Composition for use in the therapy of lactose intolerance or conditions arising from lactase deficiency

Abstract

The invention provides a composition for use in therapy of lactose intolerance or conditions arising from lactase deficiency, wherein the composition is a non-dairy solid dosage form comprising: (a) a lactase; and (b) one or more lactase-producing and/or lactase containing microorganisms selected from Lactobacillus delbrueckii ssp bulgaricus and Steptococcus thermophilus ; wherein the lactase (a) is other than a lactase derived from the said one or more microorganisms (b); and wherein the one or more lactase-producing and/or lactase-containing microorganisms (b) are in dried form. Also provided are uncoated capsule and tablet compositions containing the lactase and the lactase-producing and/or lactase-containing microorganisms.

1 - 21 . (canceled) 
     
     
         22 . A method for the therapy of lactose intolerance or conditions arising from lactase deficiency, which method comprises administering to a subject in need thereof an effective amount of a composition which is a non-dairy solid dosage form comprising:
 (a) a lactase which is stable and active in a pH range of 3 to 6; the term stable meaning that the lactase (a) still has at least 30% of its activity after one hour at 37° C. at a pH in the range from 3 to 6; and   (b) one or more lactase-producing and/or lactase-containing microorganisms selected from  Lactobacillus delbrueckii  ssp  bulgaricus  and  Steptococcus thermophilus;      wherein the lactase (a) is other than a lactase derived from the said one or more microorganisms (b); and wherein the one or more lactase-producing and/or lactase-containing microorganisms (b) are in dried form.   
     
     
         23 . A method according to  claim 22  wherein the dosage form is other than a capsule coated with an enteric coating. 
     
     
         24 . A method according to  claim 22  wherein the lactase-producing and/or lactase-containing organisms are not enterically coated. 
     
     
         25 . A method according to  claim 22  wherein the lactase (a) exhibits peak activity at a pH in the range from 3 to 6. 
     
     
         26 . A method according to  claim 22  wherein the lactase (a) is derived from a microorganism, and the composition is substantially free of the microorganism from which the lactase is derived. 
     
     
         27 . A method according to  claim 22  which contains both  Lactobacillus delbrueckii  ssp  bulgaricus  and  Steptococcus thermophilus.    
     
     
         28 . A method according to  claim 22  wherein the solid dosage form is selected from capsules, tablets, dragees, powders, pellets and granules. 
     
     
         29 . A method according to  claim 22  wherein the composition is in unit dosage form. 
     
     
         30 . A method according to  claim 29  wherein the unit dosage form is a capsule. 
     
     
         31 . A method according to  claim 22  wherein the composition contains between 2000 and 12000 FCC enzyme units of the lactase (a). 
     
     
         32 . A method according to  claim 22  wherein the composition contains from 50 million to 10 billion colony forming units of  Lactobacillus bulgaricus  and from 50 million to 10 billion colony forming units of  Steptococcus thermophilus.    
     
     
         33 . A method according to  claim 22  wherein the composition is substantially free of lactose. 
     
     
         34 . A method according to  claim 22  wherein the  Lactobacillus bulgaricus  is  Lactobacillus delbrueckii  LB-VC18 (deposition number: DSM 23320). 
     
     
         35 . A method according to  claim 22  wherein the  Steptococcus thermophilus  is  Streptococcus thermophilus  ST-VC18 (deposition number: DSM 23319). 
     
     
         36 . A method according to  claim 22  wherein the lactase (a) is derived from an  Aspergillus  species. 
     
     
         37 . A method according to  claim 36  wherein the  Aspergillus  species is  Aspergillus oryzae.    
     
     
         38 . A method according to  claim 22  wherein the composition is other than a composition containing in combination two or more added herbal extracts together with exogenous lipase and exogenous protease. 
     
     
         39 . A solid dosage form selected from capsules, tablets, dragees, powders, pellets and granules which is not coated by an enteric coating and which contains both (a) a lactase which is stable and active in a pH range of 3 to 6; the term stable meaning that the lactase (a) still has at least 30% of its activity after one hour at 37° C. at a pH in the range from 3 to 6; and (b) one or more lactase-producing or lactase-containing microorganisms selected from  Lactobacillus delbrueckii  ssp  bulgaricus  and  Steptococcus thermophilus ; wherein the lactase (a) is other than a lactase derived from the said one or more microorganisms (b); and wherein the one or more lactase-producing and/or lactase-containing microorganisms (b) are in dried form; and provided that the solid dosage form is other than a solid dosage form containing in combination two or more added herbal extracts together with exogenous lipase and exogenous protease. 
     
     
         40 . A solid dosage form according to  claim 39  wherein the lactase (a) exhibits peak activity at a pH in the range from 3 to 6. 
     
     
         41 . A solid dosage form according to  claim 39  wherein the lactase (a) is derived from a microorganism, and the solid dosage form is substantially free of the microorganism from which the lactase is derived. 
     
     
         42 . A solid dosage form according to  claim 39  which contains both  Lactobacillus delbrueckii  ssp  bulgaricus  and  Steptococcus thermophilus.    
     
     
         43 . A solid dosage form according to  claim 39  wherein the solid dosage form is selected from capsules, tablets and dragees. 
     
     
         44 . A solid dosage form according to  claim 39  wherein the solid dosage form is in unit dosage form. 
     
     
         45 . A solid dosage form according to  claim 44  wherein the unit dosage form is a capsule. 
     
     
         46 . A solid dosage form according to  claim 39  which contains between 2000 and 12000 FCC enzyme units of the lactase (a). 
     
     
         47 . A solid dosage form according to  claim 39  wherein the composition contains from 50 million to 10 billion colony forming units of  Lactobacillus bulgaricus  and from 50 million to 10 billion colony forming units of  Steptococcus thermophilus.    
     
     
         48 . A solid dosage form according to  claim 39  which is substantially free of lactose. 
     
     
         49 . A solid dosage form according to  claim 39  wherein the  Lactobacillus bulgaricus  is  Lactobacillus delbrueckii  LB-VC18 (deposition number: DSM 23320). 
     
     
         50 . A solid dosage form according to  claim 39  wherein the  Steptococcus thermophilus  is  Streptococcus thermophilus  ST-VC18 (deposition number: DSM 23319). 
     
     
         51 . A solid dosage form according to  claim 39  wherein the lactase (a) is derived from an  Aspergillus  species. 
     
     
         52 . A solid dosage form according to  claim 51  wherein the  Aspergillus  species is  Aspergillus oryzae.