Method for terminal sterilization of transdermal delivery devices
First Claim
1. A method for terminally sterilizing a transdermal device adapted to deliver a natriuretic peptide, 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 natriuretic peptide 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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Abstract
A method and system for providing a terminally sterilized transdermal natriuretic peptide delivery device. A microprojection member having a plurality of stratum corneum-piercing microprojections is coated with a natriuretic peptide- formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the natriuretic peptide. 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 14-21 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.
34 Citations
32 Claims
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1. A method for terminally sterilizing a transdermal device adapted to deliver a natriuretic peptide, 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 natriuretic peptide 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 natriuretic peptide, 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 natriuretic peptide 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 natriuretic peptide, 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 natriuretic peptide 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 natriuretic peptide, 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 natriuretic peptide 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 natriuretic peptide, 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 natriuretic peptide 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 natriuretic peptide, 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 natriuretic peptide, 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 natriuretic peptide, comprising:
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a microprojection member including a plurality of microprojections that are adapted to pierce the stratum corneum 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 natriuretic peptide, 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