Pseudoephedrine hydrochloride extended-release tablets

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In a preferred embodiment of the present invention a combination comprising at least one active ingredient together with hydroxypropylmethylcellulose (HPMC) and microcrystalline cellulose is directly compressed to form tablets.
Preferably, the composition is prepared by dry mixing the ingredients.
Preferably, one of the active ingredients is pseudoephedrine or a pharmacologically acceptable salt thereof, such as pseudoephedrine hydrochloride or pseudoephedrine sulfate, or a mixture thereof.
More preferred is pseudoephedrine hydrochloride.
Preferably about 15-25% of the active ingredient, based on the final weight of the tablets, is used; more preferably, about 16-22%; most preferably about 17-20%.
In a preferred embodiment, the amount of active ingredient used is that which is sufficient to produce tablets, each comprising about 120 mg of active ingredient.
In an alternate embodiment, the amount of active utilized is sufficient to produce tablets comprising about 60 mg of active ingredient each.
The HPMC preferably has a hydroxypropyl content of less than 9% and a molecular weight below 50K.
More preferably, the molecular weight is below about 30K.
A preferred HPMC is Methocel.
RTM.
K100LV (produced by The Dow Chemical Co.
of Midland, Mich.
).
Preferably about 20-40% HPMC is used, more preferably about 25-30%.
Suitable microcrystalline cellulose products include Emcocel.
RTM.
(produced by the Edward Mendell Co.
of Patterson, N.
Y.
), Avicel.
RTM.
(produced by FMC Corp.
of Philadelphia, Pa.
), and mixtures thereof.
In a preferred embodiment, about 25-50%, by final weight of the tablets, of microcrystalline cellulose is used, more preferably about 25-30%.
Not more than a combined amount of about 80% (by final weight of the tablets) of disintegrant/binder and HPMC should be used.
Also, the amount of microcrystalline cellulose should not substantially exceed that of HPMC, e.
g.
, by more than 20-25% by weight.
Glidants, fillers, and other excipients that may be used in the preferred embodiments include those described, e