Abstract

A protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 38/39 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• A23J 3/00 - Working-up of proteins for foodstuffs
• A23L 2/66 - Proteins
• A23L 33/17 - Amino acids, peptides or proteins
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]

Abstract

A biotherapeutic ophthalmic solution that may include a silk-derived protein as an active ingredient. Ophthalmic formulations are critical to the delivery of dosage forms, user requirements, and maintaining product stability. The formulations described herein are ophthalmic solutions that are comfortable to the user while product stability is maintained, even after long-term storage. Numerous excipients, manufacturing processes, and container closures were evaluated for their ability to stabilize silk-derived protein under ambient and accelerated conditions. Analyses showed that a small sub-set of protein-containing formulations meet the high physiochemical property standards required for therapeutic ophthalmic solutions.

IPC Classes  ?

• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
• A61P 27/02 - Ophthalmic agents

Abstract

Described herein are methods for reducing inflammation by administration of an effective amount of silk-derived proteins (SDP) or a fraction thereof to a subject having an inflammatory condition. The methods include the treatment of inflammatory conditions and wounds, including corneal wounds, comprising the topical administration of an effective amount of SDP material as described herein.

IPC Classes  ?

• C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 47/02 - Inorganic compounds
• A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
• 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
• A61K 47/38 - CelluloseDerivatives thereof
• A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• A61K 38/01 - Hydrolysed proteinsDerivatives thereof
• A61K 47/10 - AlcoholsPhenolsSalts thereof, e.g. glycerolPolyethylene glycols [PEG]PoloxamersPEG/POE alkyl ethers
• A61F 2/14 - Eye parts, e.g. lenses or corneal implantsArtificial eyes
• A61K 47/42 - ProteinsPolypeptidesDegradation products thereofDerivatives thereof, e.g. albumin, gelatin or zein

Abstract

A protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 38/39 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• A23L 33/17 - Amino acids, peptides or proteins
• A23J 3/00 - Working-up of proteins for foodstuffs
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A23L 2/66 - Proteins
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

A biotherapeutic ophthalmic solution that may include a silk-derived protein as an active ingredient. The specific formulation of an ophthalmic composition is critical to meeting user requirements, to the delivery of dosage forms, and to maintaining product stability. The formulations described herein are ophthalmic solutions that are comfortable to the user while product stability is maintained, even after long-term storage. Numerous excipients, manufacturing processes, and container closures were evaluated for their ability to stabilize silk-derived protein under ambient and accelerated conditions. Analyses showed that only a very small subset of vehicle formulations were able to meet the high physiochemical property standards required for stabilizing protein-containing therapeutic ophthalmic solution formulations.

IPC Classes  ?

• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
• A61K 9/00 - Medicinal preparations characterised by special physical form

Abstract

A biotherapeutic ophthalmic solution that may include a silk-derived protein as an active ingredient. Ophthalmic formulations are critical to the delivery of dosage forms, user requirements, and maintaining product stability. The formulations described herein are ophthalmic solutions that are comfortable to the user while product stability is maintained, even after long-term storage. Numerous excipients, manufacturing processes, and container closures were evaluated for their ability to stabilize silk-derived protein under ambient and accelerated conditions. Analyses showed that a small sub-set of protein-containing formulations meet the high physiochemical property standards required for therapeutic ophthalmic solutions.

IPC Classes  ?

• A61F 2/14 - Eye parts, e.g. lenses or corneal implantsArtificial eyes
• A61K 47/02 - Inorganic compounds
• A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• A61K 47/42 - ProteinsPolypeptidesDegradation products thereofDerivatives thereof, e.g. albumin, gelatin or zein
• A61P 27/02 - Ophthalmic agents

Abstract

A biotherapeutic ophthalmic solution that may include a silk-derived protein as an active ingredient. Ophthalmic formulations are critical to the delivery of dosage forms, user requirements, and maintaining product stability. The formulations described herein are ophthalmic solutions that are comfortable to the user while product stability is maintained, even after long-term storage. Numerous excipients, manufacturing processes, and container closures were evaluated for their ability to stabilize silk-derived protein under ambient and accelerated conditions. Analyses showed that a small sub-set of protein-containing formulations meet the high physiochemical property standards required for therapeutic ophthalmic solutions.

IPC Classes  ?

