Hydrogel particle formulation

• US 7,022,313 B2
• Filed: 08/03/2001
• Issued: 04/04/2006
• Est. Priority Date: 02/03/1999
• Status: Expired due to Fees

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Maa, Yuh-Fun, O'Connor, Barbara Horsey, Prestrelski, Steven Joseph, Burkoth, Terry Lee, Muddle, Andrew, Hafner, Roderick
• Primary Examiner(s): Kishore, Gollamudi S.
• Application Number:
  US09/922,218
• Publication Number:
  US 20020061336A1
• Time in Patent Office: 1,705 Days
• Field of Search: 424489-502, 424/422
• US Class Current: 424/48
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623

Abstract

New compositions formed from the combination of an active substance with a hydrogel carrier moiety are provided. The compositions are suitable for use in high-velocity transdermal particle injection techniques. Methods of providing the new compositions are also provided. In addition, methods for administering pharmacologically active agent to a subject are provided. These methods are useful for delivering drugs, biopharmaceuticals, vaccines and diagnostics agents.

Claims

1. A method for making a powdered pharmaceutical composition, said method comprising:

(a) providing a mixture of pre-formed hydrogel particles;

(b) contacting the hydrogel particles with an aqueous composition containing at least one pharmacologically active agent for a period sufficient to allow the agent to associate with the hydrogel particles and be incorporated therewith;

(c) separating the hydrogel particles from the aqueous composition in at least a partial drying step to obtain primary loaded hydrogel particles having the active agent incorporated therewith;

(d) contacting the primary loaded hydrogel particles with an aqueous composition containing said pharmacologically active agent for a period sufficient to allow further agent to associate with the hydrogel particles and be incorporated therewith;

(e) separating the hydrogel particles formed in step (d) from the aqueous composition in at least a partial drying step to obtain secondary loaded hydrogel particles having the active agent incorporated therewith; and

(f) drying the secondary loaded hydrogel particles to obtain a powdered pharmaceutical composition.

2. The method of claim 1, wherein prior to step (f), the secondary loaded hydrogel particles formed in step (e) are contacted at least one further time with an aqueous composition containing said pharmacologically active agent for a period sufficient to allow still further agent to associate with the hydrogel particles and be incorporated therewith.

3. The method of claim 1, wherein the hydrogel particles in step (b) are contacted with the aqueous composition while in a dry state.

4. The method of claim 1, wherein the hydrogel particles in step (b) are contacted with the aqueous composition while in a wet, prehydrated state.

5. The method of claim 1, wherein the hydrogel particles comprise agarose, dextran, cellulose, chitin, starch, polyvinylpyrrolidone or polyvinyl alcohol.

6. The method of claim 1, wherein the active agent is present in the powdered pharmaceutical composition in an amount ranging from about 0.1 to 85 wt % of the composition.

7. The method of claim 1, wherein the powdered pharmaceutical composition is formed using a freeze-drying step.

8. The method of claim 1, wherein the powdered pharmaceutical composition is formed using a spray-drying step.

9. A method for making a powdered pharmaceutical composition, said method comprising:

(a) providing a mixture of pre-formed hydrogel particles;

(b) contacting the hydrogel particles with an aqueous composition containing at least one pharmacologically active agent for a period sufficient to allow the agent to associate with the hydrogel particles and be incorporated therewith;

(c) separating the hydrogel particles from the aqueous composition in at least a partial drying step to obtain primary loaded hydrogel particles having the active agent incorporated therewith;

(d) contacting the primary loaded hydrogel particles formed in step (c) at least one further time with an aqueous composition containing said pharmacologically active agent for a period sufficient to allow further agent to associate with the bydrogel particles and be incorporated therewith arid separating the hydrogel particles formed from the aqueous composition at least one further time in at least a partial diying step to obtain loaded hydrogel particles having the active agent incorporated therewith; and

(e) drying the loaded hydrogel particles to obtain a powdered pharmaceutical composition.

10. The method of claim 9, wherein the hydrogel particles in step (b) are contacted with the aqueous composition while in a dry state.

11. The method of claim 9, wherein the hydrogel particles in step (b) are contacted with the aqueous composition while in a wet, prehydrated state.

12. The method of claim 9, wherein the hydrogel particles comprise agarose, dextran, cellulose, chitin, starch, polyvinylpyrrolidone or polyvinyl alcohol.

13. The method of claim 9, wherein the active agent is present in the powdered pharmaceutical composition in an amount ranging from about 0.1 to 85 wt % of the composition.

14. The method of claim 9, wherein the powdered pharmaceutical composition is formed using a freeze-drying step.

15. The method of claim 9, wherein the powdered pharmaceutical composition is formed using a spray-drying step.