Controlled release compositions for macrolide antimicrobial agents

DETAILED DESCRIPTION OF THE INVENTION In the context of the present invention a number of terms have been used.
In order to provide a clear and consistent understanding of the specification, claims and the scope, the following definitions are provided.
Where specifically not indicated the terms used herein are used according to their normal and or art recognized meaning.
"Controlled release" as used herein, means sustained release or slow release or modified release or prolonged release or extended release or other similar terms used to indicate a composition providing an extended profile of drug release from the composition when exposed to aqueous environment either in-vitro or in-vivo as compared to an immediate release composition.
"Poorly soluble or poor solubility" as used herein, has the same meaning as is described in U.
S.
Pharmacopoeia XXIV and is used interchangeably with slightly soluble.
Typically, a slightly soluble compound has a solubility of about 1 part in from about 100 to about 1000 parts of solvent, e.
g.
, water.
(Further, a saturated solution of a slightly soluble compound in water can have a concentration of from about 1 mM to about 100 mM of the compound or a saturated solution and an insoluble of a compound in water can have a concentration of less than about 1 mM.
) "Acid susceptible compounds" as used herein, refers to compounds or active agents that degrade when allowed to contact an acidic environment such as acidic gastric juices.
"Therapeutic agent, active agent or drug" as used herein, have been used interchangeably and have the meanings recognized by one skilled in the art.
The therapeutic agent is a macrolide antibacterial agent.
Specific macrolide antibacterial agents include compounds such as, for example, clarithromycin, erythromycin, azithromycin, dirithromycin, roxithromycin, derivatives thereof and pharmaceutically acceptable salts thereof.
Preferably the macrolide antibacterial agent is clarithromycin, derivatives thereof or a pharmaceutically acceptable salt thereof