Manage your formulary budget
Deep knowledge on
small-molecule drugs and
the 110,000 global patents
Anticipate generic drug launch
Find generic entry opportunities
Drug patents …
… from Kazakhstan to Kalamazoo
Proactively manage your pharmacy inventory
Flat-rate pricing for predictable budgeting
Short-term plans for project- or client-based billing
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|Title:||Abuse-resistant mucoadhesive devices for delivery of buprenorphine|
|Abstract:||The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.|
|Inventor(s):||Finn; Andrew (Raleigh, NC), Vasisht; Niraj (Cary, NC)|
|Assignee:||BioDelivery Sciences International, Inc. (Raleigh, NC)|
1. An abuse deterrent mucoadhesive device for use in managing pain or opioid dependence, the device comprising: a mucoadhesive layer comprising between about 0.075 and
about 12 mg of buprenorphine buffered to a pH of between about 4.0 and about 6.0; and a backing layer comprising between about 0.0125 and about 2 mg of naloxone buffered to a pH between about 4.0 and about 4.8, wherein the pH of the mucoadhesive layer
and the pH of the backing layer are different, wherein the mucoadhesive layer and the backing layer comprise different combinations of polymers but each layer comprises at least one water-erodible polymer selected from the group consisting of: cellulosic
polymers, olefinic polymers, polyethers and polyalcohols, and wherein following transmucosal administration excessive exposure to buprenorphine is avoided while the abuse-deterrent effect of naloxone is retained.
2. The device according to claim 1, wherein the w/w ratio of buprenorphine to naloxone present in the device is between 1:1 and 10:1.
3. The device according to claim 2, wherein the w/w ratio of buprenorphine to naloxone present in the device is 6:1.
4. The device according to claim 3, wherein the mucoadhesive layer is buffered to a pH of between about 4.50 and about 5.50 and the wherein the backing layer is buffered to a pH of between about 4.10 and about 4.4.
5. The device according to claim 4, wherein the mucoadhesive layer is buffered to a pH of about 4.75 and the backing layer is buffered to a pH of about 4.25.
6. The device according to claim 1 wherein the bioavailability of buprenorphine absorbed from the device is greater than 40%.
7. The device according to claim 1, wherein the at least one water-erodible polymer is selected from the group consisting of: polyacrylic acid (PAA), sodium carboxymethyl cellulose (NaCMC), hydroxypropylmethyl cellulose (HPMC), polyvinylpyrrolidone (PVP), hydroxyethylmethyl cellulose (HEMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), polyvinyl alcohol (PVA), polyethylene glycol (PEG), polyethylene oxide (PEO), and ethylene oxide-propylene oxide co-polymers.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.