Immediate release formulations and dosage forms of gamma-hydroxybutyrate
Inventors
ROURKE, ANDREA MARIE • MURPHY, MAURA PATRICIA • PFEIFFER, JAMES FREDERICK • ALLPHIN, CLARK PATRICK • McGinlay, Alya Kahn
Assignees
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Publication Number
US-9795567-B2
Publication Date
2017-10-24
Expiration Date
Abstract
The present invention provides a solid immediate release dosage form adapted for oral administration of GHB. The solid immediate release dosage form includes an immediate release formulation comprising a relatively high weight-percentage of GHB with a bioavailability similar to that of a liquid GHB dosage form.
Core Innovation
The disclosed invention concerns an immediate release compressed tablet for oral delivery of gamma-hydroxybutyrate (GHB). The tablet comprises an immediate release formulation comprising a pharmaceutically acceptable salt of GHB in a high amount by weight, together with at least one binder and at least one lubricant, and is directed to an immediate release performance target after administration.
A key aspect of the invention is that the immediate release compressed tablet exhibits friability of less than 1% while releasing at least 90% of the GHB salt contained therein within less than one hour after administration. The independent tablet compositions specify a pharmaceutically acceptable salt of GHB present at least at 70% by weight of the immediate release formulation and at least 70% by weight of the immediate release compressed tablet.
The disclosed framework further supports particular GHB salts and component selections within the same performance constraints. The claims specify tablets for delivery of sodium oxybate and define tablets for treating a condition treatable with GHB by administering such an immediate release compressed tablet. Dependent claim refinements include selectable binder types and lubricant types, along with optional inclusion of surfactants and narrower quantitative ranges and quality parameters.
Claims Coverage
The document contains three independent claims: two directed to an immediate release compressed tablet for oral delivery of GHB and one directed to a method of treating an individual by administering an immediate release compressed tablet for oral delivery of sodium oxybate. Across the independent claims, the inventive features are defined by high GHB-salt content, binder and lubricant ranges, and immediate release performance characterized by friability and release within less than one hour.
Immediate release compressed tablet with high GHB salt content and rapid release
An immediate release compressed tablet for oral delivery of gamma-hydroxybutyrate (GHB), the compressed tablet comprising a pharmaceutically acceptable salt of GHB in an amount of 600 mg to about 1,500 mg and comprising at least 70% by weight of the immediate release formulation; at least one binder in an amount of about 1%-5% by weight; and at least one lubricant in an amount of about 0.5%-5% by weight; wherein the immediate release compressed tablet exhibits a friability of less than 1% and releases at least 90% of the GHB salt contained therein within a period of less than one hour after administration.
Immediate release compressed tablet with defined GHB amount and performance criteria
An immediate release compressed tablet for oral delivery of gamma-hydroxybutyrate (GHB), the compressed tablet comprising GHB in an amount of about 600 mg to about 1,500 mg and comprising at least 70% by weight of the immediate release compressed tablet; at least one binder in an amount of about 1%-5% by weight; and at least one lubricant in an amount of about 0.5%-5% by weight; and wherein the immediate release compressed tablet exhibits a friability of less than 1% and releases at least 90% of the GHB contained therein within a period of less than one hour after administration.
Method of treating a GHB-treatable condition with sodium oxybate immediate release compressed tablets
A method for treating an individual afflicted with a condition treatable with gamma-hydroxybutyrate (GHB), the method comprising administering an immediate release compressed tablet for oral delivery of sodium oxybate, the immediate release compressed tablet comprising sodium oxybate in an amount of about 600 mg to about 1,500 mg and comprising at least 70% by weight of the immediate release compressed tablet; at least one binder in an amount of about 1%-5% by weight; and at least one lubricant in an amount of about 0.5%-5% by weight; wherein the immediate release compressed tablet exhibits a friability of less than 1% and releases at least 90% of the GHB contained therein within a period of less than one hour after administration.
Across the independent claims, the core coverage is directed to immediate release compressed oral tablets containing a high-weight fraction of a GHB salt, including sodium oxybate, together with defined binder and lubricant amounts, achieving friability of less than 1% and release of at least 90% within less than one hour. The method claim covers treating a GHB-treatable condition by administering the sodium oxybate immediate release compressed tablet with the same composition and performance criteria.
Stated Advantages
Provides an immediate release compressed tablet having friability of less than 1%.
Achieves rapid release by releasing at least 90% of the GHB salt within less than one hour after administration.
Supports oral delivery of high-dose gamma-hydroxybutyrate (GHB) as a pharmaceutically acceptable salt in a compressed immediate release tablet format.
Documented Applications
Treating an individual afflicted with a condition treatable with gamma-hydroxyl butyrate (GHB).
The condition is cataplexy and excessive daytime sleepiness associated with narcolepsy.
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