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Sustained release buprenorphine microspheres (SRBM) and methods of use thereof

A slow-release, microsphere technology, applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problem of not providing pain control and other issues

Inactive Publication Date: 2018-12-21
BIODELIVERY SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral formulations are approved for once or twice daily dosing, but can be administered three times daily in some cases, and transdermal patches often do not provide 7-day pain control due to variable pharmacokinetics

Method used

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  • Sustained release buprenorphine microspheres (SRBM) and methods of use thereof
  • Sustained release buprenorphine microspheres (SRBM) and methods of use thereof
  • Sustained release buprenorphine microspheres (SRBM) and methods of use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0115] The purpose of this part of the toxicology study was to evaluate the blood plasma levels of Buprenorphine following a single dose of two 3 mg / kg subcutaneous injections of sustained-release buprenorphine reservoir microspheres (SRBM) on day 1 in male and female Göttingen minipigs. Pharmacokinetics (PK) of prenorphine and its major metabolite norbuprenorphine up to 60 days. The PK of three (3) different formulations of SRBM were evaluated and compared.

[0116] Blood samples were collected at time 0 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Blood samples were also collected for the remainder of the study at 48, 72, 120 and 168 hours post-dose and approximately weekly thereafter. Plasma concentration x time data for buprenorphine were evaluated.

[0117] for C max Values, compared with Group 2 preparation 1068-60 (25.0-32.5ng / ml) and Group 3 preparation 1068-78 (8.8-32.5ng / ml), Group 1 preparation 1068-57 (5.3-7.1ng / ml) ml) was significa...

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Abstract

The present invention is directed to a sustained release buprenorphine microsphere (SRBM) formulation capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 7days to about 6 months.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 62 / 298,777, filed February 23, 2016, the entire contents of which are incorporated herein by reference. Background technique [0003] Buprenorphine is sold under several trade names, one of which is For the maintenance treatment of opioid dependence. The molecular formula of buprenorphine hydrochloride is C 29 h 41 NO 4 HCl, and has a molecular weight of 504.10. It is a white or off-white crystalline powder, slightly soluble in water, easily soluble in methanol, soluble in ethanol, and practically insoluble in cyclohexane. Buprenorphine has been used to treat opioid dependence and pain. There are tablet formulations, sublingual oral film and buccal film formulations, and 7-day transdermal patches available. Oral formulations are approved for once or twice daily dosing, but three times daily dosing is possible in some cases, and transdermal patche...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/34A61K9/16A61K31/485A61P25/04A61P25/36
CPCA61K31/485A61K9/1647A61K9/0019A61P25/04A61P25/36A61K9/1635A61K9/1617
Inventor N·维斯特A·芬恩
Owner BIODELIVERY SCI