Orally administrable pharmaceutical preparation containing protein
AssigneeIndian Institute of Technology Bombay
InventorsJayesh BELLARE, Neelam Vishwanath DWIVEDI, Arunagirinathan Manickam ADHIMOOLAM, Somesh Datt SHARMA
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Abstract
An orally administrable pharmaceutical preparation containing a protein. More particularly, an orally administrable pharmaceutical preparation including a protein loaded on metal oxide nanoparticles and an amino acid; wherein the amino acid forms an adduct with the protein loaded on metal oxide nanoparticles. An process for the production of the afore-mentioned orally administrable pharmaceutical preparation is also disclosed.
Claims19
An orally administrable pharmaceutical preparation comprising a protein loaded on metal oxide nanoparticles and an amino acid;
- wherein the amino acid forms an adduct with the protein loaded on metal oxide nanoparticles.
The orally administrable pharmaceutical preparation as claimed in claim I, wherein the protein is selected from the group consisting of insulin, insulin analog, insulin derivative, insulin growth factor, GLP-1, calcitonin, interferon, human growth hormone, glucagon, gonadotropin-releasing hormone, glycoprotein, cytokine, interleukin, vaccine, enzyme, hormone analog, an antibody, a Fab Fragment, trypsin, enfuvertide, pramlintide acetate or enzyme inhibitors.
A process for the production of orally administrable pharmaceutical preparation comprising the steps of:
- a. synthesizing metal oxide nanoparticles by hydrolysis of metal salts and storing the nanoparticles suspension at 0° C. to 10° C.;
- b. dissolving a protein in an aqueous solution and adjusting the pH of the solution from 7 pH to 2 pH;
- c. adding the protein solution of step (b) to the nanoparticles suspension of step (a);
- d. mixing an amino acid solution with a carbodiimide (CDI) solution for 1 minute to 120 minutes and adjusting the pH of the resultant solution to 8 to 9 using an acid;
- e. adding the amino acid-CDI mixture of step (d) to the suspension of step (c) and maintaining the pH of the solution at the isoelectric point of the protein and storing the resultant solution at 0° C. to 10° C. for 12 hours to 48 hours;
- and
- f. washing the settled nanoparticles with an aqueous solution to obtain the orally administrable pharmaceutical preparation containing protein.
Dependencies are inferred from the claim text.