Ophthalmic Suspension Preparations
A suspension and preparation technology, applied in the field of ophthalmic suspension preparations, can solve the problems of patient invasiveness and patient pain, and achieve the effect of avoiding side effects and reducing burden
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[0133] The present invention will be described in detail below by referring to Examples, Reference Examples, Comparative Examples, Tests, etc., but should not be limited thereto.
reference example 1
[0134] Reference Example 1: Preparation of Compound A
[0135] Compound A according to T. Negoro et al. J. Med. Chem. 1998, 41, 4118-4129 prepared by the method described in. Activated carbon (50% humidity, 0.8g) and 2-propanol (101g) were added to its crude product (10g), and the reaction solution was heated to its reflux temperature (about 84°C) and allowed to stand at the same temperature for 30 minutes. The reaction solution was filtered at the same temperature, washed with 2-propanol (13.8 g). The resulting filtrate was heated to 75°C or higher, cooled to 60°C, kept at 60°C for 1 hour, and then cooled to 0°C. The precipitated solid was collected on a filter and dried in vacuo to afford compound A as white crystals (9.3g).
[0136] XRD; 32.4.
[0137] Differential scanning calorimetry (DSC) showed an endothermic peak with an extrapolated melting onset temperature of 186.7 °C.
[0138] The measurement of the above-mentioned powder X-ray diffraction is carried out usi...
reference example 2
[0141] Reference example 2: Preparation of dispersion medium (pH5.0)
[0142]To an aqueous solution of 0.9% (w / v) sodium chloride in 0.02 mol / L aqueous disodium hydrogen phosphate (a) was added a solution of 0.9% (w / v) sodium chloride in 0.01 mol / L aqueous citric acid (b ) to adjust the pH of the solution (a) to 5.0 (addition ratio (a):(b) = about 1:1), to obtain a citrate-phosphate buffer solution with a pH of 5.0. 20 g of hydroxypropyl methylcellulose was dissolved in 380 g of pure water to prepare 400 g of a 5% aqueous solution of hydroxypropyl methylcellulose, to which 1600 g of citrate-phosphate buffer solution of pH 5.0 was added to prepare 2000 g of 1 % hydroxypropyl methylcellulose in water. Dissolve 500mg of 27-33% aqueous solution of alkyldiaminoethylglycine hydrochloride in 400g of 1% aqueous solution of hydroxypropyl methylcellulose, add 2.5g of polysorbate 80 to it, and then dissolve the mixture . The weight of the solution was made 500 g by adding 1% hydroxypr...
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