Orodispersible formulations

An orodispersible solid dosage form consisting of an intragranular component and an extragranular component,

• wherein the intragranular component consists of an estrogen, an intragranular diluent, an intragranular binder, an intragranular disintegrant, and, optionally, at least one additional intragranular agent,
• wherein the extragranular component consists of an extragranular diluent, an extragranular binder, an extragranular disintegrant, and, optionally, at least one additional extragranular agent,
• wherein:
• the estrogen is in an amount of up to 0.05% w/w of the orodispersible solid dosage form;
• the intragranular diluent is microcrystalline cellulose and mannitol at a content of 84% w/w to 97% w/w of the intragranular component;
• the intragranular disintegrant is croscarmellose sodium or sodium starch glycolate at a content of 2.2% w/w to 4.5% w/w of the intragranular component;
• the intragranular binder is a pregelatinized starch or povidone at a content of 0.5% w/w to 6% w/w of the intragranular component;
• the extragranular diluent is microcrystalline cellulose and mannitol at a content of 72% w/w to 88% w/w of the extragranular component;
• the extragranular disintegrant is croscarmellose sodium or sodium starch glycolate at a content of 5% w/w to 12% w/w of the extragranular component;
• the extragranular binder is a pregelatinized starch at a content of 3.5% w/w to 12% w/w of the extragranular component;
• the at least one additional intragranular agent and the at least one additional extragranular agent are, independently, at least one selected from the group consisting of a progestogen, a lubricant, an antioxidant, a flavoring agent, a sweetener, and a coloring agent,
• wherein the intragranular component constitutes from 42% w/w to 75% w/w of the orodispersible solid dosage form,
• wherein the orodispersible solid dosage form disintegrates in 30 seconds or less,
• wherein the orodispersible solid dosage form has a hardness from 2 kp to 7 kp and a friability of 0.3% or less, and
• wherein a content uniformity of the estrogen in the orodispersible solid dosage form satisfies ASTM E2709/E2810.