Methods and dosage forms with modified viscosity layers
First Claim
1. A dosage form for delivery of a drug to a patient, the dosage form comprising:
- (a) an inner wall defining an internal compartment;
(b) a core within the internal compartment comprising a drug layer, the drug layer having a drug therein;
(c) an outer wall around at least a portion of the inner wall and the core, the outer wall and the inner wall having at least one exit therethrough and communicating with the core;
(d) the dosage form having a delay period wherein the drug is not delivered through the at least one exit for a period of about 4 hours after administration and a delivery period wherein the drug is delivered through the at least one exit in a controlled fashion for a period of about 16 hours after the delay period.
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Abstract
Dosage forms and methods for providing a modulated release of cyclobenzaprine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma cyclobenzaprine concentrations when administered once per day. The composition of the delay layer and the composition of the drug layer are characterized by the viscosity of the hydrated delay layer remaining higher than the viscosity of the hydrated drug layer during operation in one embodiment. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate. In other embodiments, the hydrated delay layer has a viscosity that is lower than the viscosity of the hydrated drug layer as well as a hydrated delay layer that is substantially similar to the hydrated drug layer.
61 Citations
24 Claims
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1. A dosage form for delivery of a drug to a patient, the dosage form comprising:
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(a) an inner wall defining an internal compartment;
(b) a core within the internal compartment comprising a drug layer, the drug layer having a drug therein;
(c) an outer wall around at least a portion of the inner wall and the core, the outer wall and the inner wall having at least one exit therethrough and communicating with the core;
(d) the dosage form having a delay period wherein the drug is not delivered through the at least one exit for a period of about 4 hours after administration and a delivery period wherein the drug is delivered through the at least one exit in a controlled fashion for a period of about 16 hours after the delay period. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method for achieving blood plasma concentration levels of a drug in a patient, the method comprising the steps of:
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(a) providing a dosage form comprising a drug layer having a drug therein;
(b) administering the dosage form to the patient;
(c) delivering the drug from the dosage form such that no drug is detectable in the plasma for a period of up to three hours from administering the dosage form, and approximately 6 ng/ml to 8 ng/ml of the drug is detectable in the plasma within three to four hours from administering the dosage form, and approximately 8 ng/ml to 12 ng/ml of the drug is detectable in the plasma from about eighteen hours to about twenty hours after administering the dosage form.
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19. A method for achieving plasma concentration levels of a tricyclic amine in a patient, the method comprising the steps of:
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(a) providing a dosage form comprising a drug layer having a tricyclic amine therein;
(b) administering the dosage form to the patient;
(c) delivering the tricyclic amine to the patient from the dosage form such that no tricyclic amine is detectable in the plasma for a period of up to three hours from administering the dosage form, and approximately 6 ng/ml to 8 ng/ml of the tricyclic amine is detectable in the plasma within three to four hours from administering the dosage form, and approximately 8 ng/ml to 12 ng/ml of the tricyclic amine is detectable in the plasma from about eighteen hours to about twenty hours after administering the dosage form.
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20. A method for achieving blood plasma concentration levels of a drug in a patient, the method comprising the steps of:
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(a) providing a dosage form comprising a drug layer having a drug therein;
(b) administering the dosage form to the patient;
(c) delivering the drug from the dosage form such that no drug is detectable in the plasma for a period of up to three hours from administering the dosage form, and approximately 6.5 ng/ml to 6.9 ng/ml of the drug is detectable in the plasma within three to four hours from administering the dosage form, and approximately 9.7 ng/ml to 10.2 ng/ml of the drug is detectable in the plasma from about eighteen hours to about twenty hours after administering the dosage form.
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21. A method for achieving plasma concentration levels of a tricyclic amine in a patient, the method comprising the steps of:
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(a) providing a dosage form comprising a drug layer having a tricyclic amine therein;
(b) administering the dosage form to the patient;
(c) delivering the tricyclic amine to the patient from the dosage form such that no tricyclic amine is detectable in the plasma for a period of up to three hours from administering the dosage form, and approximately 65 ng/ml to 6.9 ng/ml of the tricyclic amine is detectable in the plasma within three to four hours from administering the dosage form, and approximately 9.7 ng/ml to 10.2 ng/ml of the tricyclic amine is detectable in the plasma from about eighteen hours to about twenty hours after administering the dosage form.
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22. A method for treating a condition in a patient, the method comprising the steps of:
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(a) providing a dosage form comprising a tricyclic amine;
(b) administering the dosage form to the patient;
(c) delivering the tricyclic amine to the patient from the dosage form such that a modulated, substantially ascending plasma concentration of the tricyclic amine is achieved ranging from about 7 ng/ml to about 11 ng/ml for a period of time from about 16 hours to about 18 hours after administering the dosage form. - View Dependent Claims (23, 24)
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Specification