Stabilized and solubilized drug formulation for topical application and transdermal efficacy for cosmetic improvement and methods of formulation
OwnerPankaj Modiinventor
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Abstract
The invention relates to a novel stabilized and solubilized topical formulation for cosmetic improvements and methods of making the same comprising multiplexed molecular penetration enhancers and essential and semi-essential amino acid protein binders for the topical application and transdermal delivery of one or more active ingredients and/or pharmaceutical agents. The invention further relates to the use of the topical formulation in connection with the providing of cosmetic improvements in individuals.
Claims20
A stabilized, low viscosity protein composition for topical application and transdermal delivery of an active agent for therapeutic use or cosmetic improvement in humans, said composition comprising a hydrogel forming combination of collagen, elastin, or a combination thereof, one or more absorption enhancers selected from a groups consisting of short chain alcohols, long chain alcohols, or polyalcohols, amines and amides, comprising urea, amino acids or their esters, amides, AZONE(R), derivatives of AZONE(R), pyrrolidones, or derivatives of pyrrolidones, terpenes and derivatives of terpenes, fatty acids and their esters, macrocyclic compounds, tensides, sulfoxides, liposomes, transfersomes, lecithin vesicles, ethosomes, water surfactants polyols, small molecule tri, tetra, penta, hexa, septa and octa peptides, Acetyl Hexapeptide-3 Cosmetic Topical Peptide, Melanotan II, ACVR2B (ACE-031), Argireline AcetateArgireline, Matrixyl Acetate (palmitoyl pentapeptide, peptide GHK spontaneously complexes with copper, Palmitoyl Tetrapeptide-3, and derivatives and analogues, (e.g., Argireline NP, Acetyl Glutamyl Heptapetide, Matrixyl, Snap-8, Syn-Tacks, Syn-Coll, Syn-Hycan, Leuphasyl, Pepha-Tight, Tego Pep 4-17 and Trylagen) and a pharmaceutically acceptable buffer capable of providing a buffered pH range to the composition of between about pH 5 and about pH 6, sodium chloride and at least one therapeutic or cosmetic concentration of an active agent encapsulated in a micelle formed by a combination of surfactants, solvents and stabilizers and wherein said protein composition is stable in low viscosity form at room temperatures of between 10 and 30 degrees C. for a period in excess of six months.
A process for making a pharmaceutical composition, the process comprising the steps of preparing a pharmaceutical composition comprising a botulinum neurotoxin and a low viscosity carrier with skin absorption enhancers for the botulinum neurotoxin by mixing together the botulinum neurotoxin, the low viscosity carrier and small molecule tri, tetra, penta, hexa, septa and octa peptides, Acetyl Hexapeptide-3 Cosmetic Topical Peptide, Melanotan II, ACVR2B (ACE-031), Argireline AcetateArgireline, Matrixyl Acetate (palmitoyl pentapeptide, peptide GHK spontaneously complexes with copper, Palmitoyl Tetrapeptide-3, and derivatives and analogues, (e.g., Argireline NP, Acetyl Glutamyl Heptapetide, Matrixyl, Snap-8, Syn-Tacks, Syn-Coll, Syn-Hycan, Leuphasyl, Pepha-Tight, Tego Pep 4-17 and Trylagen) and a pharmaceutically acceptable buffer capable of providing a buffered pH range to the composition of between about pH 5 and about pH 6, sodium chloride.
A pharmaceutical composition comprising a botulinum neurotoxin type A and a cross linked, polymeric, hyaluronic acid carrier for the botulinum neurotoxin, wherein the polymeric hyaluronic acid has a molecular weight between about 10,000 Daltons and about 1 million Daltons, the concentration of the polymeric hyaluronic acid in the pharmaceutical composition is between 0.1 wt % and 0.5 wt % and the viscosity of the pharmaceutical composition is between 100 cps and about 500 cps at 25° C., at a shear rate of 0.1/second and small molecule tri, tetra, penta, hexa, septa and octa peptides, Acetyl Hexapeptide-3 Cosmetic Topical Peptide, Melanotan II, ACVR2B (ACE-031), Argireline AcetateArgireline, Matrixyl Acetate (palmitoyl pentapeptide, peptide GHK spontaneously complexes with copper, Palmitoyl Tetrapeptide-3, and derivatives and analogues, (e.g., Argireline NP, Acetyl Glutamyl Heptapetide, Matrixyl, Snap-8, Syn-Tacks, Syn-Coll, Syn-Hycan, Leuphasyl, Pepha-Tight, Tego Pep 4-17 and Trylagen) and a pharmaceutically acceptable buffer capable of providing a buffered pH range to the composition of between about pH 5 and about pH 6, sodium chloride.
A topical composition comprising (i) at least one active agent;
- (ii) a first compound, and (iii) a second compound, wherein the first compound and second compound are different, and each is selected from the group consisting of N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate and sodium lauryl sulfoacetate and small molecule tri, tetra, penta, hexa, septa and octa peptides, Acetyl Hexapeptide-3 Cosmetic Topical Peptide, Melanotan II, ACVR2B (ACE-031), Argireline AcetateArgireline, Matrixyl Acetate (palmitoyl pentapeptide, peptide GHK spontaneously complexes with copper, Palmitoyl Tetrapeptide-3, and derivatives and analogues, (e.g., Argireline NP, Acetyl Glutamyl Heptapetide, Matrixyl, Snap-8, Syn-Tacks, Syn-Coll, Syn-Hycan, Leuphasyl, Pepha-Tight, Tego Pep 4-17 and Trylagen) and a pharmaceutically acceptable buffer capable of providing a buffered pH range to the composition of between about pH 5 and about pH 6, sodium chloride.
A method comprising the steps of:
- (a) non-chemically disrupting the stratum corneum of the patient's skin to reduce impermeability of the stratum corneum:
- (b) applying a fluid to the patient's skin;
- (c) applying a transdermal formulation to the skin of the patient in an area that had the stratum corneum disrupted in step (a), comprising;
- (i) a pharmaceutical composition comprising a stabilized botulinum toxin provided in a dried state and an enhancing agent that is mixable with the stabilized botulinum toxin provided in a dried state and facilitates transdermal administration of a botulinum toxin in a bioactive form to a subdermal target site of a human patient
Dependencies are inferred from the claim text.