Freezable Unit Dosage Delivery System and Method of Preparation

A method for preparing a freezable unit dosage, comprising the steps of:

• (a) providing a composition comprising at least one active ingredient and a physiologically or pharmaceutically acceptable carrier, said composition has a freezing point of about 5° C. or less;
• (b) providing a storage container comprising one or more liquid-impermeable cavities, each cavity configured to receive a unit dosage quantity of the composition,
• (c) placing a unit dosage quantity of the composition into at least one or more of the cavities;
• and
• (d) applying a sealing sheet to sealing engage the storage container, the sealing sheet cooperating with at least one cavity to define a unit dosage of the composition and forming a leak resistant seal enclosing the unit dosage quantity of the composition within the cavity,
• wherein the unit dosage quantity solidifies into a solid unit dosage of the composition within each cavity upon freezing.

A method for locally or systemically treating symptoms or conditions of a human in need of such treatment comprising the steps of:

• (a) providing a solid unit dosage prepared by:
• (i) providing a composition comprising at least one active ingredient and a physiologically or pharmaceutically acceptable carrier, said composition has a freezing point of about 5° C. or less;
• (ii) providing a storage container comprising one or more liquid-impermeable cavities, each cavity configured to receive a unit dosage quantity of the composition,
• (iii) placing a unit dosage quantity of the composition into at least one or more of the cavities;
• and
• (iv) applying a sealing sheet to sealing engage the storage container, the sealing sheet cooperating with at least one cavity to define a unit dosage of the composition and forming a leak resistant seal enclosing the unit dosage quantity of the composition within the cavity;
• (b) subjecting the storage container containing the unit dosages to freezing;
• (c) removing at least one of the solid unit dosages from said storage container;
• and
• (d) administering said at least one solid unit dosage to a human.

A kit comprising:

• (a) a composition comprising at least one active ingredient and a physiologically or pharmaceutically acceptable carrier, said composition having a freezing point of 5° C. or less;
• (b) a storage container comprising one or more liquid-impermeable cavities, each cavity configured to receive a unit dosage quantity of the composition;
• and
• (c) a sealing sheet for sealing engagement with the storage container, the sealing sheet adapted to cooperate with at least one cavity to define a unit dosage of the composition and to form a leak resistant seal enclosing the unit dosage quantity of the composition within the cavity;
• and
• (d) an instruction to subject the storage container containing the unit dosages in at least one or more of the cavities to freezing;
• wherein the unit dosage quantity solidifies into a solid unit dosage of the composition within each cavity upon freezing, said solid unit dosage form suitable for one of oral, rectal or vaginal administration.