Digestive/laxative compositions

• US 8,057,831 B2
• Filed: 09/20/2002
• Issued: 11/15/2011
• Est. Priority Date: 03/21/2000
• Status: Active Grant

• Current Assignee: Mundipharma Singapore Holding Pte. Limited
• Original Assignee: Vital Food Processors Ltd. (Mundipharma International Limited)
• Inventors: Donaldson, Bruce William
• Primary Examiner(s): Vivlemore; Tracy
• Assistant Examiner(s): BERRIOS, JENNIFER A
• Application Number:
  US10/247,721
• Publication Number:
  US 20040058025A1
• Time in Patent Office: 3,343 Days
• Field of Search: 424/1
• US Class Current: 424/777
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents

Abstract

The use of actinidin as a digestive/laxative aid. Method of obtaining actinidin from fruit.

Claims

1. A method of treating digestive dysfunction comprising orally administering to a patient in need thereof an oral composition in the form of a tablet or capsule comprising about 1 to 30% by weight of actinidin together with pulp, at least a portion of said pulp being pulp of a fruit of genus Actinidia, and wherein said composition is obtained by processing said fruit at a temperature in the range of −

10°

C. to 10°

C. to prevent significant degradation of actinidin.

2. A method as claimed in claim 1 wherein when the actinidin is present in said composition in a proportion of about 1 to 30% by weight, a balance of said composition comprises said pulp.

3. A method as claimed in claim 1 wherein the actinidin is present in said composition in a proportion of about 10 to 20% by weight.

4. A method as claimed in claim 1 further comprising administering said composition before a meal.

5. A method as claimed in claim 1 further comprising administering about 10 to 250 mg of said actinidin per day.

8. A method as claimed in claim 1 wherein the pulp in the tablet or capsule is freeze dried pulp.

9. A method as claimed in claim 8 wherein the freeze dried pulp comprises about 83% w/w of the tablet or capsule.

10. A method as claimed in claim 9 wherein the actinidin is present in said composition in a proportion of about 17% by weight.

11. A method as claimed in claim 10 wherein the tablet or capsule weighs about 350 mg.

12. A method as claimed in claim 11 wherein the tablet or capsule contains about 60 mg of actinidin.

13. A method as claimed in claim 1 wherein the oral composition is administered orally from about 15 to 45 minutes prior to eating a meal.

14. A method as claimed in claim 10 wherein the oral composition is administered orally about 30 minutes prior to eating a meal.

30. A method as claimed in claim 1 wherein, when the actinidin is present in said composition in a proportion of about 1 to 30% by weight, a balance of said composition comprises about 99 to 70% by weight of said pulp.

6. An oral composition in the form of a tablet or capsule suitable for treating digestive dysfunction comprising about 1 to 30% by weight of actinidin together with processed pulp that has been recovered from fruit of the genus Actinidia.

7. A composition as claimed in claim 6, wherein said composition has been produced by:

(a) pulping fruit of the genus Actinidia to produce a pulped material,

(b) clarifying the pulped material to produce a clarified pulped material, and

(c) freeze drying the clarified pulped material,

wherein the steps (a) to (c) of said method are performed at a temperature of about minus 10°

C. to plus 10°

C., such that substantial degradation of actinidin is prevented.

23. An oral composition as claimed in claim 6 wherein the proportion of actinidin in the resulting composition is about 10% to 20% by weight.

24. An oral composition as claimed in claim 6, wherein the tablet or capsule contains milled freeze dried processed pulp recovered from the genus Actinidia.

25. An oral composition as claimed in claim 6, wherein the proportion of processed pulp in the tablet or capsule is at least 70% by weight.

26. An oral composition as claimed in claim 25, wherein the capsule is a gelatin capsule.

27. An oral composition as claimed in claim 26, wherein the proportion of processed pulp in the capsule is about 83% by weight.

28. An oral composition as claimed in claim 27, wherein the proportion of actinidin in the capsule is about 17% by weight.

29. An oral composition as claimed in claim 25, wherein the oral composition also contains a product chosen form the group comprising tabletting aids, flavouring agents, texture improving agents, and product improving additives.

15. A method of preparing a digestive/laxative composition comprising from about 1% to 30% by weight of actinidin, comprising the steps of:

(a) selecting fruit of the genus Actinidia containing an effective amount of the enzyme actinidin,

(b) pulping the fruit to produce a pulped material,

(c) clarifying the pulped material to produce a clarified pulped material,

(d) freeze drying the clarified pulped material to produce a freeze dried pulped material,

(e) milling the freeze dried pulped material into a powder containing both the active enzyme actinidin and the milled freeze dried pulped material, and

(f) forming the powder into a tablet or capsule suitable for oral administration to a human,

wherein at least steps (b) to (c) of said method are performed at a temperature of about minus 10°

C. to about 0°

C., such that substantial degradation of actinidin is prevented.

16. A method as claimed in claim 15, wherein said steps (a) to (e) are carried out without the addition of a reducing agent.

17. A method as claimed in claim 16, wherein said pulped material is clarified by centrifugation.

18. A method as claimed in claim 16, wherein said pulped material is clarified by freeze-concentrating.

19. A method as claimed in claim 18 wherein the proportion of actinidin in the resulting composition is at least about 3% by weight.

20. A method as claimed in claim 19 wherein the proportion of actinidin in the resulting composition is about 10% to 20% by weight.

21. A method as claimed in claim 20 wherein the proportion of pulped material in the tablet or capsule is about 83% w/w.

22. A method as claimed in claim 21 wherein the powder is mixed with a product chosen from the group comprising tabletting aids, flavouring agents, texture improving agents, and product improving additives, before being formed into said tablet or capsule.