Polymer-Based Films and Drug Delivery Systems Made Therefrom

Abstract

The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component which includes polyethylene oxide, optionally blended with at least one additional polymer. The films may alternatively contain a polymer component which includes polyvinyl alcohol, optionally blended with at least one additional polymer. The films also may contain a pharmaceutical and/or cosmetic active agent.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in part of U.S. application Ser. No. 10 / 856,176 filed May 28, 2004, which claims the benefit of U.S. Provisional Application No. 60 / 473,902, filed May 28, 2003 and is a continuation-in-part of PCT / US02 / 32575 filed Oct. 11, 2002. which claims priority to U.S. application Ser. No. 10 / 074,272, filed Feb. 14, 2002 which claims priority to U.S. Provisional Application No. 60 / 328,868. filed Oct. 12 2001 and U.S. Provisional Application No. 60 / 386,937, filed Jun. 7, 2002; PCT / US02 / 32594, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. 60 / 414,276, filed Sep. 7, 2002, U.S. application Ser. No. 10 / 074,272, filed Feb. 14, 2002, which claims priority to U.S. Provisional Application No. 60 / 328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60 / 386,937, filed Jun. 7, 2002; and PCT / US / 02 / 32542, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. ...

AI Technical Summary

Problems solved by technology

However, this form of preparing and dispensing medications has many disadvantages including that a large proportion of adjuvants that must be added to obtain a size able to be handled, that a larger medication form requires additional storage space, and that dispensing includes counting the tablets which has a tendency for inaccuracy.

In addition, many persons, estimated to be as much as 28% of the population, have difficulty swallowing tablets.

While tablets may be broken into smaller pieces or even crushed as a means of overcoming swallowing difficulties, this is not a suitable solution for many tablet or pill forms.

For example, crushing or destroying the tablet or pill form to facilitate ingestion, alone or in admixture with food, may also destroy the controlled release properties.

However, historically films and the process of making drug delivery systems therefrom have suffered from a number of unfavorable characteristics that have not allowed them to be used in practice.

Examination of films made in accordance with the process disclosed in Fuchs, however, reveals that such films suffer from the aggregation or conglomeration of particles, i.e., self-aggregation, making them inherently non-uniform.

When large dosages are involved, a small change in the dimensions of the film would lead to a large difference in the amount of active per film.

Since sheets of film are usually cut into unit doses, certain doses may therefore be devoid of or contain an insufficient amount of active for the recommended treatments.

Failure to achieve a high degree of accuracy with respect to the amount of active ingredient in the cut film can be harmful to the patient.

For this reason, dosage forms formed by processes such as Fuchs, would not likely meet the stringent standards of governmental or regulatory agencies, such as the U.S. Federal Drug Administration (“FDA”), relating to the variation of active in dosage forms.

Schmid specifically pointed out that the methods disclosed by Fuchs did not provide a uniform film and recognized that that the creation of a non-uniform film necessarily prevents accurate dosing, which as discussed above is especially important in the pharmaceutical area.

Moreover, his process is a multi-step process that adds expense and complexity and is not practical for commercial use.

These methods have the disadvantage of requiring additional components, which translates to additional cost and manufacturing steps.

Furthermore, both methods employ th

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