1. A pharmaceutical composition in solid dosage form comprising, as active ingredient, MTC, said composition further comprising at least one diluent suitable for direct compression, characterised in that the MTC exists in a substantially pure and stable polymorphic form.
2. A composition as claimed in claim 1, wherein the MTC is in polymorph Form A.
3. A composition as claimed in claim 1 or claim 2, wherein the amount of MTC in the composition is more than about 10% ww, or more than 20%, or more than 30% ww.
4. A composition as claimed in claim 3, wherein the amount of MTC is less than about 75% ww, or less than 60% or less than 50% ww.
5. A composition as claimed in claim 4, wherein the amount of MTC in the composition is from about 10% ww (or 20% or 30%) to about 70% ww (or 60% or 50%).
6. A composition as claimed in any preceding claim, which comprises at least 15% ww, at least 20%, at least 30%, at least 40% or at least 50% ww of diluent(s).
7. A composition as claimed in any preceding claim, wherein the diluent(s) are selected from the group consisting of microcrystalline cellulose, lactose, mannitol, calcium salts such as calcium phosphate dibasic, calcium sulphate and calcium carbonate, and sugars such as lactose, sucrose, dextrose and maltodextrin.
8. A composition as claimed in any preceding claim, which further comprises a lubricant.
9. A composition as claimed in claim 8, wherein the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, stearic acid, glycerylbehaptate, polyethylene glycol, ethylene oxide polymers, sodium lauryl sulphate, magnesium lauryl stearate, mixtures of magnesium stearate with sodium lauryl sulphate, and hydrogenated vegetable oil.
10. A composition as claimed in claim 8, wherein the lubricant is magnesium stearate.
11. A composition as claimed in any one of claims 8 to 10, which comprises from about 0.5 to about 5.0% ww lubricant.
12. A composition as claimed in any preceding claim, which further comprises one or more disintegrants selected from the group consisting of crosslinked polyvinylpyrrolidone, sodium starch glycolate, crosslinked sodium carboxymethyl cellulose (sodium croscarmellose), and pregelatinized starch.
13. A composition as claimed in any preceding claim, which further comprises a binder selected from the group consisting of cellulose derivatives (carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethylcellulose, ethylcellulose, microcrystalline cellulose) and sugars such as lactose, sucrose, dextrose, glucose, maltodextrin, and mannitol, xylitol, polymethacrylates, polyvinylpyrrolidone, sorbitol, pregelatinized starch, alginic acids, and salts thereof such as sodium alginate, magnesium aluminum silicate, polyethylene glycol, and the like.
14. A composition as claimed in any preceding claim, which is a tablet.
15. A composition as claimed in any preceding claim, which is a capsule.
16. A composition as claimed in claim 14, to which a film coating has been applied.
17. A composition as claimed in claim 14, wherein the film coating comprises hydroxypropylmethylcellulose (HPMC) or polyvinyl alcohol-part hydrolysed (PVA).
18. A composition as claimed in claim 14, wherein the capsule is an HPMC or Gelatin capsule.
19. A free-flowing, cohesive powder, comprising MTC in a substantially pure polymorphic form, at least one diluent suitable for direct compression, and optionally one or more other excipients, said powder being capable of being directly compressed into a pharmaceutical composition according to any preceding claim.
20. A process for the manufacture of a pharmaceutical composition according to claim 1, which process comprises the dry compression process of an intimate powder mixture of MTC in a substantially pure polymorphic form with at least one diluent suitable for direct compression, and optionally one or more other excipients.
21. A process according to claim 20, which process comprises the direct compression of an intimate powder mixture of MTC in a substantially pure polymorphic form with at least one diluent suitable for direct compression, and optionally one or more other excipients.
22. A process as claimed in claim 20, which is a direct compression process in which MTC, diluent(s) and other optional excipients are blended together in solid, particulate form to create an intimate mixture, and then compressed using a tablet machine.
23. A process as claimed in claim 20, which is a dry granulation process in which MTC, diluent(s) and other optional excipients are formed into a compressed mass, milled and then compressed using a tablet machine.
24. A process as claimed in claim 20, which is a moist granulation process in which the diluent(s) are wet massed using a granulating fluid and the wet mass is then dried to form granules which are subsequently blended with MTC and compressed to form tablets.
25. A process as claimed in any one of claims 20 to 24, which further comprises the step of applying a film coating to the tablets.
26. A process as claimed in claim 25, wherein the step of applying a film coating is carried out in a coating pan and comprises pre-heating of the coating pan, prior to introduction of the tablets to be coated.
27. A process as claimed in claim 26, wherein the temperature of the tablets is maintained during coating at a temperature of 38-48\xb0 C., more preferably 42-44\xb0 C.
28. A method of treatment or prophylaxis of a disease condition in a patient, said method comprising administering to said patient a therapeutically-effective amount of a solid dosage form composition as claimed in any one of claims 1 to 18.
29. A method as claimed in claim 28 wherein the disease is a tauopathy.
30. A drug product for the treatment of a disease state associated with tau protein aggregation in a mammal suffering therefrom, comprising a container labeled or accompanied by a label indicating that the drug product is for the treatment of said disease, the container containing one or more dosage units each comprising a solid dosage form composition as claimed in any one of claims 1 to 18.
