TH1601003296A - Composition for the oral delivery of biologically active substances - Google Patents

Abstract

Page 1 of 23 pages Invention details Name that represents the invention Composition for oral delivery of biologically active substances Branch of science related to invention Pharmacognosy with respect to compositions for the oral delivery of biologically active substances: background in the relevant art or science. This patent application has the benefit of counting from the past filing date of the patent application. United States No. 61/912,958, which was applied for on December 6, 2013, which contains all contents. of referenced documents are included as part of this request. Oral administration of drugs and vaccines offers many advantages. It can be administered to large numbers of animals through food or drinking water with restraint and minimal labor. Restraint also causes stress to animals, which makes medicines or vaccinations more effective. It is less effective and increases the risk of infectious diseases for meat-producing animals. Oral administration has another advantage in that it avoids the risk of response at the injection site. Broken needles, contamination of the injection site, or use of highly reactive adjuvants Can cause 'abscess' that damages the carcass and skin. These responses reduce value. of animals at slaughterhouses. This is also a problem in vaccination programs in fish that need to be captured from tanks. or their open sea cages and individual injections are administered orally (oralinocululation) It is fast and efficient and eliminates the need for multiple animal manipulations to be administered. Giving vaccines to stimulate (boosterinoculation) later an adverse immune response. After oral administration it also occurs relatively less frequently and is therefore safer. Oral vaccination is an exceptionally cost-effective method of vaccination. or treating a large number of fish at once in a fish farming system with minimal stress and force. This is especially true when oral administration of a vaccine can be induced through digested during feeding/drinking periods and oral vaccines can be produced efficiently. More cost-effective than injectable vaccine formulations due to less purification steps required Needed to create an orally administered vaccine, oral vaccines also have the advantage of being less likely to have side effects. than such as stress or other responses to injections Page 2 of 23 pages Regardless of the advantages of oral administration of drugs and, in particular, vaccines. Technology development has been slowed by a lack of adequate vaccine delivery systems. In the absence of an appropriate delivery system, most orally administered vaccines suffer from degradation in the oral system. Specific dietary (GI) exposure under gastric pH conditions results in limited absorption. This later results in an inadequate immune response. In the past, immunization was based on the induction of humoral immunity by administering vaccines by injecting antibodies induced by injection. However, this has not been the case. It is necessary to reach the mucosal surface, which is the site of entry for most infectious agents. The immune layer Mucous membranes develop on the surface of the mucous membranes, which include the small intestines, lungs, mouth, eyes, mammary glands, and the nervous system. urinary tract and also the skin and gills in fish as a result of contact of antigens with tissues. Mucus is the first line of defense against important infectious agents. Several vehicles have been developed to deliver drugs or vaccines to the polymeric mucosal tissues of the intestines. Biodegradable substances such as poly-(DL-lactide) and poly-(DL-lactide-co-glycolide) have been used for produce compositions for oral administration of antigens, however, the production of these polymer particles Requires the use of solvents that can harm fragile antigens. In addition, the use of solvents Prevents the incorporation of weakened living organisms such as viruses or bacteria inside. those elements Other challenges in developing an adequate oral delivery system include the need to Choose food grade or feed grade and biodegradable compounds and adjuvants. That's all it takes and is necessary for a long-lasting and durable immune response. Characteristics and purpose of the invention In an aspect the invention provides a composition for the oral administration of a biologically active substance to an aquatic species or a terrestrial animal species consisting of particles, each of which contains: Biologically active substances dispersed in oil mistOil mist is dispersed in a C matrix. Contains entericcoating polymer that is applied to each particle. It is additionally composed of a polymer that adheres to the mucous membrane. In another aspect, the invention provides a method for the intestinal delivery of the active substance. Biological medicine to animals consists of the steps of oral administration to animals of the following components: The description above describes biologically active substances, which are substances that stimulate the body to create immunity (immunogen). Page 3 of 23 pages. In another aspect, the invention provides a method for administering genetic vaccines to animals or species. The drug consists of steps for oral administration to the species with the components described above at The composition is the delivery vehicle for vaccines. In another aspect the invention provides a method for preparing a composition, the method comprising: respectively: (a) the formation of an aqueous mixture containing a biologically active substance; that is dispersed or dissolved; (b) Making the aqueous mixture according to step (a) into a paste in oil to produce an emulsion of mixtures containing water in oil; (c) Slurry formation of the product according to step (b) in an aqueous solution containing release polymer coating in the small intestine; and either (dl) spray, drip or slurry as in step (c) into the aqueous solution. Contains a cross-linker for the intestinal release polymer coating to form particles that The aqueous mixture according to step (a) is supplemented with a mucoadhesive polymer or (d2) the particle formation from the slurry according to step (c). that step (b) further consists of Forms emulsion droplets in the aqueous mucoadhesive polymer and cross-links the adhesive polymer. Sharpen the mucosa to form an intermediate particle. Full disclosure of the invention. Unless otherwise specified herein, the scientific and technical terms used in this disclosure It should be given a meaning that is normally understood and used by those with ordinary expertise in the art. Additionally, as used herein and in the claims, the words at least "and at least one or more debts" have the same meaning and consist of, unless otherwise specified, percentages of, two, three or more debts. T or part of a component in a composition based on its weight, the term "distributed" means this Suspended and/or dissolved "Oral vaccination" is defined as administration by mouth through food that contains a ketamine material. Immune system to stimulate the immune system throughout the animal's body to develop a specific immune response to pathogens. Page 4 of 23 pages. Cross-linking" and its variations refer to the joining of two materials and/or substances. or more consisting of any one of those substances described herein through co-combination. one or more covalent and/or non-covalent (for example, ionic) links Cross-linking may occur naturally (for example, by disulfide bonds of cystine residues) or through cellular pathways. Synthesis or the synthesis pathway by which cross-linking of charged polymers can occur By ionic combination with polyvalent counterions of opposite charges, a solid structure that For example, hydrogels can be prepared by cross-linking them. Stomach protection” refers to protecting biologically active substances from degradation. in the stomach and loses its potency The composition of the invention includes a particulate material comprising an active substance. Biological agents and mucous membrane-adhesive polymers in which biologically active substances are dispersed in the aerosol oil. The oil is then embedded in or coated by an external matrix of release polymer coating in the shaft. The outer matrix surrounds the oil mist, preventing the contents from exposing the inner pH environment. Stomach of animals because the polyester remains insoluble at pH and maintains the integrity of the coating. Or layers, particles usually have a geometric mean size (sometimes referred to as diameter) in the range 10 to 5000 micrometers and may be directly formed within that size range or be reduced to