関与物質
| 役割 | 名称 | HCID | 仕込み量 |
|---|
| 反応物 | Mannitol | HCID 6251 | — |
| 反応物 | Cetirizine Hydrochloride | HCID 55182 | — |
| 反応物 | (2R,3S,4R,5R,6S)-2-[(2R,3S,4S,5S)-2,5-bis(chloromethyl)-3,4-dihydroxyoxolan-2-yl]oxy-5-chloro-6-(hydroxymethyl)oxane-3,4-diol | HCID 70683051 | — |
| 溶媒 | Hydrochloric Acid | HCID 313 | — |
| 生成物 | Cetirizine | HCID 2678 | — |
反応手順
Cetirizine Dihydrochloride ODT, 10 mg: 903.67 g of taste-masked microparticles and 2418.4 g of rapidly-dispersing microgranules (comprising mannitol and crospovidone at a ratio of 95/5) were blended with 400 g of microcrystalline cellulose (Avicel PH101), 200 g of crospovidone, 64 g of strawberry flavor, and 14 g of Sucralose (a sweetener) in a V-blender and compressed into tablets (13 mm in diameter) with an average weight of 650-653 mg and average hardness of 29-31 N and friability of 0.22-0.39% using a rotary tablet press equipped with an external lubrication system to lubricate the die and punch surfaces prior to each compression to demonstrate robustness of the manufacturing (taste-masking and tabletting) process and a dissolution of 100% (meeting target dissolution specifications of not less than about 75% released in 15 minutes in 0.1N HCl).
情報源と証拠
| DOI | 10.6084/m9.figshare.5104873.v1 |
|---|
| 特許番号 | US08962022B2 |
|---|
| 出典データセット | uspto-grants-2015_02 |
|---|
| ORD ID | ord-bce1cc2fe47a45839093522b92ebf7df |
|---|
| 出典メモ | uspto-grants-2015_02 |
|---|
