Adobe Systems 1st practical lesson Adobe Systems Adobe Systems Practicals in Pharmacology, 2006 Hadasova, Novakova, Pistovcakova, Vinklerova, Sulcova, Starobova Literature Pdf available at: IS.muni.cz Adobe Systems „GENERICS“ Drug which is produced and distributed after ending of patent protection - mostly manufactured by other company which has not developed the original drug (the same active substance!) Mostly cheaper than original preparation Assumed to be identical in dose, strength, route of administration, safety, efficacy, and intended use Bioequivalent trials are needed before registration Registration procedures are much easier than in orig. preparation Drug patents give 10 years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between 7 and 12 years Adobe Systems „GENERIC PRESCRIPTION“ prescription of the generic name (INN) on Rx formulary + dose, number of doses Pharmacist will chose apropriate ready-mady preparation after consultation with the patient „ GENERIC SUBSTITUTION“ substitution of the prescribed preparation with another one (generic) Adobe Systems recept Latin terminology in drug prescription Adobe Systems Pharmacopoeia pharmacon = drug poieo = prepare Substances in pharmacopoeia- called officinal drugs Adobe Systems Definition basic reference work for pharmaceutical drug specifications published by the authority of a government or a medical or pharmaceutical society book containing directions for the identification of samples and the preparation of compound medicines assures quality, efficacy, safety, standards Adobe Systems Pharmacopoeias may be: • • •National e.g. Brazilian, British, Chinese, Indian, Japanese, Mexican, Spanish, United States • •Regional e.g. European (Ph.Eur.) The 7th Edition of the European Pharmacopoeia • • •International The International Pharmacopoeia Adobe Systems National and regional pharmacopoeias Cover medicines used in the relevant country or region Are legally binding "official" in the relevant country or region Are prepared by a national or regional authority Adobe Systems International Pharmacopoeia A few dates… The history of the International Pharmacopoeia dates back 1874… → 1948 First World Health Assembly established Expert Committee on Unification of Pharmacopoeia → 1950 WHA approved publication of Pharmacopoeia Internationalis Adobe Systems International Pharmacopoeia →implementation: “ready for use” by Member States "The Ph.Int [… ] is intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements. The pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into appropriate legislation." [World Health Assembly resolution WHA3.10, WHO Handbook of Resolutions and Decisions, Vol. 1, 1977, p. 127] Adobe Systems International Pharmacopoeia A collection of monographs and requirements for: → Drug substances → Excipients → Finished dosage forms → General methods and requirements: dosage forms, e.g. tablets, liquid preparation for oral use dissolution testing → Supplementary information, e.g. General guidelines for Chemical Reference Substances → Infrared reference spectra Adobe Systems Specifications of substances Description, Chemistry, Solubility, Storage, Labelling Definition, with information on polymorphism if relevant Identification Assay Specific tests (sulphated ash, optical rotation, loss on drying…) Related substances Adobe Systems Specifications of substances Precise description of analytical methods Impurities (chemical names, structures, origin) Any relevant information on Performance testing (e.g. dissolution) Stability Validation of analytical methods Adobe Systems International Pharmacopoeia current: 4th Edition + 1st Supplement → Consolidated in : 2 Volumes Vol. 1: pharmaceutical substances (A-O) Vol. 2: pharmaceutical substances (P-X) + dosage forms + radiopharmaceuticals + methods of analysis + reagents 1st Supplement - new requirements and revisions Adobe Systems PHARMACOPOEIA BOHEMICA Ø3 volumes + CD, 2017 Ø ØTranslation of 7th ed. of Eur. Pharmacopoieia Ø ØIssued by The Czech Ph. Comm. Of Ministry of Health Adobe Systems ØVol. 1 General methods and requirements Ø Ø ØVol. 2 Monographs A-N ØMedicines, excipients Ø ØVol. 3 Monographs N-Z ØMedicines, excipients National part General methods and requirements Tables (I-XII) ØMedicines, excipients Ø Adobe Systems PHARMACOPOEIA WHAT we can not find there ! pharmacological properties of drugs, their pharmacodynamics, pharmacokinetics indications, contra-indications toxic effects Adobe Systems Compounded medications Examples: Acidi salicylici unguentum Aluminii acetotartratis otoguttae Aqua carminativa Chloramphenicoli oculoguttae Hartmanni infusio Iodi solutio ethanolica Natrii tetraboratis globulus Paracetamoli suppositorium Salia pro gargarismate pulvis Sirupus simplex Zinci oxidi pasta Adobe Systems ČL TAB4 2 Adobe Systems ATC CLASSIFICATION SYSTEM ̶Active substances – hierarchy with five different levels ̶14 main anatomical/pharmacological groups or 1st levels ̶Each main group divided into 2nd levels (pharmacological or therapeutic groups) ̶The 3rd and 4th levels are chemical, pharmacological or therapeutic subgroups ̶5th level is the chemical substance Adobe Systems Adobe Systems ATC DRUG CLASSIFICATION SYSTEM ̶ATC code = international alphanumerical code for every individual pharmaceutical substance in defined indication group – see metformin: ̶ Adobe Systems ̶