EP3344064A1 - Kits et procédés d'utilisation d'enzymes pour modifier des charges polysaccharidiques et des systèmes d'administration - Google Patents

Kits et procédés d'utilisation d'enzymes pour modifier des charges polysaccharidiques et des systèmes d'administration

Info

Publication number
EP3344064A1
EP3344064A1 EP16769585.7A EP16769585A EP3344064A1 EP 3344064 A1 EP3344064 A1 EP 3344064A1 EP 16769585 A EP16769585 A EP 16769585A EP 3344064 A1 EP3344064 A1 EP 3344064A1
Authority
EP
European Patent Office
Prior art keywords
polysaccharide
mass
enzyme
agalsidase
kit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP16769585.7A
Other languages
German (de)
English (en)
Other versions
EP3344064A4 (fr
Inventor
Leonard B. MILLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Aesthetic Technologies Inc
Original Assignee
Advanced Aesthetic Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Aesthetic Technologies Inc filed Critical Advanced Aesthetic Technologies Inc
Publication of EP3344064A1 publication Critical patent/EP3344064A1/fr
Publication of EP3344064A4 publication Critical patent/EP3344064A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66—Enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0036—Galactans; Derivatives thereof
    • C08B37/0039—Agar; Agarose, i.e. D-galactose, 3,6-anhydro-D-galactose, methylated, sulfated, e.g. from the red algae Gelidium and Gracilaria; Agaropectin; Derivatives thereof, e.g. Sepharose, i.e. crosslinked agarose

