Composition and method for lactose hydrolysis

• US 6,410,018 B1
• Filed: 10/17/1995
• Issued: 06/25/2002
• Est. Priority Date: 09/28/1993
• Status: Expired due to Fees

• Current Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Smith, Leonard P., Eisenhardt, Peter F.
• Primary Examiner(s): Witz, Jean C.
• Application Number:
  US08/543,975
• Time in Patent Office: 2,443 Days
• Field of Search: 424/94.6, 424/94.61, 435/200
• US Class Current: 424/94.6
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases

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.

Claims

1. A solid, orally administrable composition for the enzymatic hydrolysis of lactose, comprising:

a therapeutic effective amount of a first, active lactase having a first optimum pH range;

a therapeutic effective amount of a second, active lactase having a second optimum pH range, wherein said first and second optimum pH ranges being different; and

a solid pharmaceutically acceptable carrier.

2. The composition of claim 1, wherein said first optimum pH range is within a pH range of about 3.0 to about 6.0.

3. The composition of claim 2, wherein said first, active lactase is a fungal lactase or bacterial lactase derived from Thermus aquaticus.

4. The composition of claim 1, wherein said second optimum pH range is within pH range of about 6.0 to about 8.0.

5. The composition of claim 4, wherein said second, active lactase is a yeast or bacterial lactase.

6. The composition of claim 1, wherein said second, active lactase is enterically coated.

7. A solid, orally administrable composition for treating or controlling the symptoms of lactose intolerance in humans, comprising:

a therapeutic effective amount of a first, active lactase having an optimum pH range which is within the pH range of the stomach environment;

a therapeutic effective amount of a second, active lactase having an optimum pH range which is within the pH range of the intestinal environment; and

a solid, pharmaceutically acceptable, orally administrable carrier material.

8. The composition of claim 7 wherein the optimum pH range of said first lactase is within the pH range of about 3.0 to about 6.0.

9. The composition of claim 8 wherein said first lactase is a fungal lactase or a bacterial lactase derived from Thermus aquaticus.

10. The composition of claim 9 wherein said first lactase is derived from the genera of fungi selected from the group consisting of Aspergillus, Mucor, Fusarium, Scopulariopsis, and Alternaria, and Curvularia.

11. The composition of claim 10 wherein said first lactase is derived from a fungi selected from the group consisting of Aspergillus oryzae, Aspergillus niger, Fusarium moniliforme, Scopulariopsis, Mucor pucillus, Alternaria alternara and Curvularia inaegualic.

12. The composition of claim 11 wherein said first lactase is derived from a fungi selected from the group consisting of Aspergillus oryzae, Aspergillus niger and Mucor pucillus.

13. The composition of claim 7 Wherein the optimum pH range of said second lactase is within the pH range of about 6.0 to about 8.0.

14. The composition of claim 13 wherein said second lactase is a yeast or bacterial lactase.

15. The composition of claim 14 wherein said second lactase is derived from the genera selected from the group consisting of Kluyveromyces, Lactobacillus, Bacillus, and Streptococcus.

16. The composition of claim 15 wherein said second lactase is derived from Kluyveromyces lactis, Kluyveromyces fragilis, Lactobacillus thermophilus, Bacillus circulans, Lactobacillus bulgaricus, Bacillus sp., Leuconostoc citrovorum, Bacillus stearothermophilus, and Streptococcus thermophilus.

17. The composition of claim 16 wherein said second lactase is Kluyveromyces lactic.

18. The composition of claim 17 wherein said second lactase is enterically coated.

19. The composition of claim 7 in a unit dosage form comprising an amount of said first lactase equivalent to about 3000 to about 6000 FCC Lac U and an amount of said second lactase equivalent to about 7000 to about 35,000 neutral lactase units.

20. A solid, 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 solid, pharmaceutically acceptable carrier.