PCOL2605 Lecture Notes - Lecture 5: Ketoprofen, Hygroscopy, Specific Storage
23 Oct 2018
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Generally, it is the time from manufacture of the product till the potency of the active substance has been reduced 10% under specific storage conditions: co(cid:374)side(cid:396) a(cid:374)(cid:455) to(cid:454)i(cid:272) deg(cid:396)adation products. Pharmaceutical significance: loss of pote(cid:374)(cid:272)(cid:455); less the(cid:396)apeuti(cid:272) effi(cid:272)a(cid:272)(cid:455, deg(cid:396)adatio(cid:374) to toxic products, fo(cid:396)(cid:373)ulatio(cid:374) becomes unsuitable for application, u(cid:374)a(cid:272)(cid:272)epta(cid:271)le appearance (colour change, bad smell, microbiological growthetc, requirement for approval by regulatory agencies. Types of instability: ph(cid:455)si(cid:272)al, che(cid:373)i(cid:272)al a(cid:374)d photo(cid:272)he(cid:373)i(cid:272)al, mi(cid:272)(cid:396)o(cid:271)iologi(cid:272)al, be a(cid:449)a(cid:396)e that o(cid:374)e t(cid:455)pe (cid:272)a(cid:374) lead to a(cid:374)othe(cid:396) Physical instability degradation: cha(cid:374)ges insolubility, e(cid:373)ulsio(cid:374) cracking, cha(cid:374)ges in tablet dissolution or disintegration, cha(cid:374)ges in semisolid rheology, caki(cid:374)g of suspensions, pa(cid:272)kagi(cid:374)g failu(cid:396)e (cid:894)(cid:272)a(cid:374) also lead to (cid:272)he(cid:373)i(cid:272)al o(cid:396) (cid:373)i(cid:272)(cid:396)o(cid:271)iologi(cid:272)al i(cid:374)sta(cid:271)ilities(cid:895) Change chemistry: i(cid:374)(cid:272)(cid:396)easi(cid:374)g (cid:373)elti(cid:374)g poi(cid:374)t, choosi(cid:374)g a (cid:374)o(cid:374)-hygroscopic form (crystal or salt form, redu(cid:272)i(cid:374)g solu(cid:271)ilit(cid:455) (cid:271)(cid:455) (cid:272)hoosi(cid:374)g a less solu(cid:271)le salt, mi(cid:272)ella(cid:396) i(cid:374)(cid:272)lusio(cid:374, e(cid:374)gi(cid:374)ee(cid:396)i(cid:374)g of the pa(cid:396)ticles (shape) Types of chemical degradation: h(cid:455)d(cid:396)ol(cid:455)sis o(cid:454)idatio(cid:374, redu(cid:272)tio(cid:374) (cid:894)less (cid:272)o(cid:373)(cid:373)o(cid:374), e. g. ketop(cid:396)ofe(cid:374) =o -oh, pol(cid:455)(cid:373)e(cid:396)isatio(cid:374) (cid:894)fo(cid:396)(cid:373)atio(cid:374) of di(cid:373)e(cid:396)s, e. g.
