Pharmaceutical compositions in semisolid form and a device for administration thereof

A non-spill delivery system for oral administration of a pharmaceutical agent, comprising:

• (a) a squeezable container having an outlet defining a flow channel;
• (b) a dispenser connected to the container comprising
• (i) a channel communicating with the outlet,
• (ii) an unvented channel closure device having a closed and an open position, the channel closure device comprising a spring biased step cylinder positioned in said dispenser with channel means which allows passage of a composition from inside the squeezable container when said spring biased step cylinder is pressed to compress the spring and which reseals the squeezable container when not pressed;
• and
• (iii) a tamper-evident seal of the channel closure device, and
• (c) 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 pharmaceutically acceptable vehicle, comprising
• a liquid base in an amount of about 45 weight-percent to about 95 weight-percent, the liquid base comprising a palatable solvent, selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof;
• a thickening agent in an amount of about 1 weight-percent to about 55 weight-percent, the thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline celllose, hydroxypropyl cellulose. other cellulose derivatives, acacia, tratacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers.
• the pharmaceutical composition having a Brookfield viscosity of about 2500 to about 70,000 cps at about 20.degree.25.degree. C. at a spindle speed of 10-20 rpm, and a consistency which allows the composition to be squeezed by manual pressure through the channel,
• whereby in response to pressure on the container when the channel closure device 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 spiing any of the composition from the container or the receptacle.

A non-spill delivery system for oral administration of a pharmaceutical agent, comprising:

• (a) a squeezable container having an outlet defining a flow channel having an internal diameter of from about 0.1 mmn to about 5 mm;
• (b) an unvented channel closure device adapted to be connected to the outlet,
• (c) a receptacle positioned to receive material dispensed from the channel;
• and
• (d) at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, palatable, 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 pharmaceutically acceptable vehicle, comprising
• a liquid base, and
• a thickening agent selected from the group consisting of starch, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, tragacanth, acacia, pectin, gelatin, polyethylene glycol and carbomer, whereby the configuration of the container, closure device, and receptacle and the consistency of the formulation are selected so that in response to pressure on the container when the channel closure device is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed by manual pressure from the container through the channel into the receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.

A pharmaceutical delivery system comprising:

• (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.degree. C. and a spindle speed of about 10 rpm;
• (b) a squeezable means for containing and dispensing substantially all of the pharmaceutical composition;
• (c) means for dispensing the composition connected to the container means, the dispenser means comprising;
• a channel communicating with the container means and having an internal diameter of from about 0.1 mm to about 5 mm
• tamper evident sealing means,
• means for reversibly sealing the channel, having sealed and open positions, opening the sealing means requiring at least two separate manipulations,
• (d) means for receiving a unit dose of the composition, whereby in response to pressure on the means for containing, when the sealing means is in the open position, a predetermined unit dose of the pharmaceutical composition can be easily squeezed into the receiving means, measured, and administered orally without spilling any of the composition from the containing means or the receiving means.

A non-spill delivery system for oral administration of a pharmaceutical agent, comprising:

• (a) a squeezable container having an outlet defining a flow channel;
• (b) a dispenser connected to the container comprising
• (i) a channel communicating with the outlet,
• (ii) an unvented channel closure device having a closed and an open position;
• and
• (iii) a tamper-evident seal of the channel closure device, and
• (c) 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 pharmaceutically acceptable vehicle, comprising
• a liquid base in an amount of about 45 weight-percent to about 95 weight-percent, the liquid base comprising a palatable solvent, selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof,
• a thickening agent in an amount of about 1 weight-percent to about 55 weight-percent, the thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers,
• the pharmaceutical composition having a Brookfield viscosity of about 2500 to about 70,000 cps at about 20.degree.-25.degree. C. at a spindle speed of 10-20 rpm, and a consistency which allows the composition to be squeezed by manual pressure through the channel,
• whereby in response to pressure on the container when the channel closure device 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.

A non-spill delivery system for oral administration of a pharmaceutical agent, comprising:

• (a) a flexible packet that can be torn or cut to open a channel;
• and
• (b) a single dose of a pharmaceutical composition contained within the packet, 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 pharmaceutically acceptable vehicle, comprising a liquid base, and
• a thickening agent, whereby when the packet is torn or cut open, and in response to pressure on the container, a single dose of the pharmaceutical composition can be easily squeezed from the container into the mouth of a patient and swallowed, without spilling any of the composition wherein the liquid base is in an amount of about 45 weight-percent to about 95 weight-percent, and comprises a palatable solvent selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof, and the thickening agent is in an amount of about 1 weight-percent to about 55 weight-percent, and is selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers.

A device for containing and measuring a unit dose of a pharmaceutical composition in semisolid form comprising a squeezable container for holding the pharmaceutical composition having an open neck and a cap suitable to fit on the neck of the squeezable container, a spoon having a shaft with channel means fixed in the cap so that the bowl-shaped end of the spoon projects outside the cap and the shaft projects into the cap and the channel means are in alignment with the open neck of the squeezable container and sealing means in said cap positioned to seal the container when the cap is fully closed and to provide space for the contents of the container to flow through the channel means into the spoon in response to pressure on the container when the cap is partially opened, whereby substantially all the contents of the squeezable container can be squeezed into the bowl-shaped end of the spoon and administered therefrom, said sealing means comprises a pin inside the channel means which projects into the cap so as to rest against the neck of the container and seal the container when the cap is fully closed due to compete engagement of the threads of the cap, but which allows for the passage of a composition from inside the squeezable container through the channel means to the spoon when the threads of the neck of the squeezable container and threads of the cap are only partially engaged, said pharmaceutical composition comprises an effective amount of an orally active pharmaceutical agent useful for systemic treatment in combination with a pharmaceutical acceptable vehicle comprising a thickening agent in an amount effective to provide a Brookfield viscosity of about 2500 to 70,000 cps at 25 degrees Celsius at a spindle speed of 10 rpm.