Enzyme delivery systems and methods of preparation and use
First Claim
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1. A method of preparing a coated controlled-release digestive enzyme preparation having enhanced flow properties, the method comprising:
- (a) screening uncoated digestive enzyme particles to obtain screened digestive enzyme particles of a suitable size for coating, wherein the digestive enzyme particles comprise digestive enzymes, and wherein the digestive enzymes comprise a protease, an amylase, and a lipase; and
(b) coating the screened digestive enzyme particles with a lipid to form coated digestive enzyme particles, wherein the coated digestive enzyme particles comprise a core that comprises the digestive enzymes and a coating that comprises the lipid, and wherein the digestive enzymes are present in the coated digestive enzyme particles in an amount of from about 75% to about 85% by weight.
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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.
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Citations
30 Claims
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1. A method of preparing a coated controlled-release digestive enzyme preparation having enhanced flow properties, the method comprising:
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(a) screening uncoated digestive enzyme particles to obtain screened digestive enzyme particles of a suitable size for coating, wherein the digestive enzyme particles comprise digestive enzymes, and wherein the digestive enzymes comprise a protease, an amylase, and a lipase; and (b) coating the screened digestive enzyme particles with a lipid to form coated digestive enzyme particles, wherein the coated digestive enzyme particles comprise a core that comprises the digestive enzymes and a coating that comprises the lipid, and wherein the digestive enzymes are present in the coated digestive enzyme particles in an amount of from about 75% to about 85% by weight. - View Dependent Claims (2, 3, 4, 5)
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6. A method of preparing a coated controlled-release digestive enzyme preparation, the method comprising:
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(a) obtaining digestive enzyme particles ranging from about 105 to 450 microns in size, wherein the digestive enzyme particles comprise digestive enzymes, and wherein the digestive enzymes comprise a protease, an amylase, and a lipase; and (b) coating the digestive enzyme particles with a lipid to form coated digestive enzyme particles, wherein the coated digestive enzyme particles comprise a core that comprises the digestive enzymes and a coating that comprises the lipid, and wherein the digestive enzymes are present in the coated digestive enzyme particles in an amount of from about 75% to about 85% by weight. - View Dependent Claims (7, 8, 9, 10)
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11. A method of preparing a coated controlled-release digestive enzyme preparation, the method comprising:
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(a) blending a lipid with one or more additives to obtain a lipid blend; (b) obtaining screened digestive enzyme particles, wherein the screened digestive enzyme particles comprise digestive enzymes, and wherein the digestive enzymes comprise a protease, an amylase, and a lipase; (c) coating the screened digestive enzyme particles with the lipid blend in a spray process to form coated digestive enzyme particles, wherein the coated digestive enzyme particles comprise a core that comprises the digestive enzymes and a coating that comprises the lipid blend, and wherein the digestive enzymes are present in the coated digestive enzyme particles in an amount of from about 75% to about 85% by weight; and (d) adjusting batch and oil temperatures during the spray process at periodic time intervals, whereby optimal spray conditions are maintained during said spray process. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification