Compressed solid dosage form manufacturing process well-suited for use with drugs of low aqueous solubility and compressed solid dosage forms made thereby
A pharmaceutical dosage form and low water solubility technology, which is applied in the field of preparation of compressed solid dosage forms, can solve the problems of limiting the use of high-concentration starch, hardness and friability (deterioration of shatter resistance, poor compression of starch, etc.)
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Example 1
Formulation 1 (comparison)
[0043] Raloxifene hydrochloride tablets containing conventional fillers were prepared by wet granulation. The ingredients in Table 1 were wet-granulated and then compressed into tablets with a weight of 250 mg. Starch is not used in formulation 1. Replace starch with microcrystalline cellulose and lactose (two commonly used fillers). In 900 mL and 2 L of 0.1% Tween 80 aqueous solution, a paddle (Apparatus II) was used to test at 50 rpm to obtain the dissolution profile of formulation 1 (see dissolution rate study, below).
Table 1
[0043] Raloxifene hydrochloride tablets containing conventional fillers were prepared by wet granulation. The ingredients in Table 1 were wet-granulated and then compressed into tablets with a weight of 250 mg. Starch is not used in formulation 1. Replace starch with microcrystalline cellulose and lactose (two commonly used fillers). In 900 mL and 2 L of 0.1% Tween 80 aqueous solution, a paddle (Apparatus II...
Example Embodiment
Example 2
Formulation 2 (comparison)
[0044] Raloxifene tablets with a weight of 250 mg were prepared from the ingredients listed in Table 2 by the wet weight compression method. Formulation 2 is an example using a lower starch content of about 0 to about 24% by weight. In 900 mL and 2 L of 0.1% Tween 80 aqueous solution, a paddle (Apparatus II) was tested at 50 rpm to obtain the dissolution profile of formulation 2 (see dissolution rate study, below).
Table 2
Weight (mg / tablet)
4. Add microcrystalline cellulose (Part III) to the granules obtained in step 3, and granulate with a granulating solution (PVP dissolved in 95% ethanol). The granules are dried and milled (0.6mm sieve).
1. Fully blend the ingredients of Part I.
2. Add the ingredients of Part II to Part I and blend, and press into a block.
4. Granulate the granules obtained in step 3 with a granulation solution (PVP dissolved in 95% ethanol). The granules are dried and milled (0.6mm sieve).
4. Granulate th...
Example Embodiment
Example 3
Example
Formulation 3
[0045] Dry granulation was used to prepare raloxifene tablets with a weight of 250 mg from the ingredients listed in Table 3. Formulation 2 is an example using a high starch content of about 35% to about 75% by weight. In 900 mL and 2 L of 0.1% Tween 80 aqueous solution, a paddle (Apparatus II) was tested at 50 rpm to obtain the dissolution profile of formulation 3 (see dissolution rate study, below).
table 3
[0043] Raloxifene hydrochloride tablets containing conventional fillers were prepared by wet granulation. The ingredients in Table 1 were wet-granulated and then compressed into tablets with a weight of 250 mg. Starch is not used in formulation 1. Replace starch with microcrystalline cellulose and lactose (two commonly used fillers). In 900 mL and 2 L of 0.1% Tween 80 aqueous solution, a paddle (Apparatus II) was used to test at 50 rpm to obtain the dissolution profile of formulation 1 (see dissolution rate study, below).
1. Fully b...
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