Dutasteride self-microemulsion freeze-dried composition and preparation method thereof
A dutasteride, self-microemulsion technology, used in freeze-dried delivery, drug combination, pharmaceutical formulations, etc.
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Embodiment 1~22
[0087] Self-microemulsion composition
[0088] prescription:
[0089]
[0090] Preparation Process:
[0091] The aforementioned dutasteride self-microemulsion can be prepared by the following process.
[0092] Preparation of self-microemulsion: Accurately weigh the prescribed amount of dutasteride, add the prescribed amount of oil phase, dissolve it in a water bath at 40-50°C, add emulsifier and co-emulsifier according to the prescribed amount, and stir evenly to obtain dutasteride self-microemulsion milk.
Embodiment 23~44
[0094] Self-microemulsion freeze-dried product
[0095] prescription:
[0096]
[0097] Preparation of self-microemulsion lyophilized powder:
[0098] Disperse the freeze-dried excipient in purified water, and keep stirring until the excipient is completely dissolved; then add dutasteride self-microemulsion, and stir for 10 minutes to obtain an O / W type microemulsion, pour the microemulsion into cillin freeze-dried in bottles.
[0099]
[0100] Dutasteride self-microemulsion freeze-dried product results:
[0101]
[0102] The freeze-dried powders obtained from the above prescriptions are all in the form of powders, and clear and transparent liquids can be obtained after reconstitution.
Embodiment 45
[0103] Example 45 Solid Oral Capsules
[0104] Prescription Composition:
[0105] Dutasteride self-microemulsion freeze-dried product (derived from Example 26) 29g (containing 14.5mg of dutasteride)
[0106] Starch 29g
[0107] Preparation method: 29 g of soluble starch, add the lyophilized product of dutasteride self-microemulsion (29 g (containing 14.5 mg of dutasteride)) in Example 26 under stirring, mix well, and add 0.5 mg of dutasteride per grain Capsules were packed, and 29 solid oral capsules were prepared in total.
[0108] Example 45 A solid oral capsule (as a comparative example of Example 45)
[0109] Prescription Composition:
[0110] Dutasteride self-microemulsion (derived from Example 4) 29g (containing 14.5mg of dutasteride)
[0111] Starch 58g
[0112] Preparation method: 58g of starch, add the dutasteride self-microemulsion (29g (containing 14.5mg of dutasteride)) of Example 4 under stirring, after mixing, pack the capsules according to the content of 0...
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