roller holder and the feed shaft to each other, to thereby inhibit the feed roller from rotating from the feed initial position.

The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.

1-23. (cancelled).
24. A process for the manufacture of 2-(2-(4-(bis(4-fluorophenyl)methyl)-1-piperazinylethoxylaceticacids, amides and related derivatives of the general formula (I)
17
wherein:
Y represents hydroxy, or NR1R2; R1 and R2 each independently represent hydrogen or C1-4 alkyl;
m is 1 or 2, and n is 1 or 2, as well as non-toxic, pharmaceutically acceptable salts, and mixtures thereof which comprises
a) reacting compound of formula (II)
18
wherein L1 represents a leaving group with a compound of formula (III)
19
wherein n and m are defined as above, in the presence of a base and an inert solvent, and
b) reacting the corresponding compound of formula (IV) thus obtained
20
with a compound of formula (V)
21
wherein L2 represents a leaving group and Y is defined as above, In the presence of an inert solvent and a proton acceptor.
25. The process according to claim 24 wherein n is 2.
26. The process according to claim 24 wherein m is 1.
27. The process according to claim 24 wherein L1 and L2 represent, independently, halogen or a sulfonic ester group.
28. The process according to claim 24 wherein L1 represents chlorine.
29. The process according to claim 24 wherein L2 represents bromine.
30. The process according to claim 24 wherein the base in step (a) is selected from the group consisting of alkali metal carbonates, hydroxides and organic tertiary amines.
31. The process according to claim 30 wherein said base is sodium carbonate or potassium carbonate.
32. The process according to claim 24 wherein the proton acceptor in step (b) is selected from the group consisting of alkali metal hydrides, alkali metal hydroxides, alkali metal alkoxides and alkali metals.
33. The process according to claim 32 wherein said proton acceptor is sodium hydride or sodium methoxide.
34. The process according to claim 24 wherein the inert solvent is selected from the group consisting of aliphatic and aromatic hydrocarbons, ethers, amides and alcohols of low reactivity.
35. The process according to claim 34 wherein the inert solvent is hexane, toluene, methyl ethyl ketone (MEK), dimethoxyethane (DME), tetrahydrofuran (THF), dimethylformamide (DMF) or tert-butanol.
36. A process for the manufacture of a compound of formula (IV)
22
wherein m is 1 or 2, and n is 1 or 2, as well as non-toxic, pharmaceutically acceptable salts, and mixtures thereof, which comprises reacting a compound of formula (II)
23
wherein L1 represents a leaving group, with a compound of formula (III)
24
wherein n and m are defined as above, in the presence of a base and an inert solvent.
37. A process for the manufacture of 2-(2-4-(bis(4-fluorophenyl)methyl)-1-piperazinylethoxy)acetic acids, amides and related derivatives of the general formula (I)
25
wherein Y represents hydroxy or NR1R2; R1 and R2 each independently represent hydrogen or C1-4 alkyl; m is 1 or 2, and n is 1 or 2, as well as non-toxic, pharmaceutically acceptable salts and mixtures thereof, which comprises reacting a compound of formula (IV)
26
wherein m and n are defined as above, with a compound of formula (V)
27
wherein L2 represents a leaving group and Y is defined as above, in the presence of an inert solvent and a proton acceptor.
38. A process according to claim 24 or 37, wherein the compound obtained is a polymorphic form of the compound of formula (I) wherein n is 2, m is 1 and Y represents OH.
39. A process comprising following steps
a) precipitating of the compound obtained by the process according to claim 24 or claim 37, in its dihydrochloride form,
b) washing the obtained precipitate with a suitable organic solvent,
c) re-dissolving the washed precipitate in an aqueous medium,
d) adjusting the pH of the aqueous medium to about 7 with a suitable base or buffer,
e) extracting the re-dissolved product with a suitable organic solvent,
f) washing the obtained organic layer,
g) drying said obtained organic layer, followed by acidification with HCl, and
h) finally precipitating and drying the obtained dihydrochloride salt, and wherein the compound obtained is a polymorphic form of the compound of formula (I) wherein n is 2, m is 1 and Y represents OH.
40. Process according to claim 39, wherein the suitable organic solvent in steps b) and e) is methyl ethyl ketone.
41. A compound obtained by any of the processes according to claim 24 or 37.
42. A polymorphic form of efletirizine, obtainable by the processes according to claim 24 or 37.
43. A polymorphic form according to claim 42 wherein its crystallographic X-ray diffraction pattern presents peaks at 2 values (0.5)) of: 7.000; 8.095; 12.000; 13.645; 14.085; 14.315; 14.870; 16.460; 17.295; 18.255; 18.755; 19.470; 20.575; 20.890; 21.660; 22.210; 22.890; 23.390; 24.210; 24.580; 25.130; 26.775; 27.855; 28.815; 29.820; 30.255; 31.460; 32.145; 32.890; 33.830; 34.695; 35.940; 38.135; 39.670; 43.065; 44.335; 46.210; 48.720.
44. A polymorphic form of efletirizine characterized in that its crystallographic X-ray diffraction pattern presents peaks at 2 values (0.5)) of: 7.000; 8.095; 12.000; 13.645; 14.085; 14.315; 14.870; 16.460; 17.295; 18.255; 18.755; 19.470; 20.575; 20.890; 21.660; 22.210; 22.890; 23.390; 24.210; 24.580; 25.130; 26.775; 27.855; 28.815; 29.820; 30.255; 31.460; 32.145; 32.890; 33.830; 34.695; 35.940; 38.135; 39.670; 43.065; 44.335; 46.210; 48.720.
45. A pharmaceutical composition comprising said polymorphic form of efletrizine according to claim 42 in association with a pharmaceutically acceptable adjuvant, diluent or carrier.
46. A compound of formula (IV)
28
wherein m is 1 or 2, and n is 1 or 2, as well as non-toxic, pharmaceutically acceptable salts, and mixtures thereof.