Estetra S.p.r.l.

Estetra Srl

Denny Johan Marijn Van Den Heuvel

Johannes Jan Platteeuw

Séverine Francine Isabelle Jaspart

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Orodispersible dosage unit containing an estetrol component

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

An orodispersible solid pharmaceutical dosage unit of estetrol is disclosed. The solid dosage unit is easy to manufacture and suited for sublingual, buccal or sublabial administration. The orodispersible solid pharmaceutical dosage unit can include at least 100 μg of an estetrol component and pharmaceutically acceptable excipients. Methods of manufacturing the orodispersible solid pharmaceutical dosage unit are also disclosed.

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 &#x3bc;g of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 &#x3bc;m to 50 &#x3bc;m. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit containing at least 100 &#x3bc;g of an estetrol component selected from estetrol, estetrol esters and combinations thereof; wherein the solid dosage unit can be obtained by a process that comprises: providing a loading liquid comprising organic solvent; estetrol component and optionally one or more other pharmaceutically acceptable ingredients; mixing 1 part by weight of the loading liquid with 0.5-20 parts by weight of carrier particles to produce wet particles; removing organic solvent from the wet particles to produce loaded particles; optionally mixing the loaded particles with one or more tabletting excipients; and forming the loaded particles or the mixture of the loaded particles and the one or more tabletting excipients into a solid dosage unit. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Orodispersible tablet containing Estetrol

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit containing at least 100 &#x3bc;g of an estetrol component selected from estetrol, estetrol esters and combinations thereof; wherein the solid dosage unit can be obtained by a process comprising: &#x22c5;providing an aqueous liquid comprising water, estetrol component and optionally one or more other pharmaceutically acceptable ingredients; &#x22c5;mixing 1 part by weight of the aqueous liquid with 0.5-20 parts by weight of the carrier particles to produce wet particles; &#x22c5;removing water from the wet particles to produce loaded particles; &#x22c5;optionally mixing the loaded particles with one or more tabletting excipients; and &#x22c5;forming the loaded particles or the mixture of loaded particles and the one or more tabletting excipients into a solid dosage unit. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Orodispersible tablet containing estetrol

An orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg is disclosed. The dosage unit comprises (a) 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and (b) 75-99.9 wt. % of one or more pharmaceutically acceptable excipients. The solid dosage unit comprises at least 100 &#x3bc;g of the estetrol component and can be obtained by a process that comprises compressing a dry blend of estetrol particles and one or more pharmaceutically acceptable excipients into a solid dosage unit. The solid dosage unit is easy to manufacture and suited for sublingual, buccal or sublabial administration.

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Beuningen, Netherlands

Denny Johan Marijn Van Den Heuvel