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Publication Number
US-12285485-B2
Publication Date
2025-04-29
Expiration Date
Abstract
Disclosed are aqueous pharmaceutical compositions which provide sustained released delivery of corticosteroid compounds. The pharmaceutical composition comprises a soluble corticosteroid and at least one viscosity enhancing agent. Also provided are methods for using the pharmaceutical compositions in an epidural injection, intra-articular injection, or an intra-lesional injection.
Core Innovation
The invention relates to aqueous pharmaceutical compositions for sustained local pain and inflammation therapy, where the composition is injected into an intralesional or intra-articular space. The compositions are aqueous and substantially free of insoluble corticosteroids.
The composition includes a soluble corticosteroid selected from soluble salts of dexamethasone, together with at least one viscosity enhancing agent. The viscosity enhancing agent is sodium hyaluronate or hyaluronic acid, having a molecular weight between 500 kDa and 3.0 MDa.
By combining the soluble corticosteroid with the specified viscosity enhancing agent, the composition provides prolonged residency and sustained corticosteroid exposure at the injection site. The disclosure further describes viscosity-related formulation constraints and characterization, including viscosity and release behavior consistent with slower dissolution/release with higher hyaluronate.
Claims Coverage
The partial content provides one independent claim (clm-00001) directed to a method for treating pain by injection of a specified aqueous pharmaceutical composition into an intralesional or intra-articular space. The independent claim includes six core inventive elements: route/space of injection, soluble corticosteroid selection, viscosity enhancing agent identity, viscosity enhancing agent molecular weight, viscosity enhancing agent concentration, and exclusion of insoluble corticosteroids.
Injecting an aqueous composition into an intralesional or intra-articular space
Injecting an aqueous pharmaceutical composition into an intralesional or intra-articular space of an individual in need thereof to treat pain.
Soluble corticosteroid as soluble salts of dexamethasone
The aqueous pharmaceutical composition comprises a soluble corticosteroid selected from the group consisting of soluble salts of dexamethasone.
Viscosity enhancing agent is sodium hyaluronate or hyaluronic acid
The at least one viscosity enhancing agent is sodium hyaluronate or hyaluronic acid.
Viscosity enhancing agent molecular weight between 500 kDa and 3.0 MDa
The molecular weight of the at least one viscosity enhancing agent is between 500 kDa and 3.0 MDa.
Viscosity enhancing agent concentration between 1.0% w/v and 1.5% w/v
The concentration of the at least one viscosity enhancing agent is between 1.0% w/v and 1.5% w/v.
No insoluble corticosteroids
The aqueous pharmaceutical composition does not comprise insoluble corticosteroids.
Overall, the independent claim coverage is centered on a pain-treatment injection method using an aqueous, insoluble-corticosteroid-free formulation that couples a soluble dexamethasone salt with sodium hyaluronate or hyaluronic acid at specified molecular weight and concentration ranges.
Stated Advantages
Sustained local pain and inflammation therapy via prolonged residency/sustained corticosteroid exposure at injection sites.
Documented Applications
Treating pain in an individual by injecting an aqueous pharmaceutical composition into an intralesional space.
Treating pain in an individual by injecting an aqueous pharmaceutical composition into an intra-articular space.
Porcine epidural imaging to show longer localization/residency half-life for a formulation embodiment (SP-102) versus commercial products.
Histopathology evaluation indicating no infection or hemorrhage for the described in vivo context.
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