Controlled release pharmaceutical composition for oral use...

Details Controlled release pharmaceutical composition for oral use... Controlled release pharmaceutical composition for oral use...

2006-07-04

2006-07-04

Spear, James M. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

C424S458000, C424S468000, C424S469000, C424S490000

Reexamination Certificate

active

07070803

ABSTRACT:
Novel controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The novel compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine.The novel compositions may be designed for administration once or twice daily, i.e. a therapeutically effective concentration of desglymidodrine is maintained for a period of at least 10-16 hours followed by a wash out period of about 8-12 hours in order to avoid the well-known midodrine related side effect with respect to supine hypertension. The therapeutically effective concentration of desglymidodrine is regarded as a plasma concentration of desglymidodrine of at least about 3 ng/ml. A composition is designed to release midodrine and/or desglymidodrine in at least the following consecutive steps: i) an initial relatively fast release of midodrine and/or desglymidodrine (in order to obtain a relatively fast onset of action), ii) a steady release or a slower release than in step 1 of midodrine and/or desglymidodrine (in order to maintain a plasma concentration of desglymidodrine which is prolonged and relatively constant), iii) a second rise in release of midodrine and/or desglymidodrine (in order to take advantage of absorption from the colon, i.e. such a second rise release is designed to take place when the composition (or the disintegrated parts of the composition) reaches the colon; normally this is regarded to take about 8 hours after oral intake, and iv) a decline in release rate corresponding to that essentially all midodrine and/or desglymidodrine have been released from the composition.Also disclosed is a method for treating orthostatic hypotension and/or urinary incontinence, the method comprising administration to a patient in need thereof of an effective amount of midodrine and/or desglymidodrine in a composition according to the invention.

REFERENCES:
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patent: 5360822 (1994-11-01), Morino et al.
patent: 3935736 (1991-05-01), None
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B. Korsatko-Wabnegg et al., Einsatz von Poly-D-(−)-3-hydroxybuttersaure zur Formulierung von Manteltabletten mit “Delayed-release”-Effekt, Pharmazie, vol. 46, pp. 204-206 (1991)l.
B. Korsatko-Wabnegg, “Entwicklung von Manteltabletten mit “controlled-release” Effekt auf der Basis von Poly-D-(−)-3-hydroxybuttersaure”, Pharmazie, vol. 45, pp. 842-844 (1990).

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