Sublingual and buccal film compositions

Abstract

The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.

Description

FIELD OF THE INVENTION[0001]The present invention relates to compositions, methods of manufacture, products and methods of use relating to films containing therapeutic actives. The invention more particularly relates to self-supporting dosage forms which provide an agonist acting alone or in combination with a buffer system to maximize therapeutic absorption of the agonist. Some embodiments also include an antagonist, with the buffer system acting to minimize the absorption of the antagonist. Such compositions are particularly useful for preventing misuse of the active while providing sufficient buccal adhesion of the dosage form.BACKGROUND OF THE RELATED TECHNOLOGY[0002]Oral administration of two therapeutic actives in a single dosage form can be complex if the intention is to have one active absorbed into the body and the other active remain substantially unabsorbed. For example, one active may be relatively soluble in the mouth at one pH, and the other active may be relatively in...

AI Technical Summary

Benefits of technology

The patent describes a film dosage composition that can be used to treat medical conditions. It includes a polymeric carrier matrix, a therapeutically effective amount of an agonist, and a buffer to help the agonist absorb better. The composition is designed to be self-supporting and can be easily applied to the skin or mouth. Its technical effect is to provide a convenient and effective way to deliver therapeutic agents.

Problems solved by technology

Oral administration of two therapeutic actives in a single dosage form can be complex if the intention is to have one active absorbed into the body and the other active remain substantially unabsorbed.

These factors represent some of the challenges in appropriately co-administering therapeutic agents.

Such individuals may have a tendency to suffer from serious physical dependence on the therapeutic agent, resulting in potentially dangerous withdrawal effects when the therapeutic agent is not administered to the individual.

In order to provide treatment to patients, it is known to provide a reduced level of a therapeutic agent, which provides an effect of treating the condition, but does not provide the “high” that may be provided by the therapeutic agent.

However, even though these therapeutic agents provide only a low level of euphoric effect, they are capable of being abused by the individuals parenterally.

However, such combinations in tablet form have the potential for abuse.

Although certain antagonists (such as highly water-soluble antagonists) may be used to help reduce the ability to separate the agonist, the potential for abuse still exists.

There is currently a need for an orally dissolvable film dosage form that provides the desired absorption levels of the agonist and antagonist, while providing an adhesive effect in the mouth, rendering it difficult to remove once placed in the mouth and achieving optimum absorption of the agonist while inhibiting absorption of the antagonist.

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