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Why is Melt better than tablets?

Melt differentiation Why is melt better than tablet ? Relationship between pharmacokinetics and clinical response : . Why is Melt better than tablets?. Through the eyes of the pharmacologist Through the eyes of the doctor Through the eyes of the parents

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Why is Melt better than tablets?

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  1. Melt differentiationWhy is melt better than tablet?Relationship between pharmacokinetics and clinical response :

  2. Why is Melt better than tablets? • Through the eyes of the pharmacologist • Through the eyes of the doctor • Through the eyes of the parents • Through the eyes of the patient

  3. Through the eyes of the pharmacologist Does MELT have superior PK-data PD data?

  4. Through the eyes of the pharmacologist • Comparative PK-study • MELT 120µg • tablet 200µg • Bioequivalent at a lowerdose /les *= p<0,05 De Guchtenaere et all, AUA May 2012 poster 1200629

  5. Through the eyes of the pharmacologist PD = pharmacodynamics in concentratingcapacity diuresis-rate • = what the drug does to the body

  6. Through the eyes of the pharmacologist BJU Int2006;97(3):603–9

  7. Through the eyes of the pharmacologist • PD response: change in concentratingcapacity • diuresis-rate Fastincrease in urinairy concentration first hour Additionaleffect 2nd and 3rd hour Fast Anti-diureticeffect first hour Additionaleffect 2nd and 3rd hour

  8. Through the eyes of the pharmacologist Ghentfoodstudy : comparative PD-data Melt versus tablet with concomitantfood-intake * = p<0.05 Desmopressin oral lyophylisateformulation: Superior pharmacodynamics compared to tablet due to low food-interaction De Guchtenaere et all J Urol. 2011 Jun;185(6):2308-13

  9. 14 12 10 8 Duration of action (hours) 6 125 mOsm/kg 4 200 mOsm/kg 2 400 mOsm/kg 0 0 30 60 120 240 360 480 Dose desmopressin (μg) Through the eyes of the pharmacologist VandeWalle JG et al. BJU Int2006;97(3):603–9

  10. Through the eyes of the pharmacologist Ghentfoodstudy : comparative PD-data Melt versus tablet with concomitantfood-intake * = p<0.05 Desmopressin oral lyophylisateformulation: Superior pharmacodynamics compared to tablet due to low food-interaction De Guchtenaere et all J Urol. 2011 Jun;185(6):2308-13

  11. Through the eyes of the doctor Does MELT have better clinical results? Is MELT safer than tablet?

  12. Through the eyes of the doctor • Clinical effect = amount of wet nights

  13. Through the eyes of the doctor PD Data in children: full anti-enuretic response ± 30 % Hjalmas (1998); Rushton (1995); Dimson (1986); Uygur (1997); Wille (1986); Post(1983); Moffat (1993); Janknegt (1997); Skoog (1997)

  14. Through the eyes of the doctor • Does MELT have betterclinicalresults? De Guchtenaere et all poster 1201511 AUA Atlanta May 2012

  15. Through the eyes of the doctor Is MELT safer comparedto tablet? • Pediatric PK/ PD data • more predictable • Lessinterferencenutrution • Lowerreporterate of SAE than spray BJU Int2006;97(3):603–9

  16. Through the eyes of the doctor Therapeutic response Antidiuretic effect Toxic response Waterintoxication MELT betterclinical response Lowerdose, same effect Dose-response data available Weight -relatedplasmaconcentration MELT smaller variability, lessfood interference higherpredictability, thus safer!

  17. Through the eyes of the parents

  18. Through the eyes of the parentsandchild Betterclinical response De Guchtenaere et all poster 1201511 AUA Atlanta May 2012

  19. Through the eyes of the parents 1-3hours beforebedtime tablet also1,5 hraftermeal Meltlessfood-interference

  20. Through the eyes of the patient

  21. Through the eyes of the patient Int J ClinPract. 2007 Sep;61(9):1454-60. Epub 2007 Jul 26.

  22. Conclusion: Is Melt better than tablet? Better PD data Better PK profyle Better clinical response Better safetyprofyle Preferredpt Less food dependent

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