Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2002-02-26
2004-10-19
Fubara, Blessing M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S192000, C514S300000, C514S253030
Reexamination Certificate
active
06806256
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to novel taste masked liquid pharmaceutical compositions for oral administration. In particular, this invention relates to taste masked liquid pharmaceutical compositions comprising a pharmaceutically active agent and a taste masking composition. More particularly, the taste masking composition comprises a taste masking effective amount of an artificial sweetener.
BACKGROUND OF THE INVENTION
Orally administered drugs are provided to the patient in many dosage forms, including solid forms such as capsules, caplets or tablets and liquid forms such as solutions, syrups, emulsions or suspensions. Pharmaceutically active agents administered in solid dosage form are usually intended to be swallowed whole. The disagreeable taste of the drug is generally not of concern when formulating oral solid dosage forms, because the pharmaceutical's taste can be easily masked with an exterior coating.
Children, older persons, and many other persons including disabled or incapacitated patients often have trouble swallowing tablets or capsules. In these situations, it is desirable to provide the drug either in a chewable solid form or a liquid form. For many patients, including pediatric and geriatric patients, a liquid oral dosage form is preferred over a chewable dosage form. A liquid dosage is especially preferred for this class of patients because of the ease with which it may be swallowed. Additionally, patients may be more inclined to comply with their medication instruction if the dosages are easier to ingest.
Many liquid pharmaceutical compositions formulated for use by pediatric or geriatric patients are often prepared by grinding a tablet dosage form into a powder and mixing the powder with a diluent. Such a formulation often allows much of the drug to remain undissolved, thereby affecting the therapeutic concentration of drug in the composition. In addition, the powder exposes the unpleasant tasting pharmaceutically active agent, thus further requiring a means of masking the taste. It is readily understood that such compositions are impractical and may result in underdosing or overdosing a patient.
A common formulation problem associated with liquid pharmaceutical dosage forms (such as solutions (including syrups) or suspensions) is masking the disagreeable taste that a pharmaceutically active agent may often manifest when administered in a liquid dosage form. Many active ingredients, such as antibiotics, possess a strong, unpleasant and bitter taste. Unpleasant and bitter tasting antibiotics include gyrase inhibitors; particularly, those of the naphthyridone-carboxylic acid and quinolone-carboxylic acid types; more particularly, those selected from levofloxacin, ciprofloxacin, norfloxacin, ofloxacin or enoxacin.
In view of these difficulties, it would be desirable to develop a ready-to-use taste masked liquid pharmaceutical dosage form, in particular, a solution or suspension. More particularly, there exists a need for a taste masked suspension dosage form that minimizes sedimentation of the pharmaceutically active agent, provides uniform distribution of the active agent and has a palatable taste.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition wherein the taste masking composition comprises a taste masking effective amount of an artificial sweetener.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the pharmaceutically active agent is bitter tasting.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the bitter tasting pharmaceutically active agent is an antibiotic.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the bitter tasting antibiotic is levofloxacin.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the taste masking effective amount of an artificial sweetener masks a bitter taste.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the taste masking composition comprises a taste masking effective amount of sucralose.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of an artificial sweetener and at least one flavoring agent.
An object of the present invention is to provide a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of an artificial sweetener, at least one flavoring agent, an optional sweetening agent and an optional debittering agent or mixtures thereof.
SUMMARY OF THE INVENTION
The present invention provides a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition.
The present invention provides a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition wherein the taste masking composition comprises a taste masking effective amount of an artificial sweetener.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the pharmaceutically active agent is bitter tasting.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the bitter tasting pharmaceutically active agent is an antibiotic.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the bitter tasting antibiotic is levofloxacin.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking effective amount of an artificial sweetener masks a bitter taste.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking composition comprises a taste masking effective amount of the artificial sweetener sucralose.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of an artificial sweetener and at least one flavoring agent.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of the artificial sweetener sucralose and at least one flavoring agent.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of an artificial sweetener, at least one flavoring agent, an optional sweetening agent and an optional debittering agent or mixtures thereof.
An embodiment of the invention is a taste masked liquid pharmaceutical composition wherein the taste masking composition further comprises a taste masking effective amount of the artificial sweetener sucralose, at least one flavoring agent, an optional sweetening agent and an optional debittering agent or mixtures thereof.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition.
The present invention provides a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition wherein the taste masking composition comprises a taste masking effective amount of an artificial sweetener.
In an embodiment of the present invention, the pharmaceutically active agent is bitter tasting and includes, but is not limited to, those selected from antibiotics, analgesics, anti-inflam
Dries Willy Maria Albert Carlo
Francois Marc Karel Jozef
Ulrich Stephen A.
Zimm Karen R.
Fubara Blessing M.
Ortho -McNeil Pharmaceutical, Inc.
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