MICRONIZED PLACENTAL TISSUE COMPOSITIONS WITH OPTIONAL SEALANT AND METHODS OF MAKING AND USING THE SAME
Described herein are compositions composed of micronized placental components and optionally a sealant, and pharmaceutical compositions thereof. Also described are systems, apparatuses, and methods for applying the combination of micronized placental components and adhesives optionally a sealant (e.g., adhesive or gelation agent) for wound care and other medical applications.
1 . A composition comprising micronized placental tissue selected from the group consisting of amnion, chorion, intermediate tissue layer, or any combination thereof and a biocompatible adhesive or biocompatible gelation agent in a suitable excipient, wherein the composition is in a flowable form prior to application to a subject.
2 . The composition of claim 1 , wherein the composition is a liquid, a gel, or a paste prior to application.
3 . The composition of claim 1 , wherein the composition becomes a solid, a semi-solid, or a gel after application to a subject.
4 . The composition of claim 1 , wherein the biocompatible gelation agent comprises a thermosensitive sol-gel reversible hydrogel.
5 . The composition of claim 4 , wherein the biocompatible gelation agent is a poloxamer.
6 . The composition of claim 1 , wherein the biocompatible adhesive is selected from the group consisting of: polyacrylate, polyisobutylene, a methylidene malonate polymer, and a cyanoacrylate.
7 . The composition of claim 1 , wherein the micronized placental tissue and the biocompatible adhesive or gelation agent are mixed immediately prior to application to the wound.
8 . The composition of claim 1 , wherein the micronized placental tissue has a particle size of less than 100 μm.
9 . The composition of claim 1 which is a topical composition.
10 . The composition of claim 1 which is a sprayable composition.
11 . A system for dressing a wound, the system comprising:
a first composition comprising micronized placental tissue selected from the group consisting of amnion, chorion, intermediate tissue layer, or any combination thereof, wherein the first composition is in a flowable form;
a second composition comprising a biocompatible adhesive or gelation agent in a suitable excipient, wherein the second composition is in a flowable form; and
an administration device, comprising a first chamber having the first composition disposed therein, a second chamber having the second composition stored therein, and one or more apertures configured to expel the first and second compositions therefrom.
12 . The composition of claim 11 , wherein the composition is a liquid, a gel, or a paste prior to application.
13 . The system of claim 11 , wherein the micronized placental tissue has a particle size of less than 100 μm.
14 . The system of claim 11 , wherein biocompatible gelation agent comprises a thermosensitive sol-gel reversible hydrogel.
15 . The system of claim 11 , wherein biocompatible gelation agent comprises a poloxamer.
16 . The system of claim 11 , wherein the biocompatible adhesive is selected from the group consisting of: polyacrylate, polyisobutylene, a methylidene malonate polymer, and a cyanoacrylate.
17 . The system of claim 11 , wherein the administration device comprises a dual-chamber sprayer.
18 . The system of claim 11 , wherein the administration device comprises a double syringe.
19 . A method for dressing a wound to promote healing, the method comprising applying to a wound the composition of claim 1 .
20 . A method for dressing a wound to promote healing, the method comprising:
providing the system of claim 11 ;
positioning the administration device over a subject at the site of a wound; and
applying a force to the administration device to simultaneously apply the first and second compositions onto the wound, wherein applying a force to the administration device causes a pressure and/or a volume to change within both the first and the second chambers, resulting in expulsion of the first composition from the first chamber and expulsion of the second composition from the second chamber.
21 . The method of claim 20 , wherein the first and second compositions mix within a chamber or tube prior to expulsion from a proximal aperture of the administration device.
22 . The method of claim 20 , wherein the first composition is expelled from a first nozzle or aperture and the second composition is expelled from a second nozzle or aperture, and wherein mixing of the first and second compositions occurs only external to the administration device.