Abrégé

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.

Classes IPC  ?

• A61K 31/11 - Aldéhydes
• A61K 38/11 - Oxytocines; Vasopressines; Peptides apparentés
• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
• A61K 9/16 - AgglomérésGranulésMicrobilles
• A61K 9/20 - Pilules, pastilles ou comprimés

Abrégé

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.

Classes IPC  ?

• A61K 38/095 - Oxytocines Vasopressines Peptides apparentés
• A61K 38/08 - Peptides ayant de 5 à 11 amino-acides
• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
• A61K 9/20 - Pilules, pastilles ou comprimés
• A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
• A61K 47/36 - PolysaccharidesLeurs dérivés, p. ex. gommes, amidon, alginate, dextrine, acide hyaluronique, chitosane, inuline, agar-agar ou pectine

Abrégé

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.

Classes IPC  ?

• A61K 9/20 - Pilules, pastilles ou comprimés
• A61K 38/11 - Oxytocines; Vasopressines; Peptides apparentés
• A61K 38/08 - Peptides ayant de 5 à 11 amino-acides
• A61P 15/06 - Agents antiabortifsTocolytiques

Abrégé

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.

Classes IPC  ?

• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
• A61K 38/11 - Oxytocines; Vasopressines; Peptides apparentés
• A61K 9/16 - AgglomérésGranulésMicrobilles