Author: claimsbot

What is claimed is:

1. A dosage form for delivering an antiepileptic drug to a gastrointestinal tract, comprising:
a compartment containing a drug formulation layer, the drug formulation layer comprising an antiepileptic drug;
a semipermeable wall surrounding the compartment, the semipermeable wall having a passageway that allows communication between the compartment and an exterior of the dosage form;
an internal lamina formed on an inner surface of the semipermeable wall, the internal lamina being substantially soluble in water;
wherein the internal lamina in a hydrated state forms a gelatinous layer that lubricates the semipermeable wall, thereby substantially preventing crack formation in the semipermeable wall while the dosage form is dispensing the drug.
2. The dosage form of claim 1, wherein the internal lamina comprises one or more water-soluble polymers.
3. The dosage form of claim 2, wherein the one or more water-soluble polymers are present in the internal lamina in an amount of at least 80% by weight.
4. The dosage form of claim 2, wherein the water-soluble polymers are selected from the group consisting of hydroxy alkylcellulose, hydroxypropyl alkylcellulose, carboxy alkylcellulose, and polyalkylene oxide.
5. The dosage form of claim 1, wherein the semipermeable material is selected from the group consisting of cellulose acylate, cellulose diacylate, and cellulose triacylate, and blends thereof.
6. The dosage form of claim 1, further comprising an expandable layer disposed in the compartment, the expandable layer assisting in delivery of the antiepileptic drug through the passageway.
7. The dosage form of claim 6, wherein the internal lamina forms a permeable interface between the semipermeable wall and the antiepileptic drug formulation layer.
8. The dosage form of claim 7, wherein the internal lamina forms a permeable interface between the semipermeable wall and the expandable layer.
9. The dosage form of claim 1, further comprising an external lamina formed on an external surface of the semipermeable wall.
10. The dosage form of claim 8, wherein the external lamina comprises an antiepileptic drug and is configured to immediately deliver the antiepileptic drug in the gastrointestinal tract.
11. A process for maintaining the integrity and performance of a dosage form having a semipermeable wall enclosing an antiepileptic drug formulation, comprising:
laminating an inner surface of the semipermeable wall with a lamina that is substantially soluble in water;
wherein the lamina when hydrated forms a gelatinous layer that lubricates the semipermeable wall, thereby substantially preventing crack formation in the semipermeable wall as the dosage form dispenses the drug.

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 receiver for a tire status monitoring apparatus that monitors statuses of a plurality of tires provided on a vehicle and includes a plurality of transmitters, provided on the tires respectively, for transmitting data indicating statuses of the respective tires, the data including an identification code to identify each tire, the receiver being supplied with an activation signal to activate a drive source of the vehicle, the receiver comprising:
a reception unit which receives the data from the transmitters; and
a control circuit connected to the reception unit, wherein upon detection of the activation signal, the control circuit collates the identification code included in the data and specifies, based on the identification code, each transmitter which has transmitted the data, wherein the control circuit has an identification code registered beforehand, determines whether or not the identification code included in the data matches with the registered identification code, and determines whether or not those identification codes included in the data received by a first predetermined number of times match with one another a second predetermined number of times less than the first predetermined number of times or more when it is determined that those two identification codes do not match with each other, and determines that that tire which is associated with the identification code included in the data has been changed when it is decided that there have been such matches.
2. The receiver according to claim 1, wherein the reception unit transmits a request signal to each individual transmitter and receives the data in response to the request signal from each transmitter.
3. The receiver according to claim 1, wherein when it is determined that a tire has been changed, the control circuit updates the registered identification code with the identification code included in the received data.
4. The receiver according to claim 1, wherein the vehicle has a key cylinder including a key switch which generates the activation signal, and the control circuit receives the activation signal from the key cylinder when the key switch is set to on.
5. A tire status monitoring apparatus for monitoring statuses of a plurality of tires provided on a vehicle, the tire status monitoring apparatus comprising:
a plurality of transmitters provided on the tires respectively, which detect statuses of the associated tires and transmit data indicating the detected statuses of the tires, the data including an identification code to identify each tire; and
a receiver provided on the vehicle, which receives the data from the plurality of transmitters and is supplied with an activation signal for activating a drive source of the vehicle,
wherein the receiver includes a control circuit, which, upon detection of the activation signal, collates the identification code included in the data and specifies, based on the identification code, each transmitter which has transmitted the data, wherein the control circuit has an identification code registered beforehand, determines whether or not the identification code included in the data matches with the registered identification code, determines whether or not those identification codes included in the data received by a first predetermined number of times match with one another a second predetermined number of times less than the first predetermined number of times or more when it is determined that those two identification codes do not match with each other, and determines that that tire which is associated with the identification code included in the data has been changed when it is decided that there have been such matches.
6. The tire status monitoring apparatus according to claim 5, wherein the receiver transmits a request signal to each transmitter and receives the data in response to the request signal from each transmitter.
7. The tire status monitoring apparatus according to claim 6, wherein the plurality of transmitters generate power induced by the request signal and transmit the data using the generated power.
8. The tire status monitoring apparatus according to claim 5, wherein when it is determined tat a tire has been changed, the control circuit updates the registered identification code with the identification code included in the received data.
9. The tire status monitoring apparatus according to claim 5, wherein the vehicle has a key cylinder including a key switch which generates the activation signal, and the control circuit receives the activation signal from the key cylinder when the key switch is set to on.
10. A method of monitoring statuses of a plurality of tires provided on a vehicle and including a plurality of transmitters which generate data indicating statuses of the respective tires, the vehicle including a receiver which receives the data from the transmitters, the data including an identification code to identify each tire, the method comprising the steps of:
detecting an activation signal for activating a drive source of the vehicle;
transmitting a request signal for generating the data and transmitting the data to the receiver to the plurality of transmitters, when the activation signal is detected;
receiving the data from the plurality of transmitters;
collating the identification code included in the data; and
specifying each transmitter which has transmitted the data, based on the identification code, wherein the receiver has an identification code registered beforehand, and the collation step includes the steps of:
determining whether the identification code included in the data matches with the registered identification code or not;
receiving the data by a first predetermined number of times when it is determined that the two identification codes do not match with each other;
determining whether or not those identification codes which are included in the data received by the first predetermined number of times do not match with one another a second predetermined number of times less than the first predetermined number of times or more; and
determining that that tire which is associated with the identification code has been changed when it is determined that the identification codes match with one another the second predetermined number of times or more.
11. The method according to claim 10, wherein the collation step further includes the step of updating the registered identification code with the identification code included in the received data when it is determined that a tire has been changed.
12. The method according to claim 10, wherein the vehicle has a key cylinder including a key switch which generates the activation signal, and the step of detecting the activation signal detects the activation signal when the key switch is set to on.

