Baclofen and r-baclofen gastroretentive drug delivery systems
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a gastro-retentive and drug delivery system technology, applied in the direction of drug compositions, peptide/protein ingredients, extracellular fluid disorder, etc., can solve the problems of traumatic brain injury loss of balance, pain and deformities,
Inactive Publication Date: 2011-04-21
INTEC PHARMA
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[0013]It is therefore an object of the invention to provide solutions to the aforementioned deficiencies in the art, enabling the administration of baclofen or R-baclofen with
Problems solved by technology
Stroke and traumatic brain injury (TBI) are another common cause of spasticity.
The muscles constantly rigidly contract and become permanently hypertonic, creating difficulty with voluntary and passive movement, pain and deformities.
Multiple sclerosis is an autoimmune disease that affects the brain and spinal cord, causing loss of balance, numbness, pain, vision loss, and impairing brain functions.
Unfortunately, baclofen is associated with significant and frequent side effects.
These undesired side effects might be associated with its considerable fluctuation of blood levels.
Moreover, the drug must be administered 3 or 4 times a d
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[0177]In order to illustrate the ability of the GRDF to provide controlled release of active ingredient, the release profile for the above (Example 1) Baclofen GRDF was determined. Baclofen was present in a total amount of 40 mg, all of which is in the internal layer.
[0178]Experiments were conducted in SGF (USP) pH 1.2 and in Acetate buffer (USP) pH 4.1 in a USP Apparatus 2, 50 rpm.
[0179]As shown in FIG. 2, the extended release was seen for 4 hours at pH 1.2 and for more than 16 for pH 4.1.
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Abstract
A biodegradable, multi-layered controlled release gastroretentive baclofen or R-baclofen dosage form which is optionally divided into a first dosage of baclofen or R-baclofen for immediate release and a second dosage of baclofen or R-baclofen for controlled release in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates upon contact with gastric juice and the dosage form unfolds rapidly upon contact with gastric juice. The biodegradable, multi-layered gastroretentive dosage forms of the invention provide fast onset of baclofen or R-baclofen activity with prolonged absorption and minimal undesirable side effects.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS[0001]The present application is a continuation in part of PCT Application PCT / IB2009 / 007419, filed Oct. 19, 2009, which claims priority to U.S. Provisional Patent Application No. 61 / 120,051, filed Dec. 4, 2008.FIELD OF THE INVENTION[0002]The present invention relates to biodegradable gastroretentive drug formulations for the immediate release and sustained release of baclofen. The gastroretentive baclofen or R-baclofen formulations of the invention may be orally administered to a subject in need thereof for the treatment of spasticity, spastic diplegia, alcoholism, alcohol addiction or alcohol dependence and abuse, gastro-esophageal reflux disease (GERD), emesis, cough, narcotic addiction or abuse, nicotine addiction or abuse, neuropathic pain and musculoskeletal pain, nocturnal acid breakthrough, chronic hiccups, dyspepsia, gastric motility disorder, migraine, PTSD (Post-traumatic Stress Disorder), depression, anxiety, lower urinary tr...
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