Formulation process method to produce spray dried products

Patent metadata

Field	Value
Publication number	US-10189957-B2
Application number	US-1988908-A
Country	US
Kind code	B2
Filing date	Jan 25, 2008
Priority date	Jan 26, 2007
Publication date	Jan 29, 2019
Grant date	Jan 29, 2019

Abstract

A method for preparing solid materials is described. One aspect of the method includes the steps of (a) providing a feedstock comprising an organic material(s) in a solvent system containing a non-solvent for the organic material at an elevated temperature and/or pressure above ambient conditions, (b) distributing the feedstock into either droplets or a film, and (d) evaporating the solvent system from the feedstock.

First claim

What is claimed is:

1. A spray drying method for preparing powders having a particle size of about less than 10 μm and with increased density comprising:
a) providing a feedstock comprising an organic material in a solvent system comprising a non-solvent, wherein:
the organic material comprises polyvinylpyrrolidine,
the non-solvent comprises a non-solvent for polyvinylpyrrolidine under ambient conditions,
the solvent system functions as a non-solvent for the polyvinylpyrrolidine under ambient conditions, and
the feedstock is at an elevated temperature of about 40° C. to about 200° C. and an elevated pressure of greater than 1 atmosphere (gauge) to about 20 atmospheres (gauge) such that the solvent system functions as a solvent for the polyvinylpyrrolidine;

b) delivering the feedstock to a device capable of atomizing the feedstock into droplets; and
c) evaporating the solvent system from the droplets of the feedstock, thereby forming particles of the organic material.

2. The method of claim 1 wherein the organic material further comprises a pharmaceutically active material.

3. The method of claim 2 wherein the organic material further comprises a polymer other than polyvinyl pyrrolidine.

4. The method of claim 3 wherein the feedstock further comprises one or more pharmaceutically acceptable ingredients.

5. The method of claim 1 wherein the solvent system comprises a solvent and non-solvent pair for at least one organic material present at a ratio of from about 5% solvent:95% non-solvent to about 95% solvent:5% non-solvent.

6. The method of claim 1 wherein the concentration of the organic material in the feedstock is from about 1% to about 90% by weight.

7. The method of claim 1 wherein the feedstock further comprises a second organic material.

8. The method of claim 7 wherein the second organic material is a pharmaceutically active agent.

9. The method of claim 2 wherein the pharmaceutically active material exhibits an increased rate of release compared to a control composition prepared using a solvent system without a non-solvent.

10. The method of claim 2 wherein the pharmaceutically active material exhibits an increased extent of release compared to a control composition prepared using a solvent system without a non-solvent.

11. The method of claim 8 wherein the solvent system comprises a solvent and a non-solvent for the polymer.

12. The method of claim 11 wherein steps b) and c) comprise spray drying the feedstock to form a spray-dried composition.

13. The method of claim 12 wherein said spray dried composition comprises at least about 25% by weight pharmaceutically active material.

14. The method of claim 12 wherein said spray dried composition comprises at least about 75% by weight pharmaceutically active material.

15. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the percent active released is at least about 25% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

16. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the initial rate of active released is at least about 25% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

17. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the percent active released is at least about 100% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

18. The method of claim 1 wherein the solvent system consists of a non-solvent.

19. The method of claim 18 wherein the non-solvent is selected from the group consisting of acetone, toluene, ethyl acetate, and mixtures thereof.

Assignees

• Brzeczko Albert W
• Doney John A
• Isp Investments Llc

Inventors

• Brzeczko Albert W
• Doney John A

Classifications

• A61K9/1635

  obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates · CPC title

• C08J3/205

  in the presence of a {continuous} liquid phase · CPC title

• A61K9/1694

  resulting in granules or microspheres of the matrix type containing more than 5% of excipient · CPC title

• C08J3/122 Primary

  Pulverisation by spraying · CPC title