Abstract

the solid dosage unit comprising at least 20 μg of the partus control substance and having a pH buffer range of 3.5-5.7.

IPC Classes  ?

• A61K 31/11 - Aldehydes
• A61K 38/11 - Oxytocins; Vasopressins; Related peptides
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 9/16 - AgglomeratesGranulatesMicrobeadlets
• A61K 9/20 - Pills, lozenges or tablets

Abstract

The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: 1-100 wt. % of particles consisting of: 0.01-10 wt. % of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof; 5-70 wt. % of buffering agent; 20-94 wt. % of branched glucan; 0-70 wt. % of other pharmaceutically acceptable ingredients; 0-95 wt. % of one or more pharmaceutically acceptable excipients; the solid dosage unit comprising at least 5 μg of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.

IPC Classes  ?

• A61K 38/095 - OxytocinsVasopressinsRelated peptides
• A61K 38/08 - Peptides having 5 to 11 amino acids
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 9/20 - Pills, lozenges or tablets
• A61K 47/12 - Carboxylic acidsSalts or anhydrides thereof
• A61K 47/36 - PolysaccharidesDerivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

Abstract

The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: ∙ 1-100 wt.% of particles consisting of: - 0.01-10wt.% of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof; - 5-70wt.% of buffering agent; - 20-94 wt.% of branched glucan; - 0-70wt.% of other pharmaceutically acceptable ingredients; ∙ 0-95 wt.% of one or more pharmaceutically acceptable excipients; the solid dosage unit comprising at least 5 µg of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.

IPC Classes  ?

• A61K 9/20 - Pills, lozenges or tablets
• A61K 38/11 - Oxytocins; Vasopressins; Related peptides
• A61K 38/08 - Peptides having 5 to 11 amino acids
• A61P 15/06 - Antiabortive agentsLabour repressants

Abstract

The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight between 50 and 1,000 mg, said dosage unit consisting of: • 5-100 wt.% of coated particles comprising 50-99 wt.% of a core particle and 1-50 wt.% of a coating that envelops the core particle, said coating consisting of: - 0.01-10 wt.%) of a partus control substance selected from oxytocin, carbetocin, atosiban and combinations thereof; - 5-50 wt.%) of buffering agent; - 15-80 wt.%) of branched glucan; - 0-78 wt.%) of other pharmaceutically acceptable ingredients; • 0-95 wt.%) of one or more pharmaceutically acceptable excipients; the solid dosage unit comprising at least 20 μg of the partus control substance and having a pH buffer range of 3.5-5.7. The solid dosage unit of the present invention is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. Furthermore, the dosage unit does not need to be stored and distributed under temperature controlled conditions.

IPC Classes  ?

• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 38/11 - Oxytocins; Vasopressins; Related peptides
• A61K 9/16 - AgglomeratesGranulatesMicrobeadlets