摘要:
The invention provides for a formulation for coating one or more microprojections which reduces or minimizes the loss of counterions from the coating in order to achieve a pH-stabilized formulation.
摘要:
The invention provides for a formulation for coating one or more microprojections which reduces or minimizes the loss of counterions from the coating in order to achieve a pH-stabilized formulation.
摘要:
An method and system for providing a terminally sterilized transdermal device adapted to delivery a PTH-based agent. A microprojection member that includes a plurality of stratum comeum-piercing microprojections is coated with PTH-based agent formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the PTH-based agent. Preferably, the microprojection member is sealed in packing with an inert atmosphere and reduced moisture. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 5-50 kGy. Also preferably, the irradiation is performed at −78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.
摘要:
Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.
摘要:
A method for formulating an immunologically active agent and an apparatus for delivery same, the method comprising the steps of providing a bulk immunologically active agent, subjecting the bulk immunologically active agent to tangential-flow filtration to provide an immunologically active agent solution, adding at least one excipient to the agent solution and spray-drying the agent solution to form an immunologically active agent product; the apparatus comprising a microprojection member that includes a plurality of microprojections having a biocompatible coating disposed thereon that includes a spray-dried immunologically active agent. In a preferred embodiment, the immunologically active agent comprises an influenza vaccine, more preferably, a split-varion influenza vaccine.
摘要:
An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the fentanyl-based agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having a fentanyl-based agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the fentanyl-based agent is contained in both the coating and the hydrogel formulation.
摘要:
A formulation for coating a transdermal delivery device having a plurality of stratum corneum-piercing microprojections, the formulation including a biologically active agent and at least one viscosity-enhancing counterion. Preferably, the formulation has a viscosity in the range of about 20-200 cp.
摘要:
Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.
摘要:
Provided herein are microprojections and microprojection arrays for delivering biologically active agents. Also provided herein are compositions suitable for coating such microprojections and microprojection arrays.
摘要:
Provided herein are microprojections and microprojection arrays wherein a microprojection is coated with at least two layers. One layer comprises a biologically active agent, for example, a PTH agent and optionally other excipients. Another layer, which is generally, initially devoid of active agent comprises a polymer or a mix of polymers to provide controlled release, for example sustained release, of the biologically active agent contained in the first layer. Microprojections coated with multiple layers, some layers containing a biologically active agent and other layers containing a polymer for controlled release are also contemplated herein.