WO2011035079A1 - Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency - Google Patents

Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency Download PDF

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Publication number
WO2011035079A1
WO2011035079A1 PCT/US2010/049203 US2010049203W WO2011035079A1 WO 2011035079 A1 WO2011035079 A1 WO 2011035079A1 US 2010049203 W US2010049203 W US 2010049203W WO 2011035079 A1 WO2011035079 A1 WO 2011035079A1
Authority
WO
WIPO (PCT)
Prior art keywords
digestive enzyme
lipase
units
usp
uncoated
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.)
Ceased
Application number
PCT/US2010/049203
Other languages
English (en)
French (fr)
Inventor
Gopi M. Venkatesh
Stephen Perrett
Ruth Thieroff-Ekerdt
Konstantino Efthymiopoulos
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.)
Adare Pharma Solutions Inc
Original Assignee
Eurand America 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43730817&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2011035079(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to JP2012529909A priority Critical patent/JP5877399B2/ja
Priority to KR1020127009516A priority patent/KR101771752B1/ko
Priority to CA2774269A priority patent/CA2774269C/en
Priority to NZ599143A priority patent/NZ599143A/en
Priority to RU2012113253/15A priority patent/RU2570376C2/ru
Priority to ES10817867.4T priority patent/ES2690661T3/es
Priority to CN201080041366.3A priority patent/CN102630164B/zh
Application filed by Eurand America Inc filed Critical Eurand America Inc
Priority to AU2010295494A priority patent/AU2010295494B2/en
Priority to EP10817867.4A priority patent/EP2477645B1/en
Priority to BR112012005837A priority patent/BR112012005837A8/pt
Priority to MX2012003214A priority patent/MX2012003214A/es
Publication of WO2011035079A1 publication Critical patent/WO2011035079A1/en
Priority to IL218656A priority patent/IL218656A/en
Anticipated expiration legal-status Critical
Priority to ZA2012/02761A priority patent/ZA201202761B/en
Priority to IL245875A priority patent/IL245875A0/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Definitions

