Method for terminal sterilization of transdermal delivery devices
First Claim
1. A method for terminally sterilizing a transdermal device adapted to deliver a PTH-based agent, comprising the steps of:
- providing a microprojection member having a plurality of microprojections that are adapted to pierce the stratum comeum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon; and
exposing said microprojection member to radiation selected from the group consisting of gamma radiation and e-beam, wherein said radiation is sufficient to reach a desired sterility assurance level.
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Accused Products
Abstract
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.
49 Citations
32 Claims
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1. A method for terminally sterilizing a transdermal device adapted to deliver a PTH-based agent, comprising the steps of:
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providing a microprojection member having a plurality of microprojections that are adapted to pierce the stratum comeum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon; and
exposing said microprojection member to radiation selected from the group consisting of gamma radiation and e-beam, wherein said radiation is sufficient to reach a desired sterility assurance level. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for terminally sterilizing a transdermal device adapted to deliver a PTH-based agent, comprising the steps of:
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providing a microprojection member having a plurality of microprojections that are adapted to pierce the stratum comeum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon;
sealing said microprojection member with a desiccant inside packaging purged with nitrogen and adapted to control environmental conditions surrounding said microprojection member; and
exposing said microprojection member to radiation selected from the group consisting of gamma radiation and e-beam radiation, wherein said radiation is sufficient to reach a desired sterility assurance level. - View Dependent Claims (18, 19, 20, 21, 22)
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23. A method for terminally sterilizing a transdermal device adapted to deliver a PTH-based agent, comprising the steps of:
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providing a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon;
sealing said microprojection member inside packaging purged with an inert gas and adapted to control environmental conditions surrounding said microprojection member; and
exposing said microprojection member to e-beam radiation, wherein said radiation is sufficient to reach a desired sterility assurance level.
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24. A method for terminally sterilizing a transdermal device adapted to deliver a PTH-based agent, comprising the steps of:
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providing a microprojection member having a plurality of microprojections that are adapted to pierce the stratum comeum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon;
placing said microprojection member inside packaging adapted to control environmental conditions;
reducing moisture content inside said packaging;
sealing said microprojection member with said packaging; and
exposing said microprojection member to radiation selected from the group consisting of gamma radiation and e-beam, wherein said radiation is sufficient to reach a desired sterility assurance level.
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25. A transdermal system, adapted to deliver a PTH-based agent, comprising:
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a microprojection member including a plurality of microprojections that are adapted to pierce the stratum comeum of a patient having a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation having at least one PTH-based agent disposed thereon; and
packaging purged with an inert gas and adapted to control environmental conditions sealed around said microprojection member;
wherein said sealed package has been exposed to radiation to sterilize the microprojection member. - View Dependent Claims (26, 27, 28, 29, 30)
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31. A transdermal system, adapted to deliver a PTH-based agent, comprising:
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a microprojection member including a plurality of microprojections that are adapted to pierce the stratum comeum of a patient;
a hydrogel formulation having at least one PTH-based agent, wherein said hydrogel formulation is in communication with said microprojection member; and
packaging purged with an inert gas and adapted to control environmental conditions sealed around said microprojection member;
wherein said sealed package has been exposed to radiation to sterilize the microprojection member.
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32. A transdermal system, adapted to deliver a PTH-based agent, comprising:
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a microprojection member including a plurality of microprojections that are adapted to pierce the stratum comeum of a patient;
a solid film disposed proximate said microprojection member, wherein said solid film is made by casting a liquid formulation comprising at least one PTH-based agent, a polymeric material, a plasticizing agent, a surfactant and a volatile solvent; and
packaging purged with an inert gas and adapted to control environmental conditions sealed around said microprojection member;
wherein said sealed package has been exposed to radiation to sterilize the microprojection member.
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Specification