Portal de Periódicos da CAPES

FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms*

2003; Volume: 10; Issue: 1 Linguagem: Inglês

10.14227/dt100103p6

2376-869X

Martin Siewert, Jennifer B. Dressman, Cynthia K. Brown, Vinod Shah,

Analytical Methods in Pharmaceuticals

i o n / Drug Release Te s t i n g I n the pharm a ce u t i cal industry,dissolution testing is a ve ry i m po rt a nt tool in drug deve l o p m e nt and quality co nt ro l .Al t h o u g h initially deve l o ped for immediate release (IR) solid oral dosage fo rms and then extended to co nt ro l l e d / m odified release solid ora l dosage fo rm s,in re ce nt years the application of dissolution testing has widened to a va ri e ty of "n ove l"or "s pe c i a l"dosage fo rms such as s u s pe n s i o n s,o rally disinte g rating tablets,c h e wable tablets,c h e w i n g g u m s,t ra n s d e rmal patc h e s,semi-solid to p i cal pre p a rat i o n s,s u p po s ito ri e s,i m p l a nts and injectable micro p a rt i c u l ate fo rm u l ations and lipos o m e s.For orally administe re d,IR solid drug prod u ct s,it is custo m a ry to re fer to the test as a 'd i s s o l u t i o n'te s t,s i n ce the inte ntion is that the d rug dissolves rapidly in the test medium.For non-oral dosage fo rm s such as to p i cal and tra n s d e rmal delive ry sys te m s,s u p po s i to ries and o t h e r s,the test is re fe rred to pre fe rably as a 'd rug re l e a s e'or 'in vitro re l e a s e'test proce d u re.Due to significa nt diffe re n ces in fo rm u l at i o n design among these nove l / s pecial dosage fo rm s,which in turn lead to ve ry diffe re nt phys i co -c h e m i cal and release chara cte ri s t i c s, it is not possible to devise a single test sys tem which could be used to study the drug release pro pe rties of each and eve ry one.Rat h e r,d i f fe re nt a p p a rat u s,p roce d u res and techniques are employed on a ca s e -bycase basis,and the method may be specific to the dosage fo rm categ o ry,fo rm u l ation ty pe,or even to a part i c u l a r,individual prod u ct .Howeve r,the general principles of dissolution tests for solid ora l dosage fo rms should also be applicable to in vitro dissolution/dru g release tests for nove l / s pecial dosage fo rm s.The ultimate goal of these tests is analogous to that for solid oral dosage fo rm s,i .e.to use the test for the biopharm a ce u t i cal chara cte ri z ation of the dru g p rod u ct,and as a tool to assure co n s i s te nt prod u ct (batch) quality within a defined set of spe c i f i cation cri te ri a .Di f fe re nt ty pes of dosage fo rms and appro p ri ate apparatus used fo r d rug release testing are discussed be l ow.For seve ral nove l / s pe c i a l dosage fo rm s,the method o l ogy is well evo l ved and specific re co mm e n d ations can be made for drug release te s t i n g,e.g. ,for suspe ns i o n s, o rally disinte g rating tablets,c h e wable tablets,s u p po s i to ri e s, t ra n s d e rmal patches and semi-solid to p i cal dosage fo rms (cre a m s, o i nt m e nts and gels).Howeve r,as for co nve ntional oral dosage fo rm s, t h e re may be s pecific fo rm u l ations in the above -m e ntioned cate g o ries for which the evo l ved methods are not applica b l e.In seve ral other instance s, e. g. ,chewing gums,powd e r s, g ra n u l e s,solid dispe r s i o n s,m i c ro p a rt i cu l ate fo rm u l at i o n s,and implant s, m o re method deve l o p m e nt and