Tranexamic acid formulations
a technology of tranexamic acid and formulation, which is applied in the direction of drug composition, extracellular fluid disorder, peptide/protein ingredients, etc., can solve the problems of significant decrease in health-related quality of life, nausea, vomiting, diarrhea, and cramping, and achieve less gi side effects and cns side effects
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example 1
[0130]In Example 1, immediate release 650 mg tranexamic acid tablets were prepared having the ingredients listed in Table 1 below:
TABLE 1Quantityper batchQuantity perIngredient(kg)tablet (mg)Active IngredientTranexamic Acid, EP (650 mg / tab)84.50650.0Inactive IngredientsMicrocrystalline Cellulose, NF5.75344.25(Avicel PH 101)Microcrystalline Cellulose, NF10.66082.00(Avicel PH 102)Colloidal Silicon Dioxide, NF0.09750.75Pregelatinized Corn Starch, NF6.43549.50Croscarmellose Sodium, NF19.5015.00Povidone, USP (K value range 29-32)4.68036.00Stearic Acid, NF (powder)2.34018.00Magnesium Stearate, NF (powder)0.5854.50Purified Water, USP*17.550135.00Film Coating (Inactive Ingredients)**Opadry White YS-1-70034.110—Purified Water, USP36.990—*Purified water is removed during processing**6 kg excess prepared to account for losses during transfer
The formulation of Example 1 was prepared as follows:[0131]1. Weigh all ingredients and keep in moisture resistant containers until ready for use.[0132]2. ...
example 2
[0144]Modified release 650 mg tranexamic acid tablets were prepared having the ingredients listed in the Table 2 below:
TABLE 2QuantityQuantityper batchper tabletIngredient(kg)(mg)Active IngredientTranexamic Acid, EP84.50650.0Inactive IngredientsMicrocrystalline Cellulose NF (Avicel PH 101)5.75344.25Colloidal Silicon Dioxide NF0.09750.75Pregelatinized Corn Starch, NF6.43549.50Hypromellose, USP (Methocel K3 Premium LV)19.110147.00Povidone, USP (K value range 29-32)4.68036.00Stearic Acid, NF (powder)2.34018.00Magnesium Stearate, NF (powder)0.5854.50Purified Water USP*17.550135.00*Purified water is removed during processing
The formulation of Example 2 was prepared as follows:[0145]1. Weigh all ingredients and keep in moisture resistant containers until ready for use.[0146]2. Measure water into a container. Mix povidone at medium speed until completely dissolved.[0147]3. Add tranexamic acid, microcrystalline cellulose (MCC), pregelatinized corn starch, and colloidal silicon dioxide to th...
example 3
[0157]In Example 3, modified release 650 mg tranexamic acid tablets were prepared as in Example 1 and coated with a film coating similar to the immediate release tablets of Example 2. The ingredients are listed in Table 3 below:
TABLE 3QuantityQuantityper batchper tabletIngredient(kg)(mg)Active IngredientTranexamic Acid, EP84.50650.0Inactive IngredientsMicrocrystalline Cellulose NF (Avicel PH 101)5.75344.25Colloidal Silicon Dioxide NF0.09750.75Pregelatinized Corn Starch, NF6.43549.50Hypromellose, USP (Methocel K3 Premium LV)19.110147.00Povidone, USP (K value range 29-32)4.68036.00Stearic Acid, NF (powder)2.34018.00Magnesium Stearate, NF (powder)0.5854.50Purified Water USP*17.550135.00Film Coating (Inactive Ingredients)**Opadry White YS-1-70034.305—Purified Water, USP38.750—*Purified water is removed during processing**6 kg excess prepared to account for losses during transfer
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