Non-tabletted, chewable, individually dosed administration forms
Non-tabletted, individually dosed administration forms comprising a composition of at least one pharmaceutically active substance dissolved or dispersed within a matrix material comprising a mixture of at least 0.2% by weight of a gelatine, at least one stabilising agent and at least one water-soluble alcohol and/or water as a solvent, which composition is plastic at elevated temperature, characterised in that: the stabilising agent is chosen from (i) esters of glycerine and fatty acids; (ii) products resulting from the alcoholysis/esterification reaction of such esters of glycerine and fatty acids with polyethylenglycols; in that the stabilising agent has a melting point in the range of 42° C. to 63° C.; and in that water is present in an amount not greater than 46% by weight of the composition.
1 . A non-tabletted, individually dosed administration form comprising a composition comprising at least one pharmaceutically active substance dissolved or dispersed within a matrix material, at least one stabilising agent, and at least one water-soluble alcohol and/or water as a solvent;
wherein the matrix material comprises a mixture comprising at least 0.2% by weight of a gelatine;
wherein the composition is plastic at elevated temperature;
wherein:
a. the at least one stabilising agent is chosen from (i) esters of glycerine and fatty acids; and (ii) products resulting from the alcoholysis/esterification reaction of said esters of glycerine and fatty acids with polyethylenglycols;
b. the at least one stabilising agent has a melting point ranging from 42° C. to 63° C.; and
c. water is optionally present in an amount not greater than 46% by weight of the composition.
2 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the at least one stabilising agent is present in an amount greater than 1% by weight of the composition.
3 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the administration form is packaged in blisters or cavities shaped from films.
4 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the administration form comprises more than 18% by weight of at least one pharmaceutically active substance.
5 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the administration form comprises an antacid.
6 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the administration form comprises at least 10% by weight of the composition of at least one water-soluble alcohol and/or water as a solvent.
7 . A non-tabletted, individually dosed administration form according to claim 6 , wherein the administration form comprises more than 46% by weight of the composition of at least one water-soluble alcohol.
8 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the composition comprises water.
9 . A non-tabletted, individually dosed administration form according to claim 1 , wherein the composition does not comprise edible gums.
10 . A process for producing a non-tabletted, individually dosed administration form comprising:
forming a composition comprising at least one pharmaceutically active substance dispersed or dissolved within a matrix material, at least one stabilising agent and at least one water-soluble alcohol and/or water as a solvent,
wherein the matrix material comprises a mixture comprising at least 0.2% by weight of a gelatine;
where the composition is plastic at elevated temperature;
keeping the composition above 37° C.;
transferring the composition, when it is fluid, into a heated dosing apparatus;
discharging the composition onto a shaped substrate, such that a constant quantity of the fluid formulation material is thereby dosed onto the substrate;
cooling the composition; and
optionally sealing the substrate containing the composition;
wherein water is optionally present in an amount not greater than 46% by weight of the composition;
wherein the at least one stabilising agent is chosen from (i) esters of glycerine and fatty acids; and (ii) products resulting from the alcoholysis/esterification reaction of said esters with polyethyleneglycols, and
wherein the at least one stabilising agent has a melting point in the range of 42° C. to 63° C.
11 . A process according to claim 10 , wherein the at least one stabilising agent is present in an amount greater than 1% by weight of the composition.
12 . A process according to claim 10 , wherein the composition comprises more than 18% by weight of at least one pharmaceutically active substance.
13 . A process according to claim 10 , wherein the at least one pharmaceutically active substance comprises an antacid.
14 . A process according to claim 10 , wherein the composition comprises water.
15 . A process according to claim 10 , wherein the composition comprises at least 10% by weight of the composition of at least one water-soluble alcohol and/or water as a solvent.
16 . A process according to claim 10 , wherein the composition comprises more than 46% by weight of the composition of at least one water-soluble alcohol.
17 . A process according to claim 10 , wherein the composition does not comprise edible gums.
18 . A process according to claim 10 , wherein the shaped substrate is a cavity or blister, and wherein the cavity or blister comprises a material chosen from PVC, PVDC, PP, Aclar and laminates.
19 . A non-tabletted, individually dosed administration form obtainable by the process of claim 10 .
20 . A method for facilitating the removal of a composition from a blister or cavity, comprising adding at least one stabilising agent to the composition;
wherein the at least one stabilising agent is chosen from (i) esters of glycerine and fatty acids and (ii) products resulting from the alcoholysis/esterification reaction of such esters with polyethyleneglycols,
wherein the at least one stabilising agent has a melting point in the range of 42° C. to 63° C.;
wherein the composition comprises at least one pharmaceutically active substance dispersed or dissolved within a matrix material;
wherein the matrix material comprises a mixture of gelatine and at least one water-soluble alcohol and/or water as a solvent, and
wherein the composition is plastic at elevated temperature.
21 . A method according to claim 20 , wherein the at least one stabilising agents is present in the composition in an amount greater than 1% by weight of the composition.
22 . (canceled)
23 . A non-tabletted, individually dosed administration form according to claim 8 , wherein the administration form comprises water in an amount exceeding 1% wt. of the composition.
24 . A process according to claim 14 , wherein the composition comprises water in an amount exceeding 1% wt. of the composition.
25 . A process according to claim 18 , wherein the cavity or blister comprises OPA-Aluminium-PVC.