Sistemi transdermici e sviluppi

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Permeabilità cuteanea in vitro Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients - March 2006 4.13. Variability / validity / reproducibility The variability of dermal absorption studies depends on the penetration rate of a particular ingredient; the lower the penetration rate, the higher the variability. This high variability is due to known intra-individual and inter-individual characteristics of the stratum corneum barrier. The relative variability of the method should be documented. Experience has shown that the high variation in dermal absorption may partly be explained by differences in skin samples. Therefore skin samples should be taken from a suitable anatomical site and the study should use a sufficient number of samples and replicates. The technical ability of the performing laboratory and the validity of the method used should be assessed at regular intervals, at least twice per year, by using reference compounds like caffeine or benzoic acid. These data should be included in the study report [OECD 2004, Van de Sandt et al. 2004]. The results of the dermal absorption studies should be reproducible. A minimum of 6 evaluable samples (human or pig skin), from each of at least 3 donors, should be used per dose tested. The coefficient of variation should be less than 30 %. If statistical evaluation is not possible, the highest observed penetration value will be used in the systemic exposure dosage (SED) calculation.
Permeabilità cuteanea in vitro Stima della permeabilità cutanea in vivo di un API Principio attivo Cl (L/h) C ss (ng/ml) C t/C ss ITF 296 138.6 2.02 0.37 2.47 NR 52.2 1.07 0.23 140.19 ISDN 224.4 0.44 0.01 10.23 NTG 300.0 0.61 0.11 1.15 Minghetti P. et al., Eur J Pharm Sci 7(3):231 –236, 1999. C ss J max TTS Cl area Concentrazioni allo stato stazionario (C ss) calcolate in base ai valori di J max ottenuti sperimentalmente
Page 1 and 2: Prof.ssa Paola Minghetti SISTEMI TR
Page 3 and 4: Milestones nello sviluppo dei cerot
Page 6 and 7: Classificazione (FUI XII ed.) • C
Page 8 and 9: Transdermal Systems (USP32-NF27 S1)
Page 10 and 11: Classificazione (Eur. Ph. 6.7) •
Page 12 and 13: Semisolid preparations for cutaneou
Page 14 and 15: Somministrazione transdermica Razio
Page 16 and 17: Biodisponibilità della nitroglicer
Page 18 and 19: Somministrazione transdermica Razio
Page 20 and 21: Case history: estradiolo C m,cpr: 4
Page 22 and 23: Razionale industriale • Prolungam
Page 24 and 25: Somministrazione regionale Razional
Page 26 and 27: Case history: acido flufenamico ORA
Page 28 and 29: Fasi di sviluppo di un cerotto (tra
Page 30 and 31: Fattibilità Permeabilità cutanea
Page 32 and 33: Permeabilità cutanea in vitro Line
Page 36 and 37: Permeabilità cuteanea in vitro Sel
Page 38 and 39: Fasi di sviluppo di un cerotto (tra
Page 40 and 41: Cerotti transdermici Sistemi “res
Page 42 and 43: Ibuprofen amount permeated mg/cm (
Page 44 and 45: amount permeated (mg/cm 2 ) Scelta
Page 46 and 47: Scelta del supporto Tipo di cerotto
Page 48 and 49: Scelta della matrice e del supporto
Page 50 and 51: Definizione delle specifiche di pro
Page 56 and 57: Segnalazioni ricevute da FDA riguar
Page 64 and 65: μg/cm2 2 coumarin pemeated in vitr
Page 66 and 67: Cerotti in commercio contenenti nit
Page 68: Prestazioni di diversi cerotti cont

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