title: Production of orally applicable new drug or drug combinations from natural origin capsaicinoids for human medical therapy.
abstract: It is well known that the capsaicin stimulates (in small doses) or impairs (in high doses) the capsaicin-sensitive afferent nerves and the final effects of capsaicin depend on its applied doses. The effects of capsaicin were analyzed on the gastrointestinal mucosal protection and injury in animal experiments and in human beings (from 1980 up to now). From 2005 to 2008 an interdisciplinary group (21 researchers) participated in the production of orally applicable drug or drug combinations from capsaicin for human medical therapy of patients suffering from cardiovascular, degenerative joint and locomotor diseases, who received in their treatments non-steroidal anti-inflammatory compounds (NSAIDs). Our studies were based on the results of the NSAIDs-induced gastrointestinal side effects could be detected by application of small doses of capsaicin. Because natural (plant origin) capsaicin is chemically does not represent a uniform entity and used in the international research, consequently the authors met a lot of unpredictable scientific problems during the time of production of new capsaicin containing (alone or in combinations) drug before receiving official permissions from the different national and international authorities to start the classical human clinical pharmacological studies. This paper summarizes the different steps from the basic physiological and pharmacological notes (in animals), plant cultivation, chemistry of substance(s), animal (general and germinative) acute and chronic toxicology, human actions, basic clinical pharmacology of natural capsaicin (capsaicinoids) to introduce and to develop a new drug (or drug combinations) in the human medical therapy.
authors.affiliation: First Department of Medicine, Medical and Health Centre, University of Pécs, Hungary, H-7624 Ifjúság út 13, Pécs, Hungary. gyula.mozsik@aok.pte.hu
authors.forename: Gyula
authors.initials: G
authors.lastname: Mózsik
authors.forename: Tibor
authors.initials: T
authors.lastname: Past
authors.forename: András
authors.initials: A
authors.lastname: Dömötör
authors.forename: Mónika
authors.initials: M
authors.lastname: Kuzma
authors.forename: Pál
authors.initials: P
authors.lastname: Perjési
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D002211:Capsaicin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use* / Q000633:toxicity; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005744:Gastric Acid / Q000378:metabolism; D005753:Gastric Mucosa / Q000187:drug effects*; D005767:Gastrointestinal Diseases / Q000188:drug therapy / Q000517:prevention & control*; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000473:pathology / Q000502:physiology; D006801:Humans; D008517:Phytotherapy; D051381:Rats
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D002211:Capsaicin