Method for administering a spill resistant pharmaceutical system

Abstract

A method for administering a spill-resistant pharmaceutical formulation comprises delivery from a squeezable container of a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent.

Description

[0001]This application is a continuation of U.S. Ser. No. 10 / 653,149, filed on Sep. 3, 2003, which is a continuation of U.S. Ser. No. 10 / 052,462, now U.S. Pat. No. 6,656,482, filed on Jan. 23, 2002, which is a divisional of U.S. Ser. No. 09 / 549,148, now U.S. Pat. No. 6,399,079, filed on Apr. 13, 2000, which is a continuation of U.S. Ser. No. 09 / 089,360 now U.S. Pat. No. 6,071,523, filed on Jun. 3, 1998. Each of these applications is hereby incorporated by reference in its entirety and for all purposes.BACKGROUND OF THE INVENTION[0002]The invention relates to compositions for administering pharmaceuticals orally without spilling. More specifically, the invention relates to vehicles and devices for delivering a variety of pharmaceutical products.[0003]Syrups, elixirs, solutions, and suspensions are traditional dosage forms for oral medication. These liquid formulations are typically measured by pouring into a spoon, but this approach has the great drawback of spillage. The risk of spi...

AI Technical Summary

Benefits of technology

[0009]The compositions of the invention are light, water-soluble gels, which are easy to clean from a spoon bowl, and from any other surfaces which they may contact. The surface tensions of the formulations are sufficiently high to provide desirable spill-resistance, while allowing the product to be sufficiently free-flowing. In the examples of the prior Ross application, the viscosity was higher, providing a firm, spill-proof product. Here, the range of viscosity is lower, providing a freer-flowing, better leveling product, that is easier to administer with spill-resistance, but one which is more prone to spillage than the prior formulations. Thus, while the prior compositions may be considered spill-proof, the compositions set forth here are optimally “spill-resistant” but have other superior characteristics e.g. as to measurability and dispensability.

[0011]Preferred compositions have good shelf life, meaning that the preferred characteristics are retained after at least three months storage at a temperature of at least about 40 degrees Celsius at 75% humidity, which extrapolates under normal assumptions accepted by the U.S. Food and Drug Administration to two years shelf-life stability at room temperature. Surprisingly, in preferred embodiments using carboxyvinyl polymers such as Carbopol 974, stability may be accomplished by minimizing sodium containing substances from the formulation. Also, the Carbopol has a surprising taste masking effect for bitter drugs like acetaminophen.

[0016]This invention omits complex mechanical elements employed in the prior art such as pumps, syringes, and elaborate measuring vessels without loss of ability, and indeed with improved performance. This provides advantages in manufacturing, distribution, and waste disposal, and other economies as well.

[0018]The inventive formulations are semi-solid, not liquid or solid. Palatability, stability (a long shelf life) compatibility of components, and ease of administration of a required dose are provided. The system allows effortless administration of predetermined measured doses to children and adults with motor problems, without spilling. It is easier to measure than a liquid and easier to swallow than a solid.

[0019]A spill-resistant pharmaceutical formulation for oral administration from a squeezable container comprises a per-unit dose effective amount of a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components and having the following properties: a viscosity within the range of about 7500 to about 25,000 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 20 rpm and 20-25° C.; a viscometric yield value of a semi-solid; a spill-resistant consistency permitting the composition to be squeezed by light manual pressure through a channel of about 1-5 mm, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for at least several seconds on spoon inversion and tilting at 90 degrees, and for at least one minute upon spoon vibration; homogeneity such that the components do not separate under conditions of use, and a storage stability such that the foregoing properties are retained for at least three months of storage at accelerated stability conditions of elevated temperature and humidity.

Problems solved by technology

These liquid formulations are typically measured by pouring into a spoon, but this approach has the great drawback of spillage.

The risk of spillage can cause people to underfill the spoon, leading to inaccurate dosage.

With elderly people, children, and the infirm, difficulty in filling a spoon with a liquid and bringing it to the mouth can be a serious impediment to administering the medicine.

Solid formulations such as pills, tablets, and capsules are also difficult for children and for elderly, infirm people to swallow.

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