• A61F 2/14 - Eye parts, e.g. lenses or corneal implantsArtificial eyes
• A61K 47/02 - Inorganic compounds
• A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids

Abstract

A protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 38/39 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• A23L 33/17 - Amino acids, peptides or proteins
• A23J 3/00 - Working-up of proteins for foodstuffs
• A23L 2/66 - Proteins

Abstract

Described herein are methods for reducing inflammation by administration of an effective amount of silk-derived proteins (SDP) or a fraction thereof to a subject having an inflammatory condition. The methods include the treatment of inflammatory conditions and wounds, including corneal wounds, comprising the topical administration of an effective amount of SDP material as described herein.

IPC Classes  ?

• C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 38/00 - Medicinal preparations containing peptides
• A61K 47/02 - Inorganic compounds
• A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
• 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
• A61K 47/38 - CelluloseDerivatives thereof
• A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• A61K 38/01 - Hydrolysed proteinsDerivatives thereof
• A61K 47/10 - AlcoholsPhenolsSalts thereof, e.g. glycerolPolyethylene glycols [PEG]PoloxamersPEG/POE alkyl ethers
• A61F 2/14 - Eye parts, e.g. lenses or corneal implantsArtificial eyes
• A61K 47/42 - ProteinsPolypeptidesDegradation products thereofDerivatives thereof, e.g. albumin, gelatin or zein

Abstract

Described herein are methods of enhancing wound healing using silk-derived proteins (SDP), including low molecular weight SDP fragments. Also described are compositions for the treatment of wounds, including corneal wounds, skin wounds, surgical incisions, burns, and skin ulcers, comprising SDP fragments, including low molecular weight SDP fragments.

IPC Classes  ?

• A21D 13/064 - Products with modified nutritive value, e.g. with modified starch content with modified protein content
• A61L 27/22 - Polypeptides or derivatives thereof
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
• A61P 27/02 - Ophthalmic agents
• A61P 17/02 - Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
• A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans

Abstract

The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 38/39 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• A23L 33/17 - Amino acids, peptides or proteins
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A23L 2/66 - Proteins
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Described herein are methods for reducing inflammation by administration of an effective amount of silk-derived proteins (SDP) or a fraction thereof to a subject having an inflammatory condition. The methods include the treatment of inflammatory conditions and wounds, including corneal wounds, comprising the topical administration of an effective amount of SDP material as described herein.

IPC Classes  ?

• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A61K 35/646 - Arachnids, e.g. spiders, scorpions, ticks or mites
• A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
• A61P 27/02 - Ophthalmic agents
• A61P 29/00 - Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agentsNon-steroidal antiinflammatory drugs [NSAID]
• C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans

Abstract

Described herein are methods for reducing inflammation by administration of an effective amount of silk-derived proteins (SDP) or a fraction thereof to a subject having an inflammatory condition. The methods include the treatment of inflammatory conditions and wounds, including corneal wounds, comprising the topical administration of an effective amount of SDP material as described herein.

IPC Classes  ?

• A61F 2/14 - Eye parts, e.g. lenses or corneal implantsArtificial eyes
• A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
• A61K 47/42 - ProteinsPolypeptidesDegradation products thereofDerivatives thereof, e.g. albumin, gelatin or zein
• C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans

Abstract

Described herein are methods of enhancing wound healing using silk-derived proteins (SDP), including low molecular weight SDP fragments. Also described are compositions for the treatment of wounds, including corneal wounds, skin wounds, surgical incisions, burns, and skin ulcers, comprising SDP fragments, including low molecular wight SDP fragments.

IPC Classes  ?

• A23L 2/66 - Proteins
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]

Abstract

The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 38/39 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A23L 2/66 - Proteins
• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A23L 33/17 - Amino acids, peptides or proteins
• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• C07K 14/78 - Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A23L 1/03 - containing additives (A23L 1/05, A23L 1/30, A23L 1/308 take precedence);;
• A23L 2/66 - Proteins

Abstract

The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A23J 3/04 - Animal proteins
• A23L 2/66 - Proteins
• A23L 33/17 - Amino acids, peptides or proteins
• A61K 35/64 - Insects, e.g. bees, wasps or fleas
• A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
• A61P 27/02 - Ophthalmic agents
• C07K 14/435 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans

Abstract

The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

IPC Classes  ?

• A61K 35/64 - Insects, e.g. bees, wasps or fleas