Pharmaceutical suspension composition

Abstract

An aqueous oral liquid pharmaceutical composition system with reduced propensity for agglomeration and phase separation which is particularly amendable to the suspension of one or more pharmaceutical actives that are substantially insoluble in water. The oral liquid pharmaceutical composition may further comprise pharmaceutical actives that are soluble in water and dissolve in the aqueous medium. In the composition of the invention both suspended and any dissolved active agents are distributed homogeneously.

Description

FIELD OF INVENTION [0001] An aqueous, oral liquid pharmaceutical composition comprising a suspension of a pharmaceutically active compound or compounds is provided. The composition is particularly well suited for the relief of cold, cough, flu, fever, headache, pain, body ache, migraine and allergy symptoms in pediatric patients. BACKGROUND OF INVENTION [0002] Orally administered pharmaceutical compositions are provided to patients in many dosage forms, including solid forms such as capsules, caplets or tablets and liquid forms such as solutions, emulsions or suspensions. Pharmaceutical compositions administered in solid form are usually intended to be swallowed whole. Children, older persons and many other persons including disabled or incapacitated patients often have trouble swallowing tablets or capsules. For many such patients, including pediatric and geriatric patients, a liquid dose form is preferable because of the ease with which it may be swallowed. [0003] Pharmaceutically...

AI Technical Summary

Benefits of technology

[0006] The pharmaceutical active is suspended in the aqueous composition and a density adjusting agent is employed to balance or match the true density of the suspended ingredients (typically the pharmaceutical active) with the specific gravity of the suspending medium. In an exemplary embodiment, the density adjusting agent comprises about 10 g / 100 mL to about 50 g / 100 mL glycerin and about 10 g / 100 mL to about 50 g / 100 mL sorbitol. Alternatively, conventional sugars and / or other polyols may be used for density adjusting. However, in some embodiments it is preferable to prepare a sugar free composition, avoiding the use of conventional sugars. Optionally, about 0.1 g / 100 mL to about 1.5 g / 100 mL of a surface modifying agent such as a surfactant may be included in the liquid pharmaceutical composition. The pharmaceutical active that is substantially insoluble in the aqueous composition may comprise ibuprofen, naproxen, ketoprofen or loratadine, or a mixture thereof, for example.

[0007] In one embodiment the pharmaceutical composition may further comprise at least one second pharmaceutical active which is soluble in the aqueous composition and whereby the at least one second pharmaceutical active remains in solution in the aqueous medium. The second pharmaceutical active may include one or more of pseudoephedrine, chlorpheniramine, dextromethorphan, brompheniramine, guaifenesin and diphenhydramine, for example.

Problems solved by technology

Children, older persons and many other persons including disabled or incapacitated patients often have trouble swallowing tablets or capsules.

Although such suspensions are known, the known systems frequently manifest the undesirable properties of irreversible agglomeration and / or phase separation particularly if a pharmaceutical active with a limited solubility in water is used.