Multi-particulate form of medicament, comprising at least...

Details Multi-particulate form of medicament, comprising at least... Multi-particulate form of medicament, comprising at least...

2004-09-27

2008-10-21

Richter, Johann (Department: 1616)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S489000

Reexamination Certificate

active

07438929

ABSTRACT:
The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.

REFERENCES:
patent: 4600577 (1986-07-01), Didriksen
patent: 4720387 (1988-01-01), Sakamoto et al.
patent: 6897205 (2005-05-01), Beckert et al.
Schmidt, C., “A Multiparticulate Drug-delivery System Based on Pellets Incorporated into Congealable Polyethylene Glycol Carrier Materials”, International Journal of Pharmaceutics 216 (2001) 9-16, Elsevier.

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