Abstract: A method for producing flavoring materials consisting of a flavor and a simple matrix material that are GRAS or approved for use in food, and that will be stable under extremely adverse conditions, greater than 50% moisture, high pH, high temperature stability (60° C.), yet be released in the oral cavity; without the use of organic solvents, and with the use of inexpensive materials and unsophisticated equipment.

Abstract: A fast-dissolving film for use as a platform for the delivery of material to the oral cavity, comprising a film forming agent; a plasticizing agent; and a fast-dissolving, water-soluble agent; and methods for producing same.

Abstract: A lyophilized polynucleotide composition contains at least one polynucleotide and at least one cryoprotectant, wherein the ratio of the polynucleotide to cryoprotectant is from about 0.001 to about 1.0 part by weight polynucleotide per 1.0 part by weight of the cryoprotectant. This composition also contains from about 0.5 weight percent to about (6) weight percent water, based on the total weight of the final lyophilized polynucleotide composition. The polynucleotide composition of this invention is characterized by enhanced stability, in that it retains at least 90% supercoil over a time period of at least (10) days at a temperature of about 37° C. The lyophilized polynucleotide composition also has improved solubility. An improved process for lyophilization of polynucleotides employs a specific primary drying cycle, that results in the above-described stable, lyophilized polynucleotide composition.

Abstract: A drug delivery system for controlled release of a protein or polypeptide comprising a hydrophobic biodegradable polymer and a protein or polypeptide. A physical interaction is present between the polymer and the protein or polypeptide, thus, allowing protection and controlled release of the protein or polypeptide in-vivo. The drug delivery system may be prepared by a polymer precipitation technique or a microsphere technique.

Abstract: A drug delivery system for controlled release of a protein or polypeptide comprising a hydrophobic biodegradable polymer and a protein or polypeptide. A physical interaction is present between the polymer and the protein or polypeptide, thus, allowing protection and controlled release of the protein or polypeptide in-vivo. The drug delivery system may be prepared by a polymer precipitation technique or a microsphere technique.

Abstract: A method for preparing biodegradable microspheres having a three-dimensional network in which biologically active macromolecular agents are physically entrapped therein. The microsphere is able to degrade and release the macromolecular agent at a controlled rate. The method involves emulsifying a vinyl derivative of a biodegradable hydrophilic polymer, a water-soluble monovinyl monomer and a biologically active macromolecule in water, and copolymerizing the biodegradable hydrophilic polymer and the water-soluble monovinyl monomer such that the biologically active macromolecule is entrapped therein.

Abstract: Controlled release drug delivery systems comprised of spherical microporous polymeric network of interconnecting channels containing pore incorporated drugs or other agents wherein the drugs or agents are confined within the pore channel are described. Also disclosed are processing parameters in connection with the novel method of the invention for obtaining drug delivery systems especially suited for parenteral as well as oral administration.

Abstract: A method for detecting leaky ampules filled with a liquid such as a parenteral solution. The ampules to be tested are immersed in a solution containing a short-lived radionuclide, and a pressure differential is imposed between the solution containing the radionuclide and the parenteral solution or other liquid contained in the ampules. The ampules are then removed from solution, decontaminated to remove any solution adhering to the outer surface and pores thereof, dried, and finally examined for electromagnetic radiation, preferably gamma radiation, emanating from the interior of the ampules which would indicate a leaky condition thereof.