  • the total amount of digestive enzymes (by weight) in the compositions or oral dosage forms of the present invention can be about 20-100%, 20-90%, 20-80%, 20- 70%, 20-60%, 20-50%, 20-40%, 20-30%, or about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100%.
  • the total amount of digestive enzymes is 60-90%.
  • the total amount of digestive enzymes e.g., pancrelipase
  • lactose lactose
  • sugar alcohols e.g. xylitol, sorbitol, maltitol
  • cellulose e.g. microcrystalline cellulose
  • modified celluloses e.g., hydroxypropylcellulose, carboxymethylcellulose sodium
  • alginic acid polyvinyl pyrrolidone (povidone)
  • suitable disintegrants include dibasic calcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, alginic acid,
  • the capsule is comprised of hydroxypropylmethylcellulose having a water content of less than about 2%.
  • the individual enterically coated beads can each have the same enteric coating composition, or can include mixtures of enterically coated beads, some of which have a different enteric coating composition. Any suitable combination of enteric coating compositions can be used to provide the desired type of therapeutic effect.
  • the uncoated digestive enzyme-containing beads further comprise lipase (in addition to protease), and the ratio of lipase activity in the enterically coated digestive enzyme-containing beads to the uncoated digestive enzyme-containing beads ranges from about 95:5 to about 50:50, whereby the lipase activity of the enterically coated beads ranges from about 1000 USP units to about 10,000 USP units; or the uncoated digestive enzyme-containing beads further comprise lipase (in addition to protease), and the ratio of lipase activity in the enterically coated digestive enzyme-containing beads to the uncoated digestive enzyme-containing beads ranges from about 95:5 to about 75:25, whereby the lipase activity of the coated beads ranges from about 1000 USP units to about 10,000 USP units.
  • the enterically coated digestive enzyme- containing beads further comprise protease (in addition to lipase), and the ratio of protease activity in the enterically coated digestive enzyme-containing beads to the uncoated digestive enzyme-containing beads ranges from about 5:95 to about 50:50, whereby the protease activity of the uncoated beads ranges from about 65,000 USP units to about 34,000 USP units; or the enterically coated digestive enzyme- containing beads further comprise protease (in addition to lipase), and the ratio of protease activity in the enterically coated digestive enzyme-containing beads to the uncoated digestive enzyme-containing beads ranges from about 5:95 to about 75:25, whereby the lipase activity of the uncoated beads ranges from about 65,000 USP units to about 34,000 USP units.
  • protease in addition to lipase
  • Each capsule of Composition A contains approximately 10 enteric coated small beads with a total of 10,000 USP Lipase Units and 34,000 USP Protease Units, and 10 non-coated beads 10,000 USP Lipase Units and 34,000 USP Protease Units.
  • Each capsule of Composition B contains approximately 2 enteric coated small beads with a total of 2,000 USP Lipase Units and 6,800 USP Protease Units, and 18 non- coated beads with a total of 18,000 USP Lipase Units and 61 ,200 USP Protease Units.
  • the individual current Pancreatic Enzyme Replacement Therapy (PERT) with enteric-coated PEP is used as the active control.
  • Patient inclusion criteria are as follows:
  • Frequency and severity of pain is recorded during Washout and the Treatment Periods on a daily basis. Efficacy is assessed by comparing frequency and severity of pain as well as use of pain medication between Treatment Periods for each of the treatment groups. Efficacy is also assessed by comparing CFA derived from a defined diet and 3 -day quantitative stool collection between Treatment Period 2 and Washout period for each of the treatment groups. Finally, frequency and severity of pain, and CFA are compared between groups in Treatment Period 2.
  • Eligible patients started the placebo baseline ambulatory phase (4 days). On day 5, they were hospitalized for 3 to 5 days, to undergo a "baseline” 72-hour CFA determination under a controlled diet and using a stool marker to indicate the beginning and end of the controlled diet period, while they continued receiving placebo treatment.
  • patients were randomized to a "high dose followed by a low dose” or to a "low dose followed by a high dose” enterically coated pancreatin dose sequence and proceeded to the first crossover phase.
  • Each crossover phase consisted of a stabilization period for 6 days at home, followed by a hospitalization of 3 to 5 days to undergo a 72-hour CFA determination using a controlled diet and using a stool marker to indicate the beginning and end of the controlled diet period.
  • a dosage form containing both enterically coated and uncoated digestive enzymes in a single pill or capsule will be effective for the treatment of chronic pancreatitis and any pancreatic disease presenting with both pain and malabsorption.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Nutrition Science (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
PCT/US2010/049203 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency Ceased WO2011035079A1 (en)

Priority Applications (14)

Application Number Priority Date Filing Date Title
MX2012003214A MX2012003214A (es) 2009-09-17 2010-09-17 Composiciones de enzima pancreatica y metodos para tratar pancreatitis e insuficiencia pancreatica.
AU2010295494A AU2010295494B2 (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
CA2774269A CA2774269C (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
NZ599143A NZ599143A (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
RU2012113253/15A RU2570376C2 (ru) 2009-09-17 2010-09-17 Композиции панкреатических ферментов и способы лечения панкреатита и недостаточности поджелудочной железы
ES10817867.4T ES2690661T3 (es) 2009-09-17 2010-09-17 Composiciones de enzimas pancreáticas y métodos para tratar la pancreatitis y la insuficiencia pancreática
CN201080041366.3A CN102630164B (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物及其用途
JP2012529909A JP5877399B2 (ja) 2009-09-17 2010-09-17 膵炎及び膵不全を治療するための膵酵素組成物及び方法
EP10817867.4A EP2477645B1 (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
BR112012005837A BR112012005837A8 (pt) 2009-09-17 2010-09-17 Composição de enzimas digestivas em multipartículas, forma de dosagem, método para o tratamento da dor proveniente da pancreatite, método para o tratamento da dor proveniente da pancreatite e da insuficiência pancreática, método para o tratamento da insuficiência pancreática exócrina e método para o tratamento da dor pancreática
KR1020127009516A KR101771752B1 (ko) 2009-09-17 2010-09-17 췌장 효소 조성물 및 췌장염 및 췌장 기능 부전을 치료하기 위하 방법
IL218656A IL218656A (en) 2009-09-17 2012-03-15 Preparations containing pancreatic enzyme and use in the preparation of a drug for the treatment of pancreatitis and pancreatic failure
ZA2012/02761A ZA201202761B (en) 2009-09-17 2012-04-16 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
IL245875A IL245875A0 (en) 2009-09-17 2016-05-26 Pancreatic enzyme preparations and methods for treating pancreatitis and pancreatic insufficiency

