Enzyme delivery systems and methods of preparation and use
First Claim
Patent Images
1. An encapsulated digestive enzyme preparation comprising:
- (a) a core containing a digestive enzyme particle; and
(b) a coating comprising an emulsifiable lipid, wherein the coating continuously coats the core and the emulsifiable lipid emulsifies upon exposure to a solvent, wherein the enzyme is present in the preparation in an amount of from about 5% to 95% by weight of the particles;
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Abstract
This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.
171 Citations
59 Claims
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1. An encapsulated digestive enzyme preparation comprising:
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(a) a core containing a digestive enzyme particle; and (b) a coating comprising an emulsifiable lipid, wherein the coating continuously coats the core and the emulsifiable lipid emulsifies upon exposure to a solvent, wherein the enzyme is present in the preparation in an amount of from about 5% to 95% by weight of the particles; - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 35)
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10. A pharmaceutical composition comprising a therapeutically effective amount of an encapsulated enzyme preparation, comprising
a core which comprises an amount of pancreatic or digestive enzymes effective for treating a subject suffering from autism, ADD, ADHD, Parkinson'"'"'s'"'"' disease, cystic fibrosis, or other neurological condition or behavioral disorder susceptible to treatment by the enzymes; - and
a coating comprising an emulsifiable lipid. - View Dependent Claims (11, 34)
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12. An enzyme delivery system comprising encapsulated enzyme preparation having particles which comprise:
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a core comprising pancreatic or digestive enzymes present in an amount of from about 5% to 95% by weight of the particles; and a generally uniform coating to provide for controlled release of the enzymes, said coating comprising an emulsifiable lipid; wherein the particles are non-aerosolizable. - View Dependent Claims (13, 21)
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36. A method for controlling rate of release of a digestive enzyme from an encapsulated digestive enzyme preparation upon exposure to a solvent, the method comprising:
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(a) providing digestive enzyme particles, (b) coating the digestive enzyme particles with an emulsifiable lipid to form an encapsulated digestive enzyme preparation;
wherein about 80% of the enzyme is released by 30 minutes in a dissolution test performed at pH 6.0. - View Dependent Claims (39, 40)
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37. A method for controlling rate of release of a digestive enzyme from an encapsulated composite upon exposure to a solvent, the method comprising:
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(a) providing digestive enzyme particles, (b) blending an emulsifiable lipid with an amount of one or more additives to obtain a lipid blend; and (c) coating the digestive enzyme particles with the lipid blend to form an encapsulated digestive enzyme preparation;
wherein the emulsifiable lipid and additive are not the same, and wherein the rate of release of the digestive enzyme from the encapsulated composite is decreased as the amount of additive is increased.
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38. A method for controlling rate of release of a digestive enzyme from an encapsulated composite upon exposure to a solvent, the method comprising:
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(a) providing digestive enzyme particles; (b) blending an emulsifiable lipid with an amount of one or more additives to obtain a lipid blend; and (c) coating the digestive enzyme particles with the lipid blend to form an encapsulated digestive enzyme preparation;
wherein the emulsifiable lipid and additive are not the same, and wherein the rate of release of the digestive enzyme from the encapsulated composite is increased as the amount of additive is decreased.
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41. A method for controlling rate of release of a digestive enzyme from an encapsulated digestive enzyme preparation upon exposure to a solvent, the method comprising:
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(a) providing digestive enzyme particles, (b) coating the digestive enzyme particles with an emulsifiable lipid to form an encapsulated digestive enzyme preparation;
wherein the encapsulated digestive enzyme preparation consists essentially of particles of less than about 150 μ
m.
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42. A method of treatment comprising administering to a subject with autism, ADD, ADHD, Parkinson'"'"'s'"'"' disease, cystic fibrosis, or other behavioral or neurological condition susceptible to treatment with digestive enzymes, at least two doses of a composition comprising a therapeutically effective amount of an encapsulated digestive enzyme preparation comprising:
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(a) a core comprising a digestive enzyme; and (b) a coating comprising an emulsifiable lipid. - View Dependent Claims (45, 46, 47)
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43. A method of administering digestive enzymes to a subject with autism, ADD, ADHD, Parkinson'"'"'s'"'"' disease, cystic fibrosis, or other behavioral or neurological condition susceptible to treatment with digestive enzymes, at least two doses of an encapsulated enzyme preparation wherein about 80% of the enzyme is released by 30 minutes in a dissolution test performed at pH 6.0.
- 44. A method of administering a sachet or pouch comprising an encapsulated digestive enzyme preparation to a patient in need thereof, the method comprising providing a powered preparation, housed in a sachet or pouch wherein the preparation is administered by addition to food or drink, through direct administration into the oral cavity, or by direct administration into the GI system through an NG-tube, G-tube or other GI entrances or deliveries.
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53. A method of preparing an encapsulated controlled release digestive enzyme preparation with enhanced flow properties useful in the treatment of individuals with autism, ADD, ADHD, Parkinson'"'"'s'"'"' Disease, cystic fibrosis and other neurological conditions, the method comprising:
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(a) screening uncoated digestive enzyme particles to obtain particles of a suitable size for encapsulation; and (b) coating the screened digestive enzyme particles with an emulsifiable lipid to form an encapsulated digestive enzyme containing a core which contains the digestive enzyme and a coating which contains the emulsifiable lipid. - View Dependent Claims (55, 57)
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54. A method of preparing an encapsulated controlled release digestive enzyme preparation useful in the treatment of individuals with autism, ADD, ADHD, Parkinson'"'"'s Disease, cystic fibrosis and other neurological conditions, the method comprising:
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(a) obtaining digestive enzyme particles ranging from about 105 to 450 microns; and (b) coating the pancreatic/digestive enzyme with an emulsifiable lipid to form an encapsulated pancreatic/digestive enzyme containing a core which contains the pancreatic/digestive enzyme and a coating which contains the blend of emulsifiable lipid. - View Dependent Claims (56)
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58. A method of preparing an encapsulated controlled release digestive enzyme preparation useful in the treatment of individuals with autism, ADD, ADHD, Parkinson'"'"'s Disease, cystic fibrosis and other neurological conditions, the method comprising:
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(a) blending an emulsifiable lipid with one or more additives to obtain a blend; (b) obtaining screened digestive enzyme particles; (c) coating the pancreatic/digestive enzyme with a lipid blend to form an encapsulated pancreatic/digestive enzyme containing a core which contains the pancreatic/digestive enzyme and a coating which contains the blend of emulsifiable lipid; and (d) adjusting batch and oil temperatures during the spray process at periodic time intervals whereby optimal spray conditions are maintained during said process. - View Dependent Claims (59)
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Specification