Dolutegravir film coated tablet preparation and preparation method thereof
A technology of film coating and dolutegravir, which is applied in the field of dolutegravir film-coated tablet formulation and its preparation, can solve the problems of high cost and achieve the effects of breaking the price monopoly, stable blood concentration and uniform distribution
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Embodiment 1
[0043] Prescription composition: Prescription amount (mg / tablet)
[0044] Dolutegravir 50
[0045] Mannitol 314
[0046] Sodium carboxymethyl starch 32
[0047] Sodium stearyl fumarate 4
[0048] According to above-mentioned prescription quantity, preparation process is as follows:
[0049] (1) Material pretreatment: sieve dolutegravir, diluent, disintegrant, lubricant, and set aside;
[0050] (2) Mixing: Weigh the prescription amount of active drug dolutegravir, diluent, disintegrant, lubricant and mix evenly;
[0051] (3) Place the mixed powder in (2) in a dry granulator for granulation:
[0052] (4) Total mixing: Mix the dry granules prepared in (3) evenly with the prescribed amount of disintegrant and lubricant;
[0053] (5) Compress plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;
[0054] (6) Film coating: film-coat the qualified tablets prepared in (5).
Embodiment 2
[0056] Dolutegravir 50
[0057] Mannitol 314
[0058] Povidone 32
[0059] Sodium stearyl fumarate 4
[0060] According to above-mentioned prescription quantity, preparation process is as follows:
[0061] (1) Material pretreatment: sieve dolutegravir, diluent, disintegrant, lubricant, and set aside;
[0062] (2) Mixing: Weigh the prescription amount of active drug dolutegravir, diluent, disintegrant, lubricant and mix evenly;
[0063] (3) Place the mixed powder in (2) in a dry granulator for granulation:
[0064] (4) Total mixing: Mix the dry granules prepared in (3) evenly with the prescribed amount of disintegrant and lubricant;
[0065] (5) Compress plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;
[0066] (6) Film coating: film-coat the qualified tablets prepared in (5).
Embodiment 3
[0068] Dolutegravir 50
[0069] Microcrystalline Cellulose 314
[0070] Sodium carboxymethyl starch 32
[0071] Sodium stearyl fumarate 4
[0072] According to above-mentioned prescription quantity, preparation process is as follows:
[0073] (1) Material pretreatment: sieve dolutegravir, diluent, disintegrant, lubricant, and set aside;
[0074] (2) Mixing: Weigh the prescription amount of active drug dolutegravir, diluent, disintegrant, lubricant and mix evenly;
[0075] (3) Place the mixed powder in (2) in a dry granulator for granulation:
[0076] (4) Total mixing: Mix the dry granules prepared in (3) evenly with the prescribed amount of disintegrant and lubricant;
[0077] (5) Compress plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;
[0078] (6) Film coating: film-coat the qualified tablets prepared in (5).
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