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In-vitro and In-Vivo Characterisation of Two Sustained Release Formulations for the Antidepressant Rolipram

In-vitro and In-Vivo Characterisation of Two Sustained Release Formulations for the Antidepressant Rolipram

M Pfeffer, N Sauerbrey, F Windt-Hanke, W Krause

Arzneimittelforschung. 1990 Nov;40(11):1191-4.

PMID: 2085329

Abstract:

Using the pellet technology two sustained release formulations for (dl)-rolipram (ZK 62 711; CAS 61413-54-5) were developed and characterised by in-vitro dissolution tests and in a cross-over study in healthy male volunteers. In-vitro, 50% release was achieved within 2.5 h for formulation A and within 4 h for B. In-vivo, Cmax values of 4.4 +/- 0.9 ng/ml (A) and 2.1 +/- 0.8 ng/ml (B) were observed 2.8 +/- 0.8 h or 10.3 +/- 3.7 h after oral intake of 3 mg (dl)-rolipram. The terminal disposition half-life in the plasma was similar for both formulations (12 +/- 13 h and 11 +/- 2 h). Expectedly, the relative bioavailability of formulation B was lower compared to A (72%). Using the pellet technology, formulations with an intended release profile can be tailored to suit by mixing pellets with different release characteristics within one dosage form.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP61413545-B	Rolipram - CAS 61413-54-5		61413-54-5	Price

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