Pharmaceutical compositions in semisolid form and a device for administration thereof
First Claim
1. A pharmaceutical delivery system for oral administration of a pharmaceutical agent, comprising:
- (a) a squeezable container having an outlet defining a flow channel,(b) a channel closure device adapted to selectively close or open the flow channel; and
(c) within the container, at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, and consists of mutually compatible components, the components comprising(i) an effective amount of an orally active pharmaceutical agent useful for systemic treatment, and(ii) a palatable pharmaceutically acceptable vehicle, comprisinga liquid base selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof,a thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers,the pharmaceutical composition having a consistency which allows the composition to be squeezed by manual pressure through the flow channel,whereby in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container into a receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.
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Abstract
A pharmaceutical delivery system for oral administration of a pharmaceutical agent comprises: (a) a squeezable container having an outlet defining a flow channel, (b) a channel closure device adapted to selectively close or open the flow channel; and (c) within the container, at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, and consists of mutually compatible components, the components comprising (i) an effective amount of an orally active pharmaceutical agent useful for systemic treatment, and (ii) a palatable pharmaceutically acceptable vehicle, comprising a liquid base selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof, a thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers, the pharmaceutical composition having a consistency which allows the composition to be squeezed by manual pressure through the flow channel, whereby in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container into a receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.
100 Citations
47 Claims
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1. A pharmaceutical delivery system for oral administration of a pharmaceutical agent, comprising:
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(a) a squeezable container having an outlet defining a flow channel, (b) a channel closure device adapted to selectively close or open the flow channel; and (c) within the container, at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, and consists of mutually compatible components, the components comprising (i) an effective amount of an orally active pharmaceutical agent useful for systemic treatment, and (ii) a palatable pharmaceutically acceptable vehicle, comprising a liquid base selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof, a thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers, the pharmaceutical composition having a consistency which allows the composition to be squeezed by manual pressure through the flow channel, whereby in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container into a receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A pharmaceutical delivery system comprising:
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(a) at least one dose of a storage stable, semisolid pharmaceutical composition comprising an effective amount of a pharmaceutical agent useful for systemic treatment in a pharmaceutically acceptable vehicle, the vehicle comprising a liquid base and a thickening agent in an amount effective to provide a Brookfield viscosity of about 2500 to 70,000 cps at about 25°
C. and a spindle speed of about 10 rpm;(b) means for containing and dispensing substantially all of the pharmaceutical composition upon manual pressure; and (c) means for dispensing the composition connected to the container means, the dispensing means comprising a channel communicating with the containing means and having an internal diameter of from about 0.1 mm to about 5 mm, and means for reversibly sealing the channel, having sealed and open positions. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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Specification