US2015174078A1PendingUtilityA1

Sustained Release Formulations of Lorazepam

37
Individually held — no corporate assignee on recordPriority: Jan 9, 2013Filed: Mar 4, 2015Published: Jun 25, 2015
Est. expiryJan 9, 2033(~6.4 yrs left)· nominal 20-yr term from priority
Inventors:Douglas A. SaltelMichael Vachon
A61P 25/24A61P 25/22A61K 9/5084A61K 9/5026A61K 9/5047A61K 31/5513A61K 47/38A61K 9/4891A61K 9/1652A61K 47/36A61K 9/50A61K 9/16
37
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

A pharmaceutical composition for delivering lorazepam in a prolonged fashion is achieved with prolonged release lorazepam pharmaceutical beads. The composition typically contains sustained release lorazepam beads and delayed sustained release lorazepam beads. The composition can provide once daily dosing that maintains 24 hour therapeutic effect under steady state conditions.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . A pharmaceutical composition, comprising:
 (i) lorazepam sustained release beads, which beads comprise lorazepam dispersed in a polymer matrix; and   (ii) lorazepam delayed sustained release beads, which delayed beads comprise a core having lorazepam dispersed in a polymer matrix and an enteric coating surrounding said core;   
       wherein said lorazepam sustained release beads and said lorazepam delayed sustained release beads are present in a ratio range of 1:0.7-1.3, respectively, at least 90% of the total amount of lorazepam in said composition is contained in the combination of said lorazepam sustained release beads and said lorazepam delayed sustained release beads, and the total amount of lorazepam contained in said composition is 0.5 to 10 mg. 
     
     
         22 . The pharmaceutical composition according to  claim 21 , wherein 100% of the lorazepam in said composition is contained in the combination of said sustained release beads and said delayed sustained release beads. 
     
     
         23 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam sustained release beads have a size of less than 1 mm. 
     
     
         24 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam delayed sustained release beads have a size of less than 1 mm. 
     
     
         25 . The pharmaceutical composition according to  claim 21 , wherein said polymer matrix in said sustained release beads and in the core of said delayed sustained release beads comprises hydroxypropyl methylcellulose (HPMC). 
     
     
         26 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam sustained release beads further comprise microcrystalline cellulose (MCC). 
     
     
         27 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam sustained release beads further comprise a starch. 
     
     
         28 . The pharmaceutical composition according to  claim 21 , wherein the core of said lorazepam delayed sustained release beads further comprises microcrystalline cellulose (MCC). 
     
     
         29 . The pharmaceutical composition according to  claim 21 , wherein the core of said lorazepam delayed sustained release beads further comprises a starch. 
     
     
         30 . The pharmaceutical composition according to  claim 21 , wherein said enteric coating is designed to release at pH 7 or greater. 
     
     
         31 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam sustained release beads comprise lorazepam, HPMC, MCC, and pregelatinized starch and wherein the amount of lorazepam in said lorazepam sustained release beads is less than 7%. 
     
     
         32 . The pharmaceutical composition according to  claim 31 , wherein said core of said lorazepam delayed sustained release beads comprises lorazepam, HPMC, MCC, and pregelatinized starch and wherein the amount of lorazepam in said lorazepam delayed sustained release beads is less than 7%. 
     
     
         33 . The pharmaceutical composition according to  claim 32 , wherein said lorazepam sustained release beads have a size within the range of 0.4 to 0.8 mm and said lorazepam delayed sustained release beads have a size within the range of 0.4 to 0.9 mm. 
     
     
         34 . The pharmaceutical composition according to  claim 32 , wherein the cores of said lorazepam delayed sustained release beads have the same composition and size as said lorazepam sustained release beads. 
     
     
         35 . The pharmaceutical composition according to  claim 21 , wherein said composition is a capsule that contains said lorazepam sustained release beads and said lorazepam delayed sustained release beads. 
     
     
         36 . The pharmaceutical composition according to  claim 21 , wherein said composition is a tablet that contains said lorazepam sustained release beads and said lorazepam delayed sustained release beads. 
     
     
         37 . The pharmaceutical composition according to  claim 21 , wherein said lorazepam is a pharmaceutically acceptable salt of lorazepam. 
     
     
         38 . A method for treating anxiety related disorders, which comprises administering once a day to a patient in need thereof a pharmaceutical composition according to claim  1 . 
     
     
         39 . The method according to  claim 38 , wherein said composition contains 2 mg, 4 mg, or 6 mg of lorazepam. 
     
     
         40 . The method according to  claim 38 , wherein said anxiety is Generalized Anxiety Disorder.

Join the waitlist — get patent alerts

Track US2015174078A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.