Method and device for transdermal delivery of parathyroid hormone using a microprojection array
AssigneeCorium International, Inc.
InventorsParminder Singh, Danir Bayramov, Guohua Chen, Robert Wade Worsham
Life of this patent
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Abstract
A method and a drug delivery system for transdermally administering parathyroid hormone (PTH) in a pulsatile fashion are provided, where the drug delivery system comprises an array of microprojections each comprising PTH.
Claims25
A method of transdermally administering a dose of PTH to a mammalian subject, comprising:
- applying to a skin site of a subject a microprotusion array comprising a plurality of microprotrusions extending from an approximately planar base, each microprotrusion comprising an end portion distal to the base and an upper portion proximal to the base, the end portion comprising a tip of the microprotrusion, at least the end portion comprising parathyroid hormone (PTH) in a water-soluble polymer matrix,
- inserting all or a portion of the plurality of microprotrusions into the skin, and
- maintaining the array on the skin site for about 15 minutes or less;
- whereby the method achieves an average time to maximum PTH plasma concentration (Tmax) of about ten minutes or less.
A microprotrusion array for transdermal administration of a dose of parathyroid hormone (PTH) to a mammalian subject, said array comprising a plurality of microprotrusions extending from an approximately planar base, each microprotrusion comprising an end portion distal to the base and an upper portion proximal to the base, at least the end portion comprising parathyroid hormone (PTH) in a water-soluble polymer matrix,
- the water-soluble polymer matrix comprised of:
- (i) about 7.5-12.8% dry weight PTH;
- (ii) about 20-70% dry weight of at least one dextran polymer;
- and
- (iii) about 10-35% dry weight of at least one sugar or sugar alcohol;
- wherein the upper portion is comprised of at least one water-insoluble polymer;
- wherein said use comprises the transdermal administration of a dose of PTH to a mammalian subject by:
- applying the microprotrusion array to a skin site of the subject;
- inserting all or a portion of the plurality of microprotrusions into the skin, and
- maintaining the array on the skin site for about 15 minutes or less;
- whereby the use achieves an average time to maximum PTH plasma concentration (Tmax) of about ten minutes or less.
A kit, comprising:
- a microprotrusion array comprised of a plurality of microprotrusions extending from an approximately planar base, each microprotrusion comprising an end portion distal to the base and an upper portion proximal to the base, the end portion of each microprotrusion comprising parathyroid hormone (PTH) in a water-soluble polymer matrix comprising about 7.5-12.8% dry weight PTH, about 20-70% dry weight of at least one dextran polymer, and about 10-35% dry weight of at least one sugar or sugar alcohol, and the upper portion being comprised of at least one water-insoluble polymer, said array comprising a therapeutically effective amount of PTH in the water-soluble polymer matrix, and
- an applicator-assembly to which the microprotrusion array is insertable or affixable;
- wherein at least the end portion of each microprotrusion is fabricated to achieve an average time to maximum PTH plasma concentration (Tmax) of about ten minutes or less when applied to a subject.
Dependencies are inferred from the claim text.