Medicinal aerosol formulation
AssigneeAeropharm Technology Incorporated
InventorsAkwete L. Adjei, Yaping Zhu, John Z. Sun, Simon Stefanos
Life of this patent
Estimating the term…
Abstract
A medicinal formulation is disclosed. The formulation comprises (a) a protein or peptide medicament; (b) a fluid carrier for containing said medicament; and a stabilizer selected from an amino acid, a derivative thereof or a mixture of the foregoing.
Claims18
A medicinal aerosol formulation, which comprises:
- (a) a therapeutically effective amount of a protein or peptide medicament having a molecular size ranging from about 1K Dalton to about 150 K Daltons which is selected from the group consisting of an insulin analog, an amylin, an immunomodulating protein, an interleukin, an interferon, an erythropoietin, a heparin, a thrombolytic, an antitrypsin, an anti-protease, a hormone, a growth factor, an enzyme, a nucleic acid, an immunoglobulin, an antiinfective, a calcitonin, a hematopoietic factor, a vaccine, a vasoactive peptide, an antisense agent, an oligonucleotide, DNase, a cyclosporin, ribavirin and a mixture of any of the foregoing medicaments;
- (b) a non-chlorofluorohydrocarbon fluid propellant carrier for containing said medicament;
- and
- (c) a stabilizer selected from an amino acid, a derivative thereof, or a mixture of the foregoing.
A medicinal aerosol formulation, which consists essentially of:
- (a) a therapeutically effective amount of a protein or peptide medicament having a molecular size ranging from about 1K Dalton to about 150 K Daltons which is selected from the group consisting of an insulin, an insulin analog, an amylin, an immunomodulating protein, an interleukin, an interferon, an erythropoietin, a heparin, a thrombolytic, an antitrypsin, an anti-protease, a hormone, a growth factor, an enzyme, a nucleic acid, an immunoglobulin, an antiinfective, a calcitonin, a hematopoietic factor, a vaccine, a vasoactive peptide, an antisense agent, an oligonucleotide, DNase, a cyclosporin, ribavirin and a mixture of any of the foregoing medicaments;
- (b) a non-chlorofluorohydrocarbon fluid propellant carrier for containing said medicament;
- and
- (c) a stabilizer selected from an amino acid, a derivative thereof, or a mixture of the foregoing.
A method of stabilizing a suspension aerosol formulation comprising a non-chlorofluorohydrocarbon propellant and a protein or peptide medicament which is selected from the group consisting of an insulin, an insulin analog, an amylin, an immunomodulating protein, an interleukin, an interferon, an erythropoietin, a heparin, a thrombolytic, an antitrypsin, an anti-protease, a hormone, a growth factor, an enzyme, a nucleic acid, an immunoglobulin, an antiinfective, a calcitonin, a hematopoietic factor, a vaccine, a vasoactive peptide, an antisense agent, an oligonucleotide, DNase, a cyclosporin, ribavirin and a mixture of any of the foregoing medicaments;
- which comprises incorporating into the formulation a stabilizer selected from the group consisting of a suitable amino acid, a derivative thereof, or any mixture of the foregoing, in an amount which is effective to prevent settling, creaming, or flocculation of the formulation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
A metered dose inhaler containing a medicinal aerosol formulation, the formulation which consists essentially of:
- (a) a protein or peptide medicament which is selected from the group consisting of an insulin, an insulin analog, an amylin, an immunomodulating protein, an interleukin, an interferon, an erythropoietin, a heparin, a thrombolytic, an antitrypsin, an anti-protease, a hormone, a growth factor, an enzyme, a nucleic acid, an immunoglobulin, an antiinfective, a calcitonin, a hematopoietic factor, a vaccine, a vasoactive peptide, an antisense agent, an oligonucleotide, DNase, a cyclosporin, ribavirin and a mixture of any of the foregoing medicaments in a therapeutically effective amount;
- (b) a non-chlorofluorohydrocarbon propellant;
- and
- (c) a suitable stabilizer selected from an amino acid, an amino acid derivative, or a mixture of the foregoing, present in an amount sufficient to stabilize the formulation to prevent settling, creaming or flocculation for a time sufficient to allow reproducible dosing of the drug after agitation of the formulation.
Dependencies are inferred from the claim text.