Reduced foaming vaccine compositions

Patent metadata

Field	Value
Publication number	US-2016256554-A1
Application number	US-201514880145-A
Country	US
Kind code	A1
Filing date	Oct 9, 2015
Priority date	Oct 10, 2014
Publication date	Sep 8, 2016
Grant date	—

Abstract

The present invention relates to novel stable compressed vaccine composition comprising at least one anhydrous antigenic component comprising a stabilizer susceptible to foaming when the composition is mixed with liquid diluent; and an effective amount of a sugar alcohol.

First claim

What is claimed is:

1 . A process for reducing the foaming of a solid vaccine composition when mixed with liquid diluent, wherein the composition comprises:
(i) at least one anhydrous antigenic component comprising a stabilizer susceptible to foaming; wherein the process comprises: (a) adding an effective amount of a sugar alcohol to the solid vaccine composition.

2 . A process according to claim 1 , wherein the process further comprises:
(b) compressing the solid vaccine composition to form a stable compressed vaccine composition.

3 . A process according to claim 1 , wherein the anhydrous antigenic component is lyophilized or dried.

4 . A process according to claim 1 , wherein the stabilizer comprises one or more amino acid or salts thereof, protein or salts thereof, albumin, gelatin, or combinations thereof.

5 . A process according to claim 1 , wherein antigenic component is newcastle disease virus, infectious bronchitis virus,fowl pox virus, avian encephalomyelitis virus, marek's disease virus, trichophyton verrucosum, avian paramyxovirus, mycobacterium paratuberculosis, meleagrid herpesvirus, off virus, or sheep pox virus.

6 . A process according to claim 1 , wherein the antigenic component is newcastle disease virus, or infectious bronchitis virus.

7 . A process according to claim 1 , wherein the composition is mixed by sonication, mechanical or chemical means.

8 . A process according to claim 1 , wherein the composition is mixed by sonication or mechanical means.

9 . A process according to claim 1 , wherein the composition is mixed by chemical means.

10 . A process according to claim 9 , wherein the chemical means is an effervescent reaction.

11 . A process according to claim 1 , wherein the composition further comprises a dissolution agent.

12 . A process according to claim 11 , wherein the dissolution agent is an effervescent agent or pair of effervescen agents.

13 . A process according to claim 11 , wherein the dissolution agent comprises a pair of effervescent agents.

14 . A process according to claim 13 , wherein the pair of effervescent agents comprises a salt and an acid.

15 . A process according to claim 14 , wherein the acid is citric acid, tartaric acid, malic acid, fumaric acid, adipic acid, succinic acid, acid anhydrides or mixtures thereof.

16 . A process according to claim 14 , wherein the salt is carbonate salts, bicarbonate salts, sesquicarbonate salts, or mixtures thereof.

17 . A process according to claim 1 , wherein the effective amount of sugar alcohol is about 10% to 40% by weight of the composition.

18 . A process according to claim 1 , wherein the effective amount of sugar alcohol is about 10% to 35% by weight of the composition.

19 . A process according to claim 1 , wherein the effective amount of sugar alcohol is about 15% to 35% by weight of the composition.

20 . A process according to claim 11 , wherein the dissolution agent is up to about 60% by weight of the composition.

21 . A process according to claim 11 , wherein the dissolution agent is about 30% to about 60% by weight of the composition.

22 . A process according to claim 1 , wherein the anhydrous antigenic component is about 20% to about 50% by weight of the composition.

23 . A process according to claim 1 , wherein anhydrous antigenic component is up about 20% to about 40% by weight of the composition.

24 . A process according to claim 1 , wherein the solid vaccine composition is characterized by complete dissolution of the composition in the diluent between about 60 and 700 seconds upon contact with the diluent.

25 . A process according to claim 1 , wherein the solid vaccine composition is characterized by complete dissolution of the composition in the diluent between about 60 and 300 seconds upon contact with the diluent.

26 . A process according to claim 1 , wherein the foaming of the solid vaccine composition is reduced relative to the foaming of the composition in the absence of the sugar alcohol.

27 . A process according to claim 1 , wherein the sugar alcohol. is xylitol, mannitol or sorbitol or a mixture thereof.

28 . A stable vaccine composition comprising:
i) at least one anhydrous antigenic component comprising a stabilizer susceptible to foaming when the composition is mixed with liquid diluent; and ii) an effective amount of a foam controlling agent which is a sugar alcohol.

29 . A stable vaccine composition according to claim 28 , wherein the anhydrous antigenic component is lyophilized or dried.

30 . A stable vaccine composition according to claim 28 , wherein the vaccine composition is compressed into a tablet.

31 . A stable vaccine composition according to claim 28 , wherein the stabilizer comprises one or more amino acid or salts thereof, protein or salts thereof, albumin, gelatin, or combinations thereof.

32 . A stable vaccine composition according to claim 28 , wherein the stabilizer is an amino acid or salts thereof, proteins or salts thereof, or combinations thereof.

33 . A stable vaccine composition according to claim 28 , wherein antigenic component is newcastle disease virus, infectious bronchitis virus,fowl pox virus, avian encephalomyelitis virus, marek's disease virus, trichophyton verrucosum, avian paramyxovirus, mycobacterium paratuberculosis, meleagrid herpesvirus, off virus, or sheep pox virus.

34 . A stable vaccine composition according to claim 28 , wherein the antigenic component is Infectious Bronchitis virus strain CR88121, Infectious Bronchitis virus strain H120 or Newcastle Disease virus strain VG/GA.

35 . A stable vaccine composition according to claim 28 , further comprising a dissolution agent.

36 . A stable vaccine composition according to claim 35 , wherein the dissolution agent is an effervescent agent or pair of effervescent agents.

37 . A stable vaccine composition according to claim 35 , wherein the dissolution agent comprises a pair of effervescent agents.

38 . A stable vaccine composition according to claim 36 , wherein the effervescent pair comprises a salt and an acid.

39 . A stable vaccine composition according to claim 28 , wherein the effective amount of sugar alcohol is about 10% to 40% by weight of the composition.

40 . A stable vaccine composition according to claim 28 , wherein the effective amount of sugar alcohol is about 10% to 35% by weight of the composition.

41 . A stable vaccine composition according to claim 28 , wherein the effective amount of sugar alcohol is about 15% to 35% by weight of the composition.

42 . A stable vaccine composition according to claim 35 , wherein the dissolution agent is up to about 60% by weight of the composition.

43 . A stable vaccine composition according to claim 35 , wherein the dissolution agent is about 30% to about 60% by weight of the composition.

44 . A stable vaccine composition according to claim 29 wherein the lyophilized antigenic component is up to 90% by weight of the composition.

45 . A stable vaccine composition according to cl

Assignees

• Merial Inc

Inventors

• Genin Noel Yves Henri Jean

Classifications

• A61K9/0056

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title

• C12N2760/18134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K9/0007

  Effervescent (A61K9/0065 takes precedence) · CPC title

• A61K9/2018

  Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates · CPC title

• A61K39/17

  Newcastle disease virus · CPC title