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 Particle delivery techniques

Details
Inventors: Burkoth, Terry Lee; Sarphie, David Francis; Muddle, Andrew Gordon; Porter, Linda Maree;
Assignee: Powderject Research Limited (GB)
Primary Examiner: Guzo; David
Assistant Examiner: Nguyen; Quang
Attorney, Agent or Firm: Foley & Lardner, LLP

A method is provided for in vivo or ex vivo delivery of a preparation of powdered nucleic acid molecules into vertebrate tissue for transformation of cells in the tissue using needleless injection techniques. The method can be used to deliver therapeutically relevant nucleotide sequences to cells in mammalian tissue to provide gene therapy, elicit immunity or to provide antisense or ribozyme functions. A method for providing densified processed pharmaceutical compositions is also described. The method is used to convert non-dense pharmaceutical powders or particulate formulations into densified particles optimally suited for transdermal delivery using a needleless syringe. The method is also used to optimize the density and particle size of powders and particulate formulations for subsequent transdermal delivery thereof. Densified pharmaceutical compositions formed by the present methods are also provided.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The practice of the present invention will employ, unless otherwise indicated, conventional methods of molecular biology and recombinant DNA techniques within the skill of the art.
Such techniques are explained fully in the literature.
See, e.
g.
, Sambrook, et al.
, Molecular Cloning: A Laboratory Manual (2nd Edition, 1989); Maniatis et al.
, Molecular Cloning: A Laboratory Manual (1982); DNA Cloning: A Practical Approach, vol.
I & II (D.
Glover, ed.
); Perbal, A Practical Guide to Molecular Cloning.
Before describing the present invention in detail, it is to be understood that this invention is not limited to particular pharmaceutical formulations or process parameters as such may, of course, vary.
It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only, and is not intended to be limiting.
It must be noted that, as used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise.
Thus, for example, reference to "a nucleic acid molecule" includes a mixture of two or more nucleic acid molecules, reference to "an excipient" includes mixtures of two or more excipients, and the like.
All publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety.
A.
Definitions Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains.
The following terms are intended to be defined as indicated below.
The term "transdermal" delivery captures both transdermal (or "percutaneous") and transmucosal administration, i.
e.
, delivery by passage of a drug or pharmaceutical agent through the skin or mucosal tissue.
See, e.
g.
, Transdermal Drug Delivery: Developmental Issues and Research Initiatives, Hadgraft and Guy (eds



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