Pharmaceutical formulation of apomorphine for buccal administration
First Claim
1. A kit comprising a container, which comprises separate first and second compartments, wherein the first compartment comprises the following components (a):
- (a) a combination of;
(i) apomorphine or a pharmaceutically acceptable acid addition salt thereof, and(ii) a pharmaceutically acceptable excipient or carrier; and
wherein the second compartment comprises the following component (b);
(b) a solution which comprises a diluent and a pH modifying agent;
wherein the first and second compartments are arranged such that components (a) and (b) can be combined at the point of use of the kit to produce a formulation having a pH ranging from mildly acidic to alkaline, and which is suitable for buccal administration.
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Accused Products
Abstract
The present invention provides a kit comprising, in separate compartments of a container, the following components (a) and (b): (a) a combination of apomorphine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable excipient or carrier; and (b) a solution which comprises a diluent and a pH modifying agent; the components being presented such that they can be combined at the point of use into a formulation which is adjusted to a pH ranging from mildly acidic to alkaline and which is suitable for buccal administration. The formulation is useful in treating Parkinson'"'"'s disease and in promoting sexual function.
29 Citations
20 Claims
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1. A kit comprising a container, which comprises separate first and second compartments, wherein the first compartment comprises the following components (a):
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(a) a combination of; (i) apomorphine or a pharmaceutically acceptable acid addition salt thereof, and (ii) a pharmaceutically acceptable excipient or carrier; and
wherein the second compartment comprises the following component (b);(b) a solution which comprises a diluent and a pH modifying agent;
wherein the first and second compartments are arranged such that components (a) and (b) can be combined at the point of use of the kit to produce a formulation having a pH ranging from mildly acidic to alkaline, and which is suitable for buccal administration. - View Dependent Claims (2, 3, 4, 5, 6)
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- 7. A process for producing a pharmaceutical composition, which process comprises combining apomorphine or a pharmaceutically acceptable acid addition salt thereof with a solution which comprises a diluent and a pH modifying agent, such that the resulting formulation is has a pH ranging from mildly acidic to alkaline, and is suitable for buccal administration.
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10. (canceled)
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11. (canceled)
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12. (canceled)
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13. (canceled)
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14. (canceled)
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15. A method of administering an apomorphine composition to a patient in need thereof, comprising:
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(a) optionally adjusting the pH of a composition comprising a pharmaceutically effective amount of apomorphine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable excipient or carrier to a pH ranging from mildly acidic to alkaline; and (b) delivering the composition buccally to a patient in need thereof. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification