A formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.

An earplug (1) for administering a fluid agent into an ear canal is provided. The earplug (1) comprises a first part (10) adapted for insertion in the ear canal. The first part comprises an elongated member (11) having a chamber (12) for containing the fluid agent, the chamber (12) having at least one outlet (13) at a proximal end (14) of the elongated member (11); and a malleable member (17) disposed laterally of the elongated member (11). The earplug (1) further comprises a second part (20) comprising a piston (21). The piston (21) has a first end (22) which is insertable in the elongated member (11), and a second end (23) which has a push member (24). The piston (21) is displaceable from a first position (A) distally of the chamber (12) to a second position (B) within the chamber (12), such that the fluid agent is injected from the chamber (12) through the outlet (13) into the ear canal.

A method of improving integration and/or functionality of gonadal organoids introduced to a subject includes the steps of pre-treating the subject with a chorionic gonadotrophin (CG), administering a therapeutically effective amount of the gonadal organoids to the subject, and administering the CG to the subject over time post-treatment to maintain LHCG receptor expression and signaling.

A method of improving integration and/or functionality of gonadal organoids introduced to a subject includes the steps of pre-treating the subject with a chorionic gonadotrophin (CG), administering a therapeutically effective amount of the gonadal organoids to the subject, and administering the CG to the subject over time post-treatment to maintain LHCG receptor expression and signaling.

Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

A therapeutic system comprises an ocular insert placed on a region outside an optical zone of an eye. The ocular insert comprises two structures: a first skeletal structure and a second cushioning structure. The first structure functions as a skeletal frame which maintains positioning of the implant along the anterior portion of the eye and provides support to the second, cushioning structure. This first structure maintains the attachment of the therapeutic system to the anterior portion of the eye for at least thirty days. In some embodiments the first structure remains a constant size and shape, e.g. a ring shape, a ring with haptics, or a curvilinear ring that is confined to and restrainingly engages the inferior and superior conjunctival fornices so as to retain the implant within the tear fluid and/or against the tissues of the eye.

A therapeutic system comprises an ocular insert placed on a region outside an optical zone of an eye. The ocular insert comprises two structures: a first skeletal structure and a second cushioning structure. The first structure functions as a skeletal frame which maintains positioning of the implant along the anterior portion of the eye and provides support to the second, cushioning structure. This first structure maintains the attachment of the therapeutic system to the anterior portion of the eye for at least thirty days. In some embodiments the first structure remains a constant size and shape, e.g. a ring shape, a ring with haptics, or a curvilinear ring that is confined to and restrainingly engages the inferior and superior conjunctival fornices so as to retain the implant within the tear fluid and/or against the tissues of the eye.

Methods of preventing and/or treating ischemia, organ dysfunction and/or organ failure, including multiple organ dysfunction syndrome (MODS), and necrosis and apoptosis associated with organ dysfunction/failure, are provided. For instance, the methods involve contacting organ(s) with an oxygenated cholesterol sulfate (OCS), e.g. 5-cholesten-3,25-diol, 3-sulfate (25H-C3S). The organ(s) may be in vivo (e.g. in a patient that is treated with the OCS) or ex vivo (e.g. an organ that has been harvested from a donor and is to be transplanted).

Methods of preventing and/or treating ischemia, organ dysfunction and/or organ failure, including multiple organ dysfunction syndrome (MODS), and necrosis and apoptosis associated with organ dysfunction/failure, are provided. For instance, the methods involve contacting organ(s) with an oxygenated cholesterol sulfate (OCS), e.g. 5-cholesten-3,25-diol, 3-sulfate (25H-C3S). The organ(s) may be in vivo (e.g. in a patient that is treated with the OCS) or ex vivo (e.g. an organ that has been harvested from a donor and is to be transplanted).