Intramammary compositions

Abstract

The stability of an oily intramammary formulation containing a suspension of a solid clavulanic acid salt is improved by incorporation therein of molecular sieve powder.

What we claim is: 
     
       1. A liquid veterinary composition adapted for intramammary administration comprising a suspension of a powered solid pharmaceutically acceptable alkali metal, alkaline earth metal or amine salt of clavulanic acid in an amount of from .[.1.]. .Iadd.0.1 .Iaddend.to 40% by weight of said composition calculated on the basis of the equivalent weight of free clavulanic acid, and from 5 to 20% by weight of a powdered solid molecular sieve in a pharmaceutically acceptable oil carrier. .[.2. A composition 
     
     
        according to claim 1 also containing a penicillin or cephalosporin..]. 3. A composition according to claim .[.2.]. .Iadd.11 .Iaddend.wherein the solid salt of clavulanic acid is the sodium potassium, calcium, magnesium or t-butylamine salt. .[.4. A composition according to claim 2 wherein the penicillin is sodium amoxycillin, amoxycillin trihydrate, sodium ampicillin, ampicillin tryhydrate, sodium cloxacillin, benzathine 
     
     
        cloxacillin or sodium flucoxacillin..]. 5. An intramammary composition comprising a suspension in fractioned coconut oil of sodium amoxycillin or amoxycillin trihydrate; sodium or potassium clavulanate; and molecular sieve powder; in which composition the weight ratio of amoxycillin to clavulanate salt .[.(as free acids).]. is from 5:1 to 1:1, .Iadd.and .Iaddend.the .[.active ingredients (as free acids) is.]. .Iadd.amoxycillin and clavulanate comprise .Iaddend.from .[.1.]. .Iadd.0.1 .Iaddend.to 40% of the composition, .Iadd.calculated on the basis of the equivalent weight of free acids, .Iaddend.and the molecular sieve .[.is.]. .Iadd.comprises .Iaddend.from 5 to 20% of the composition .Iadd.by weight.Iaddend.. .Iadd. 6. A composition according to claim 11 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 1 to 40% by weight. .Iaddend..Iadd. 7. A composition according to claim 11 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 4 to 8% by weight. .Iaddend..Iadd. 8. A composition according to claim 11 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 15 to 25% by weight. .Iaddend..Iadd. 9. A composition according to claim 11 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 30 to 40% by weight. .Iadd. 10. A composition according to claim 1 wherein the molecular sieve is a crystalline sodium, potassium or calcium alumino-silicate. .Iaddend..Iadd. 11. A composition according to claim 1 wherein the sieve is a calcium alumino-silicate. .Iaddend..Iadd. 12. A composition according to claim 44 in unit dosage form which contains from 100 to 1200 mg of amoxycillin calculated on the basis of the equivalent weight of the free acid and from 20 to 300 mg. of clavulanate salt calculated on the basis of the equivalent weight of free acid in each dosage unit. .Iaddend..Iadd. 13. A composition according to claim 44 in unit dosage form which contains from 200 to 100 mg. of amoxycillin calculated on the basis of the equivalent weight of the free acid and from 25 to 100 mg. of clavulanate salt calculated on the basis of the equivalent weight of free acid in each dosage unit. .Iaddend..Iadd. 14. A method for the treatment or prophylaxis of mammary disorders in animals which comprises the intramammary administration of a therapeutically effective amount of a composition comprising a suspension of a powdered solid pharmaceutically acceptable alkali metal, alkaline earth metal or amine salt of clavulanic acid in an amount of from 0.1 to 40% by weight of said composition calculated on the basis of the equivalent weight of free clavulanic acid, and from 5 to 20% by weight of a powdered solid molecular sieve in a pharmaceutically acceptable oil carrier. .Iaddend..Iadd. 15. A method according to claim 21 wherein the solid salt of clavulanic acid is the sodium, potassium, calcium, magnesium or t-butylamine salt. .Iaddend..Iadd. 16. A method according to claim 21 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 1 to 40% by weight. .Iaddend..Iadd. 17. A method according to claim 21 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 4 to 8% by weight. .Iaddend..Iadd. 18. A method according to claim 21 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 15 to 25% by weight. .Iaddend. .Iadd. 19. A method according to claim 21 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 30 to 40% by weight. .Iaddend..Iadd. 20. A method according to claim 14 wherein the molecular sieve is a crystalline sodium, potassium or calcium alumino-silicate. .Iaddend..Iadd. 21. A method according to claim 14 wherein the sieve is a calcium alumino-silicate. .Iaddend..Iadd. 22. A method for the treatment or prophylaxis of mammary disorders in animals which comprises the intramammary administration of a composition comprising a suspension in fractioned coconut oil of sodium amoxycillin or amoxycillin trihydrate; sodium or potassium clavulanate; and molecular sieve powder; in which composition the weight ratio