InCube Labs, LLC (San Jose, CA)

The invention provides shaped masses (SM), which contain some or all drugs, like proteins or peptides as well as methods for creating or delivering these SM’s. A particular embodiment of the invention provides a SM which includes a drug, e.g., a polypeptide or a protein with biological activity in the mammal’s body. The compression of a precursor material (PM) which contains the drug, creates the SM. The SM is comprised of a small quantity of biologically active drugs. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-.alpha.-inhibiting antibodies. The embodiments of the invention are particularly beneficial for oral administration of drugs that would be degraded in the GI tract. In this instance, the SM containing drug is made into or incorporated into a tissue penetration member and then placed into the intestinal wall after oral intake.

While there has been an increasing development of new drugs to treat various ailments, many, like proteins, antibodies, and peptides have limited application due to the fact that they aren’t in a form that is easily shaped into solid shapes fororal or other form of administration and/or sealed. This is due to the fact that the production of medicines that contain a protein, protein, or antibody can result in a change in the protein’s structure. This is because numerous proteins possess complex internal structures that define their bioactivity. Disruption in the structure of the protein or polypeptide could result in its deactivation or substantial reduction in bioactivity. The cause of this can be manufacturing processes like molding, compression, milling, grinding, encapsulation or any other similar processes. What is needed is a method forforming bioactive compounds such as proteins, antigens and peptides into solid or semisolid shapes for oral or other form of delivery to a human or other mammal without significant loss of bioactivity of the compound.

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