Pharmaceutical composition for subcutaneous administration
Inventors
Lucera, Erick • Barnes, Jessica • Saldanha, Joseph
Assignees
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Publication Number
US-12576093-B2
Publication Date
2026-03-17
Expiration Date
Abstract
This application concerns pharmaceutical compositions comprising cannabinoids which are suitable for subcutaneous administration in human subjects. Thus, this application concerns pharmaceutical compositions for subcutaneous administration. The pharmaceutical compositions according to the invention are particularly suitable for subcutaneous administration, which is advantageous for improving bioavailability and reducing toxicity.
Core Innovation
The invention relates to a pharmaceutical composition for subcutaneous administration that includes a cannabinoid, propylene glycol, diethylene glycol monoethyl ether, and optionally water for injection. The composition is defined by a cannabinoid concentration of at least about 25 g/L and a viscosity less than about 420 cP as measured at 25 degrees Celsius.
The patent also describes an ambulatory subcutaneous fluid delivery device that delivers a pharmaceutical composition through a needle to a subject with a basal delivery characteristic. The device includes a hydraulic fluid and a hydraulic basal chamber configured to drive a generally constant delivery of the pharmaceutical composition over time, with thermal coupling or thermal insulation to keep the fluid near skin temperature despite ambient temperature changes.
The patent further describes bolus dosing control integrated with the ambulatory basal delivery. It describes mechanical bolus dosing controls and a basal actuator arrangement using compression springs to minimize force drop and support consistent basal delivery, with optional temperature maintenance features keeping the fluid temperature about the same as the subject’s temperature.
Claims Coverage
The provided material identifies two independent claim groupings: a cannabinoid liquid composition claim and device/method coverage tied to hydraulic subcutaneous delivery, thermal regulation, and bolus/basal actuator functionality. Across these groupings, the inventive features focus on the excipient formulation constraints and ambulatory hydraulic delivery with temperature maintenance.
Cannabinoid liquid composition with defined excipients and viscosity
A pharmaceutical composition for subcutaneous administration consisting of a cannabinoid, propylene glycol, diethylene glycol monoethyl ether, and optionally water for injection, wherein the concentration of the cannabinoid is at least about 25 g/L and wherein the viscosity of the composition is less than about 420 centipoise (cP), as measured at 25 degrees Celsius.
Ambulatory hydraulic delivery with generally constant basal delivery through a needle
A fluid delivery device with a hydraulic pump chamber uses a first amount of hydraulic fluid to drive a fluid reservoir piston to deliver a generally constant amount of a pharmaceutical composition through a needle subcutaneously to a subject over a period of time.
Intermittent bolus dosing on top of sustained basal rate with selectable actuator operation and thermal temperature matching
Selectable actuator operation intermittently transfers hydraulic fluid to deliver additional bolus dosing in addition to sustained basal rate, optionally using compression springs, a positioned second hydraulic reservoir, a fixed-aperture flow restrictor, and/or a low specific heat capacity fluid reservoir to keep fluid temperature about the same as the subject’s temperature.
The claim coverage centers on a defined subcutaneous cannabinoid liquid formulation with constrained cannabinoid concentration and viscosity, combined with an ambulatory hydraulic subcutaneous delivery device that provides generally constant basal delivery through thermal regulation. The material further covers selectable actuator operation that adds intermittent bolus dosing on top of the sustained basal rate, with optional structural and thermal-temperature-matching features.
Stated Advantages
Addresses limitations of oral delivery, including bioavailability, short half-life, and liver toxicity concerns, by supporting subcutaneous administration.
Supports generally constant basal delivery with optional discrete bolus dosing via the described ambulatory fluid delivery device architecture.
Helps mitigate viscosity-driven flow variability by including temperature regulation features to keep fluid temperature about the same as the subject’s temperature.
Documented Applications
No documented applications found
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