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24346709P 2009-09-17 2009-09-17
US61/243,467 2009-09-17

Publications (1)

Publication Number Publication Date
WO2011035079A1 true WO2011035079A1 (en) 2011-03-24

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ID=43730817

Family Applications (1)

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PCT/US2010/049203 Ceased WO2011035079A1 (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

Country Status (23)

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US (2) US8784884B2 (enExample)
EP (1) EP2477645B1 (enExample)
JP (1) JP5877399B2 (enExample)
KR (1) KR101771752B1 (enExample)
CN (2) CN102630164B (enExample)
AR (1) AR078291A1 (enExample)
AU (1) AU2010295494B2 (enExample)
BR (1) BR112012005837A8 (enExample)
CA (1) CA2774269C (enExample)
CL (1) CL2012000658A1 (enExample)
CO (1) CO6531419A2 (enExample)
ES (1) ES2690661T3 (enExample)
HK (1) HK1218886A1 (enExample)
IL (2) IL218656A (enExample)
MX (1) MX2012003214A (enExample)
MY (1) MY161843A (enExample)
NZ (1) NZ599143A (enExample)
RU (1) RU2570376C2 (enExample)
SA (1) SA110310695B1 (enExample)
TW (2) TW201639545A (enExample)
UY (1) UY32896A (enExample)
WO (1) WO2011035079A1 (enExample)
ZA (1) ZA201202761B (enExample)

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US9884025B2 (en) 2000-11-15 2018-02-06 Aptalis Pharma S.R.L. Microspheres of pancreatic enzymes with high stability and production method thereof
US9976171B2 (en) 2011-08-08 2018-05-22 Allergan Pharmaceuticals International Limited Method for dissolution testing of solid compositions containing digestive enzymes
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
US10206882B2 (en) 2007-02-20 2019-02-19 Allergan Pharmaceuticals International Limited Stable digestive enzyme compositions
US10993996B2 (en) 2013-08-09 2021-05-04 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
US11364205B2 (en) 2010-10-01 2022-06-21 Societe Des Produits Nestle S.A. Stable low digestive enzyme content formulation

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FR3079146B1 (fr) * 2018-03-23 2020-04-17 Karim Ioualalen Formulation gastroprotectrice de complexes d’enzymes permettant de restaurer la fonction digestive.
WO2021202363A1 (en) * 2020-03-30 2021-10-07 Wall Jai Combined animal-derived and synthetically produced pancreatic enzyme replacement therapy

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US4079125A (en) 1975-06-10 1978-03-14 Johnson & Johnson Preparation of enteric coated digestive enzyme compositions
US5260074A (en) 1992-06-22 1993-11-09 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5302400A (en) 1992-06-22 1994-04-12 Digestive Care Inc. Preparation of gastric acid-resistant microspheres containing digestive enzymes and buffered-bile acids
US5324514A (en) 1992-06-22 1994-06-28 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5460812A (en) 1992-06-22 1995-10-24 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5578304A (en) 1992-06-22 1996-11-26 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5378462A (en) 1992-08-19 1995-01-03 Kali-Chemie Pharma Gmbh Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin and a lower alcohol by extrusion and rounding
WO1997028788A1 (en) 1996-02-09 1997-08-14 Quadrant Holdings Cambridge Ltd. Solid formulations containing trehalose
US5750104A (en) 1996-05-29 1998-05-12 Digestive Care Inc. High buffer-containing enteric coating digestive enzyme bile acid compositions and method of treating digestive disorders therewith
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US10993996B2 (en) 2013-08-09 2021-05-04 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration

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US8784884B2 (en) 2014-07-22
CA2774269C (en) 2017-03-21
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US20140287035A1 (en) 2014-09-25
HK1218886A1 (zh) 2017-03-17
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AU2010295494A1 (en) 2012-03-29
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RU2012113253A (ru) 2013-10-27
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US20110064799A1 (en) 2011-03-17
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