US2020297640A1PendingUtilityA1

Orally administrable compositions comprising calcium

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Assignee: CEROLIFE LLCPriority: Mar 15, 2013Filed: Jun 3, 2020Published: Sep 24, 2020
Est. expiryMar 15, 2033(~6.6 yrs left)· nominal 20-yr term from priority
Inventors:Manish S. ShahRay J. Difalco
A61K 33/10A61K 9/2027A61K 33/06A61K 9/209A61K 9/2054A61K 9/2031
54
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Claims

Abstract

Orally administrable compositions comprising calcium, methods of administration, and methods of making the same.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . An orally administrable pharmaceutical composition comprising: a first portion comprising a calcium compound and one or more pharmaceutically acceptable excipients, wherein the first portion is formulated for immediate release, and a second portion comprising a calcium compound and one or more pharmaceutically acceptable excipients, wherein the second portion is formulated for extended release, and wherein the calcium compound of the second portion may comprise the same or different calcium compound as the calcium compound of the first portion. 
     
     
         2 . The orally administrable pharmaceutical composition of  claim 1 , wherein the first portion is in direct physical contact with the second portion. 
     
     
         3 . The orally administrable pharmaceutical composition of  claim 2 , wherein about 25% to 75% of the surface area of the first portion is in direct physical contact with the second portion. 
     
     
         4 . The orally administrable pharmaceutical composition of  claim 1 , wherein the first portion is not in direct physical contact with the second portion. 
     
     
         5 . The orally administrable pharmaceutical composition of  claim 4 , wherein the composition comprises a further portion between the first portion and the second portion. 
     
     
         6 . The orally administrable pharmaceutical composition of  claim 1 , wherein the first portion and second portion form a layered tablet. 
     
     
         7 . The orally administrable pharmaceutical composition of  claim 6 , wherein the layered tablet is a bilayer tablet. 
     
     
         8 . The orally administrable pharmaceutical composition of  claim 1 , wherein the calcium compound of the first portion comprises calcium carbonate. 
     
     
         9 . The orally administrable pharmaceutical composition of  claim 1 , wherein the calcium compound of the first portion comprises calcium citrate. 
     
     
         10 . The orally administrable pharmaceutical composition of  claim 1 , wherein the calcium compound of the first portion comprises calcium carbonate and calcium citrate. 
     
     
         11 . The orally administrable pharmaceutical composition of  claim 1 , wherein the calcium compound of the second portion comprises calcium citrate. 
     
     
         12 . The orally administrable pharmaceutical composition of  claim 1 , wherein the second portion layer comprises about 25% to 90% of the total amount of calcium compound(s) in the composition. 
     
     
         13 . The orally administrable composition of  claim 1 , wherein the second portion layer comprises about 50% to 75% of the total amount of calcium compound(s) in the composition. 
     
     
         14 . The orally administrable composition of  claim 1 , wherein the first portion comprises about 400 mg to 600 mg of the calcium compound. 
     
     
         15 . The orally administrable composition of  claim 1 , wherein the first portion comprises about 200 mg to 300 mg of calcium citrate and about 200 mg to 300 mg of calcium carbonate. 
     
     
         16 . The orally administrable composition of  claim 1 , wherein the second portion comprises about 700 mg to 800 mg of the calcium compound. 
     
     
         17 . The orally administrable composition of  claim 1 , wherein the first portion comprises about 250 mg of calcium carbonate and about 350 mg of calcium citrate, and the second portion comprises about 750 mg of calcium citrate. 
     
     
         18 . The orally administrable composition of  claim 1 , wherein about 25% or more of the total amount of calcium compound(s) is released in the upper gastrointestinal tract. 
     
     
         19 . The orally administrable composition of  claim 1 , wherein about 50% or more of the total amount of calcium compound(s) is released in the upper gastrointestinal tract. 
     
     
         20 . A method of treating or reducing the symptoms associated with a medical condition, comprising administering to a subject in need thereof the orally administrable pharmaceutical composition of  claim 1 . 
     
     
         21 . The method of  claim 20 , wherein the medical condition is selected from the group consisting of: calcium deficiency, osteoporosis, and osteopenia.

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