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Claims for Patent: 4,305,502

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Claims for Patent: 4,305,502

Title: Pharmaceutical dosage form packges
Abstract:The invention relates to packages containing shaped articles carrying chemicals, particularly to pharmaceutical dosage forms carrying pharmaceuticals. The shaped articles, which disintegrate rapidly in water are contained in depressions in sheets of filmic material and are enclosed by a covering sheet adhering to the filmic material. The shaped articles may be formed in the depressions by a sublimation process.
Inventor(s): Gregory; George K. E. (Marlow, GB2), Ho; David S. S. (Maidenhead, GB2)
Assignee: John Wyeth & Brother Limited (Maidenhead, GB2)
Application Number:05/925,002
Patent Claims: 1. A package comprising a sheet of filmy material having one or more depressions therein; one or more of the depressions containing a shaped article molded within said one or more depressions, said shaped article carrying a pharmaceutical dosage form for oral administration as a solid, which dosage form can be rapidly disintegrated by water and comprises an open matrix network carrying a unit dosage of a pharmaceutical substance, the open matrix network comprising a pharmacologically acceptable water-soluble or water-dispersible carrier material; and a peelable covering sheet adhering to the sheet of filmy material so as to enclose the dosage form or forms.

2. A package as claimed in claim 1 wherein the carrier material comprises partially hydrolysed gelatin.

3. A package as claimed in claim 1 wherein the carrier material comprises dextrin, hydrolysed dextran or an alginate.

4. A package as claimed in claim 1 wherein the filmic material is thermoplastic material.

5. A package as claimed in claim 1 wherein the covering sheet is an aluminium foil or aluminium foil laminate.

6. A package comprising a sheet of filmy thermoplastic material having one or more depressions therein, one or more of said depressions containing a shaped article molded within said one or more depressions, said shaped article carrying a pharmaceutical dosage form for oral administration as a solid, which dosage form can be rapidly disintegrated by water and comprises an open matrix network carrying a unit dosage of a pharmaceutical substance, the open matrix network comprising a pharmaceutically acceptable water soluble or water-dispersible carrier material selected from partially hydrolized gelatin, dextrin, hydrolized dextrin, and alginate, and a peelable covering sheet selected from aluminum foil and aluminum foil laminate adhering to said sheet of filmy thermoplastic material so as to enclose the dosage form or forms.

7. In a process for preparing a pharmaceutical dosage form for oral administration as a solid which dosage form can rapidly be disintegrated by water, by subliming solvent from a composition comprising a pharmaceutical substance in a solvent of a pharmaceutical acceptable water-soluble or water-dispersible carrier material, the composition being in the solid state in a mold corresponding in size and shape to that of the pharmaceutical dosage form, so as to produce an open matrix network of carrier material carrying the pharmaceutical substance which matrix network is capable of being rapidly disintegrated by water,

the improvement which comprises carrying out the sublimation from the solid state in a mold, being one or more depressions in a sheet of filmy material, and after the solvent is sublimed adhering a peelable covering sheet over the pharmaceutical dosage form containing depression or depressions to enclose the pharmaceutical dosage form.

8. A process as claimed in claim 7 wherein the filmy material is thermoplastic material.

9. A process as claimed in claim 7 wherein the filmy material is a polyvinylchloride film or a polyvinylchloride/polyvinylidenechloride, polyvinylchloride/polytetrafluoroethylene or polyvinylchloride/polyvinylidenechloride/polyethylene laminate.

10. A process as claimed in claim 7 wherein the covering sheet is an aluminium foil or aluminium foil laminate.
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