Bromhexine delayed-release pharmaceutical form

Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Polymer from ethylenic monomers only

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Details

424 19, A61K 922, A61K 924

Patent

active

044380917

ABSTRACT:
This invention relates to vehicles for the administration of bromhexine. More specifically, this invention relates to a composition for the delayed release of bromhexine which comprises (i) spheroid particles or tablets comprised of (a) bromhexine and/or acid addition salts thereof and (b) at least one pharmacologically acceptable acid or acidic substance, the total amount of acid substance from acid addition salts present and the acid or acidic substance being in a ratio of at least 2 mols to 1 mol of bromhexine, and (ii) a coating surrounding said spheroid particles or tablets, said coating being comprised of from about 50 to 100 percent by weight of acid-insoluble lacquers soluble in intestinal juices and from about 0 to 50 percent by weight of lacquers insoluble in gastric and intestinal juices and said coating being present in an amount of from about 2 to 30 percent by weight, based upon the weight of the spheroid particles or tablets.

REFERENCES:
patent: 2928770 (1960-03-01), Bardani
patent: 2971889 (1961-02-01), Swintosky
patent: 3247066 (1966-04-01), Milosovich
patent: 3344029 (1967-09-01), Berger
patent: 3538214 (1970-11-01), Polli et al.
patent: 3775537 (1973-11-01), Lehmann et al.
patent: 3835221 (1974-09-01), Fulberth et al.
patent: 3917813 (1975-11-01), Pedersen
patent: 4083949 (1978-04-01), Benedickt
patent: 4361546 (1982-11-01), Stricker et al.
patent: 4367217 (1983-01-01), Gruber et al.
Spitael et al. Pharm. Ind. 39(S): 502-505(1977) "Factors Affecting The Dissolution Rate of Enteric Coatings".

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