1-19. (canceled)
20. A sustained-release pharmaceutical dosage form for oral administration to a subject in need thereof comprising a therapeutically effective amount of at least one bile acid sequestrant selected from colesevelam, colesevelam hydrochloride or sevelamer and a gastric-retention vehicle composition comprising one or more hydrogels, wherein the dosage form expands upon contact with gastric fluid and is used for treating or preventing a gastro esophageal reflux disease (GERD)-related respiratory disorder chosen from cystic fibrosis, asthma, cough, chronic cough, chronic obstructive pulmonary disease (COPD), laryngeal disorders and pharyngeal related diseases and disorders.
21. The sustained-release pharmaceutical dosage form according to claim 20, wherein after ingestion by a person in need thereof, the gastric retention vehicle composition expands to retain the dosage form in the person’s stomach for a period of three hours or more.
22. The sustained-release pharmaceutical dosage form according to claim 21, wherein after ingestion by a person in need thereof the gastric retention vehicle composition expands to retain the dosage form in the person’s stomach for a period of 8 hours or more.
23. The sustained-release pharmaceutical dosage form according to claim 22, wherein after ingestion by a person in need thereof the gastric retention vehicle composition expands to retain the dosage form in the person’s stomach for a period of 24 hours or more.
24. The sustained-release pharmaceutical dosage form according to claim 20, wherein the gastric retention vehicle composition further comprises at least one binder.
25. The sustained-release pharmaceutical dosage form according to claim 20, wherein the hydrogel is selected from hydroxypropyl methylcellulose and hydroxypropylcellulose.
26. The sustained-release pharmaceutical dosage form according to claim 20, wherein the percentage of active ingredient(s) is present in an amount from between 10% to about 75% of the total weight.
27. The sustained-release pharmaceutical dosage form according to claim 26, wherein the percentage of active ingredient(s) is 15% of the total weight.
28. The sustained-release pharmaceutical dosage form according to claim 26, wherein the percentage of active ingredient(s) is 40% of the total weight.
29. The sustained-release pharmaceutical dosage form according to claim 20, wherein the therapeutically effective amount of bile acid sequestrant is in a range from 0.01 g to 300 g.
30. The sustained-release pharmaceutical dosage form according to claim 29, wherein the therapeutically effective amount of bile acid sequestrant is in a range from 1 g to 30 g.
31. The sustained-release pharmaceutical dosage form according to claim 29, wherein the therapeutically effective amount of bile acid sequestrant is in a range from 0.2 g to 6 g.
32. The sustained-release pharmaceutical dosage form according to claim 29, wherein the therapeutically effective amount of bile acid sequestrant is in a range from 0.1 g to 3 g.
33. The sustained-release pharmaceutical dosage form according to claim 20 further comprising a therapeutically effective amount of at least one proton pump inhibitor.
34. The sustained-release pharmaceutical dosage form according to claim 33, wherein the at least one proton pump inhibitor is selected from omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, tenatoprazole, laminoprazole, dontoprazole and ransoprazole.
35. The sustained-release pharmaceutical dosage form according to claim 34, wherein the at least one proton pump inhibitor is omeprazole.
36. The pharmaceutical dosage form according to claim 34, wherein the therapeutically effective amount of at least one proton pump inhibitor is in a range from 1 mg to 200 mg.
37. The pharmaceutical dosage form according to claim 20 further comprising a therapeutically effective amount of at least one agent chosen from a \u03b3-aminobutyric acid-B (GABA-B) agonist or a pro-drug thereof, optionally formulated in combination with the at least one proton pump inhibitor.
38. A method for preventing or treating a gastrointestinal (GI) tract disorder andor a gastroesophageal reflux disease (GERD)-related respiratory disorder, the method comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical dosage form according to claim 20.
39. A kit for treating a gastrointestinal tract (GI) tract disorder andor a gastroesophageal reflux disease (GERD)-related respiratory disorder comprising, in one or more containers, a therapeutically effective amount of the pharmaceutical dosage form according to claim 20, and a label or packaging insert containing instructions for use.
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 configurable circuit, comprising:
a plurality of configurable functions;
a configuration memory coupled to the configurable functions to store configuration data to configure the configurable functions;
an inputoutput (IO) interface;
a cipher device coupled to the IO interface, and adapted to encipher configuration data received through the IO interface, and to output the resulting ciphered configuration data outside the configurable circuit through the IO interface, wherein the cipher device is further adapted to be placed into a disabled state; and
a decipher device coupled to the IO interface, adapted to decipher previously outputted ciphered configuration data received back through the IO interface, and to output the resulting deciphered configuration data to the configuration memory.
2. The configurable circuit of claim 1, wherein the configurable circuit is a Field Programmable Gate Array (FPGA) reconfigurable circuit.
3. The configurable circuit of claim 1, wherein said cipher and decipher devices are coupled to the IO interface through a switch, the switch adapted to route clear configuration data to the cipher device and to route subsequent enciphered configuration data to the decipher device.
4. The configurable circuit of claim 1, further comprising a first nonvolatile storage coupled to the cipher device and the decipher device, the first nonvolatile storage adapted to store cipheringdeciphering keys to be used by the cipher device to encipher the configuration data and the decipher device to decipher the configuration data.
