CA2798280A1 - Micropellet compositions comprising pancreatin containing digestive enzyme mixture - Google Patents

Micropellet compositions comprising pancreatin containing digestive enzyme mixture Download PDF

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Publication number
CA2798280A1
CA2798280A1 CA2798280A CA2798280A CA2798280A1 CA 2798280 A1 CA2798280 A1 CA 2798280A1 CA 2798280 A CA2798280 A CA 2798280A CA 2798280 A CA2798280 A CA 2798280A CA 2798280 A1 CA2798280 A1 CA 2798280A1
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CA
Canada
Prior art keywords
pharmaceutical composition
particles
polymer
digestive enzyme
optionally
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.)
Abandoned
Application number
CA2798280A
Other languages
French (fr)
Inventor
Gopi M. Venkatesh
Craig Kramer
Flavio Fabiani
Luigi Mapelli
Giovanni Ortenzi
Massimo Latino
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.)
Allergan Pharmaceuticals Holdings Ireland ULC
Original Assignee
Aptalis Pharma Ltd
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 Aptalis Pharma Ltd filed Critical Aptalis Pharma Ltd
Publication of CA2798280A1 publication Critical patent/CA2798280A1/en
Abandoned legal-status Critical Current

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Classifications

    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/50—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/50—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
    • A61K9/5089—Processes
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention relates to a small particle size composition comprising pancreatin containing digestive enzymes for use in patients in need, including pediatric, geriatric, and adult patients, particularly those patients with dysphagia or wherein enteral administration using such composition would be suitable. In addition, the invention is directed to the composition as particles, such as micropellets or microgranules having a high potency, high useable yield and at least 10% - 90% of 400-800 µm. Furthermore, the composition optionally has an improved enteric coating and concomitant improved stability and enzyme activity compared to conventional prepared enterically coated pancreatic enzyme particles.

Claims (39)