31. Use of system comprising a diluent and direct compression for enhancing the stability of a substantially pure MTC polymorph in a pharmaceutical composition.
32. Use as claimed in claim 31, wherein the pharmaceutical composition is the solid dosage form composition as claimed in any one of claims 1 to 14 or claim 16 or claim 17.
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 positioning a patient support apparatus powered by a line voltage at a desired speed, comprising:
receiving a control signal indicative of the line voltage supplied to the patient support apparatus; and
driving a motor configured to move the patient support apparatus at the desired speed using the control signal, wherein driving the motor further includes driving the motor at the desired speed for a first period corresponding to a first portion of a distance traveled by the support apparatus and at a second desired speed for a second period corresponding to a second portion of the distance traveled by the support apparatus.
2. The method of claim 1, wherein using the control signal further includes customizing the desired speed.
3. The method of claim 1, wherein receiving the control signal further includes determining a voltage indicative of the line voltage.
4. The method of claim 1, wherein receiving the control signal further includes receiving input from a voltage regulator device.
5. The method of claim 1, wherein receiving the control signal further includes determining a voltage delivered to the motor.
6. The method of claim 1, wherein receiving the control signal further includes receiving a measurement determined by at least one of a: a voltage sensor and a current sensor.
7. The method of claim 1, wherein driving the motor further includes comparing a determined voltage to a reference voltage.
8. The method of claim 1, wherein driving the motor further includes modifying a duty cycle of the motor according to the control signal.
9. The method of claim 1, wherein driving the motor further includes correlating the control signal to a power level associated with the desired speed.
10. The method of claim 1, wherein driving the motor further includes increasing a duty cycle if a determined voltage is less than a reference voltage.
11. The method of claim 1, wherein driving the motor further includes decreasing a duty cycle if a determined voltage is greater than a reference voltage.
12. The method of claim 1, wherein driving the motor further includes generating the control signal.
13. The method of claim 1, wherein receiving the control signal further includes receiving at least one of: directional data indicative of a desired direction of movement of the support surface, a speed measurement, a voltage level, a load and a patient weight.
14. A method of positioning a patient support apparatus at a desired speed, comprising:
receiving input indicating a desired speed at a controller of the patient support apparatus, wherein the patient support apparatus includes a moveable support surface, wherein receiving the input further includes receiving input particular to at least one of a direction, a first portion of a distance traveled by the movable support apparatus, and a second desired speed for a second period corresponding to a second portion of the distance traveled by the movable support apparatus;
processing the input to generate a control signal; and
moving the moveable support surface at the desired speed in response to receiving the control signal.
15. The method of claim 14, wherein receiving the input further includes receiving a reference voltage.
16. The method of claim 14, further comprising programmatically restricting a range in which the movable support surface moves.
17. The method of claim 14, wherein processing the input further includes correlating the input to a power level.
18. A patient support apparatus, comprising:
a moveable support surface;
an electric motor for driving the moveable support surface at a desired speed in response to a power signal comprising a power level;
a sensor having an output used to generate a control signal indicative of line voltage supplied to the patient support apparatus; and
a controller for processing the control signal and initiating generation of the power signal according to the control signal.
19. The apparatus of claim 18, wherein the control signal includes a voltage indicative of the line voltage.
20. The apparatus of claim 18, further comprising an input means for modifying the desired speed.
21. The apparatus of claim 18, wherein the controller is configured to compare a determined voltage derived from the control signal to a reference voltage.
22. The apparatus of claim 18, wherein the controller is configured to modify a duty cycle of the motor according to the control signal.
23. The apparatus of claim 18, wherein the controller is configured to correlate the control signal to a power level associated with the desired speed.
24. The apparatus of claim 18, wherein the controller is configured to increase a duty cycle if a voltage used to generate the control signal is less than a reference voltage.
25. The apparatus of claim 18, wherein the controller is configured to decrease a duty cycle if a voltage used to generate the control signal is greater than a reference voltage.
26. The apparatus of claim 18, further comprising an actuator for mechanically cooperating with the motor to move the moveable support surface.
27. The apparatus of claim 18, wherein the desired speed changes according to the relative position of the moveable support surface.
28. The apparatus of claim 18, wherein the sensor includes a resistor.
29. The apparatus of claim 18, wherein the sensor is configured to determine a current flowing through the electric motor.
30. The apparatus of claim 18, wherein the sensor is configured to determine a motor voltage applied to the electric motor.
31. A patient support apparatus, comprising:
a moveable support surface;
an electric motor for driving the moveable support surface at a desired speed in response to a power signal;
an input mechanism for receiving input indicating the desired speed, wherein receiving the input further includes receiving input particular to at least one of a direction, a first portion of a distance traveled by the movable support surface, and a second desired speed for a second period corresponding to a second portion of the distance traveled by the movable support surface; and
a controller for initiating generation of the power signal configured to cause the electric motor to drive the moveable support surface at the desired speed, wherein the power signal is generated according to the desired speed.