PHARMACEUTICAL COMPOSITIONS IN PARTICULATE FORM

• US 20070190158A1
• Filed: 03/26/2007
• Published: 08/16/2007
• Est. Priority Date: 11/19/2001
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Montgomery, David, Sullivan, Vincent, Bhuta-Wills, Anjana, Huang, Juan, Hwang, Robin, Ford, Brandi, Mikszta, John, Wang, Zhaolin
• Application Number:
  US11/691,280
• Publication Number:
  US 20070190158A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/1688 resulting in pure drug agglomerate optionally containing up to 5% of excipient
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses

Abstract

A method of preparing a pharmaceutical composition is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles at about atmospheric pressure to produce a powder, wherein said drying is performed in the presence of vibration, internals, mechanical stirring, or a combination thereof. Another method is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles to produce a powder; wherein the atomized formulation comprises droplets having an average mean diameter of between about 35μ and about 300μ, and/or the powder comprises dried particles having an average mean diameter of between about 35μ and about 300μ. Compositions made by the above methods, and methods of using the compositions, are also described.

Claims

1. A method of preparing a pharmaceutical composition in the form of a powder within a chamber, the method comprising the steps of:

a) atomizing a liquid formulation of a therapeutic or prophylactic agent to produce atomized droplets;

b) freezing the atomized droplets by introducing a cold medium into the chamber to form frozen particles; and

c) collecting and drying the frozen particles to produce a dry powder.

2. The method of claim 1, wherein the liquid formulation comprises more than one therapeutic or prophylactic agent.

3. The method of claim 1, wherein the cold medium is a gas.

4. The method of claim 1, wherein the therapeutic or prophylactic agent is suspended or dissolved in the liquid formulation.

5. The method of claim 1, wherein the frozen particles are collected on a filter.

6. The method of claim 5, wherein the frozen particles are partially dried after being collected on the filter.

7. A method of creating a powder within a chamber, the method comprising the steps of:

providing a flow of liquid droplets containing a powder forming ingredient to form a flow of liquid droplets;

treating the liquid droplets with a flow of coolant inside the chamber to freeze the liquid droplets to form frozen particles prior to deposition;

depositing the frozen particles on a collector; and

after deposition of the frozen particles, drying the deposited frozen particles to form a dry powder.

8. The method of claim 7 in which the flow of liquid droplets contains more than one powder forming ingredient.

9. The method of claim 7 in which the coolant is a gas.

10. The method of claim 7 in which the powder forming ingredient is suspended or dissolved in the carrier liquid.

11. The method of claim 7 in which the frozen particles are collected on a filter.

12. The method of claim 11 in which the frozen particles are substantially dried after being collected on the filter.