|Title of Invention
A FORMULATION FOR THE STABILIZATION OF ALLERGENIC EXTRACTS USED IN DIAGNOSIS AND THERAPY OF ALLERGY.
|The invention discloses a formulation, which stabilizes allergen extracts, increases the shelf life and maintains the biological potency of the said extract when stored at 4°C. The formulation consists of a combination of preservatives, which enhances the shelf life of the extract as compared to the extracts without preservatives and those preserved with individual preservatives.
1. A synergistic formulation for stabilizing protease rich allergen extract wherein the said
formulation comprising 0.025M-0.1M epsilon-aminocaproic acid (EACA) and 0.25M-0.75M
sucrose. 5-10% glycerol, l-5µM pepstatinA and 2-10 µM aprotnin.
2. A synergistic formulation as claimed in claim 1 wherein a preferable concentration of epsilon-aminocaproic acid (EACA) is 0.05M and a preferable concentration of sucrose is 0.25M
3. A method for stabilizing the protease rich allergen extract as claimed in claim 1 wherein the said method comprises of following steps:
(a) preparing the allergen extract by extracting the grounded defatted cockroaches inh aqueous buffer at neutral pH followed by lyophilization;
(b) storing the allergen extract as obtained in step (a) with the said formulation as claimed in claim 1, at temperature ranging between 4°-37°C;
(c) evaluating the stabilized allergen extracts for various immuno-biochemical properties and
allergy diagnosis potential.
4. A method as claimed in claim 3 wherein the buffer used for preparing the allergen extract is
selected from the group containing Tris buffer saline, phosphate buffer, phosphate buffer saline.
5. A method as claimed in claim 3 wherein the pH of the buffer for allergen extract is in range of
6. A method as claimed in claim 3 wherein the stability of the extract after treating with the said formulation is evaluated for immuno-biochemical properties such as protein stability, imunoblotting, ELISA, ELISA inhibition and intradermal test and compared to the standard lyophilizes extract stored at -70°C.
|Indian Patent Application Number
|PG Journal Number
|Date of Filing
|Name of Patentee
|COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH
|ANUSANDHAN BHAWAN, RAFI MARG, NEW DELHI - 110001, INDIA
|PCT International Classification Number
|PCT International Application Number
|PCT International Filing date