MICRONIZED PLACENTAL TISSUE COMPOSITIONS AND METHODS OF MAKING AND USING THE SAME
Described herein are compositions composed of micronized placental components, extracts of micronized placental components, and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the micronized compositions and the extracts thereof are also described herein.
1 . A pharmaceutical composition comprising micronized placental tissue selected from the group consisting of amnion, chorion, intermediate tissue layer, or any combination thereof.
2 . The composition of claim 1 , wherein the composition comprises micronized amnion, chorion, intermediate tissue layer, or any combination thereof as individual components.
3 . The composition of claim 1 , wherein the composition comprises a micronized tissue graft comprising amnion, chorion, intermediate tissue layer, or any combination thereof.
4 . The composition of claim 1 , wherein the composition comprises micronized amnion and intermediate tissue layer as individual components, wherein the intermediate tissue layer has been removed from the amnion.
5 . The composition of claim 4 , wherein the micronized amnion has a particle size less than 200 μm.
6 . The composition of claim 4 , wherein the weight ratio of amnion to intermediate tissue layer is from 10:1 to 1:10.
7 . The composition of claim 4 , wherein the weight ratio of amnion to intermediate tissue layer is from 2:1 to 1:1 and the micronized amnion and intermediate tissue layer has a particle size from 25 μm to 200 μm.
8 . The composition of claim 1 , wherein the composition comprises a micronized tissue graft comprising at least two layers of chorion, at least two layers of amnion membrane, or at least one layer of chorion and amnion membrane.
9 . The composition of claim 1 , wherein the composition comprises a micronized amnion chorion tissue graft.
10 . The composition of claim 9 , wherein the micronized particles have a particle size less than 400 μm.
11 . The composition of claim 9 , wherein the micronized particles have a particle size from 150 μm to 350 μm.
12 . The composition of claim 9 , wherein the weight ratio of chorion to amnion is from 10:1 to 1:10.
13 . The composition of claim 9 , wherein the weight ratio of chorion to amnion is from 4:1 to 1:1 and the micronized particles have a particle size from 25 μm to 200 μm.
14 . The composition of claim 1 , wherein the composition further comprises a filler.
15 . The composition of claim 14 , wherein the filler comprises allograft pericardium, allograft acellular dermis, Wharton's jelly, purified xenograft Type-1 collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, or any combination thereof.
16 . The composition of claim 14 , wherein the filler comprises Wharton's jelly.
17 . The composition of claim 1 , wherein the amnion, chorion, intermediate tissue layer, or any combination thereof are cross-linked.
18 . The composition of claim 1 , further comprising a bioactive agent.
19 . The composition of claim 18 , wherein the bioactive agent comprises a hemostatic agent, a fibrin glue, an allograft, or an autogenous material.
20 . The composition of claim 1 , wherein the composition further comprises a pharmaceutically acceptable carrier.
21 . The composition of claim 20 , wherein the pharmaceutically acceptable carrier comprises water, aqueous hyaluronic acid, saline, Ringer's solution, dextrose solution, Hank's solution, a buffer, or a nonaqueous vehicle.
22 . The composition of claim 21 , wherein the buffer comprises a phosphate buffer, bicarbonate buffer, or Tris buffer.
23 . The composition of claim 20 , wherein the composition is injectable.
24 . The composition of claim 20 , wherein the composition is a liquid, gel, or paste.
25 - 48 . (canceled)
49 . A topical composition comprising the micronized composition of claim 1 and a pharmaceutically acceptable carrier.
50 . The composition of claim 49 , wherein the composition comprising micronized particles having a particle size from 20 μm to 100 μm.
51 . The composition of claim 49 , wherein the composition comprising micronized particles at from 0.5% to 20% by weight of the topical composition.
52 . The composition of claim 49 , wherein the composition comprising micronized particles at from 2% to 5% by weight of the topical composition.
53 . The composition of claim 49 , wherein the pharmaceutically acceptable carrier comprises a surfactant, an emulsifier, or a combination thereof.
54 . The composition of claim 49 , wherein the pharmaceutically acceptable carrier comprises a polyalkylene glycol.
55 . The composition of claim 49 , wherein the pharmaceutically acceptable carrier comprises a mixture of polyalkylene glycol and a fatty alcohol.
56 . The composition of claim 55 , wherein the polyalkylene glycol is polyethylene glycol and the fatty alcohol comprises capryl alcohol (1-octanol), 2-ethyl hexanol, pelargonic alcohol (1-nonanol), capric alcohol (1-decanol, decyl alcohol), undecyl alcohol (1-undecanol, undecanol, hendecanol), lauryl alcohol (dodecanol, 1-dodecanol), tridecyl alcohol (1-tridecanol, tridecanol, isotridecanol), myristyl alcohol (1-tetradecanol), pentadecyl alcohol (1-pentadecanol, pentadecanol), cetyl alcohol (1-hexadecanol), palmitoleyl alcohol (cis-9-hexadecen-1-ol), heptadecyl alcohol (1-n-heptadecanol, heptadecanol), stearyl alcohol (1-octadecanol), isostearyl alcohol (16-methylheptadecan-1-ol), elaidyl alcohol (9E-octadecen-1-ol), oleyl alcohol (cis-9-octadecen-1-ol), linoleyl alcohol (9Z,12Z-octadecadien-1-ol), elaidolinoleyl alcohol (9E,12E-octadecadien-1-ol), linolenyl alcohol (9Z,12Z,15Z-octadecatrien-1-ol) elaidolinolenyl alcohol (9E,12E,15-E-octadecatrien-1-ol), ricinoleyl alcohol (12-hydroxy-9-octadecen-1-ol), nonadecyl alcohol (1-nonadecanol), arachidyl alcohol (1-eicosanol), heneicosyl alcohol (1-heneicosanol), behenyl alcohol (1-docosanol), erucyl alcohol (cis-13-docosen-1-ol), lignoceryl alcohol (1-tetracosanol), ceryl alcohol (1-hexacosanol), montanyl alcohol, cluytyl alcohol (1-octacosanol), myricyl alcohol, melissyl alcohol (1-triacontanol), geddyl alcohol (1-tetratriacontanol), cetearyl alcohol, or any combination thereof.
57 . The composition of claim 55 , wherein the polyalkylene glycol is polyethylene glycol and the fatty alcohol is cetyl alcohol.
58 - 69 . (canceled)