Absorption enhancers for intranasal interferon administration
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Publication Number
US-8551468-B2
Publication Date
2013-10-08
Expiration Date
Abstract
A composition including a surfactant and at least one alkyl glycoside and/or saccharide alkyl ester and a drug. The surfactant composition(s) when admixed with a drug is non-toxic and non-irritating, while stabilizing and increasing the bioavailability of the drug. The invention also provides compositions that enhance absorption of drugs via the oral, ocular, nasal, nasolacrimal, inhalation or pulmonary, oral cavity (sublingual or Buccal cell) or CSF delivery route of a patient, including but not limited to insulin, glucagon and exendin-4.
Core Innovation
The invention relates to non-toxic, non-irritating surfactant compositions comprising alkyl glycosides and/or saccharide alkyl esters, including dodecyl-β-D-maltoside and tetradecylmaltoside, that stabilize therapeutic agents and enhance bioavailability. These carbohydrate-based nonionic surfactants function as mucosal delivery-enhancing agents, including for intranasal administration routes.
The problem addressed is the need for increasing absorption of therapeutic proteins and peptides, including interferon, via mucosal delivery while maintaining non-toxicity and non-irritating effects on mucosal surfaces. The background describes limitations that require absorption increasing agents to improve stability and uptake of therapeutic agents delivered through routes such as intranasal administration.
A core aspect is increasing absorption of interferon into cerebrospinal fluid (CSF) by intranasal administration of interferon together with an absorption increasing amount of a suitable nontoxic, nonionic alkyl glycoside. The document supports this by describing effects on intranasal bioavailability and subsequent delivery following intranasal administration, including CSF-related routes.
More broadly, the compositions and methods are described for enhancing absorption and systemic effects of multiple therapeutic cargos delivered through mucosal routes, including insulin and incretin-related peptides such as GLP-1/exendin-4, as well as other listed therapeutic agents including PYY. The described nonionic alkyl glycosides and saccharide alkyl esters are presented as aggregation inhibitory agents and aggregation inhibitory agents for drug/protein stabilization.
Claims Coverage
The partial content provides one independent claim. That claim defines a method with a single core inventive combination: intranasal interferon together with a specified nontoxic nonionic alkyl glycoside to increase interferon absorption into CSF.
Intranasal interferon with absorption increasing dodecyl-β-D-maltoside for CSF delivery
Administering intranasally interferon and an absorption increasing amount of a suitable nontoxic, nonionic alkyl glycoside, wherein the alkyl glycoside is dodecyl-β-D-maltoside, to increase absorption of interferon into the cerebrospinal fluid (CSF) of a subject.
Across the provided independent claim, the inventive concept is intranasal co-administration of interferon with a specified nontoxic nonionic alkyl glycoside (dodecyl-β-D-maltoside) to increase interferon absorption into CSF, with dependent claim refinements indicated in the partial content.
Stated Advantages
Non-toxic and non-irritating surfactant compositions.
Stabilizes therapeutic agents.
Enhances bioavailability.
Increases absorption of interferon into cerebrospinal fluid (CSF) following intranasal administration.
Documented Applications
Increasing absorption of interferon into cerebrospinal fluid (CSF) by intranasal administration of interferon together with an absorption increasing amount of dodecyl-β-D-maltoside.
Enhancing intranasal bioavailability and less variable intranasal bioavailability for MIACALCIN® (salmon calcitonin) when using alkyl glycoside.
Producing systemic hypoglycemic effects from ocular and intranasal insulin when using alkylmaltosides.
Improving intranasal glucose-lowering efficacy for exendin-4/exenatide with TDM (tetradecylmaltoside) relative to controls.
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