Claims
- 1. A formulation for the transmucosal delivery of calcitonin to a patient comprising:
i) an effective amount of calcitonin particles; ii) an orally-acceptable mucosal permeation enhancer mixed with said calcitonin particles and adapted to modify a mucosal surface membrane such that the absorption of calcitonin through the surface membrane is initiated or enhanced; iii) an orally-acceptable solvent or carrier.
- 2. A formulation according to claim 1 wherein said calcitonin particles are lyophilized essentially dehydrated calcitonin particles.
- 3. A formulation according to claim 1 further comprising a pharmaceutically acceptable surfactant deposited on said lyophilized calcitonin particles for increasing the miscibility of the ingredients or reducing the droplet size.
- 4. A suspension formulation according to claim 1 for the oral delivery of calcitonin across buccal mucous membranes.
- 5. An inhalant formulation according to claim 1 for the intranasal or pulmonary delivery across respiratory mucous membranes.
- 6. A formulation according to claim 1 wherein said mucosal permeation enhancer is RSO3−M+ wherein:
i) R is selected from a group consisting of C6-C20 alkyl and C6-C20 alkenyl; and, ii) M is an alkali metal cation.
- 7. A formulation according to claim 3 wherein said surfactant is a nonionic surfactant.
- 8. A formulation according to claim 1 wherein said solvent is selected from a group consisting of ethanol, glycerol, glycol, propylene glycol, polyethylene glycol, sorbitol, Vitamin E, derivatives of Vitamin E and polyvinylpyrrolidone.
- 9. A formulation according to claim 1 wherein said mucosal permeation enhancer is sodium lauryl sulfate, said surfactant is a Brij surfactant and said solvent is ethanol.
- 10. A formulation according to claim 1 wherein said mucosal permeation enhancer is sodium lauryl sulfate and or sodium salicylate, said surfactant is a Pluronic surfactant and said solvent is ethanol.
- 11. A formulation according to claim 1 wherein said mucosal permeation enhancer is sodium lauryl sulfate and or sodium salicylate, said surfactant is a Tween surfactant and said solvent is ethanol.
- 12. A formulation according to claim 1 which further comprises a propellant.
- 13. A formulation according to claim 12 wherein the propellant is HFA 134a or HFA 227.
- 14. A formulation for the non-invasive delivery of calcitonin comprising
i) said calcitonin is substantially aqueous free particles mixed with at least one of a permeation enhancers and a surfactant; and, ii) a delivery medium comprising at least one of a suspending media or a pharmaceutically-acceptable propellant; the solid-phase particles being suspended within the delivery medium to define the formulation adapted for non-invasive delivery to the patient's targeted site where the permeation enhancer modifies the mucosal surface membrane at the targeted site to initiate or enhance absorption of the core comprising calcitonin.
- 15. A method for the non-invasive delivery of polypeptides comprising orally administering a formulation comprising substantially aqueous free particles of said polypeptide coated with at least one of a permeation enhancer and a surfactant, and a delivery medium comprising at least one of a pharmaceutically-acceptable suspending media or a pharmaceutically-acceptable propellant wherein the solid-phase particles are suspended within the delivery medium to define the formulation adapted for non-invasive delivery to the patient's targeted site wherein the coating modifies the mucosal surface membrane at the targeted site to initiate or enhance absorption of the said polypeptide.
- 16. A method according to claim 15 wherein the polypeptide is calcitonin.
- 17. A process for preparing a formulation for use in delivering calcitonin to a patient, the process comprising the steps of:
i) obtaining a quantity of said calcitonin; ii) dissolving said calcitonin in a pharmaceutically acceptable buffer to form a solution with a pH from about 3 to about 8; iii) mixing said solution with at least one pharmaceutically acceptable surfactant and at least one permeation enhancer to form a homogenous solution; and, iv) lyophilizing the homogeneous solution to form dehydrated solid particles comprising calcitonin mixed with said surfactant and said permeation enhancer.
- 18. The process of claim 17, further comprising the step of dispersing said dehydrated solid particles containing calcitonin in suspending media or a pharmaceutically acceptable propellant.
- 19. A process according to claim 17 wherein the buffer is a citrate buffer, the absorption enhancer is sodium lauryl sulfate, the surfactant is Tween 80, and the propellant is HFA 134a.
- 20. A process according to claim 17 wherein the buffer is a citrate buffer, the absorption enhancer is sodium lauryl sulfate, the surfactant is Tween 80, and the suspending media is ethanol.
- 21. A formulation according to claim 1 wherein said calcitonin particles were produced by lyophilization of a buffered aqueous calcitonin solution.
REFERENCE TO PREVIOUS APPLICATIONS
[0001] This application claims benefit of U.S. Provisional Application No. 60/204,308 filed on May 15, 2000 entitled “Formulations for Administering Calcitonin and Process for Preparing the Same”, hereby incorporated by reference into this application.
Provisional Applications (1)
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Number |
Date |
Country |
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60204308 |
May 2000 |
US |