Definitions

  • Embodiments of the present invention were not conceived or reduced to practice with Federal sponsorship.
  • Polysaccharides are used as cosmetic fillers and as a component of injectable drug delivery systems.
  • the polysaccharides may have a long period of time before such are resorbed into the body through metabolism or other means.
  • Embodiments of the present invention facilitate the use of polysaccharides, particularly as such polysaccharides are used as fillers and drug delivery vehicles.
  • Embodiments of the present invention allow the polysaccharide to be modified in vivo or in vitro to impart special physical and chemical properties. For example, without limitation, the physical properties of texture, feel, resistance to pressure, viscosity and the like can be altered or modified, in vivo or in vitro. Similarly, the chemical properties resistance to degradation and speed of degradation can be modified or altered.
  • polysaccharide fillers used for cosmetic purposes typically comprise solutions of 1.0 to 5.0 %. These solutions may also comprise other materials to improve the flow or feel of the filler, such as hyaluronic acid, and anesthetic agents to address the potential discomfort during the administration of the filler. Anesthetic agents are well known in the art and include, without limitation, lidocaine. These fillers are administered to the deep layer of the skin.
  • One embodiment of the present invention is directed to a method of altering or modifying a mass comprising a polysaccharide held in the body of an animal.
  • the method comprises the steps of administering an effective amount of an enzyme for the polysaccharide to the mass.
  • the enzyme can be administered to the mass prior to the mass being placed in the body or after the mass has been placed in the body.
  • One embodiment of the method features a polysaccharide having one or more sugars selected from the group consisting of D-galactose and 3, 6-anhydro-L-galactopyranose.
  • a "drug delivery vehicle” comprises a polysaccharide and one or more drugs.
  • One embodiment of the method features an enzyme, alpha-galactosidase.
  • the enzyme is known in recombinant forms asagalsidase, in alpha and beta forms.
  • the enzyme is selected from the group consisting of agalsidase alpha and agalsidase beta.
  • Algalsidase beta is sold under the mark FABRAZYME ® (Genzyme, Cambridge, MA 02142).
  • Algalsidase alpha is sold in Europe under the mark REPLAGAL ® (Shire, Dublin, Ireland).
  • the enzyme has utility to remove the polysaccharide, control the delivery or release of drug and minimize the mark on the skin from the injection of drug.
  • one embodiment of an invention directed to a drug delivery system comprises a polysaccharide and an enzyme for said polysaccharide held in a vessel for reconstitution. Upon reconstitution, the enzyme begin metabolizing the polysaccharide. This metabolizing may continue after injection of the drug delivery system into a patient.
  • drug is used to refer to any compound or compounds used to effect a biological change or treat a medical condition. The drug may be incorporated into the polysaccharide prior to reconstitution or after
  • a further embodiment of the present invention is directed to a kit for performing dermal filling procedures or for the administration of drug.
  • the kit comprises a polysaccharide for forming a mass in the body of an animal and an enzyme for degrading the polysaccharide for administration to the mass held in the body to effect a modification or speeding the resorption of said mass.
  • One embodiment of the present kit features a polysaccharide having one or more sugars selected from the group consisting of D-galactose and 3, 6-anhydro-L-galactopyranose. These sugars are constituents of the polysaccharide, agarose.
  • agalsidase is selected from the group consisting of agalsidase alpha and agalsidase beta.
  • Figure 1 depicts a kit embodying features of the present invention. Detailed Description of the Invention
  • kits for performing dermal filling procedures or for the administration of drug will now be described in detail with respect to a kit for performing dermal filling procedures or for the administration of drug.
  • the present description is directed to embodiments which are considered to be the best mode to practice the present invention at the time of the writing of the present description. Those skilled in the art will recognize that the understanding of the best mode may change in time. Those skilled in the art will also recognize that the features of the present invention described are subject to alteration and modification and such that the present discussion should not be considered limiting.
  • kit is used to denote a bundled assembly of parts and constituents for performing a method.
  • the kit 11 comprises two vials, a first vial 13 containing a polysaccharide for forming a mass in the body of an animal and a second vial 15 containing an enzyme for degrading the polysaccharide for administration to the mass held in the body.
  • the first vial 13 and second vial 15 are bundled or held in a package 17 with means for administering the polysaccharide and means for administering the enzyme, in the form of first syringe 19 and second syringe 21 , and instructions 23.
  • the first vial 13 contains a polysaccharide for forming a mass in the body of an animal or patient.
  • the polysaccharide can be pre-made and in a final form ready for administration or be lyophilized for reconstitution with water.
  • the first syringe 19 is used to withdraw the reconstituted or pre-made polysaccharide for injection into an animal or patient.
  • a human subject may use the mass to conceal wrinkles or to build bulk to areas of the body showing signs of atrophy or for which a fuller appearance is desired.
  • the present kit features a polysaccharide having one or more sugars selected from the group consisting of D-galactose and 3, 6-anhydro-L-galactopyranose. These sugars are constituents of the polysaccharide, agarose, which is used as a dermal filler. Agarose is sold as a dermal filler under the mark ALGINESS ®.
  • the second vial 15 contains an enzyme to effect a modification or speeding the resorption of the mass.
  • the enzyme can be pre-made and in a final form ready for administration or be lyophilized for reconstitution with water.
  • the second syringe 21 is used to withdraw the reconstituted or pre-made polysaccharide for injection into the mass.
  • the subject may desire the mass to have a softer feel.
  • the enzyme is placed in the mass and the mass manipulated to distribute the enzyme where the enzyme may effect a degradation of the polysaccharide. The degradation of the polysaccharide softens the mass.
  • Embodiments of the present invention facilitate the use of polysaccharides, particularly as such polysaccharides are used as fillers and drug delivery vehicles.
  • Embodiments of the present invention allow the polysaccharide to be modified in vivo or in vitro to impart special physical and chemical properties. That is, the enzyme can be distributed into the
  • polysaccharide prior to administration of the polysaccharide or after administration of the polysaccharide to create a desired physical property of texture, feel, resistance to pressure, viscosity and the like.
  • chemical properties of resistance to degradation and speed of degradation can be modified or altered.
  • the modification of physical and chemical features of a polysaccharide used as a filler or drug delivery system allows the health practitioner to modify the filler mass after it has been placed in the body or prior to placement in the body.
  • embodiment of the present invention directed to a method of altering or modifying a mass comprising a polysaccharide held in the body of an animal.
  • the instructions direct the user to reconstitute the polysaccharide held in first vial 13 and the enzyme held in second vial 15 if reconstitution is needed.
  • the instructions 21 direct the user to administer polysaccaride held in the first vial 13.
  • the instructions 21 further direct the user to administer an effective amount of an enzyme for the polysaccharide to the mass.
  • the enzyme can be administered to the mass prior to the mass being placed in the body or after the mass has been placed in the body.
  • Embodiments of the method and kits feature a polysaccharide having one or more sugars selected from the group consisting of D-galactose and 3, 6-anhydro-L-galactopyranose. These sugars are the constituents of algarose. Algarose is used as a dermal filler and as a drug delivery vehicle.
  • Embodiments of the method and kits features an enzyme, agalsidase.
  • the enzyme is selected from the group consisting of agalsidase alpha and agalsidase beta.
  • Algalsidase beta can be administered in doses up to 1 mg/ kg body weight, but is typically used in an amount based on the mass of polysaccharide. Monographs for such enzymes are available from the respective manufacturers and are incorporated herein by reference.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Birds (AREA)
  • Biochemistry (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Organic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Des modes de réalisation de la présente invention concernent des kits, des compositions et des procédés permettant de modifier et d'altérer des charges polysaccharidiques et des systèmes d'administration de médicaments avec application d'une enzyme.
EP16769585.7A 2015-03-24 2016-03-23 Kits et procédés d'utilisation d'enzymes pour modifier des charges polysaccharidiques et des systèmes d'administration Pending EP3344064A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562137558P 2015-03-24 2015-03-24
PCT/US2016/023726 WO2016154277A1 (fr) 2015-03-24 2016-03-23 Kits et procédés d'utilisation d'enzymes pour modifier des charges polysaccharidiques et des systèmes d'administration

