US2018333362A1PendingUtilityA1

Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems

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Assignee: ODIDI ISAPriority: Dec 23, 2005Filed: Jul 31, 2018Published: Nov 22, 2018
Est. expiryDec 23, 2025(expired)· nominal 20-yr term from priority
Inventors:Isa OdidiAmina Odidi
A61K 9/2866A61K 9/2013A61K 9/2086A61K 31/381A61K 31/27A61K 31/145A61K 9/4816A61K 9/5078A61K 9/5073A61K 9/5047A61K 9/5026A61K 9/2846A61K 9/2018A61K 9/2054A61K 9/4808A61K 31/138A61K 31/135A61K 9/2004
60
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Claims

Abstract

The disclosure is directed to drug delivery devices that provide for combinations of extended- and pulsed controlled release delivery of active pharmaceutical ingredient(s) APIs. The described drug delivery devices for oral administration of therapeutic compositions can include two or more populations of unit dosage forms including one or more API's in various combinations of pulsed and delayed/extended delivery formulations. The population of unit dosage forms are provided in a variety of different vehicles such as granules, beads, pellets, or tablets and can be contained within a drug delivery device of the present disclosure.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A drug delivery device for oral administration of an active pharmaceutical ingredient (API), the device comprising:
 a) a first population of unit dosage forms comprising a core, wherein the core comprises a pharmaceutically acceptable bead and an API loaded coating, wherein the API loaded coating comprises an API and hydroxypropyl methyl cellulose and wherein the first population of unit dosage forms further comprises a pH-reactive coat; and   b) a second population of unit dosage forms comprising a core, wherein the core comprises a pharmaceutically acceptable bead and an API loaded coating, wherein the API loaded coating comprises the API and hydroxypropyl methyl cellulose and wherein the second population of unit dosage forms comprises an extended release coat on the core and further comprises a pH-reactive coat on the extended release coat.   
     
     
         2 . The drug delivery device of  claim 1 , wherein the API is duloxetine. 
     
     
         3 . The drug delivery device of  claim 2 , wherein the API is present in the API loaded coating in both the first population and second population in an amount of 67%. 
     
     
         4 . The drug delivery device of  claim 1 , wherein the pharmaceutically acceptable bead comprises a non pareil bead. 
     
     
         5 . The drug delivery device of  claim 4 , wherein the non pareil bead is less than 3 mm in diameter. 
     
     
         6 . The drug delivery device of  claim 1 , wherein the hydroxypropyl methyl cellulose is present in the API loaded coating of the first and second population of unit dosage forms in an amount of 17%. 
     
     
         7 . The drug delivery device of  claim 1 , wherein the API loaded coating of the first and second population of unit dosage forms further comprises an excipient in an amount of 17%. 
     
     
         8 . The drug delivery device of  claim 7 , wherein the excipient is sodium lauryl sulphate. 
     
     
         9 . The drug delivery device of  claim 1 , wherein the first and second population of unit dosage forms is each coated with the pH reactive coat to a coverage of 4 mg per cm 2 . 
     
     
         10 . The drug delivery device of  claim 1 , wherein the extended release coat of the second population of unit dosage forms comprises a mixture of ethylcellulose and hydroxypropyl methyl cellulose. 
     
     
         11 . The drug delivery device of  claim 10 , wherein the ratio of ethylcellulose and hydroxypropyl methyl cellulose is 50:50. 
     
     
         12 . The drug delivery device of  claim 1 , wherein the extended release coat of the second population of unit dosage forms is applied to a weight gain of 4%. 
     
     
         13 . The drug delivery device of  claim 1 , wherein the first and second population of unit dosage forms are present in the drug delivery device in a ratio of 1:3. 
     
     
         14 . A drug delivery device for oral administration of an active pharmaceutical ingredient (API), the device comprising:
 a) a first population of unit dosage forms comprising a core, wherein the core comprises an API and microcrystalline cellulose and wherein the first population of unit dosage forms further comprises a pH-reactive coat; and   b) a second population of unit dosage forms comprising a core, wherein the core comprises an API and microcrystalline cellulose and wherein the second population of unit dosage forms comprises an extended release coat on the core and further comprises a pH-reactive coat on the extended release coat.   
     
     
         15 . The drug delivery device of  claim 14 , wherein the API is rivastigmine. 
     
     
         16 . The drug delivery device of  claim 15 , wherein the API is present in both the first population and second population in an amount of 3%. 
     
     
         17 . The drug delivery device of  claim 14 , wherein the microcrystalline cellulose is present in the core of the first and second population of unit dosage forms in an amount of 97%. 
     
     
         18 . The drug delivery device of  claim 14 , wherein the core for the first and second population of unit dosage forms is made by dissolving the API in water, granulating the API solution with the microcrystalline cellulose, extruding the granulated API-microcrystalline cellulose mixture to produce an extrudate, and forming core particles from the extrudate. 
     
     
         19 . The drug delivery device of  claim 14 , wherein the core particles are spheroids. 
     
     
         20 . The drug delivery device of  claim 14 , wherein the first and second population of unit dosage forms is each coated with the pH reactive coat to a coverage of 4 mg per cm 2 . 
     
     
         21 . The drug delivery device of  claim 14 , wherein the extended release coat of the second population of unit dosage forms comprises a mixture of ethylcellulose and hydroxypropyl methyl cellulose. 
     
     
         22 . The drug delivery device of  claim 21 , wherein the ratio of ethylcellulose and hydroxypropyl methyl cellulose is 60:40. 
     
     
         23 . The drug delivery device of  claim 14 , wherein the extended release coat of the second population of unit dosage forms is applied to a weight gain of 4% 
     
     
         24 . The drug delivery device of  claim 14 , wherein the first and second population of unit dosage forms are present in the drug delivery device in a ratio of 1:3.

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