# US 9,750,689 B2 · Transdermal silicone gel (silogel) compositions and methods of preparation

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- Number: US 9,750,689 B2
- Document ID: US9750689B2
- Status: Granted
- Kind: B2
- Application number: 14/551,644
- Filed: 2014-11-24
- Published: 2015-05-28
- Granted: 2017-09-05
- Earliest claimed: 2013-11-26
- Assignees: Humco Holding Group, Inc.
- Applicants: Humco Holding Group, Inc.
- Inventors: John Olin Trimble
- Web page: https://patentgrep.com/patent/US9750689B2

## CPC

- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/113: Multiple emulsions, e.g. oil-in-water-in-oil {(A61K9/0026 takes precedence)}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/195: having an amino group
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A silicone gel (“silogel”) composition used to deliver pharmaceutical products transdermally as well as a method for producing the silogel composition, which may contain up to 80% additive ingredients. Preferred embodiments of the invention may include silogel compositions which provide high viscosity/no separation due to API. They are not temperature-sensitive, have no shear stress from the ointment mill/EMP, have no gumming up/stickiness, and no hardening.

## Claims

### Claim 1

A silicone gel composition comprising:
a hydrophilic silicone copolyol, wherein the hydrophilic silicone copolyol comprises phenyl trimethicone, and wherein the phenyl trimethicone is present in a concentration of about 2.0 weight percent;
a lipophilic silicone copolyol, wherein the lipophilic silicone copolyol comprises C30-45 dimethicone, and wherein the C30-45 dimethicone is present in a concentration of about 2.50 weight percent;
a non-ionic oil-in-water (O/W) emulsifier agent, wherein the non-ionic oil-in-water (O/W) emulsifier agent comprises a blend of cetearyl alcohol and ceteareth-20, and wherein the non-ionic oil-in-water (O/W) emulsifier agent is present in a concentration of about 10.00 weight percent;
a non-ionic water-in-oil (W/O) emulsifier agent, wherein the non-ionic water-in-oil (W/O) emulsifier agent comprises a copolymer of hydroxyethyl acrylate and sodium acryloyldimethyl taurate, and wherein the non-ionic water-in-oil (W/O) emulsifier agent is present in a concentration of about 1.90 weight percent;
an inorganic hydrocolloid, wherein the inorganic hydrocolloid comprises magnesium aluminum silicate, and wherein the magnesium aluminum silicate is present in a concentration of about 1.50 weight percent;
an organic hydrocolloid, wherein the organic hydrocolloid comprises hydroxypropyl starch phosphate, and wherein the hydroxypropyl starch phosphate is present in a concentration of about 0.10 weight percent;
a biocompatible surfactant with phosphatidylcholine, wherein the biocompatible surfactant comprises lecithin, and wherein the lecithin is present in an amount of about 0.33 weight percent;
a first non-polar solvent, wherein the first non-polar solvent is light mineral oil, and wherein the light mineral oil is present in an amount of about 18 weight percent; and
a second non-polar solvent, wherein the second non-polar solvent is isopropyl palmitate, and wherein the isopropyl palmitate is present in an amount of about 0.33 weight percent.