Extended release suspension compositions

Abstract

The present invention relates to extended release suspension compositions of an active ingredient. Said extended release suspension compositions comprise multiple coated cores of the active ingredient and a suspension base, wherein the suspension base generates a hypertonic condition such that there is no substantial change in the in-vitro dissolution release profile of the extended release suspension compositions upon storage for at least seven days. The invention also relates to processes for the preparation of said extended release suspension compositions.

Description

FIELD OF THE INVENTION[0001]The present invention relates to extended release suspension compositions of an active ingredient. Said extended release suspension compositions comprise multiple coated cores of the active ingredient and a suspension base, wherein the suspension base generates a hypertonic condition such that there is no substantial change in the in-vitro dissolution release profile of the extended release suspension compositions upon storage for at least seven days. The invention also relates to processes for the preparation of said extended release suspension compositions.BACKGROUND OF THE INVENTION[0002]Extended release solid compositions are preferred dosage forms over immediate release solid compositions, especially for active ingredients showing fluctuations in the plasma concentration and for active ingredients having short half-lives. Extended release solid compositions can be in the form of tablets or capsules, wherein the release of the active ingredient is con...

AI Technical Summary

Benefits of technology

This patent describes extended release suspension compositions that have several benefits. These compositions are easy to use, which improves patient compliance. They also offer flexibility in dosage depending on the patient's age and weight. Additionally, these compositions are stable, easy to make and give consistent results. Furthermore, they have a pleasant taste, which makes them even more appealing to patients.

Problems solved by technology

However, extended release solid compositions suffer from certain drawbacks such as difficulty in swallowing, particularly for certain groups of patients, e.g., pediatrics and geriatrics, resulting in poor patient compliance.

Further, high doses of active ingredient lead to large-sized compositions which aggravates this problem.

Also, there remains a tendency to divide extended release solid compositions such as tablets into small pieces in order to facilitate administration, which may ultimately lead to inaccurate dosing and / or dose dumping.

Although extended release liquid compositions are advantageous, there remain some complexities involved in formulating such compositions.

In the formulations disclosed in the prior art, there is a possibility of leaching of the active ingredients from the coated units into the media during storage.

Further, although ion-exchange resin systems provide the desired extended release without significant leaching during storage, these systems require chemical binding of the active ingredient to the resin, which is complicated and not suitable for many active ingredients.

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