1) V diagramu sta prikazana plazemska koncentracijska profila po večkratnem intravenskem odmerjanju učinkovine v dveh različnih primerih (1 in 2).
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1 NALOGE ) V diagramu sta prikazana plazemska koncentracijska profila po večkratnem intravenskem odmerjanju učinkovine v dveh različnih primerih ( in ) Primera in se razlikujeta samo v enem parametru (D, τ, n V d, Cl). Ugotovi kakšen je bil režim odmerjanja pri načinu (izpolni spodnjo preglednico). Rezultat komentiraj! ( točka) Odmerjanje Plazemski profil D (mg) 6 C av, ss (mg/l) τ (h) 6 C max, ss (mg/l) n 8 C min, ss (mg/l) V d (l) 00 k e (h - ) Cl (l/h) 40 r.43.0 C av, ss povprečna koncentracija v stacionarnem stanju C max, ss maksimalna koncentracija v stacionarnem stanju C min, ss minimalna koncentracija v stacionarnem stanju k e hitrostna konstanta izločanja r faktor akumulacije
2 ) Glipizid je derivat sulfonil sečnine, ki se uporablja v terapiji sladkorne bolezni tipa. Po peroralni aplikaciji se glipizid hitro in skoraj v celoti absorbira, je močno vezan na plazemske albumine (>98%), iz telesa pa se izloča s presnovo v jetrih (t / je 4 ure). Periodična poročila o varnosti zdravil z glipizidom nakazujejo povečano tveganje za hipoglikemijo pri bolnikih, ki se zaradi okužbe spodnjih sečil sočasno zdravijo s sulfametoksazolom (sulfonamid). Domnevajo, da gre za interakcijo med zdraviloma. Domnevo so preverili z naslednjo klinično raziskavo. Zdravemu prostovoljcu so dajali glipizid 48 ur s kontinuirano intravensko infuzijo ( mg/h). 4 ur po začetku infuzije z glipizidom so pacientu začeli dajati sulfametoksazol (bolus intravenska injekcija 500 mg, nato intravenska infuzija, 40 mg/h, 4 ur). 48 ur po začetku poskusa so obe infuziji prekinili. Podatki o časovnem poteku celokupne plazemske koncentracije glipizida so v preglednici in prikazani v diagramu. Čas (h) Celokupna koncentracija glipizida Koncentracija glipizida (mg/l) Čas (h) a) Izračunaj navidezni volumen porazdelitve, očistek in biološko razpolovno dobo glipizida pred in po aplikaciji sulfametoksazola. b) Ali so s tem poskusom uspeli pokazati, da je vzrok hipoglikemije pri sočasnem zdravljenju interakcija med zdraviloma? c) Zakaj so v poskusu sulfametoksazol odmerjali s kombinacijo bolus intravenske injekcije in infuzije)? Kaj so dosegli s takim načinom odmerjanja? d) Na osnovi rezultatov poskusa razložite mehanizem interakcije. ( točki)
3 3) Razvili smo farmacevtsko obliko z nadzorovanim sproščanjem za peroralno aplikacijo učinkovine FFA-003/. Zanima nas biološka uporabnost, zato smo naredili pilotni klinični test, v katerem smo šestim zdravim prostovoljcem 00 mg učinkovine najprej aplicirali peroralno v obliki raztopine in po enemu tednu še 300 mg s farmacevtsko obliko z nadzorovanim sproščanjem. Spremljali smo časovni potek plazemske koncentracije učinkovine. Povprečna plazemska profila sta podana v Tabeli in prikazana na Sliki in Sliki. 4 Raztopina 0.0 Ra ztop in a N ad zo rov an o sproščanje Nadzorovano spr ošč an je C p (mg/l) C p (mg/l) t (h) t (h) Slika Časovni potek plazemske koncentracije FFA-003/. Slika Časovni potek plazemske koncentracije FFA-003/ (semilogaritemski prikaz). a) Kakšno je razmerje med biološko uporabnostjo FFA003/ po aplikaciji oblike z nadzorovanim sproščanjem in po aplikaciji raztopine? (0,6 točke) b) Kakšna je biološka razpolovna doba eliminacije FFA003/! (0,4 točke) Raztopina Nadzorovano sproščanje t (h) (mg/l) (mg/l)
4 Selected Computer Simulations of Pharmacokinetic Problems with Discussions Some of the examples are from Jeff Stark, University of Florida D (mg) t max (h).0.53 F C max (mg/l) k a (h - ) k e (h - ) V d (l) t / (h) Cl (l/h) 0 40 AUC (mg h/l) The goal in working through the following problems is to understand how changes in the input parameters (basic pharmacokinetic parameters such as bioavailability, absorption rate, clearance, etc.) will affect the concentration-time profile of a drug. The ability to predict results or determine the reasons for changes observed is very important in optimizing drug therapy for a patient. In working through these problems, your goal should not be to memorize each change/response - there is no way to cover every hypothetical situation - but rather to understand how to interpret the data and arrive at some conclusions which correctly explain the differences observed in the Cp-t profiles. To accomplish this, approach the problems from different angles: Predict results from the input given; Deduce input from the results given; Sketch the Cp-t profiles by considering only the input/results (that is, without looking at the simulations provided). At times, it may be helpful to reach into our bag of pharmacokinetic tools - the mathematical equations that relate certain parameters. You are also encouraged to do simulations of these cases. In the problems listed below, only one input parameter has been changed. By considering the plots and the results, you should be able to determine which parameter has changed and possibly calculate the new value. For example, in the plots above the peak concentrations are obviously different and from the results provided we see that the AUC s are changed by a factor of. Ask yourself: "What caused these differences? On what parameters are peak levels dependent upon? What determines AUC?" This may seem complicated at first. However, be patient with yourself and things should start to come together after you work through a few of these simulations.
5 # Single dose extravascular application D (mg) 0 t max (h).0.0 F C max (mg/l) k a (h - ) k e (h - ) V d (l) 00 t / (h) Cl (l/h) 0 AUC (mg h/l)
6 # Single dose extravascular application D (mg) 60 t max (h) F C max (mg/l) k a (h - ) 0.5 k e (h - ) V d (l) 00 t / (h) Cl (l/h) 0 AUC (mg h/l)
7 #3 Single dose extravascular application D (mg) 60 t max (h).53.0 F C max (mg/l) k a (h - ) k e (h - ) V d (l) 50 t / (h) Cl (l/h) 0 AUC (mg h/l)
8 #4 Single dose extravascular application D (mg) 60 t max (h).53.0 F C max (mg/l) k a (h - ) k e (h - ) V d (l) 00 t / (h) Cl (l/h) 40 AUC (mg h/l).5 3.0
9 #5 Intravenous infusion k 0 (mg/h) 00 C ss (mg/l).6 3. T (h) 0 k e (h - ) V d (l) 00 t / (h).. Cl (l/h) 64 AUC (mg h/l)
10 #6 Intravenous infusion D (mg) 4000 C ss (mg/l).6 3. T (h) 40 k e (h - ) V d (l) 00 t / (h).. Cl (l/h) 64 AUC (mg h/l)
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