of amoxycillin to clavulanic salt is from 5:1 to 1:1 and the amoxycillin and clavulanate comprise from 0.1 to 40% of the composition, calculated on the basis of the equivalent weight of free acids, and the molecular sieve comprises from 5 to 20% of the composition by weight. .Iaddend..Iadd. 23. A method according to claim 45 wherein the composition is administered in unit dosage form, wherein each unit dose contains from 100 to 1200 mg of amoxycillin calculated on the basis of the equivalent weight of the free acid and from 20 to 300 mg. of clavulanate salt calculated on the basis of the equivalent weight of free acid in each dosage unit. .Iaddend..Iadd. 24. A method according to claim 45 wherein the composition is administered in unit dosage form, wherein each unit dose contains from 200 to 1000 mg. of amoxycillin calculated on the basis of the equivalent weight of the free acid and from 25 to 100 mg. of clavulanate salt calculated on the basis of the equivalent weight of free acid in each dosage unit. .Iaddend..Iadd. 25. A liquid veterinary composition adapted for intramammary administration comprising a suspension of a powdered solid pharmaceutically acceptable alkali metal, alkaline earth metal or amine salt of clavulanic acid, from 5 to 20% by weight of a powdered solid molecular sieve and an antibacterially effective amount of a penicillin or cephalosporin, the amount of clavulanate and penicillin or cephalosporin being from 0.1 to 40% by weight of said composition calculated on the basis of the equivalent weight of free acids, in combination with a pharmaceutically acceptable oil carrier. .Iaddend..Iadd. 26. A method for the treatment of prophylaxis of mammary disorders in animals which comprises the intramammary administration of a therapeutically effective amount of a composition comprising a suspension of a powdered solid pharmaceutically acceptable alkali metal, alkaline earth metal or amine salt of clavulanic acid, from 5 to 20% by weight of a powdered solid molecular sieve and an antibacterially effective amount of a penicillin or cephalosporin, the amount of clavulanate and penicillin or cephalosporin being from 0.1 to 40% by weight of said composition calculated on the basis of the equivalent weight of free acids, in combination with a pharmaceutically acceptable oil carrier. .Iaddend..Iadd. 27. A composition according to claim 36 wherein the penicillin is sodium amoxycilin, amoxycillin trihydrate, sodium ampicillin, ampicillin trihydrate, sodium cloxacillin, benzathine cloxacillin or sodium flucoxacillin. .Iaddend..Iadd. 28. A method according to claim 43 wherein the penicillin is sodium amoxycillin, amoxycillin trihydrate, sodium ampicillin, ampicillin trihydrate, sodium cloxacillin, benzathine cloxacillin or sodium flucoxacillin. .Iaddend..Iadd. 29. A composition according to claim 36 wherein the weight ratio of penicillin or cephalosporin to the clavulanate is from 5:1 to 1:1 calculated on the basis of the equivalent weight of the free acids. .Iaddend..Iadd. 30. A method according to claim 43 wherein the weight ratio of penicillin or cephalosporin to the clavulanate is from 5:1 to 1:1 calculated on the basis of the equivalent weight of the free acids. .Iaddend. .Iadd. 31. A composition according to claim 36 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 1 to 40% by weight. .Iaddend..Iadd. 32. A composition according to claim 36 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 4 to 8% by weight. .Iaddend..Iadd. 33. A composition according to claim 36 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 15 to 25% by weight. .Iaddend..Iadd. 34. A composition according to claim 36 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 30 to 40% by weight. .Iaddend..Iadd. 35. A composition according to claim 25 wherein the molecular sieve is a crystalline sodium, potassium or calcium alumino-silicate. .Iaddend..Iadd. 36. A composition according to claim 25 wherein the sieve is a calcium alumino-silicate. .Iaddend..Iadd. 37. A method according to claim 43 wherein the solid salt of clavulanic acid is the sodium, potassium, calcium, magnesium or t-butylamine salt. .Iaddend..Iadd. 38. A method according to claim 43 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 1 to 40% by weight. .Iaddend..Iadd. 39. A method according to claim 43 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 4 to 8% by weight. .Iaddend..Iadd. 40. A method according to claim 43 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 15 to 25% by weight. .Iaddend..Iadd. 41. A method according to claim 43 wherein the amount of alkali metal, alkaline earth metal or amine salt of clavulanic acid is from 30 to 40% by weight. .Iaddend..Iadd. 42. A method according to claim 26 wherein the molecular sieve is a crystalline sodium, potassium or calcium alumino-silicate. .Iaddend..Iadd. 43. A method according to claim 26 wherein the sieve is a calcium alumino-silicate. .Iaddend. .Iadd. 44. A composition according to claim 5 wherein the sieve is calcium alumino silicate. .Iaddend..Iadd. 45. A method according to claim 22 wherein the sieve is a calcium alumino silicate. .Iaddend.