Stable lenalidomide oral solid preparation
A technology of lenalidomide and solid preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of changing appearance and color, affecting the stability of preparations, and increasing the impurity content of solid oral preparations, achieving improved stability, low impurity content, and high solubility Effect
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Example Embodiment
[0082] Example 1
[0083] 5mg lenalidomide capsules
[0084] Premix powder prescription
[0085] Lactose 3000g
[0086] Microcrystalline cellulose 2000g
[0087] 5000g in total
[0088] Attachment: Preparation of adhesive (10% povidone ethanol solution):
[0089] Povidone K30 200g
[0090] Add absolute ethanol to 2000ml
[0091] Capsule prescription
[0092] Lenalidomide 50g
[0093] Premixed accessories 800g
[0094] Croscarmellose Sodium 100g
[0095] 10% povidone ethanol solution 350ml
[0096] Magnesium stearate 10g
[0097] Filled with 10,000 grains
[0098] Preparation:
[0099] (1) Preparation of adhesive Weigh 100g of povidone K30, put it in a 1000ml beaker, add an appropriate amount of absolute ethanol, stir to dissolve, add absolute ethanol to 1000ml, stir well, and set aside.
[0100] (2) Take lactose and microcrystalline cellulose, crush them and pass through a 100-mesh sieve, and mix them evenly according to the prescription of premixed auxiliary materials to obtain premixed auxiliary m...
Example Embodiment
[0109] Example 2
[0110] 10mg lenalidomide capsules
[0111] The premixed powder prescription is the same as in Example 1
[0112] Capsule prescription
[0113] Lenalidomide 100g
[0114] Premixed accessories 750g
[0115] Croscarmellose Sodium 100g
[0116] 10% povidone ethanol solution 350ml
[0117] Magnesium stearate 10g
[0118] Filled with 10,000 grains
[0119] Preparation method: the same as in Example 1.
Example Embodiment
[0120] Example 3
[0121] 25mg lenalidomide capsules
[0122] The premixed powder prescription is the same as in Example 1
[0123] Capsule prescription
[0124] Lenalidomide 250g
[0125] Premixed accessories 600g
[0126] Croscarmellose Sodium 100g
[0127] 10% povidone ethanol solution 350ml
[0128] Magnesium stearate 10g
[0129] Filled with 10,000 grains
[0130] Preparation method: the same as in Example 1.
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