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48results about How to "Good batch-to-batch reproducibility" patented technology

Nanocrystalline of hydrophobic drug, as well as preparation and application methods of nanocrystalline

The invention relates to nanocrystalline of a hydrophobic drug. The nanocrystalline of the hydrophobic drug is characterized by comprising the hydrophobic drug and amphipathic molecule of wrapping the outside of the hydrophobic drug, wherein the nanocrystalline is obtained by removing solvent molecules of an O / W type emulsion containing the hydrophobic drug. The nanocrystalline of the hydrophobic drug provided by the invention is uniform in particle size and good in dispersity in water and has universality; the effective components of the drug are kept well; the surface-wrapped amphipathic molecule can be doped with a targeting molecule; after the amphipathic molecule is doped with the targeting molecule, the targeting functionalization of a nanocrystalline preparation can be achieved; distribution of the drug in a tumor tissue is increased; and the toxic and side effects of chemotherapy drugs are reduced. The preparation method of the nanocrystalline of the hydrophobic drug provided by the invention is simple to operate and good in repeatability; the controllability of the particle size of the hydrophobic drug can be achieved; the product quality is easy to control; and the batch reproducibility of the drug is good.
Owner:INST OF PROCESS ENG CHINESE ACAD OF SCI

Methotrexate oral disintegrating tablet and its preparation method

The invention provides a methotrexate oral disintegrating tablet for rapid disintegrating in oral cavity without water, which is prepared by comminuting methotrexate, sodium carboxymethylstarch, crystalline cellulose, mannitol, magnesium stearate, passing through 100 mesh sieves, mixing homogeneously, and pelleting directly.
Owner:马晶

Montelukast tablet composition and preparation method thereof

The invention discloses a Montelukast tablet composition. The composition comprises Montelukast, porous filling agent, disintegrating agent, lubricant, opadry film coating premixing agent and purified water; and the stability of the Montelukast can be remarkably improved. The invention further discloses a preparation method for the Montelukast tablet composition; the powder is adopted to directly compress tablets, so that the operation is convenient, the influence to the product quality from the drying process and the hot and humid condition is avoided, the content of related substances is low, and the stability is remarkably improved.
Owner:SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD

Preparation technology of roflumilast film-coated tablets

InactiveCN111643470AFriability meets requirementsGood granulationPharmaceutical non-active ingredientsRespiratory disorderAdhesiveMagnesium stearate
The invention relates to the technical field of tablet preparation, in particular to a preparation technology of roflumilast film-coated tablets. The preparation technology comprises the following steps of S1, micronizing roflumilast, and filtering starch, lactose and magnesium stearate through an 80-mesh sieve for later use; S2, dissolving hydroxypropyl methylcellulose into water to prepare aqueous solutions of different concentrations for later use; S3, mixing a mixture obtained by multiple equal incremental blending of 1 g of roflumilast and 15 g of starch with 398 g of lactose and remaining starch in the step S1; S4, adding an adhesive for granulation after mixing is ended; S5, preparing wet granules from prepared soft materials; S6, drying the wet granules obtained in the step S5; S7,carrying out granulation on the dried granules through a 20-mesh sieve; and S8, carrying out tableting by using a shallow concave mold with the diameter of 9 mm. When granulation is carried out by using the method, the granulation condition is good, the granules are uniform, the tablets are bright and clean, and the friability of tablet cores meets the requirements. Samples meeting the standard can be prepared through the method, the interbatch reproducibility is good, the samples are equivalent to originally commercially available products in quality, and production can be smoothly implemented through the preparation technology of a prescription.
Owner:山东希尔康泰药业有限公司

Roxatidine acetate hydrochloride slow-release capsules and preparation method thereof

The invention discloses roxatidine acetate hydrochloride slow-release capsules and a preparation method thereof. A main medicine is roxatidine acetate hydrochloride, auxiliary materials consist of blank pill cores, slow release materials, a plastifier and a pore-forming agent, wherein the weight ratio of the roxatidine acetate hydrochloride to the blank pill cores to the slow release materials tothe plastifier to the pore-forming agent is 1.00 to (0.90-1.00) to (0.10-0.20) to (0.01-0.02) to (0.01-0.02). A preparation method of the roxatidine acetate hydrochloride slow-release capsules disclosed by the invention is simple and convenient to operate, good in inter-batch repeatability and easy in amplified production. The coating effects are good, during coating, good film forming characteristics of a coating solution are maintained, the coating uniformity is good, and the loss of the coating solution can be reduced. The dissolving-out behaviors of the roxatidine acetate hydrochloride slow-release capsules in four kinds of dissolving-out mediums of water, a dissolving-out medium of which the pH is 1.2, a dissolving-out medium of which the pH is 4.0 and a dissolving-out medium of whichthe pH is 6.8 are consistent in those of an original developing agent.
Owner:FUZHOU MINHAI PHARMA
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