PULSATILE DRUG RELEASE
2 Assignments
0 Petitions
Accused Products
Abstract
In one aspect, the present invention is concerned with a treatment where it is desired that an active agent is designed to be released in a pulse at a time point some time after administration of the active agent. The present invention is particularly suited to administering an agent which may be released whilst a subject is sleeping. As well as treating certain conditions by a particular regime, the invention also provides novel formulations for a delayed, followed by a pulsed release of drug.
-
Citations
33 Claims
-
1-15. -15. (canceled)
-
16. A press-coated tablet formulation for a delayed, followed by a pulsed release of an active agent, the tablet comprising
(a) a core comprising the active agent(s) together with an excipient(s); - and
(b) a delayed release layer surrounding the core and comprising a wax and L-HPC in a ratio of 40;
60 to 60;
40 w/w;
wherein the delayed release layer substantially delays release of the active agent within the core for between 1-8 hours after administration of the tablet by a subject and thereafter a pulsed release of the active agent from the core occurs, such that at least 70% of the active agent in the core is released within 5-80 mins. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
- and
- 26. A press-coated tablet comprising a sedative or hypnotic agent for treating sleep maintenance insomnia, wherein the tablet is intended to be administered immediately prior to a subject going to sleep and wherein the agent is substantially not released from the formulation for a period between 1-8 hours after administration of the formulation to the subject and thereafter the agent is released from the formulation as a pulse such that at least 70% of the agent within the formulation is released within 5-80 mins.
- 28. A method of treating sleep maintenance insomnia, the method comprising administering a press-coated tablet comprising a sleep inducing agent, to a subject, immediately before the subject intends sleeping, wherein the formulation substantially delays release of the drug for 1-8 hours following administration of the formulation and thereafter the drug is released in a pulse over a period of 5-80 mins.
Specification