Stepwise delivery of topiramate over prolonged period of time
First Claim
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1. A controlled release dosage form comprising a compound, characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof, a disintegrant and no surfactant adapted to release as an erodible solid over a prolonged period of time at a stepwise, increasing rate.
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Abstract
Compositions and dosage forms for enhanced dispersion of topiramate in a controlled release dosage form released from the dosage form as a dry or substantially dry erodible solid over a prolonged period of time at a stepwise increasing rate of release are described.
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Citations
30 Claims
- 1. A controlled release dosage form comprising a compound, characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof, a disintegrant and no surfactant adapted to release as an erodible solid over a prolonged period of time at a stepwise, increasing rate.
- 6. A bioerodible composition comprising a compound characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof adapted to release the compound over a prolonged period of time at a stepwise, increasing rate of release with no surfactant.
- 13. A method of treating a condition in a subject responsive to administration of a compound characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof which comprises orally administering to the subject a dosage form adapted to release the compound at a stepwise increasing rate of release over a prolonged period of time with no surfactant.
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17. A dosage form comprising:
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a) a wall defining a compartment, at least a portion of the wall being semipermeable;
b) an exit orifice formed or formable in the wall; and
c) an expandable layer located within the compartment remote from the exit orifice and in fluid communication with the semipermeable portion of the wall; and
d) a drug layer located within the compartment adjacent the exit orifice, the drug layer comprising a compound characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof with no surfactant. - View Dependent Claims (18, 19)
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20. A method of treating a condition responsive to administration of a compound comprising administering to a subject a compound characterized by having a high dosage, low solubility and poor dissolution rate or a pharmaceutically acceptable acid addition salt thereof with no surfactant which comprises maintaining over a prolonged period of time a steady state concentration of compound in the plasma of a subject between 5 ng/ml and 2500 ng/ml, wherein the quotient formed from [Cmax−
- Cmin]/Cavg is 3 or less.
- View Dependent Claims (21, 22, 23)
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24. A controlled release oral dosage form of topiramate for once-a-day
administration to a subject comprising: -
(a) A core comprising;
i. Topiramate;
ii. a structural polymer;
iii. a disintegrant;
iv. no surfactant;
(b) a semipermeable membrane at least partially surrounding the core; and
(c) an exit orifice through the semipermeable membrane which communicates with the core so as to allow release of the topiramate to the environment;
wherein the dosage form releases the topiramate over a prolonged period of time at a stepwise increasing rate of release. - View Dependent Claims (25)
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26. A method for treating a condition responsive to topiramate comprising orally administering once a day to a subject a capsule shaped tablet core dosage form containing topiramate, a disintegrant and a pharmaceutically acceptable structural polymer carrier wherein the dosage form releases the topiramate at a substantially ascending release rate for a prolonged period of time.
- 27. A capsule shaped tablet dosage form comprising a drug composition containing topiramate, a structural polymer carrier and a disintegrant wherein the dosage form, following oral administration to a subject, releases the active agent from the dosage form at a substantially ascending release rate for a prolonged period of time.
Specification