Coated preparation soluble in the lower digestive tract

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form

Reexamination Certificate

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Details

C424S489000, C424S497000

Reexamination Certificate

active

07138143

ABSTRACT:
A coating dispersion soluble in the lower digestive tract which is prepared by blending a hydroxypropyl methylcellulose acetate succinate (HPMCAS) soluble at around pH 7 with a conventional plasticizer and an anion surfactant and further adding an acid, wherein the HPMCAS has an average particle size of 10 μm or less and is dispersed at a concentration of 2 to 20% by weight, and the acid is used in an amount of 1 to 10 parts by weight per 100 parts by weight of HPMCAS, and a sustained release coated preparation capable of releasing a medicament in the large intestine at the lower digestive tract, which is prepared by coating a medicament-containing solid preparation such as a granular core with the coating dispersion.

REFERENCES:
patent: 4385078 (1983-05-01), Onda et al.
patent: 5026559 (1991-06-01), Eichel et al.
patent: 5914132 (1999-06-01), Kelm et al.
patent: 0 391 518 (1990-10-01), None
patent: 0 648 487 (1995-04-01), None
patent: 1 393 374 (1975-05-01), None
“Organic acids as excipients in matrix granules for colon-specific drug delivery,” P. Nykänen et al., International Journal of Pharmaceutics, 184 (1999) 251-261.

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