3. The "purpose and principal object" of the
invention is (specification, page 2, lines 33-38):
to provide an improved method for the treatment of
Parkinson's disease by using novel formulations of the
combination carbidopa-levodopa which a) are effective in
preventing the symptoms of Parkinson's disease and yet which
b) act rapidly avoiding significant onset delay common to
the standard controlled release therapy.
4. The formulations of the invention have (1) an
immediate release component and (2) a controlled (or delayed)
release component (specification, page 3, lines 2-4). The nature
of the invention is described as following in the specification
(page 3, lines 2-9):
The novel oral dosage formulations of the present
invention each contain immediate release and controlled
release components of the antiparkinson agents carbidopa
(5-200 mg) and levodopa (25-600 mg). The conventional
immediate release combination of carbidopa-levodopa reaches
peak plasma concentrations in 30 minutes whereas the onset
of the controlled release component is two hours followed by
prolonged release over a four- to six-hour period.
5. According to applicant (specification, page 3,
lines 10-16):
The usual daily therapeutic dose of levodopa, when
administered with carbidopa, is 300-750 mg and the dose of
carbidopa approximately 75 mg per day but the latter is
apparently devoid of adverse effects even at doses of 400 mg
per day ***.
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