Publications (2)

Publication Number Publication Date
EP3344064A1 true EP3344064A1 (fr) 2018-07-11
EP3344064A4 EP3344064A4 (fr) 2019-08-07

Family

ID=56978996

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16769585.7A Pending EP3344064A4 (fr) 2015-03-24 2016-03-23 Kits et procédés d'utilisation d'enzymes pour modifier des charges polysaccharidiques et des systèmes d'administration

Country Status (2)

Country Link
EP (1) EP3344064A4 (fr)
WO (1) WO2016154277A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3582749A4 (fr) * 2017-02-18 2020-12-30 Advanced Aesthetic Technologies, Inc. Kits et procédés d'utilisation d'hyaluronidase pour modifier des charges polysaccharidiques et systèmes d'administration

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2540699A1 (fr) * 2003-10-01 2005-04-14 Momenta Pharmaceuticals, Inc. Polysaccharides pour l'administration pulmonaire d'agents actifs
EP1768687A2 (fr) * 2004-06-29 2007-04-04 Massachusetts Institute Of Technology Procedes et compositions concernant la modulation de jonctions intercellulaires
WO2007019554A2 (fr) * 2005-08-08 2007-02-15 Momenta Pharmaceuticals, Inc. Polysaccharides destines a l'administration de principes actifs
US20090274736A1 (en) * 2006-01-19 2009-11-05 Solazyme Inc. Nutraceutical Compositions From Microalgae And Related Methods of Production And Administration
WO2010065784A2 (fr) * 2008-12-03 2010-06-10 Jakk Group, Inc. Procédés, dispositifs et compositions pour un remplissage dermique
CN105745329B (zh) * 2012-01-18 2020-07-03 高丽大学校产学协力团 3,6-脱水-l-半乳糖的制备方法及其用途
ITMI20130507A1 (it) * 2013-04-04 2014-10-05 Ghimas Spa Composizione riempitiva (filler) per il trattamento di lipoatrofie

Also Published As

Publication number Publication date
WO2016154277A1 (fr) 2016-09-29
EP3344064A4 (fr) 2019-08-07

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