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« SECTION TITLE Titratable Dosage Transdermal

Delivery System; C. Wright IV; U.S. Patent # 9,289,397, March 22. 2016.

The current transdermal patches deliver actives at fi xed dosages. The fl ux or the rate of release and subsequent absorption of drug depends upon an individual patient. There is high inter-subject variability. It means, some patients will get higher doses at faster rate whereas some others will get low doses at a slower fl ux. The current invention provides a transdermal delivery system that can deliver titratable dosage of therapeutic agent. It provides plurality of patches with diff erent dose strengths. Based on the fl ux, patients can apply diff erent number of patches. Each patch unit comprises (1) a backing layer having one or more borders, (2) a drug layer, (3) an impermeable layer in contact with the drug layer, in which the impermeable layer is between the backing layer and the drug layer, and (4) an adhesive layer; the drug layer comprises a polymer, levulinic acid and buprenorphine.

Gastric Retentive Dosage Forms for Extended Release of Acamprosate into the Upper

Gastrointestinal Tract; B. Berner and C. Chen; U.S. Patent # 9,301,934; April 5, 2016.

Acamprosate is a synthetic analog of .gamma.-amino butyric acid (GABA) and is used as an adjunct for treatment of alcohol dependence. As alcohol inhibits the activity of N-methyl-D- aspartate receptors (NMDARs), chronic alcohol consumption leads to the upregulation of these receptors. Sudden alcohol abstinence results in excessive activation of NMDARs, leading to symptoms such as delirium tremens and excitotoxic neuronal death. Acamprosate reduces this eff ect in vivo. Acamprosate exhibits poor absorption in the intestine after oral dosing. In this invention, a gastric retained extended release oral dosage form comprising a dose of acamprosate dispersed in a polymer matrix comprising at least one hydrophilic polymer is provided. Upon administration, the polymer matrix swells upon imbibition of fl uid to a size suffi cient such that the dosage form is retained in the stomach of a subject in a fed mode and the dose of acamprosate is released over an extended period of time.

Drug Coated Balloon With In-Situ Formed Drug

Containing Microspheres; S.D. Pacetti and J.J. Stankus; U.S. Patent # 9,295,663, March 29, 2016.

The current invention describes methods of forming a coating that involves the in-situ formation of drug microspheres. The coating is then applied to a medical device, such as a catheter balloon or a stent. Using catheter techniques originally developed for heart exploration, infl atable balloons were employed to re-open occluded regions in arteries. The procedure is relatively non-invasive, takes a very short time compared to by-pass surgery and the recovery time is minimal. However, it involves problems such as, elastic recoil of the stretched arterial wall, the re-clogging of the treated artery, formation of intimal fl aps or torn arterial linings which can collapse and occlude the blood conduit after the balloon is defl ated. To control these side eff ects, a stent may be implanted in the artery to keep the artery open. An alternative to a drug-delivery stent is a drug coated balloon (DCB). When the balloon is infl ated, and the balloon walls contact the vessel walls, the drug is released.

Topical Formulations

of Flucytosine; J. Qasem, R.H. Farmen, and K. Phelphs; U.S. Patent # 9,314,524; April 19, 2016.

Vulvovaginal candidiasis (VVC) is one of the most common conditions aff ecting women. Azole antifungal agents are used in complicated VVC. There have been reports of azole resistance in Candida species. Flucytosine, when given orally, has serious side-eff ects. One aspect of the present invention is to provide formulations of fl ucytosine in which the minimization of systemic absorption of the drug is controlled by careful choice of the nature and relative amount of excipient ingredients. Another aspect of the present invention is to provide fl ucytosine compositions for topical use, which retain therapeutically eff ective drug levels at the site of infection, so that the drug concentration is not depleted by systemic absorption and diff usion of the drug away from the site of application. In addition, the present invention provides formulations wherein the concentration of active drug is lower than had been previously considered eff ective. |

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