flP Guidelines for Dissolution Testing of Solid Oral Products Joint Report of the Section for O"icial laboratories and Medicines Control Services and the Section of Industrial Pharmacists of the FIP

Abstract

Joint Report of the Section for O"icial laboratories and Medicines Control Services and the Section of Industrial Pharmacists of the FIP III 1981 FrP pllblisb,d Gllidelilles }or Dissoilltioll Testing of Solid ami Prodllcts Ilf If )oilll " ' p01./ oftbe Section for Official Lnbornwries fi nd Medicines Coutrol Services fllld tbe Section oj l11dustrifll Pbn17l1ocists. Tllese guitldillrs were il1ft'lltled flS suggestions primflrily directed to rompendifll c01J1mittees, working 011 the illnwluctioll oJdissollltioll/"clellsc tests for the rCJpcctive pl)(wlIlflcopoeius. During tbe pflSt 15 years there bove befl11!1f1I1Y developmems. Biopbflrlllflcelitics bns flttrflrled 7Jlllcb scientific liS well os politicnl imrrest. Dissollltioll test 1IIftbodology bos been introduced to 1I1011Y phu17llflcopoeios lind 1I1l11111ber ofregulllfions IIl1d guidelines 011 bioovnilnbiJity, bioeqllivnlt11fe and ill vitro dissolution terri11g hllve been ismed nt IIntiOllfll lll1d ill/ernntiollal level. The joint working group 011 dissolution of/be two PIP sections tberejore decided to eSfflb/ish (llIew dissollltioll guidelille, ttlkillg rill these developments illfo cOllsitiemtion bllt addiug proposfllsJorjil1'ther bflrmoJliulfiol/ fllld for d('jillitiollS fllld pro(edures whieb (Ire 110t yt'f L'Ovel'ed b)1 imemntiollfll recommeudotiol1s. PIP pI/bJis/wl tbe "jillfll d/'llft" version ill 1995 IIl1d co-sponsored fll1ll1fer'l1l1fiol1nl f.Vorksbop il1 November 1996 to give collet1glles from IIniversities, drug III1/horities, phfll1l1acopoeills find pbllrmoeellti(fll illdustries the opp011lmi~y to contribute v.;itb tbeil' c01Jl7llellls fo1' fil11ber i1Jlprove1llem of tbe gllidelim text prior to tbis pllbJimtio11 of tbe fi1l1l1 "officiar veniol/.