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Assignees
Member
Libero PharmaLibero Pharma develops transdermal delivery systems for established opioid receptor antagonists, primarily focusing on Naltrexone, to address high unmet medical needs in chronic conditions including addiction, fibromyalgia, and Crohn’s disease. By employing patient-friendly transdermal patches, the company aims to enable better therapeutic outcomes through sustained drug delivery for individuals where existing oral or injectable treatments offer limited access or efficacy. The company has received notable research support, including a significant grant from the National Institute of Drug Abuse (NIDA), and focuses on expedited regulatory pathways leveraging established safety and efficacy data.
Libero Pharma develops transdermal delivery systems for established opioid receptor antagonists, primarily focusing on Naltrexone, to address high unmet medical needs in chronic conditions including addiction, fibromyalgia, and Crohn’s disease. By employing patient-friendly transdermal patches, the company aims to enable better therapeutic outcomes through sustained drug delivery for individuals where existing oral or injectable treatments offer limited access or efficacy. The company has received notable research support, including a significant grant from the National Institute of Drug Abuse (NIDA), and focuses on expedited regulatory pathways leveraging established safety and efficacy data.
Publication Number
US-9700552-B2
Publication Date
2017-07-11
Expiration Date
Abstract
The invention provides transdermal patches comprising an adhesive and a composition comprising naltrexone and either methyl oleate or isopropyl myristate, a kit comprising a plurality of such transdermal patches, a composition comprising naltrexone and methyl oleate, such a composition for use as a medicament, and compositions comprising naltrexone and methyl oleate or isopropyl myristate for use in the treatment of alcoholism or opiate addiction.
Core Innovation
The invention relates to a pharmaceutical transdermal patch that includes an adhesive and a composition comprising naltrexone and methyl oleate. The naltrexone and the methyl oleate of the composition are contained in a common matrix of the transdermal patch, so that both components are co-localized within the patch matrix for transdermal delivery.
The invention further supports transdermal patch performance by defining adhesive and membrane-related features. In particular, the adhesive is characterized by a Hildebrand solubility parameter of greater than about 17 (J/cm3)1/2, and the patch may include a naltrexone-permeable membrane layer having a defined porosity range.
The invention also describes transdermal patch embodiments directed to delivering therapeutically relevant naltrexone for treating alcoholism and opiate addiction. The described patch formats and related compositions include transdermal patch elements such as reservoir or monolithic patch configurations, adhesive matrix features, and naltrexone-permeable membrane layers, with methyl oleate and/or isopropyl myristate used as penetration enhancers in the patch matrix.
Claims Coverage
The independent claim is centered on a transdermal patch in which naltrexone and methyl oleate are both contained in a common matrix, with dependent claims adding specific adhesive, solubility, membrane, and use limitations. The main inventive features across the independent claim and its dependents are five: the common matrix arrangement, adhesive solubility parameter constraints, naltrexone solubility constraints in the adhesive, a naltrexone-permeable membrane porosity range, and optional temperature-elevating and patient-treatment use limitations.
Common-matrix naltrexone and methyl oleate transdermal patch
A transdermal patch comprising an adhesive and a composition comprising naltrexone and methyl oleate, wherein the naltrexone and the methyl oleate of the composition are contained in a common matrix of the transdermal patch.
High Hildebrand solubility parameter adhesive
The transdermal patch includes an adhesive whose Hildebrand solubility parameter is greater than about 17 (J/cm3)1/2.
Defined naltrexone solubility in adhesive
The transdermal patch is characterized by an adhesive in which naltrexone has solubility between about 2 and about 10 g per 100 g of adhesive.
Naltrexone-permeable membrane porosity range
The transdermal patch includes a naltrexone-permeable membrane layer with porosity between about 0.1 and 1 Å.
Heat-generating system for elevating composition temperature
The transdermal patch further includes a heat-generating system for elevating the temperature of the composition.
Treating alcoholism or opiate addiction by transdermal naltrexone delivery
A transdermal patch for treating a human patient with alcoholism or opiate addiction by applying the transdermal patch to deliver naltrexone through the skin.
Overall claim coverage focuses on a transdermal patch where naltrexone and methyl oleate are co-contained within a common patch matrix, supported by adhesive selection defined via a Hildebrand solubility parameter and by optional membrane porosity constraints. Additional coverage includes a defined adhesive naltrexone solubility range, optional heat-generating temperature elevation, and use for treating alcoholism and opiate addiction via transdermal naltrexone delivery.
Stated Advantages
Enables therapeutically relevant transdermal naltrexone flux for treating alcoholism and opiate addiction.
Enhanced naltrexone transport through skin when formulated with methyl oleate and/or isopropyl myristate in transdermal patch formats.
Documented Applications
Treating alcoholism in a human patient by applying a transdermal patch to deliver naltrexone through the skin.
Treating opiate addiction in a human patient by applying a transdermal patch to deliver naltrexone through the skin.
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