Appeal No. 1997-4344
Application 08/380,218
microlayers of (1) micronized ambroxol hydrochloride active agent and (2) delayed-
release film material, said coated microgranules including an external microlayer of
delayed-release film material, and said coated microgranules having particle sizes
ranging from 0.6 to 1.5 mm.
11. A process for the production of the programmed-release dosage form as
defined by Claim 1, comprising (a) providing a plurality of inert core microgranules of a
variety of particle sizes ranging from 0.3 to 1.2 mm, (b) providing a therapeutically effective
amount of micronized ambroxol hydrochloride, (c) applying on said inert core
microgranules multiple alternating microlayers of said micronized ambroxol hydrochloride
and of a solvent solution of a delayed-release film-coating material wherein said delayed-
release film-coating material is external to said micronized ambroxol hydrochloride, and
(4) consolidating each microlayer to dryness.
The reference relied on by the examiner is:
Ghebre-Sellassie et al. (Ghebre-Sellassie) 5,084,287 Jan. 28, 1992
Claims 1 through 13 stand rejected under 35 U.S.C. § 103(a). As evidence of
obviousness, the examiner relies upon Ghebre-Sellassie. We reverse.
DISCUSSION
Claim 1 is directed to a programmed-release ambroxol·HCl pharmaceutical
dosage form. The dosage form comprises a plurality of inert core microgranules having a
variety of particle sizes ranging from 0.3 to 1.2 mm. Importantly, the core microgranules
are coated with multiple alternating microlayers of (1) micronized ambroxol hydrochloride
2
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