1. A monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope comprises the amino acid sequence Glu-Val-His-Leu-Lys-Leu-His-Gly-Glu-Lys-Gln-Gly-Thr-Gln (SEQ ID NO:1).
2. The monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope consists of amino acid sequence His-Gly-Glu-Lys-Gln-Gly-Thr-Gln (SEQ ID NO:2).
3. The monoclonal antibody of claim 1, wherein a light chain of the monoclonal antibody comprises SEQ ID NO:5.
4. The monoclonal antibody of claim 1, wherein a heavy chain of the monoclonal antibody comprises SEQ ID NO:6.
5. A composition comprising a monoclonal antibody, wherein the composition comprises monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope consists of SEQ ID NO:1.
6. The composition of claim 5, wherein the antibody comprises a light chain comprising SEQ ID NO:5.
7. The composition of claim 5, wherein the antibody comprises a heavy chain comprising SEQ ID NO:6.
8. The composition of claim 5, wherein the composition further comprises a pharmaceutically acceptable carrier.
9. A method of inhibiting osteoclastogenesis in a DC-STAMP expressing osteoclast precursor cell, the method comprising administering to the cell the composition of claim 5.
10. The method of claim 9, wherein the composition is administered in vitro.
11. The method of claim 9, wherein the cell is a mammalian cell.
12. The method of claim 11, wherein the mammalian cell is a human cell.
13. The method of claim 9, wherein the composition is administered to a subject in vivo.
14. The method of claim 13, wherein the composition further comprises a pharmaceutically acceptable carrier.
15. A monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein a heavy chain of the antibody comprises SEQ ID NO: 6 or all complementarity determining regions (CDRs) thereof and a light chain of the antibody comprises SEQ ID NO: 5 or all CDRs thereof.

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 administering pirfenidone to a human patient in need thereof comprising administering to the patient (1) food and (2) a pharmaceutical composition comprising a therapeutically effective dose of pirfenidone, wherein the ratio of the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (Cmax(fed)) to the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to said patient under fasted conditions (Cmax(fasted)) is about 0.35 to about 0.7.
2. The method of claim 1, wherein the total daily amount of pirfenidone administered to the patient is about 2403 mg.
3. The method of claim 1, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
4. The method of claim 1, wherein the ratio of the mean absorption half life of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (t12, abs(fed)) to the mean absorption half life of pirfenidone when said pharmaceutical composition is administered to the patient under fasted conditions t12, abs(fasted)) is about 2.5 to about 3.5.
5. The method of claim 4, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
6. The method of claim 3, wherein the total daily amount of pirfenidone administered to the patient is about 2403 mg.
7. The method of claim 1, wherein the administration of the food is within one hour of the administration of the pirfenidone.
8. The method of claim 1, further comprising advising the patient that taking pirfenidone under fed conditions may reduce the incidence of adverse events resulting from pirfenidone therapy in comparison to taking pirfenidone under fasted conditions.
9. The method of claim 8, wherein the adverse event comprises one of more of dizziness, somnolence, or headaches.
10. A method of providing pirfenidone therapy to a human patient in need thereof comprising advising the patient that the mean maximum plasma concentration of pirfenidone when administered under fed conditions (Cmax(fed)) is lower than the mean maximum plasma concentration of pirfenidone when administered under fasted conditions (Cmax(fasted)), wherein the ratio of Cmax(fed):Cmax(fasted) is about 0.35 to about 0.7.
11. The method of claim 10, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
12. The method of claim 10 further comprising advising the patient that the mean absorption half-life of pirfenidone under fed conditions (t12, abs(fed)) is longer than the mean absorption half-life of pirfenidone under fasted conditions (t12, abs(fasted)), wherein the ratio t12, abs(fed):t12, abs(fasted) is about 2.5 to about 3.5.
13. The method of claim 12, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
14. The method of claim 11 further comprising advising the patient that taking pirfenidone under fed conditions may reduce the incidence of adverse events resulting from pirfenidone therapy in comparison to taking pirfenidone under fasted conditions.
15. The method of claim 14, wherein the adverse event comprises one or more of dizziness, somnolence, or headaches.
16. The method of claim 10, further advising the patient to take a total daily amount of pirfenidone of about 2403 mg.