Transcutaneous
Provided are topical delivery systems and methods for treating and/or preventing a disease or disorder in a subject, or for eliciting an immune response in a subject including applying, to at least a portion of the subject's post-auricular region, a topical delivery system including a therapeutically effective amount of a topical pharmaceutical composition comprising at least one active agent and a pharmaceutically acceptable carrier and/or adjuvant. The topical pharmaceutical composition can include a topical immunogenic composition. The topical delivery system can further include a flexible substrate in communication with the topical immunogenic composition. The subject can be a pediatric subject.
1. A topical delivery system, comprising:
a topical immunogenic composition comprising a therapeutically effective amount of a pharmaceutical composition comprising at least one Haemophilus influenzae vaccine agent and a pharmaceutically acceptable topical carrier and/or adjuvant and
a flexible substrate in communication with the topical immunogenic composition, wherein the flexible substrate is a bandage, cotton pad, gauze pad, poultice, tape or skin patch, and
wherein the topical delivery system is configured for application to the intact surface of the skin of a subject at a location in the post-auricular region of the subject.
2. The topical delivery system according to claim 1 , wherein the topical immunogenic composition comprises at least one adjuvant comprising a mucosal adjuvant.
3. The topical delivery system according to claim 2 , wherein the mucosal adjuvant is dmLT.
4. The topical delivery system according to claim 1 , wherein the flexible substrate comprises a skin-contacting surface.
5. The topical delivery system according to claim 4 , wherein the flexible substrate comprises the topical pharmaceutical composition.
6. The topical delivery system according to claim 4 , wherein the topical immunogenic composition is provided on the skin-contacting surface.
7. The topical delivery system according to claim 1 , wherein the flexible substrate comprises an backing having a lower surface and at least one active agent containing layer comprising the at least one active agent or the topical immunogenic composition, the active agent containing layer having a skin-contacting surface, the active agent containing layer provided on the lower surface of the backing such that during use the skin-contacting surface is in contact with a skin surface of a subject.
8. The topical delivery system according to claim 7 , wherein the at least one active agent containing layer comprises a polymeric matrix layer.
9. The topical delivery system according to claim 8 , wherein the active agent or the topical immunogenic composition is dispersed or suspended in the polymeric matrix layer.
10. The topical delivery system according to claim 8 , wherein the polymeric matrix layer is a pressure-sensitive adhesive matrix layer.
11. The topical delivery system according to claim 10 , wherein the wherein the active agent or the topical immunogenic composition is dispersed or suspended in the pressure-sensitive adhesive matrix layer.
12. The topical delivery system according to claim 8 , wherein the polymeric matrix layer releases the active agent at a predetermined controlled rate.
13. The topical delivery system according to claim 8 , wherein the polymeric matrix layer comprises one or more biodegradable or bioerodable polymers.
14. The topical delivery system according to claim 7 , wherein the backing is an adhesive backing or an occlusive adhesive backing.
15. The topical delivery system according to claim 7 , wherein the backing is an occlusive backing.
16. The topical delivery system according to claim 1 , wherein the post-auricular region does not comprise any portion of the subject's pinnae.
17. The topical delivery system according to claim 16 , wherein the subject is a pediatric subject.