1. A pharmaceutical composition comprising a plurality of particles comprising at least one digestive enzyme, wherein the particles have low particle size dimensions.
2. The pharmaceutical composition of claim 1, wherein the particles have a volume diameter d(v,0.1) of not less than about 400 µm and a volume diameter d(v,0.9) of no more than about 800 µm.
3. The pharmaceutical composition of claim 1, wherein the particles have particle size of less than about about 800 µm.
4. The pharmaceutical composition of claims 1 or 3, wherein the particles have particle size of about 400 µm to about 600 µm.
The pharmaceutical composition of claims 1 or 3, wherein the particles have particle size of about 250 µm to about 500 µm.
6. The pharmaceutical composition of claims 1, 2, 3, 4 or 5, wherein said particles have at least one coating and the particles comprise: about 40-98 wt.% of digestive enzyme mixture; about 2 -20 wt.% a polymer; optionally about 0-30 wt.% inert core;
and optionally one or more pharmaceutically acceptable excipients.
7. The pharmaceutical composition of claim 6, wherein said particles comprise at least about 60 % by weight of digestive enzyme mixture.
8. The pharmaceutical composition of claim 6, wherein said particles are micropellets and have at least one coating and they comprise: about 40-98 wt.% of digestive enzyme mixture; about 2 -10 wt.% a water soluble polymer; optionally about 0-wt.% inert core; and optionally one or more pharmaceutically acceptable excipients.
9. The pharmaceutical composition of claim 8, wherein the polymer is a polymer binder.
10. The pharmaceutical composition of claims 8 or 9, wherein the polymer binder is selected from the group consisting of hydroxypropylcellulose, povidone, methylcellulose, hydroxypropyl methylcellulose, carboxyalkylcellulose, polyethylene oxide, vinylpyrrolidone-vinyl acetate copolymer, polysaccharide, and mixtures thereof.
11. The pharmaceutical composition of claim 6, wherein said particles are microgranules and have at least one coating and they comprise: about 80-95 wt.% of digestive enzyme mixture; about 5 -20 wt.% a water insoluble polymer; and optionally one or more pharmaceutically acceptable excipients.
12. The pharmaceutical composition of claim 11, where the water insoluble polymer is a coacervated polymer.
13. The pharmaceutical composition of claims 11 or 12, wherein the polymer is ethylcellulose.
14. The pharmaceutical composition of claims 6, 7, 8, 9 or 10, wherein the coating comprises: one or more hydrophilic polymer, one or more plasticizers, and an optional pharmaceutically acceptable hydrophobic material.
15. The pharmaceutical composition of claims 6, 7, 8, 9,10, 11, 12 or 13, wherein the coating comprises: one or more enteric polymers, and one or more plasticizers.
16. The pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, wherein the at least one digestive enzyme is selected from the group consisting of pancrelipase, lipase, trypsin, chymotrypsin, chymotrypsin B, pancreatopeptidase, carboxypeptidase A, carboxypeptidase B, glycerol ester hydrolase, phospholipase, phospholipase A2, sterol ester hydrolase, ribonuclease, deoxyribonuclease, alpha-amylase, papain, chymopapain, bromelain, ficin, beta-amylase, cellulase, beta-galactosidase, and mixtures thereof.
17. The pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, wherein the at least one digestive enzyme is a mixture that comprises at least one lipase, at least one amylase, and at least one protease.
18. The pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, wherein the at least one digestive enzyme is derived from animal, bacterial, fungal, plant, recombinant origin or is chemically modified.
19. The pharmaceutical composition of claim 14, wherein the hydrophilic polymer is selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, low viscosity ethylcellulose, vinylpyrrolidone-vinyl acetate copolymer, polyvinyl alcohol, and mixtures thereof.
20. The pharmaceutical composition of claim 14, wherein the hydrophobic material selected from the group consisting of talc, colloidal silicon dioxide, and magnesium stearate, calcium stearate, zinc stearate, fatty acids glyceryl behenate, glyceryl palmitostearate, and mixtures thereof.
21. The pharmaceutical composition of claim 15, wherein the enteric polymer is selected from the group consisting of cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, and mixtures thereof.
22. The pharmaceutical composition of claim 15, wherein the plasticizer is selected from the group consisting of triacetin, tributyl citrate, triethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono-glyceride, acetylated di-glyceride, cetyl alcohol, and mixtures thereof.
23. The composition of claim 15, wherein said enteric coating further comprises an inorganic agent at a ratio of the enteric polymer to the inorganic agent of from about 4:1 to about 1:25 by weight.
24. The pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22 or 23, wherein the composition has a moisture content of about 3% or less as measured by loss on drying.
25. The pharmaceutical composition of of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, 16,17, 18, 19, 20, 21, 22, 23 or 24, wherein the digestive enzyme exhibits a loss of digestive enzyme activity of no more than about 20% after six months of accelerated stability testing.
26. The pharmaceutical composition of claim 25, wherein the accelerated stability testing comprises storing the composition in a sealed Nialene bag at 40°C, 75%
relative humidity for 6 months.
27. A method for preparing the pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, 16,17, 18, 19, 20, 21, 22 or 23, comprising forming of particles by controlled spheronization, powder layering or coacervation.
28. The method of claim 27, wherein the controlled spheronization is carried out by simultaneously directing a powder mixture comprising at least one digestive enzyme with a volume median diameter d(v,0.5) of no more than about 25 µm and optionally a polymer binder and a flow aid into a powder bed in a product chamber while spraying a polymer binder solution.
29. The method of claim 27, wherein the powder layering is carried out by directing to inert cores suspended in the product chamber a powder mixture comprising at least one digestive enzyme with a volume median diameter, d(v,0.5) of no more than about 25 µm and optionally a polymer binder and a flow aid while spraying a polymer binder solution.
30. The method of claim 27, wherein the coacervation is carried out with a water insoluble polymer dissolved in a hydrophobic organic solvent in presence of a phase separating agent.
31. The method of claim 30, where the water insoluble polymer is ethylcellulose, the hydrophobic organic solvent is cyclohexane and the phase separating agent is polyethylene.
32. A method of preparing a pharmaceutical composition comprising:

a) forming particles comprising at least one digestive enzyme with a d(v,0.1)-d(v,0.9) particle size in the range of about 400-800 µm, b) optionally coating the particles of step a) with a coating formulation comprising at least one hydrophilic polymer, and at least one plasticizer; and c) applying an enteric coating comprising an enteric polymer and optionally a plasticizer to the particles of step a) or to the particles of step b).
33. A method of preparing a pharmaceutical composition comprising:

a) forming particles comprising at least one digestive enzyme with particles size of about 250 µm to about 500 µm;

