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Powder compositions

A technology of powder and substance, applied in the field of vaccine composition, can solve the problems such as the method of non-specific immunity is not disclosed

Inactive Publication Date: 2003-08-27
POWDER JECT VACCINES INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this document only deals with hepatitis B vaccine and does not disclose a general method of non-specific immunization

Method used

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  • Powder compositions
  • Powder compositions
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0139] 1) Aluminum glue: 3% by weight of aluminum hydroxide

[0140] 2) Phosphate adjuvant: 2% by weight of aluminum phosphate

[0141] recipe

Powder yield (g)

% yield

MMAD

1

0.52

68.4

8-10μm

2

0.48

53.9

8-10μm

3

0.91

74.1

8-10μm

4

0.38

31.0

8-10μm

Al(OH) 3

Mannitol

Glycine

dextran

total solids

Recipe 1

suspension for spray drying

Solid content in floating liquid (%)

Content in powder

2.9

48.3％

2.1

35.0％

0.9

15.0％

0.1

1.7％

6

Recipe 2

suspension for spray drying

Solid content in floating liquid (%)

Content in powder

0.5

8.2％

4.6

75.4％

0.9

14.8％

0.1

1.6％

6.1

...

Embodiment 2

[0149] Two vaccine formulations were prepared as follows:

[0150] Recipe A:

[0151] A concentrated alum-HBsAg suspension was prepared as follows: The alum adsorbed HBsAg vaccine from RheinAmerican S.A. containing 500 μg of alum (approximately 1500 μg of aluminum hydroxide) was first washed with deionized distilled water to remove buffer salts , the alum adsorbed 20 μg of HBsAg (about 1 human dose). The alum gel was placed in a 250ml Nalgene narrow mouth square polycarbonate bottle and left to stand overnight at 2-8°C. The supernatant (150 ml) was removed and the same volume of water was added to the pellet and stirred. Repeat this step one more time.

[0152] 100 g of the washed Alum-HBsAg formulation was weighed out in a Nalgene square bottle and left overnight at 2-8°C. After 90 ml of supernatant was removed, the remaining suspension was transferred to a 50 ml polypropylene centrifuge tube and centrifuged at 200 rpm for 4 minutes using a table top centrifuge (Allegra...

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Abstract

A gel-forming free-flowing powder suitable for use as a vaccine is prepared by spray-drying or spray freeze-drying an aqueous suspension that contains an antigen adsorbed to an aluminum salt or calcium salt adjuvant, a saccharide, an amino acid or a salt thereof, and a colloidal substance. Powder for vaccine purposes are also prepared by spray freeze-drying an aqueous suspension of such an adjuvant having an antigen adsorbed therein. Processes for forming these powder compositions are also described, as well as methods of using the compositions in a vaccination procedure.

Description

technical field [0001] The present invention relates to vaccine compositions. More specifically, the present invention relates to vaccine compositions suitable for administration by transdermal particles from needle-free syringes. Background technique [0002] Administration of an agent into and across the surface of the skin (transdermal administration) has many advantages over oral or parenteral administration. Specifically, transdermal delivery is a safe, convenient, and infection-free alternative to traditional delivery, which conveniently avoids the major problems associated with oral delivery (e.g., uncertainties in adsorption and metabolic rates). , irritation of the gastrointestinal tract and / or a bitter or unpleasant taste of the drug) or major problems associated with parenteral administration (eg, needle sting, risk of infection to patients, Be aware of the risk of infection or contamination from needle sticks, and disposal of discarded needles). [0003] Howev...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/10A61K9/16A61K9/14A61K39/29A61K47/02A61K47/10A61K47/18A61K47/26A61K47/36A61K47/42A61P31/12
CPCA61K9/0021A61K9/1694A61K9/1611A61P31/12A61K9/14
Inventor 尤哈·富恩·马赵路史蒂文·约瑟夫·普雷斯蒂若斯科
Owner POWDER JECT VACCINES INC
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