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...

2005-05-24

2005-05-24

Pryor, Alton (Department: 1616)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Ortho-hydroxybenzoic acid or derivative doai

C514S169000, C514S222200

Reexamination Certificate

active

06897205

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.
V.K. Gupta et al.: “Statistical optimization of a novel multi-unit colonic delivery system containing multiple coatings of aqueous polymethacrylates” 27thInternational Symposium on Controlled Release of Bioactive Materials and 3rdConsumer and Diversified Products Conference. Proceedings Book 2000. Paris, France, Jul. 7-13, 2002.
Chong-Dong Fu et al.: “Preparations and evaluation of pH-dependent and sustained-release pellets for mesalazine colon targeted delivery” Database Biosis 'Online! Biosciences Information Service, Philadelphia, PA, US Database Accession No. PREV200100122930, XP002192585.

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