b) optionally coating the particles of step a) with a coating formulation comprising at least one hydrophilic polymer, and at least one plasticizer; and c) applying an enteric coating comprising an enteric polymer and optionally a plasticizer to the particles of step a) or to the particles of step b).
34. The method of claims 29 or 30, where step a) is carried out by spheronization, powder layering or coacervation.
35. A dosage form comprising the composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, 16,17, 18, 19, 20, 21, 22 or 23.
36. The dosage form of claim 35 which is a capsule, sachet, or tablet.
37. The dosage form of claim 36, wherein the capsule comprises hydroxypropylmethylcellulose with moisture content of about 3% or less.
38. A method of treating or preventing a patient with a disorder associated with digestive enzyme deficiency comprising administering the pharmaceutical composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, 16,17, 18, 19, 20, 21, 22 or 23 to a patient for the treatment of digestive disorders, exocrine pancreatic insufficiency, cystic fibrosis, diabetes type I and/or type II.
39. A method of treating or preventing a patient with a disorder associated with digestive enzyme deficiency comprising administering a composition of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, 16,17, 18, 19, 20, 21, 22 or 23 in combination with a medicament which increases GI tract pH, to patients in need thereof.
CA2798280A 2010-05-03 2011-05-03 Micropellet compositions comprising pancreatin containing digestive enzyme mixture Abandoned CA2798280A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33076810P 2010-05-03 2010-05-03
US61/330,768 2010-05-03
PCT/US2011/035023 WO2011140106A1 (en) 2010-05-03 2011-05-03 Micropellet compositions comprising pancreatin containing digestive enzyme mixtures

Publications (1)

Publication Number Publication Date
CA2798280A1 true CA2798280A1 (en) 2011-11-10

Family

ID=44904036

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2798280A Abandoned CA2798280A1 (en) 2010-05-03 2011-05-03 Micropellet compositions comprising pancreatin containing digestive enzyme mixture

Country Status (10)

Country Link
EP (1) EP2566466A1 (en)
JP (1) JP2013525488A (en)
CN (1) CN102946872A (en)
AU (1) AU2011248293A1 (en)
CA (1) CA2798280A1 (en)
CO (1) CO6640298A2 (en)
IL (1) IL222796A0 (en)
MX (1) MX2012012794A (en)
RU (1) RU2012148776A (en)
WO (1) WO2011140106A1 (en)

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CN104906565B (en) * 2015-05-13 2018-06-19 西南大学 A kind of pancreatic enzymes enteric coated pellets and preparation method thereof
CN106237315A (en) * 2016-08-02 2016-12-21 马南行 A kind of compositions of external curing diabetes and preparation method thereof
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IT201700021852A1 (en) * 2017-02-27 2018-08-27 Bioscreen Tech S R L RELEASED COMPOSITION OF PHYSIOLOGICALLY ACTIVE SUBSTANCES AND PROCESS FOR ITS PREPARATION
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EP3755376A4 (en) * 2018-02-23 2021-12-01 Mucpharm Pty Ltd Formulations containing mucin-affecting proteases
CN108531538A (en) * 2018-04-08 2018-09-14 武汉藤欣生物工程有限公司 A kind of method that enzyme process prepares phytosterin ester
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CN110075279A (en) * 2019-04-25 2019-08-02 淮安麦德森制药有限公司 Pancreatin microballoon and its production method
CN110331138A (en) * 2019-06-29 2019-10-15 南京永正生物科技有限公司 A kind of production technology of biological complex enzyme microcapsules
RU2706003C1 (en) * 2019-09-09 2019-11-13 Акционерное общество "АВВА РУС" Microgranules containing pancreatin
CN112220916A (en) * 2020-10-26 2021-01-15 西南药业股份有限公司 Preparation process of biological enzyme tablet and product thereof
CN114767639A (en) * 2022-05-13 2022-07-22 天津博菲德科技有限公司 Acid-resistant enzyme preparation granule and preparation method thereof

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Also Published As

Publication number Publication date
CO6640298A2 (en) 2013-03-22
IL222796A0 (en) 2012-12-31
CN102946872A (en) 2013-02-27
RU2012148776A (en) 2014-06-10
JP2013525488A (en) 2013-06-20
AU2011248293A1 (en) 2012-11-15
EP2566466A1 (en) 2013-03-13
WO2011140106A1 (en) 2011-11-10
MX2012012794A (en) 2013-03-12

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Effective date: 20160504