Composition and method for lactose hydrolysis
AssigneeMcNeil-PPC, Inc.
InventorsPeter F. Eisenhardt, Leonard P. Smith
Life of this patent
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Abstract
The present invention relates to a composition for the enzymatic hydrolysis of lactose containing two lactase enzymes having distinct pH optima. The composition is suitable for treating or controlling the symptoms of lactose intolerance in humans.
Claims46
A composition for the enzymatic hydrolysis of lactose, comprising:
- a first, active lactase having a first optimum pH range;
- and
- a second, active lactase having a second optimum pH range, wherein said first and second optimum pH ranges being different.
A process for the enzymatic hydrolysis of lactose in mammals, comprising:
- hydrolyzing in the stomach environment having a first pH a first portion of said lactose with first, active lactase having a first optimum pH range which encompasses said first pH;
- and
- hydrolyzing in the intestinal environment having a second pH a second portion of said lactose with a second, active lactase having a second optimum pH range which encompasses said second pH, said first pH and second pH being of a different magnitude.
A composition for treating or controlling the symptoms of lactose intolerance, in humans comprising:
- a first lactase having an optimum pH range which encompasses the pH range of the stomach environment and
- a second lactase having an optimum pH range which encompasses the pH range of the intestinal environment.
An oral dosage form for treating or controlling the symptoms of lactose intolerance in humans, comprising:
- an amount of a lactase derived from the fungi selected from the group consisting of Aspergillus oryzae and Aspergillus niger equivalent to about 3000 to about 6000 FCC Lac U;
- an amount of an enterically coated lactase derived from Kluyvercomyces lactis equivalent to about 7000 to about 35,000 neutral lactase units;
- and
- a pharmaceutically acceptable carrier.
A method for treating or controlling the symptoms of lactose intolerance comprising the oral administration of a composition comprising a first lactase having an optimum pH range which encompasses the pH of the stomach environment and a second lactase having an optimum pH range which encompasses the pH of the intestinal environment.
A method for treating or controlling the symptoms of lactose intolerance comprising the oral administration prior to or concurrently with the ingestion of lactose-containing food a composition comprising:
- an amount of a lactase derived from fungi selected from the group consisting of Aspergillus oryzae and Aspergillus niger equivalent to about 3000 to about 6000 FCC Lac U;
- an amount of an enterically coated lactase derived from Kluyvercomyces lactis equivalent to about 7000 to about 35,000 neutral lactase units;
- and
- a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.