US 12,246,098 B2
Trans-epithelial membrane drug delivery system
John J. Masiz, Gloucester, MA (US); and Zhen Zhu, Andover, MA (US)
Assigned to BioPhysics Pharma, Inc., Gloucester, MA (US); and John J. Masiz, Gloucester, MA (US)
Filed by BioPhysics Pharma, Inc., Gloucester, MA (US); and John J. Masiz, Gloucester, MA (US)
Filed on Mar. 13, 2024, as Appl. No. 18/604,319.
Application 18/604,319 is a continuation in part of application No. 18/526,864, filed on Dec. 1, 2023.
Application 18/526,864 is a continuation of application No. 17/884,727, filed on Aug. 10, 2022, granted, now 11,865,217, issued on Jan. 9, 2024.
Application 17/884,727 is a continuation of application No. 16/582,922, filed on Sep. 25, 2019, granted, now 11,446,257, issued on Sep. 20, 2022.
Claims priority of provisional application 62/737,479, filed on Sep. 27, 2018.
Prior Publication US 2024/0216292 A1, Jul. 4, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/70 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 47/18 (2017.01)
CPC A61K 9/7084 (2013.01) [A61K 9/0014 (2013.01); A61K 45/06 (2013.01); A61K 47/18 (2013.01)] 24 Claims
OG exemplary drawing
 
1. A formulation for trans-epithelial membrane delivery of an active ingredient to a mammal; the formulation comprises:
a) at least one first penetration agent, wherein the at least one first penetration agent is present in an amount ranging from 0.01% w/w to 2.0% w/w, wherein the at least one penetration agent is acetylcysteine, N-acetylcysteine, L-cysteine, ambroxol, bromhexine, carbocisteine, erdosteine, mecysteine, dornase alfa, althea extract, Marshmallow root, bromelain, thyme, salt water, eucalyptol, rosemary extract, cineole, peppermint, frankincense, oregano, bergamot, nutmeg, cypress, camphene, geranium, pelargonium sidoide, cinnamon, lemon, citrus, d-limonene, 1-limonene, lavender, lemon grass, chamomile, basil or a combination thereof;
b) at least one basement membrane disruptor, wherein the at least one basement membrane disruptor is present in an amount ranging from 0.2% w/w to 10% w/w, wherein the at least one basement membrane disruptor is a serine protease, a cysteine protease, a threonine protease, an aspartic protease, a glutamic protease, a lipase, a lactase, an ox bile extract, a phytase, a pancreatin, a pepsin, Chymotrypsin A, α-trypsin, and β-trypsin, papain, papaya, bromelain, pineapple, or a combination thereof;
c) at least one vaso-modulator present in an amount ranging from 0.001% w/w to 15% w/w; and
d) at least one active ingredient;
wherein the formulation has a pH of between about 5.0 and about 6.5; and wherein the formulation allows for penetration of the active ingredient past the basement membrane.