Pulsatile drug release
AssigneeUniversity of Strathclyde
InventorsAlexander Mullen, Howard Stevens, Sarah Eccleston
Life of this patent
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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 while 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.
Claims22
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 consisting essentially of granules having a size of from 500 μm to 1 mm as measured by sieves;
- said granules comprising a wax and particles of a low-substituted hydroxypropyl cellulose (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 3-8 hours after administration of the tablet to 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 minutes;
- wherein the L-HPC has a mean particle size of 55 μm, a hydroxypropyl content of 11%, and a molecular weight of 130,000, or a mean particle size of 20 μm, a hydroxypropyl content of 8%, and a molecular weight of 115,000.
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 consisting essentially of granules having a size of from 500 μm to 1 mm as measured by sieves;
- said granules comprising a wax and particles of a low-substituted hydroxypropyl cellulose (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 3-8 hours after administration of the tablet to 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 minutes;
- wherein the L-HPC has a mean particle size of 55 μm, a hydroxypropyl content of 11%, and a molecular weight of 130,000, or a mean particle size of 20 μm, a hydroxypropyl content of 8%, and a molecular weight of 115,000;
- wherein the delay in release is measured in 900 ml sodium phosphate buffer (0.01 M, at pH7) at 37° C., with UV analysis.
Dependencies are inferred from the claim text.