5. The configurable circuit of claim 4, further comprising a random cipher key generator coupled to the first nonvolatile storage to generate and store cipheringdeciphering keys in the first nonvolatile storage.
6. The configurable circuit of claim 4, wherein said first nonvolatile storage adapted to receive from an external key source, cipheringdeciphering keys.
7. The configurable circuit of claim 4, further comprising a second nonvolatile storage coupled to said cipher device adapted to store enabledisable indicator to indicate to said cipher device whether said cipher device is enabled or disabled, said enabledisable indicator capable of transitioning from an enable to a disable state but not from the disable state to the enable state.
8. The configurable circuit of claim 7, further comprising:
a third nonvolatile storage coupled to said cipher device adapted to store another enabledisable indicator to indicate to said cipher device whether said cipher device is enabled or disabled for ciphering another configuration data, said enabledisable indicator capable of transitioning from an enable to a disable state but not from the disable state to the enable state; and
a fourth nonvolatile storage coupled to the cipher device and the decipher device adapted to store additional cipheringdeciphering keys to be used by the cipher device to cipher the another configuration data and the decipher device to decipher the another configuration data.
9. A method, comprising:
providing a configurable circuit, including:
a plurality of configurable functions;
a configuration memory coupled to the configurable functions to store configuration data to configure the configurable functions;
an inputoutput (IO) interface;
a cipher device coupled to the IO interface, and adapted to encipher configuration data received through the IO interface, and to output the resulting ciphered configuration data outside the configurable circuit through the IO interface, wherein the cipher device is further adapted to be placed into a disabled state; and
a decipher device coupled to the IO interface, adapted to decipher previously outputted ciphered configuration data received back through the IO interface, and to output the resulting deciphered configuration data to the configuration memory; and
providing cipheringdeciphering keys, the cipheringdeciphering keys to be used by the cipher and decipher devices to encipher and decipher the configuration data respectively.
10. The method of claim 9, wherein said providing cipheringdeciphering keys comprises providing cipheringdeciphering keys from an external key source.
11. The method of claim 9, wherein said providing a configurable circuit comprises providing a Field Programmable Gate Array (FPGA) reconfigurable circuit having the reconfigurable functions, the configurable memory, the IO interface, and the cipher and decipher devices.
12. The method of claim 9, wherein said providing comprises providing a configurable circuit that includes a first nonvolatile storage coupled to the cipher device and the decipher device to store cipheringdeciphering keys to be used by the cipher device to encipher the configuration data and the decipher device to decipher the configuration data.
13. The method of claim 12, wherein the configurable circuit further includes a random key generator coupled to the first nonvolatile storage and said providing cipheringdeciphering keys comprises operating the random key generator to generate cipheringdeciphering keys, and storing the generated cipheringdeciphering keys into the first nonvolatile storage.
14. The method of claim 12, wherein said providing comprises providing a configurable circuit that includes a second nonvolatile storage coupled to said cipher device adapted to store enabledisable indicator to indicate to said cipher device whether said cipher device is enabled or disabled, said enabledisable indicator capable of transitioning from an enable to a disable state but not from the disable state to the enable state.
15. A method, comprising:
providing a configurable circuit, including:
a plurality of configurable functions;
a configuration memory coupled to the configurable functions to store configuration data to configure the configurable functions;
an inputoutput (IO) interface;
a cipher device coupled to the IO interface, and adapted to encipher configuration data received through the IO interface, and to output the resulting ciphered configuration data outside the configurable circuit through the IO interface, wherein the cipher device is further adapted to be placed into a disabled state; and
a decipher device coupled to the IO interface, adapted to decipher previously outputted ciphered configuration data received back through the IO interface, and to output the resulting deciphered configuration data to the configuration memory; and
providing the configuration data through the IO interface to the cipher device and recieving the resulting enciphered configuration data.
16. The method of claim 15, further comprising coupling the IO interface of the configurable circuit to one or more external devices.
17. The method of claim 16, wherein said one or more external devices comprises an external nonvolatile storage device, and the method further comprises storing said received enciphered configuration data in the external nonvolatile storage.
18. The method of claim 17, wherein the method further comprises storing the configuration data in the external nonvolatile storage before the configuration data is enciphered.
19. The method of claim 16, wherein said providing to the cipher device the configuration data comprises providing to the cipher device the configuration data from one of the one or more external devices.
20. The method of claim 15, wherein said providing a configurable circuit comprises providing a Field Programmable Gate Array (FPGA) reconfigurable circuit having the reconfigurable functions, the configuration memory, the IO interface, and the cipher and decipher devices.
21. The method of claim 15, wherein said providing comprises providing a configurable circuit that includes a nonvolatile storage coupled to said cipher device adapted to store enabledisable indicator to indicate to said cipher device whether said cipher device is enabled or disabled, said enabledisable indicator capable of transitioning from an enable to a disable state but not from the disable state to the enable state.
22. The method of claim 21, further comprising disabling the cipher device by storing a disabling indicator into the nonvolatile storage.